01 February 2015
28 January 2015
UK DAILY MAIL: NHS to pay for SOLIRIS (USA Alexion Pharm.) for atypical Haemolytic Uraemic Syndrome @ GBP 340,000/year.
A
drug costing up to £9million per patient is to be made available on the
NHS - making it the health service’s most expensive medicine.
Eculizumab
- also known as Soliris - will be offered to about 200 people suffering
from a rare kidney condition, the treatments watchdog confirmed last
night.
The
National Institute for Health Care and Excellence (NICE) said the drug –
which will cost the NHS up to £82million a year – would allow patients
to live independently for decades.
Sir Andrew
Dillon, left, of the National Institute for Health Care and Excellence
(NICE) said he was pleased to have authorised the new wonder drug
Soliris, also known as Eculizumab to treat a rare kidney condition
A NICE spokeswoman confirmed last night that the drug would be the most expensive funded by the NHS.
The
drug will treat atypical Haemolytic Uraemic Syndrome (aHUS) - a
life-threatening disease affecting around hundreds of people in England.
It causes inflammation of blood vessels and the formation of blood clots throughout the body.
There are only around 200 sufferers, with 20 to 30 new patients with the condition diagnosed each year.
Patients are constantly at risk of sudden damage and failure of their vital organs, particularly the kidneys.
NICE
said the drug – which will be funded on an interim basis - was a
‘significant innovation’ and offered ‘gains of a magnitude that is
rarely seen for any new drug treatment’.
Its
chief executive Sir Andrew Dillon conceded the drug would prove to
‘very expensive’ and recommended NHS England to find ways of reducing
the cost.
The
decision to provide Eculizumab, developed and marketed by US firm
Alexion Pharmaceuticals, was only approved on the basis of ultra-rare
conditions, rather than being assessed on its standard value-for-money
formula.
The
health watchdog said that it was unfair to apply the usual rules
because it was such a rare condition – meaning drug companies had to
recoup their research costs from only a handful of patients.
With
the drug offering an extra 25 years of good-quality life, NICE deemed
it worth he annual £340,000 cost per patient to the NHS.
But
the decision will come as a blow to cancer patients after a quarter of
treatments that can offer a few extra months of life were stopped on
cost grounds this month.
Sir
Andrew Dillon said: ‘aHUS is a very distressing condition that imposes a
significant burden both on those with the condition and their carers
and families. We are therefore pleased to be able to recommend
Eculizumab for funding.
‘The
Committee accepted that eculizumab is a step change in the management
of aHUS and can be considered a significant innovation for a disease
with a high unmet clinical need.’
He
added: ‘The drug is, however, very expensive. The Committee felt that
the budget impact of eculizumab would be lower if the potential for
adjusting the dose of the drug and stopping treatment was explored.
‘This
is reflected in the guidance which recommends eculizumab should be
funded only if important conditions are met, including the development
of rules for starting and stopping treatment for clinical reasons.
In
the meantime NHS England and the company should consider what
opportunities might exist to reduce the cost of eculizumab to the NHS.’
26 January 2015
TORONTO RITZ-CARLTON HOTEL has BIDETS in the BATHROOM
Relatively new Toronto Ritz-Carlton has bidets. Rare in Toronto.hotels.Ritz hotels mainly subsidiaries of Marriott Int.
25 January 2015
USA Harvard PROMED:
Antibiotic-resistant Enterobacteriaceae - USA: (WA) fatal, ERCP endoscopes
ANTIBIOTIC-RESISTANT ENTEROBACTERIACEAE - USA: (WASHINGTON) FATAL,
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ENDOSCOPES
******************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>
[1]
Date: Thu 22 Jan 2015
Source: GreenwichTime, AP (Associated Press) report [edited]
<http://www.greenwichtime.com/
A multidrug-resistant superbug has sickened dozens of people at a
Seattle [Washington] hospital, spread from patient-to-patient through
contaminated equipment.
The Seattle Times reports (<http://is.gd/m4JVhK>) investigators found
the rare bacteria known as CRE -- carbapenem-resistant
Enterobacteriaceae -- was likely spread through specialized endoscopes
that had been cleaned according to manufacturers' directions but still
had some of the deadly germs.
Virginia Mason Medical Center officials say they've changed their
cleaning protocol for the devices, even though federal officials found
no problem with their infection-control practices.
Doctors say 11 of the at least 35 patients infected at the hospital
died, but it's not clear what role, if any, the infection played in
their deaths.
--
Communicated by:
ProMED-mail from HealthMap Alerts
<promed@promedmail.org>
******
[2]
Date: Wed 21 Jan 2015
Source: Seattle Times [edited]
<http://seattletimes.com/html/
An outbreak of multidrug-resistant superbugs spread by contaminated
endoscopes infected at least 32 patients at Virginia Mason Medical
Center between 2012 and 2014. Neither the hospital nor health
officials notified patients or the public.
Eleven of those patients died, but it's not clear what role, if any,
the infections played, doctors said.
The rare bacteria likely were transmitted from patient to patient by
specialized endoscopes, flexible tools used to treat pancreatic cancer
and other gut problems, which had been cleaned according to
manufacturers' directions but still harbored the potentially deadly
germs.
The Seattle outbreak appears to be among the worst so far in the US,
where problems with dirty endoscopes have been tied to superbug
infections in Chicago [Illinois] and Pittsburgh [Pennsylvania] in
recent years. Although the bacteria weren't exactly the same, the
situation raises new questions about the design, disinfection and
regulation of the devices, critics charge.
Investigators found a rare type of multidrug-resistant bacteria on
some scopes after disinfection that matched the same dangerous germs
detected in dozens of already critically ill patients who had
undergone a specific procedure.
Some of the bacteria were resistant to some carbapenem antibiotics,
drugs of last resort, echoing other outbreaks of CRE --
carbapenem-resistant Enterobacteriaceae, which may have a mortality
rate as high as 50 percent, according to the Centers for Disease
Control and Prevention [CDC].
Virginia Mason officials say they've overhauled their cleaning
protocol for the devices, known as duodenoscopes, even though
investigations by local and federal health officials found no breach
in infection-control practice at the hospital. "This makes us the
safest place in the country to have this done," said Dr. Andrew Ross,
section head for the gastroenterology department.
Some patients may have been aware of their infections. However,
neither the patients nor their families have been notified
specifically about the outbreak or its source -- not by Virginia Mason
nor by Public Health-Seattle & King County. Officials said Wednesday
[21 Jan 2015] there's little the very sick people could have done in
response to this information.
"Are you going to create unnecessary fear in the public about
something we can't do anything about?" said Dr. Chris Baliga, Virginia
Mason's medical director of infection prevention. "Patients are at the
same or higher risk all across the country," said Dr. Jeffrey Duchin,
King County interim health officer, who helped investigate the
outbreak. "We didn't feel like it was a new issue that warranted
emergency notification."
That couldn't be further from the truth, said Lawrence F. Muscarella,
a Philadelphia infection-control expert who has been monitoring
endoscope-associated superbug outbreaks for several years. "My concern
now is that when we talk about there being a risk, there is no longer
just a risk. It's a reality. People are dying from it," Muscarella
said. He's worried that growing numbers of patients undergoing a
special procedure known as endoscopic retrograde
cholangiopancreatography, or ERCP, which examines and treats disease
of the bile or pancreatic ducts, may be contracting the dangerous,
hard-to-treat CRE infections spread by the medical devices.
Worse, Muscarella said, he's convinced that the design of the scopes
is to blame. The distal ends of the long, flexible scopes include
so-called "elevator wire channels," or tiny flaps that hold stents and
other accessories -- but may also harbor bacteria that can't be
cleaned, even with recommended disinfection techniques, Muscarella
said.
That's a view shared by officials at Public Health, Virginia Mason and
the Centers for Disease Control and Prevention. In a report on
Seattle's outbreak, CDC officials said the complex design of the
scopes "makes them difficult to clean with the potential for
contamination persisting following reprocessing and subsequent
transmission of pathogenic bacteria to patients."
The CDC has reached out to officials at the Food and Drug
Administration [FDA], which regulates medical devices. But so far, the
FDA has issued no warning or recalls. Leslie Wooldridge, an agency
spokeswoman, said the FDA is aware of and closely monitoring the
association between CRE infection and reprocessed endoscopes. But, she
added, the design of the devices, including the elevator mechanism,
allows changes in the angle of the accessory instruments that make
certain treatments possible. "The FDA feels that the lifesaving nature
of ERCP, performed on more than 500 000 patients annually in the US,
makes it important for these devices to remain available." The risk of
infection is very low, she added.
News of the rare, multidrug-resistant infections at Virginia Mason was
released this fall, more than 2 years after the 1st infections were
detected, in a small abstract published at a conference of the
Infectious Diseases Society of America.
Investigators with Public Health, Virginia Mason and the CDC said
they'd identified at least 30 cases of a rare type of
multidrug-resistant bacteria known as a hyper-AmpC producer, or HAC.
Ten cases showed resistance to some carbapenem antibiotics, but most
did not. That meant the infections were difficult, but not impossible
to treat, doctors said. Seven patients died within 30 days of
collection of the superbug samples, health officials said.
Investigators now say they have identified at least 32 cases and 11
deaths through March 2014, although they emphasize that the patients
were critically ill, mostly with terminal pancreatic or colon cancer,
and it's not clear whether the superbug infections were to blame.
Since spring [2014], however, Virginia Mason has taken steps to
culture and quarantine all the duodenoscopes used in some 1800 ERCP
procedures performed there each year. Each device is held for 48 hours
to make sure it's free of CRE and other dangerous bugs. Virginia Mason
has bought 20 additional USD 37 500 devices made by the Olympus
Medical System Corp., to allow time for some to be out of service.
"It's way beyond what anybody else in the country is doing," Duchin
said. "We think that the steps they've put in place to culture and
quarantine the scopes have been effective."
CRE infections have been associated with scopes made by all 3 top
manufacturers.
Art Caplan, a bioethicist at New York University's Langone Medical
Center, said hospital and public-health officials should have notified
patients and the public about the outbreak far sooner. "People have a
right to know that's intrinsic or inherent," Caplan said. "If my
spouse died because of an infected piece of medical equipment or
dental equipment, I would like to know. I would even like to examine a
lawsuit."
Virginia Mason's problem was 1st revealed by voluntary CRE
surveillance conducted by state and local health officials, but the
hospital is not alone in facing problems with potentially contaminated
endoscopes, Duchin added. "The truth is, nobody else is looking," he
said. Dr. Michael Gluck, Virginia Mason's chief of medicine, said the
hospital would like to join groups putting pressure on the FDA and
manufacturers to change the scopes to allow thorough cleaning. "What
we would like to see is a better design of the elevator," he said.
Mark A. Miller, a spokesman for Olympus, said the firm is aware of
reports of CRE infections after ERCP procedures and is "monitoring the
issue closely. All types of endoscopes require thorough reprocessing
after patient use, and customers who purchase Olympus duodenoscopes,
as with all of our products, receive instruction and documentation to
pay careful attention to cleaning and reprocessing steps to ensure
effective reprocessing," he said in an email.
Meanwhile, health experts said patients who might need endoscopic
exams or treatment, particularly ERCP procedures, should discuss the
issue with their doctors. The procedures carry risks and benefits that
must be considered, Duchin said. The risk of transmission of a
multidrug-resistant bug must be weighed against the risk of not
receiving a necessary treatment. "If you need the procedure because
you have an obstructed biliary duct and are going to die without it,
it's worth the risk," Duchin said.
[Byline: JoNel Aleccia]
--
Communicated by:
ProMED-mail
<promed@promedmail.org>
[A discussion of carbapenemases produced by Enterobacteriaceae can be
found in my comments in prior ProMED-mail posts Enterobacteriaceae,
carbapenem resistant - Europe: survey 20130712.1822582 and ampC
beta-lactamase hyperproducers in Enterobacter cloacae - Belize: (BZ)
fatal, neonatal ICU 20130525.1736926.
A discussion of the nosocomial transmission of carbapenemase-producing
Enterobacteriaceae (CPE) via contaminated endoscopes that are used to
perform endoscopic retrograde cholangiopancreatography (ERCP), which
is a type of upper gastrointestinal (GI) endoscopic procedure, can be
found in my comments in another prior ProMED-mail post: NDM-1 carrying
E. coli - USA: (IL) ERCP 20140104.2151607. Also see
<http://endoscopereprocessing.
for a description of other outbreaks of CPE associated with ERCP
endoscopes. The design of ERCP endoscopes poses a problem for cleaning
and disinfection when reused for multiple patients. A CDC discussion
of transmission of CPE linked to use of contaminated endoscopes used
for ERCP can be found at
<http://www.cdc.gov/mmwr/
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ENDOSCOPES
******************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>
[1]
Date: Thu 22 Jan 2015
Source: GreenwichTime, AP (Associated Press) report [edited]
<http://www.greenwichtime.com/
A multidrug-resistant superbug has sickened dozens of people at a
Seattle [Washington] hospital, spread from patient-to-patient through
contaminated equipment.
The Seattle Times reports (<http://is.gd/m4JVhK>) investigators found
the rare bacteria known as CRE -- carbapenem-resistant
Enterobacteriaceae -- was likely spread through specialized endoscopes
that had been cleaned according to manufacturers' directions but still
had some of the deadly germs.
Virginia Mason Medical Center officials say they've changed their
cleaning protocol for the devices, even though federal officials found
no problem with their infection-control practices.
Doctors say 11 of the at least 35 patients infected at the hospital
died, but it's not clear what role, if any, the infection played in
their deaths.
--
Communicated by:
ProMED-mail from HealthMap Alerts
<promed@promedmail.org>
******
[2]
Date: Wed 21 Jan 2015
Source: Seattle Times [edited]
<http://seattletimes.com/html/
An outbreak of multidrug-resistant superbugs spread by contaminated
endoscopes infected at least 32 patients at Virginia Mason Medical
Center between 2012 and 2014. Neither the hospital nor health
officials notified patients or the public.
Eleven of those patients died, but it's not clear what role, if any,
the infections played, doctors said.
The rare bacteria likely were transmitted from patient to patient by
specialized endoscopes, flexible tools used to treat pancreatic cancer
and other gut problems, which had been cleaned according to
manufacturers' directions but still harbored the potentially deadly
germs.
The Seattle outbreak appears to be among the worst so far in the US,
where problems with dirty endoscopes have been tied to superbug
infections in Chicago [Illinois] and Pittsburgh [Pennsylvania] in
recent years. Although the bacteria weren't exactly the same, the
situation raises new questions about the design, disinfection and
regulation of the devices, critics charge.
Investigators found a rare type of multidrug-resistant bacteria on
some scopes after disinfection that matched the same dangerous germs
detected in dozens of already critically ill patients who had
undergone a specific procedure.
Some of the bacteria were resistant to some carbapenem antibiotics,
drugs of last resort, echoing other outbreaks of CRE --
carbapenem-resistant Enterobacteriaceae, which may have a mortality
rate as high as 50 percent, according to the Centers for Disease
Control and Prevention [CDC].
Virginia Mason officials say they've overhauled their cleaning
protocol for the devices, known as duodenoscopes, even though
investigations by local and federal health officials found no breach
in infection-control practice at the hospital. "This makes us the
safest place in the country to have this done," said Dr. Andrew Ross,
section head for the gastroenterology department.
Some patients may have been aware of their infections. However,
neither the patients nor their families have been notified
specifically about the outbreak or its source -- not by Virginia Mason
nor by Public Health-Seattle & King County. Officials said Wednesday
[21 Jan 2015] there's little the very sick people could have done in
response to this information.
"Are you going to create unnecessary fear in the public about
something we can't do anything about?" said Dr. Chris Baliga, Virginia
Mason's medical director of infection prevention. "Patients are at the
same or higher risk all across the country," said Dr. Jeffrey Duchin,
King County interim health officer, who helped investigate the
outbreak. "We didn't feel like it was a new issue that warranted
emergency notification."
That couldn't be further from the truth, said Lawrence F. Muscarella,
a Philadelphia infection-control expert who has been monitoring
endoscope-associated superbug outbreaks for several years. "My concern
now is that when we talk about there being a risk, there is no longer
just a risk. It's a reality. People are dying from it," Muscarella
said. He's worried that growing numbers of patients undergoing a
special procedure known as endoscopic retrograde
cholangiopancreatography, or ERCP, which examines and treats disease
of the bile or pancreatic ducts, may be contracting the dangerous,
hard-to-treat CRE infections spread by the medical devices.
Worse, Muscarella said, he's convinced that the design of the scopes
is to blame. The distal ends of the long, flexible scopes include
so-called "elevator wire channels," or tiny flaps that hold stents and
other accessories -- but may also harbor bacteria that can't be
cleaned, even with recommended disinfection techniques, Muscarella
said.
That's a view shared by officials at Public Health, Virginia Mason and
the Centers for Disease Control and Prevention. In a report on
Seattle's outbreak, CDC officials said the complex design of the
scopes "makes them difficult to clean with the potential for
contamination persisting following reprocessing and subsequent
transmission of pathogenic bacteria to patients."
The CDC has reached out to officials at the Food and Drug
Administration [FDA], which regulates medical devices. But so far, the
FDA has issued no warning or recalls. Leslie Wooldridge, an agency
spokeswoman, said the FDA is aware of and closely monitoring the
association between CRE infection and reprocessed endoscopes. But, she
added, the design of the devices, including the elevator mechanism,
allows changes in the angle of the accessory instruments that make
certain treatments possible. "The FDA feels that the lifesaving nature
of ERCP, performed on more than 500 000 patients annually in the US,
makes it important for these devices to remain available." The risk of
infection is very low, she added.
News of the rare, multidrug-resistant infections at Virginia Mason was
released this fall, more than 2 years after the 1st infections were
detected, in a small abstract published at a conference of the
Infectious Diseases Society of America.
Investigators with Public Health, Virginia Mason and the CDC said
they'd identified at least 30 cases of a rare type of
multidrug-resistant bacteria known as a hyper-AmpC producer, or HAC.
Ten cases showed resistance to some carbapenem antibiotics, but most
did not. That meant the infections were difficult, but not impossible
to treat, doctors said. Seven patients died within 30 days of
collection of the superbug samples, health officials said.
Investigators now say they have identified at least 32 cases and 11
deaths through March 2014, although they emphasize that the patients
were critically ill, mostly with terminal pancreatic or colon cancer,
and it's not clear whether the superbug infections were to blame.
Since spring [2014], however, Virginia Mason has taken steps to
culture and quarantine all the duodenoscopes used in some 1800 ERCP
procedures performed there each year. Each device is held for 48 hours
to make sure it's free of CRE and other dangerous bugs. Virginia Mason
has bought 20 additional USD 37 500 devices made by the Olympus
Medical System Corp., to allow time for some to be out of service.
"It's way beyond what anybody else in the country is doing," Duchin
said. "We think that the steps they've put in place to culture and
quarantine the scopes have been effective."
CRE infections have been associated with scopes made by all 3 top
manufacturers.
Art Caplan, a bioethicist at New York University's Langone Medical
Center, said hospital and public-health officials should have notified
patients and the public about the outbreak far sooner. "People have a
right to know that's intrinsic or inherent," Caplan said. "If my
spouse died because of an infected piece of medical equipment or
dental equipment, I would like to know. I would even like to examine a
lawsuit."
Virginia Mason's problem was 1st revealed by voluntary CRE
surveillance conducted by state and local health officials, but the
hospital is not alone in facing problems with potentially contaminated
endoscopes, Duchin added. "The truth is, nobody else is looking," he
said. Dr. Michael Gluck, Virginia Mason's chief of medicine, said the
hospital would like to join groups putting pressure on the FDA and
manufacturers to change the scopes to allow thorough cleaning. "What
we would like to see is a better design of the elevator," he said.
Mark A. Miller, a spokesman for Olympus, said the firm is aware of
reports of CRE infections after ERCP procedures and is "monitoring the
issue closely. All types of endoscopes require thorough reprocessing
after patient use, and customers who purchase Olympus duodenoscopes,
as with all of our products, receive instruction and documentation to
pay careful attention to cleaning and reprocessing steps to ensure
effective reprocessing," he said in an email.
Meanwhile, health experts said patients who might need endoscopic
exams or treatment, particularly ERCP procedures, should discuss the
issue with their doctors. The procedures carry risks and benefits that
must be considered, Duchin said. The risk of transmission of a
multidrug-resistant bug must be weighed against the risk of not
receiving a necessary treatment. "If you need the procedure because
you have an obstructed biliary duct and are going to die without it,
it's worth the risk," Duchin said.
[Byline: JoNel Aleccia]
--
Communicated by:
ProMED-mail
<promed@promedmail.org>
[A discussion of carbapenemases produced by Enterobacteriaceae can be
found in my comments in prior ProMED-mail posts Enterobacteriaceae,
carbapenem resistant - Europe: survey 20130712.1822582 and ampC
beta-lactamase hyperproducers in Enterobacter cloacae - Belize: (BZ)
fatal, neonatal ICU 20130525.1736926.
A discussion of the nosocomial transmission of carbapenemase-producing
Enterobacteriaceae (CPE) via contaminated endoscopes that are used to
perform endoscopic retrograde cholangiopancreatography (ERCP), which
is a type of upper gastrointestinal (GI) endoscopic procedure, can be
found in my comments in another prior ProMED-mail post: NDM-1 carrying
E. coli - USA: (IL) ERCP 20140104.2151607. Also see
<http://endoscopereprocessing.
for a description of other outbreaks of CPE associated with ERCP
endoscopes. The design of ERCP endoscopes poses a problem for cleaning
and disinfection when reused for multiple patients. A CDC discussion
of transmission of CPE linked to use of contaminated endoscopes used
for ERCP can be found at
<http://www.cdc.gov/mmwr/
Inbox
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22:56 (19 hours ago)
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SYPHILIS HEALTH CHECK $8 a test.
 |
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Products
USA: OFFICE TEST FOR SYPHILIS
The Food and Drug Administration has granted a waiver to the
makers of the Syphilis Health Check test that makes the rapid test more
widely available in community health settings. A blood sample from a
finger stick is collected and tested for syphilis antibodies, with
results available in minutes.
(Diagnostics Direct LLC)
By
Email the author | Follow on Twitter
on January 22, 2015 at 8:00 AM, updated January 22, 2015 at 8:08 AM
CLEVELAND, Ohio – Syphilis is back.
Actually, it never went away. But after a steady increase in the number of reported cases in Cuyahoga County, peaking in 2010 at 161, the numbers started going back down again.
The decline was short-lived; the preliminary number of syphilis cases reported in 2014 – 122 - was up more than 28 percent from the year before.
Of those cases, 37 were primary and secondary syphilis, the most contagious stages of the disease (up from 29 the year before); left untreated, people can pass the disease to others for up to two years.
The rise in cases is alarming enough that the Cleveland Department of Public Health is stepping up its ongoing campaign to urge people - specifically gay and bisexual males ages 16 to 35 who represent most of the new cases - to know their health status, said Health Commissioner Myron Bennett.
And the Ohio Department of Health is in the early stages of exploring the feasibility of purchasing rapid syphilis screening tests for use in select local health departments across the state.
Cleveland accounted for 28 of the county's primary and secondary syphilis cases, for a rate of 7.2 per 100,000 people.
Why the resurgence?
Until the end of the 1990s, syphilis primarily occurred among heterosexual men and women of racial and ethnic minority groups. Since then, men who have sex with other men account for the majority of primary and secondary syphilis cases.
Free, confidential syphilis and HIV testing is available to anyone age 13 and older at the Sexually Transmitted Disease Clinics at J Glen Smith Health Center, 11100 St. Clair Ave., and Thomas McCafferty Health Center, 4242 Lorain Ave., both in Cleveland. The Free Medical Clinic of Greater Cleveland, at 12201 Euclid Ave., also provides testing as well as treatment.
SOURCE: Centers for Disease Control and Infection, Cleveland Department of Public Health
"Some of this is related to the fact that even HIV is being considered a treatable condition," says Dr. Robert Salata, chief of infectious diseases at University Hospitals Case Medical Center. "For that reason, certain high-risk practices are coming back into play."
Caught early, the disease can be treated with penicillin or other antibiotics. But if ignored until later stages, the results are destructive, sometimes deadly.
The message of prevention is already widespread, but the syphilis increase is proof that safe sex practices aren't being adopted by everyone, Bennett said.
"They no longer see it as a fatal risk, so we've decided to focus on the importance of getting checked," he said. "That way, we can narrow that transmission net."
Data released in December by the Centers for Disease Control and Prevention show an increase in syphilis cases nationally in 2013.
The numbers of primary and secondary cases rose 10 percent over 2012, to 17,357 cases, a rate of 5.5 per 100,000 people. According to the CDC, about 55,000 people in the U.S. are newly infected with syphilis annually.
Ruling allows wider use of rapid syphilis test
The rise in syphilis cases locally and nationally makes a move by the Food and Drug Administration even more significant.
The FDA first granted clearance in 2011 for the use of the Syphilis Health Check test, which is made in a French lab for New Jersey-based Diagnostics Direct. The test detects the presence of syphilis antibodies.
In December, the FDA granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for the test. Following a review of new data submitted showing the test's ease of use and accuracy, the FDA no longer considers the test to fall under the moderate- and high-complexity designation.
Now, it can be used in non-lab settings - health fairs, community health clinics, and even prisons - and no specialized training is needed to administer it.
The rapid test involves the collection of a blood sample from a finger stick. Results are available in as little as 12 minutes. If the test is positive, a patient then undergoes a clinical exam and a second test to confirm the presence of the infection.
"Between 12 and 15 million syphilis tests are done in this country every year, none of which can be done on the spot," said Diagnostics Direct President and CEO Norman Proulx.
"That's why the CLIA waiver is such a big deal – the test is given to the person immediately," he said. "A simple finger prick of whole blood, in 10 minutes, gives you the answers. It brings the answer much closer to the patient while the patient is within the confines of the medical group.
"And," Proulx said, "You don't need a PhD chemist to [perform] the test."
In contrast, other tests used for screening purposes are typically run only a few times a week in large batches; a positive result requires a second test for confirmation.
The cost of the Syphilis Health Check test is comparable to similar rapid HIV tests on the market, Proulx said.
It will likely be spring before the Ohio Department of Health begins using the test for contact tracing - identifying, notifying and testing people who may have been exposed to someone diagnosed with syphilis - and only in areas of the state with a high transmission rate, department spokeswoman Melanie Amato told The Plain Dealer.
Before that happens, though, ODH is awaiting more updated information from the CDC about the syphilis incidence rate. The department will then train staff at both the state and local levels on the use of the test.
One of the advantages of a rapid test is its potential use in pregnant women who haven't had any prenatal care or screenings, says UH's Salata. "The speed of diagnosis can be critical."
Being able to get test results in a matter of minutes – and not days – could be the difference between someone getting treatment and someone not bothering to return to a health clinic for follow-up care, Salata said.
And in the case of a pregnant woman in labor, knowing her health status is essential in order to provide critical treatment to her baby.
In 2013, 348 cases of congenital syphilis – which occurs when a pregnant woman with untreated syphilis passes it on to her baby – were reported in the U.S., a 4 percent increase since 2012. No cases of congenital syphilis were reported in Cuyahoga County in 2014.
"In terms of public health importance, we need to be able to get information more rapidly than we have and get them into treatment," Salata said.
Actually, it never went away. But after a steady increase in the number of reported cases in Cuyahoga County, peaking in 2010 at 161, the numbers started going back down again.
The decline was short-lived; the preliminary number of syphilis cases reported in 2014 – 122 - was up more than 28 percent from the year before.
Of those cases, 37 were primary and secondary syphilis, the most contagious stages of the disease (up from 29 the year before); left untreated, people can pass the disease to others for up to two years.
The rise in cases is alarming enough that the Cleveland Department of Public Health is stepping up its ongoing campaign to urge people - specifically gay and bisexual males ages 16 to 35 who represent most of the new cases - to know their health status, said Health Commissioner Myron Bennett.
And the Ohio Department of Health is in the early stages of exploring the feasibility of purchasing rapid syphilis screening tests for use in select local health departments across the state.
Cleveland accounted for 28 of the county's primary and secondary syphilis cases, for a rate of 7.2 per 100,000 people.
Why the resurgence?
The facts on syphilis
- Syphilis,
caused by a type of bacteria, is transmitted during vaginal, anal or
oral sex through direct contact with a syphilis sore. It can also be
spread through contact from sores on the lips and in the mouth. Symptoms
can include sores, body rashes, fever, swollen lymph glands, sore
throat, patchy hair loss, headaches, weight loss, muscle aches and
fatigue.
Until the end of the 1990s, syphilis primarily occurred among heterosexual men and women of racial and ethnic minority groups. Since then, men who have sex with other men account for the majority of primary and secondary syphilis cases.
Free, confidential syphilis and HIV testing is available to anyone age 13 and older at the Sexually Transmitted Disease Clinics at J Glen Smith Health Center, 11100 St. Clair Ave., and Thomas McCafferty Health Center, 4242 Lorain Ave., both in Cleveland. The Free Medical Clinic of Greater Cleveland, at 12201 Euclid Ave., also provides testing as well as treatment.
SOURCE: Centers for Disease Control and Infection, Cleveland Department of Public Health
"Some of this is related to the fact that even HIV is being considered a treatable condition," says Dr. Robert Salata, chief of infectious diseases at University Hospitals Case Medical Center. "For that reason, certain high-risk practices are coming back into play."
Caught early, the disease can be treated with penicillin or other antibiotics. But if ignored until later stages, the results are destructive, sometimes deadly.
The message of prevention is already widespread, but the syphilis increase is proof that safe sex practices aren't being adopted by everyone, Bennett said.
"They no longer see it as a fatal risk, so we've decided to focus on the importance of getting checked," he said. "That way, we can narrow that transmission net."
Data released in December by the Centers for Disease Control and Prevention show an increase in syphilis cases nationally in 2013.
The numbers of primary and secondary cases rose 10 percent over 2012, to 17,357 cases, a rate of 5.5 per 100,000 people. According to the CDC, about 55,000 people in the U.S. are newly infected with syphilis annually.
Ruling allows wider use of rapid syphilis test
The rise in syphilis cases locally and nationally makes a move by the Food and Drug Administration even more significant.
The FDA first granted clearance in 2011 for the use of the Syphilis Health Check test, which is made in a French lab for New Jersey-based Diagnostics Direct. The test detects the presence of syphilis antibodies.
In December, the FDA granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for the test. Following a review of new data submitted showing the test's ease of use and accuracy, the FDA no longer considers the test to fall under the moderate- and high-complexity designation.
Now, it can be used in non-lab settings - health fairs, community health clinics, and even prisons - and no specialized training is needed to administer it.
The rapid test involves the collection of a blood sample from a finger stick. Results are available in as little as 12 minutes. If the test is positive, a patient then undergoes a clinical exam and a second test to confirm the presence of the infection.
"Between 12 and 15 million syphilis tests are done in this country every year, none of which can be done on the spot," said Diagnostics Direct President and CEO Norman Proulx.
"That's why the CLIA waiver is such a big deal – the test is given to the person immediately," he said. "A simple finger prick of whole blood, in 10 minutes, gives you the answers. It brings the answer much closer to the patient while the patient is within the confines of the medical group.
"And," Proulx said, "You don't need a PhD chemist to [perform] the test."
In contrast, other tests used for screening purposes are typically run only a few times a week in large batches; a positive result requires a second test for confirmation.
The cost of the Syphilis Health Check test is comparable to similar rapid HIV tests on the market, Proulx said.
It will likely be spring before the Ohio Department of Health begins using the test for contact tracing - identifying, notifying and testing people who may have been exposed to someone diagnosed with syphilis - and only in areas of the state with a high transmission rate, department spokeswoman Melanie Amato told The Plain Dealer.
Before that happens, though, ODH is awaiting more updated information from the CDC about the syphilis incidence rate. The department will then train staff at both the state and local levels on the use of the test.
One of the advantages of a rapid test is its potential use in pregnant women who haven't had any prenatal care or screenings, says UH's Salata. "The speed of diagnosis can be critical."
Being able to get test results in a matter of minutes – and not days – could be the difference between someone getting treatment and someone not bothering to return to a health clinic for follow-up care, Salata said.
And in the case of a pregnant woman in labor, knowing her health status is essential in order to provide critical treatment to her baby.
In 2013, 348 cases of congenital syphilis – which occurs when a pregnant woman with untreated syphilis passes it on to her baby – were reported in the U.S., a 4 percent increase since 2012. No cases of congenital syphilis were reported in Cuyahoga County in 2014.
"In terms of public health importance, we need to be able to get information more rapidly than we have and get them into treatment," Salata said.
Real Estate
20 January 2015
UK: INDEPENDENT DOCTORS FEDERATION ( i.e NOT part of NHS)
History of the IDF
The IDF was started in 1989 under the name Independent Doctors Forum and it incorporated as a company limited by guarantee in 1992. It was set up by a group of conscientious, like-minded and enthusiastic doctors working fulltime in the independent sector, who felt a platform was needed for open discussion, voicing ideas and exchanging views.Since that time the IDF has grown in stature and significance and has taken on roles which far exceed the boundaries initially envisaged. This has been particularly true with the introduction of appraisal and revalidation and its implications for member doctors. It is also lobbying hard to make sure that the voice of the independent sector is heard within government, DOH, GMC, CQC.
Although aptly describing the initial aims of the group it was felt that the word Forum no longer fitted with the IDF's changing role and at a General Meeting held on 11th June 2009 members voted to change the company name from Independent Doctors Forum to Independent Doctors Federation.
Membership of the IDF currently stands at just under 1200 - these are all GMC registered doctors in Independent Practice. Members are currently split 2/3 Consultants; 1/3 GPs. We also have 46 corporate sponsors.
To download a copy of the IDF's most recent accounts please click here.
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