text:
Budget Watch: Strickland Likely to Veto Special Ed. Vouchers
The budget passed its floor vote with a unanimous-minus-one vote last night. Still not definitive word from Strickland about special ed. vouchers, but word seems to be that he will veto. Last night Jill noted a quick mention in Openers that Strickland said he would "almost certainly" veto the program.
Then this morning, this in the Dispatch story:
A key item likely to be excised is a proposed voucher test program for special-needs students. The program would offer about 8,000 students with individualized education programs up to $20,000 apiece toward the cost of private-school tuition.
No source is given, but it looks like Dispatch reporters are hearing murmurs. All of this is consistent with the grapevine hum I'm hearing. Rest assured, special ed. vouchers will come up again. This is the second go round; Sen. Kevin Coughlin proposed much the same bill last year, and he's nothing if not persistent.
It's entirely possible that at some point we will have a special ed vouchers bill. This one is as bad as a proposal can be -- basically a new middle class entitlement. Even voucher supporters should think twice about it.
Posted by Scott Piepho at Thursday, June 28, 2007
Philed under: Academically Challenged, Budget Fussing, Laws and Sausages, Privateers
Thanks for flagging the Dispatch article on this - I hadn't seen it yet. I can understand protecting sources, but if you're a newspaper of record, I would have thought that there was greater expectation, by the editors, that the reporter provide a source in the article.
But what do I know?
On the merits, again - I'm completely stymied as to why, after all these literally decades of everyone knowing that public schools, in general, do a much better job in providing special education services, legislators think that vouchers are they way to go.
The only answer? Because they think it's politically the easy route into wholesale voucher conversion.
I actually think it shows the legislators up for being incredibly shallow about the subject of special education and simply using a particularly sympathetic student and family population to further their interest in privatizing education.
I don't see it happening. But I've been wrong many times.
This voucher approach to providing educational services for our special education children acknowledges that one size doesn't fit all and that there are effective alternative programs beyond the traditional classroom. Private providers are, in many cases, able to tailor programs to fit the individual needs of students. In addition, the private provider class sizes are frequently smaller, which means more individual attention for each child.
This alternative approach also recognizes that disabled students face important and significant non-academic challenges. Behavior problems are one such challenge. Parents participating in the McKay Scholarship Program, a similar scholarship program in Florida, report significantly fewer behavior problems. Another challenge is non-special-needs students bullying special education students. Results from the Florida program suggest that private schools are able to develop more effective and flexible discipline policies than public schools, and they are better prepared to protect these vulnerable children.
Please read this Wall Street Journal article below which emphasizes the need for these vouchers--school districts are not doing a good job of inclusion and meeting the needs of these students.
Disabled Children Join
Peers, Strain Teachers;
'We Need More Help'
By JOHN HECHINGER
June 25, 2007; Page A1
SCRANTON, Pa. -- When school started last August, veteran first-grade
teacher Patricia McDermott made sure to place one student, 8-year-old Andrea
Gavern, in a seat beside her own desk.
Andrea suffers from a rare genetic condition called Williams Syndrome, which
causes learning disabilities and medical ailments such as heart problems and
difficulty eating. Knowing that Andrea had disrupted her kindergarten
classes a year earlier, Ms. McDermott wanted to keep her new pupil under
close watch.
The strategy backfired. One morning, Andrea swept an arm
along the teacher's desk, scattering framed photos of Ms. McDermott's family
across the classroom. A glass frame shattered, and another hit a student in
the arm. Though no one was hurt, Ms. McDermott says she lost hours of
instruction time getting the children to settle down after the disruption.
From the first weeks of school, Ms. McDermott found Andrea's plight
heartbreaking. "No! No! No!" she remembers her student screaming at times.
"Want Mommy! Want Mommy!"
"She looked at me, like she was saying, 'Help me,' and I couldn't. How could
I possibly give Andrea what she needs?"
Years ago, students like Andrea would have been taught in separate
classrooms. Today, a national movement to "mainstream" special-education
students has integrated many of them into the general student body. As a
result, regular teachers are instructing more children with severe
disabilities -- often without extra training or support.
This year, Ms. McDermott counted 19 students in her class at Whittier
Elementary School. Five had disabilities, including attention deficit
disorder and delays in reading and math. The teacher worried that she was
failing all her students -- especially Andrea. "It used to be a joy to go to
work," she says. "Now all I want to do is run away."
In Scranton and elsewhere, the rush to mainstream disabled students is
alienating teachers and driving some of the best from the profession. It has
become a little-noticed but key factor behind teacher turnover, which
experts say largely accounts for a shortage of qualified teachers in the
Each year, about 16% of teachers quit their jobs, either leaving the
profession or moving to another school, according to recent U.S. Department
of Education surveys. Of those, 35% cite difficulties with mainstreaming
special-education students as a main reason for their dissatisfaction,
according to an analysis of the data by Richard Ingersoll, a professor of
education and sociology at the University of Pennsylvania.
"It's a red flag," Prof. Ingersoll says. "Mainstreaming is putting pressure
on teachers... and the proponents of this reform are going to need to
address it sooner or later."
Neil Hunt, a seventh-grade math teacher in the Fairfax County, Va., public
schools, recently quit his job in part because of mainstreaming. "I don't
feel I can do what's necessary for these kids," says Mr. Hunt, a former Navy
lieutenant who plans to return to the service in a civilian job. "And some
of the kids' behavior is such a distraction for the rest of the class that
they're losing a lot of time, too."
In Arizona, Tom Horne, the state's superintendent of schools, says
mainstreaming special-education students with behavior problems can be
"extremely destructive" to teachers' morale and "a big factor in teachers'
leaving."
Also known as "inclusion," mainstreaming reverses a once-common practice
that Congress determined was unjust: the segregation of disabled children in
settings without proper instruction. Many educators say children learn more
through mainstreaming because they are taught by better-qualified teachers
and gain valuable social skills from their peers. By 2005, about 54% of
special-education students were taught in "fully inclusive" settings --
spending 80% or more of the school day in a regular classroom -- up from 33%
Pennsylvania has been a major battleground in the national wars over special
education. Litigation here helped lead to the 1975 federal legislation now
known as the Individuals with Disabilities Education Act, which requires a
"free appropriate" public education for children with disabilities. The law
fostered mainstreaming by mandating that disabled children, when possible,
be taught in the "least restrictive environment. "
Despite its key role, Pennsylvania was slow to embrace inclusion until 2005,
when the state and the Public Interest Law Center of Philadelphia received
court approval to settle a decade-old class-action case brought on behalf of
280,000 special-education students who demanded inclusion in regular
classrooms. Districts that aren't sufficiently inclusive risk losing
But even some advocates of inclusion say it isn't working as they had hoped.
Judith Gran, the plaintiffs' lead attorney on the case, says that some
districts aren't mainstreaming but "main-dumping" -- packing classes with
disabled children without adequate staffing. "You hear a lot about it from
teachers," she says. "They are the ones on the front lines, and they aren't
getting support."
The Scranton district has 9,800 students, 16% of whom are in special
education. About half have learning disabilities, such as dyslexia. Others
struggle with problems that include intellectual impairment, autism and
emotional disorders.
• The Issue: The trend of mainstreaming special-education students is
drawing increasing criticism, especially from teachers.
• Behind the Debate: Some parents and educators say students with
disabilities get better treatment in general classroom settings. But many
teachers lack training and support.
• The Bottom Line: Dissatisfaction with mainstreaming has become a factor
driving teacher turnover, a major problem in U.S. education.
Until 2004, most of these students were set apart in about 70
special-education classes. By last year, the system had eliminated most of
those classes, which generally had 15 students, a special-education teacher
and an aide. Last year, 75% of students with disabilities in the Scranton
School District spent 80% of their day or more in regular classrooms, up
from 28% in 2003.
The shift has sparked fierce opposition from the Scranton chapter of the
American Federation of Teachers, which has long been critical of
mainstreaming. The issue is expected to be an important part of negotiations
next year, when the teachers' contract expires. In a recent union survey of
Scranton's 750 teachers, two-thirds of those responding listed inclusion as
their No. 1 or No. 2 complaint, outranking all other concerns. (The survey
didn't ask about pay and benefits.)
"Inclusion doesn't work unless class sizes are greatly reduced," wrote one
teacher. "Children are suffering due to lack of support," wrote another. "We
need more help!" added a third.
Janet Strelecki, president of Whittier's Parent Teacher Association, says
she was inclined to favor inclusion because she runs a home for the
developmentally disabled. But when her own daughter, Miranda, who has no
special needs, was placed in Ms. McDermott's classroom last year, Ms.
Strelecki changed her mind. She says Miranda often felt frustrated because
she didn't get much attention from Ms. McDermott, whom she calls "a
wonderful teacher."
Ms. Strelecki says as many as 40 Whittier parents have complained about
inclusion. "The general consensus is that it doesn't work having all these
kids together," she says.
Some, however, praise inclusion. Sarene O'Malley says her dyslexic daughter
Jessica felt "ashamed" when she was in a separate special-education
classroom. Educators say that's a common sentiment among children with
learning disabilities. Through the inclusion program, Ms. O'Malley says
Jessica, who just graduated from Scranton High School, won new friends and
confidence and plans to go to college next year. "She never would have gone
on this path" without inclusion, Ms. O'Malley says.
Michael Sheridan, Scranton's school chief, says he sees only "pockets of
resistance" to inclusion. For evidence that the policy is working, Mr.
Sheridan cites the system's overall results. Last year, Standard & Poor's,
the bond-rating agency, listed Scranton as one of only 29 Pennsylvania
school systems that were "outperformers" in state tests of reading and math
proficiency for each of the preceding four years.
Mr. Sheridan says that President Bush's No Child Left Behind law requires
that all students take the same state tests and be instructed by a teacher
"highly qualified" in each subject. In his view, inclusion is the best way
to meet the demands of both No Child Left Behind and the federal
disabilities law.
Still, many teachers complain that they lack training and support. When
Scranton started the program three years ago, teachers say they received
about three days of training, primarily in "differentiated instruction, "
which often entails breaking up classes into several groups and using
different sets of materials for each. Administrators say principals often
provided more training, including sessions on autism and other disabilities.
Special-education instructors assist in regular classrooms and pull students
out for extra help, but there are few to go around. Scranton has 86
specially trained instructors, along with a support staff of 30 speech and
language experts, psychologists and others. Together, they must serve
roughly 1,600 special-education students in 18 schools.
Under the teachers' union contract, the district is supposed to place no
more than two disabled students in each classroom "where possible." But,
despite that wording, principals often use their discretion to place more
special-education students in certain classes.
Ann Langan, a ninth-grade teacher at Scranton High School, teaches a basic
science class. This year, she had 16 children in one class, 12 of whom were
in special education. Another of her classes had 20, 14 with disabilities.
Jennifer Zaleski, a fifth-grade teacher, had 16 students, half of whom were
in the special-education program. She says the IQs in her class range from
50 to 150. As far as understanding how to teach disabled children, she says,
"How much knowledge did I have? Probably zip."
Last October, the union filed a grievance with the school system, alleging a
violation at the high school of the teachers' contract. Administrators told
the union they would divide special-education students more evenly this
Few have struggled more with inclusion than Ms. McDermott, who teaches at
Whittier Elementary, a century-old red-brick building perched on a hillside
with views of downtown Scranton's faded storefronts and factories.
Ms. McDermott tries to maintain a bright, welcoming classroom, with shiny
laminated paper apples hanging on strings from the ceiling, a "birthday
train" marking each child's big day with a cake and a candle, and a picture
of Martin Luther King Jr. by the door.
The daughter of a fireman and a Scranton schools' secretary, Ms. McDermott
wanted to be a teacher since she was in kindergarten. In 1974, she graduated
from Penn State with a degree in elementary education, then worked as a
substitute teacher until she won her own classroom a decade later. "I ran to
work," says Ms. McDermott, now 54 years old. "I couldn't wait to get there.
I loved being in charge of this world of learning."
Whittier, which is housed in two buildings several blocks apart, has only
one special-education teacher -- and two aides -- for the entire school,
leaving Ms. McDermott largely on her own. Larry Miner, Whittier's principal,
says he tends to concentrate special-needs students in one classroom for
each grade to make it easier to schedule services. He acknowledges that Ms.
McDermott has an unusually large number. But to handle those children, he
says he looks for the most capable instructors. Ms. McDermott "is a very
gifted teacher," he says. "She is very patient."
From the start of this year, Ms. McDermott's biggest challenge was Andrea.
Along with Williams Syndrome, Andrea has sensory processing disorder, also
common among autistic children. The first-grader, who gets nourishment from
a feeding tube in her stomach, hit other children, screamed for hours,
pounded computer keyboards with her fists and tore up worksheets, according
to the teacher.
Mr. Miner says the school system offered to have her attend one of the
district's few separate classrooms for the severely disabled. Her parents,
Philip and Johanna Gavern, recall no such offer. Based on the report of a
private psychologist they hired, they believed that Andrea could make
academic progress in a mainstream classroom, as long as she had a full-time
aide trained in special education. They asked the school system for one, but
were refused.
Mr. Miner maintains that the approach wouldn't have made "much difference."
The school's special-education aides, he says, have only high-school
diplomas and scant disability training. Andrea did get full-time classroom
assistance from a local mental-health agency, paid for by the state. But
that aide has no education training and was present only to help Andrea stay
focused and perform basic tasks.
Andrea received 6½ hours of special services a week. These included speech
and language support and occupational therapy -- mostly in half-hour or
one-hour pullout sessions, according to Andrea's individualized education
program, or IEP, the legal document that outlines what the district must
provide. After school, Andrea's family privately arranged for her to spend
afternoons receiving a variety of physical, music and social-group
Ms. McDermott has no expertise in handling Williams Syndrome or any of the
other disorders she must manage each day. So she improvised, finding a
number board with tiles that engaged Andrea, and, with her own money, buying
kindergarten reading primers.
Soon after the start of the school year, Ms. McDermott started keeping a
journal, recording her time with Andrea to document what she considered an
intolerable situation.
Ms. McDermott wrote of Andrea touching and hitting other students -- albeit
gently, with a kind of slapping motion that didn't pose any threat. Andrea
also threw papers and tore up assignments.
Her behavior could be unpredictable and unnerving. "At story-time, Andrea
turned to children next to her on either side and was making forceful
spitting sounds into their ears," she wrote in an entry for Aug. 31.
"I can't listen because of Andrea," Shaun Hopkins, 6, a general education
student, said recently.
Andrea, who can be quick to smile and laugh and wears a neat part in her
short blonde hair, loves computers and, at home, enjoys listening on
headphones to the Lion King and other Disney movies. But, even when happily
ensconced on a terminal in the back of the classroom, she could grow
frustrated. On Sept. 7, she banged the keyboard with her fists, took off her
headset and threw it down on the keys. Her aide from the mental-health
agency took her out of the room.
On Sept. 27, Andrea, who had been moaning quietly, launched into a
full-throated scream, which lasted from 1:25 p.m. to 2:15 p.m., according to
a journal entry. Ms. McDermott didn't know why. Andrea's aide moved her into
the hall and then to a room in the basement, though the class could still
hear muffled cries, the teacher says.
The school called her mother to take her home. Ms. McDermott says she still
remembers Ms. Gavern picking up her screaming child and carrying her, legs
dangling, past other parents gathered for pickup. Ms. McDermott says she
later learned that Andrea was feeling pain from her feeding tube.
Through December or January, Ms. Gavern says she would have to pull Andrea
out of school and take her home once or twice a week, usually in the late
morning. Ms. Gavern used to work as a property manager for the rental units
she owns with her husband, a real-estate agent. The couple had to hire
others to do her job, so she would be available to pick up Andrea. "I
couldn't do anything because I was waiting by the phone," Ms. Gavern says.
Tensions grew between teacher and parent. Ms. Gavern says she became
convinced that Ms. McDermott didn't want Andrea in her class and, at a fall
IEP meeting, expressed her concerns.
"I don't think she has the knowledge," Ms. Gavern says of Ms. McDermott. "I
don't think she has the support. It's not entirely her fault. She was
overwhelmed. The school system was not there to back her up. I blame them,
too."
Ms. McDermott says she agrees with that assessment, adding that "the system
was not set up for children like Andrea."
On May 3, Ms. McDermott planned an art project painting flower pots for
Mother's Day. "Oh, no! Oh, no!" Andrea shouted, stamping her feet and waving
her arms, before being led out of the room. Andrea had wanted to spend more
time on the computer.
With the art assignment finished, Andrea, dressed in an embroidered blouse,
a pressed khaki skirt and pink sneakers, returned to her place in the back
of the classroom, where she sat next to her mental-health aide. The two
worked on their own, while the class did a reading lesson.
"Do you know six minus three?" her aide asked. "No!" Andrea replied. With
the help of her attendant, Andrea copied the numbers 16, 19 and 20 from a
workbook. "Very nice 20," her aide said.
Later, Andrea briefly rejoined the class. Andrea raised her hand,
volunteering to read a book out loud in front of the class. "All fall down,"
Andrea read, clearly, though from a book simpler than those of her
classmates. "Good job!" Ms. McDermott told her.
Despite such glimmers of hope, the Gaverns have given up on Scranton. This
month, due to their dissatisfaction with Andrea's school, they sold their
house and moved to nearby Clarks Summit. The family had heard positive
reports from other parents about the school system, which may put Andrea in
a separate class for at least part of the day.
"It just hasn't worked out at all," says Mr. Gavern, surrounded by packing
boxes. "Inclusion sounds great on paper. But the [Scranton] school system
isn't prepared."
With the school year just over, Ms. McDermott says she feels tremendous
relief, and the migraine headaches that once afflicted her almost weekly
have disappeared. But she is still struggling with her own future. Ms.
McDermott has decided to stay through the end of next year -- her 31st as a
teacher -- when she can quit with full health benefits and start a new
career.
"It's the end," Ms. McDermott says. "I don't have it in me any more. I used
to think I'd stay forever until they kicked me out. It's sad. It's too sad."
Write to John Hechinger at john.hechinger@ wsj.com3
I agree with ohiopolitical , parents shouldn't have the option to send thier children where they want to. It's the States responsibility to educate the child. Only the wealthy should be able to send thier children to a school of thier choice. Government schools provide a good enough education for everyone . Besides Strickland owes the teachers unions this one. He should be thankful to us for getting him elected.
Scott Piepho said...
Cute, Dave. I hope everyone else knows sarcasm when they see it.
Blogger apparently ate the comment I wrote. My basic point is that the purveyors of the special ed scholarship scheme are less interested in providing alternatives than in sticking the Trojan horse's nose under the tent. This was a bad, overbroad proposal that would have paid wealthy people to do something they are already doing.
I appreciate the story, which is heartrending. But I doubt that any private providers are out there willing to take on the Andreas of the world for $20K/year.
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text:
Unutilized Foreign Tax Credit isn't a tax deductible expenditure: Ahmedabad ITAT
a) Assessee pointed out that in terms of the Explanation 1 to Section 40(a)(ii), bar on deduction under section 40(a)(ii) is confined to only such income tax paid abroad in respect of which tax credit is granted under section 90 or 91. There is no bar on deduction under section 40(a)(ii) in respect of foreign tax for which no tax credit is available.
b) The issue before the Tribunal was as under:
'Whether deduction under section 37(1) could be allowed in respect of foreign tax credit for which only partial credit was allowed in the current year?'
Tribunal held in favour of revenue as under:-
1) As per Explanation 1 to section 40(a)(ii), any sum paid on account of any rate or tax levied includes and shall be deemed always to have included any sum eligible for relief of tax under section 90 or, as the case may be, deduction from the Indian income-tax payable under section 91 and as per Explanation 1 to section 40(a)(ii) any sum paid on account of any rate or tax levied includes any sum eligible for relief of tax under section 90A;
2) The scope of Explanations to Section 40(a)(ii), on which assessee had relied upon so much, it may be noticed that if the main provision does not cover the taxes paid abroad, there cannot be any occasion to include under Explanations to Section 40(a)(ii), taxes in respect of which relief under section 90 and 91 is not admissible.
3) These Explanations do not extend the scope of the Section 40(a)(ii) but rather explain the scope of the said section. If something is covered by the Explanation, it cannot be said that it is not covered by the main provision. If taxes in respect of which tax credit under section 90 or 91 are covered by the proviso, these are covered by the scope of Section 40(a)(ii) as well. And if these taxes are covered by Section 40(a)(ii), the theory that meaning of 'tax' under section 40(a)(ii) must remain confined to the taxes levied under Income Tax Act, 1961 comes to a naught since the taxes in respect of which credits are available under section 90 or 91 cannot be, under any circumstances, imposed under the Indian Income Tax Act.
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redpajama_set_name: RedPajamaCommonCrawl


In ranking the states for CNBC's fourth edition of "America's Top States For Business," we scored all 50 on some 40 measures of competitiveness, almost exactly as we did in 2009.
States received points based on their rankings in each metric. Then, we separated those metrics into ten broad categories, weighting the categories based on how frequently they are cited in state economic-development marketing materials. That way, our study ranks the states based on the criteria they use to sell themselves.
Many states point with great pride to the quality and availability of workers, as well as government-sponsored programs to train them. We rated states based on the education level of the workforce, as well as the number of available workers. We also considered union membership. While organized labor contends that a union workforce is a quality workforce, that argument, more often than not, doesn't resonate with business. We also looked at the relative success of each state's worker training programs in placing participants in jobs.
The best places to do business are also the best places to live. We scored the states on several factors, including local attractions, crime rate, health care, air and water quality, as well as overall perceived livability.
A solid economy is good for business. So is a diverse economy, with access to the biggest players in a variety of industries. We looked at basic indicators of economic health and growth. We also gave credit to states based on the number of major corporations located there.
Access to transportation in all its modes is key to getting your products to market and your people on the move. We measured the vitality of each state's transportation system by the value of goods shipped by air, land and water. We looked at the availability of air travel in each state, and the quality of the roads.
Succeeding in the new economy—or any economy—takes innovation. The top states for business prize innovation, nurture new ideas, and have the infrastructure to support them. We evaluated the states on their support for innovation, the number of patents issued to their residents, and the deployment of broadband services. We also considered federal health and science research grants to the states.
Education and business go hand in hand. Not only do companies want to draw from an educated pool of workers, they want to offer their employees a great place to raise a family. Higher education institutions offer companies a source to recruit new talent, as well as a partner in research and development. We looked at traditional measures of K-12 education including test scores, class size and spending. We also considered the number of higher education institutions in each state.
Regulation and litigation are the bane of business. Sure, some of each is inevitable. But we graded the states on both perceptions as well as hard data about their legal and regulatory frameworks.
Companies go where the money is, and venture capital—an increasingly important source of funding—flows to some states more than others.
The cost of living helps drive the cost of doing business. From housing to food to energy, wages go further when the cost of living is low.


These days, anyone finding a rum three decades old had better hold on to it, because they're getting rarer all the time. As prices for the 1970s and 1980s rums climb past the fourth digit, locating one can be an equally fortunate and frustrating exercise…depending on how it turns out. As to why Velier chose to issue two rums of the same distillation and aging dates, at two different strengths, well, we know he has done this before, most famously with the entire Caroni line and some of the pre-Age Demerara rums.
Of course, it's possible that Velier in this instance worked on the principle of taking a the entire outturn and bottling some at cask strength and the remainder at a more quaffable proof appealing to a broader audience. That's reasonable, I guess (L'Esprit does the same) – yet although the 54% Courcelles 1972 and this 42% version share the same years, there's a difference in that the 54% was laid to rest in steel vats for nearly two additional years, and both are referred to as the dernière distillation which suggests that a bunch of barrels were involved, each with its own peculiarities.
And those peculiarities are important because they make this softer rhum individual on its own merits and different from its brawnier frere. Take the nose for example: it's lovely and sweet, light without actually being delicate. It presents bags of light fruit – pears, ripe apples, watermelons, cherries – that go on forever, to which are added soft red-wine notes, honey, thyme and a drizzle of hot caramel on vanilla ice cream. In a way it reminds me a lot of the Savanna 15 Year Old Porto Finish from Reunion (haven't written about this yet), but somewhat deeper even so, because the scents grow richer over time in spite of its relatively low proof point and their overall mildness.
Tasting a rum like this is a mixed experience – one appreciates the subtlety, but strains to pick apart the notes. That said, it's quite good, with lovely clear and clean notes of light fruitiness – pears again, watermelon again, some grapes, raisins and ripe mangoes, set off by softer nuances that speak of nougat, white chocolate, a flirt of coffee, rosemary, caramel, vanilla, thyme and some florals. It also has a background of honey that I quite enjoy with a profile like this because it strengthens the whole in a quiet kind of way, provides a bed for the rest of the flavours to emerge onto and do their thing. About the weakest point of the whole experience may be how it ends – the finish is short and faint, a zephyr following from a stiff breeze, with just some barely discernible floral and fruity hints and a bit of orange zest and tart yoghurt, and then it's all over.
After writing up my notes, I keep coming back to how differently it presents when rated against the 54% version – it's like they are different branches from the tree, growing in different directions while still conforming to underlying and similar standards (many of the tasting components, for example, are quite similar). The 42% iteration, I have to somewhat reluctantly note, is less when placed next to its masterful stronger sibling. On its own, with nothing else to compare it to, it's quietly, subtly brilliant and will not disappoint the casual drinker. But side by side, its potential clarion call is muted and dialled down, it is deferential and says much less…and when it does, it whispers.
The Courcelles distillery in Grande Terre (one of the two "wings" of Guadeloupe island) was established in the 1930s and closed way back in 1964 when the then owner, M. Despointes, transferred the inventory and equipment to another distillery, that of Ste Marthe. They continued using Courcelles's pot still and distilled this rum in 1972. This is probably the last year any Courcelles distillate was made – I've never been able to find one produced more recently.
The profile does not suggest an agricole, and since Guadeloupe is not AOC compliant, it probably derives from molasses. The taste certainly suggests it.
About that strength differential – in my essay about the Age of the Demeraras, I remarked that the first three releases of Velier Demeraras were all issued at standard proofs because Luca was nervous about moving too fast with releasing >50% cask strength rums. I suspect that he had similar feelings about the 42% version of the Courcelles, which was why it was bottled first – two years later, just when he was putting out the full proof Skeldons in 2005, he went full bore with the rest of the Courcelles stock and never looked back.
Velier's star shone brightly in 2017, so much so that if you were following the October 2017 UK rumfest on Facebook, it almost seemed like they took over the joint and nothing else really mattered. Luca's collaboration with Richard Seale of Foursquare over the last few years resulted the vigorous promotion of a new rum classification system, as well as the spectacular 2006 ten year old and the Triptych (with more to come); and for Velier's 70th Anniversary – marked by events throughout the year – a whole raft of rums got issued from Jamaica, Barbados, St. Lucia, Guadeloupe, Mauritius, Japan….So much happened and so much got done that I had to re-issue an updated company biography, and that's definitely a first. The Age of Velier's Demeraras might be over and the Caronis might be on a decline as the stocks evaporate…but company is in no danger of becoming an also-ran anytime soon.
Still, all these great rums aside, let us not forget some of the older, lesser known, more individual rums they put out the door, such as the Damoiseau 1980 and the Basseterre 1995 and 1997, some of the Papalins and Liberation series, the older Guyanese rums distributed at lesser proofs by Breitenstock…and this one which is on nobody's must-have list except mine. It holds a special place in my heart – not just because it was issued by Velier (thought this surely is part of it), but because the original Courcelles 1972 is the very rum that started my love affair with French island rhums and agricoles…so for sure this one had some pretty big shoes to try and fill.
It filled them and then some. Reddish gold and at a robust 54% ABV (there's another 42% version floating around) it started off with a beeswax, honey and smoke aroma, heavy and distinct, and segued into treacle, nougat, white chocolate and nuts. Not much of an agricole profile permeated its nose, and since it's been observed before that since Guadeloupe – from which this hails – is not AOC controlled and uses molasses as often as juice for its rhums, the Courcelles could be either one. No matter: I loved it. Even after an hour or two, more scents kept emerging from the glass – caramel and a faint saltiness, aromatic flower-based hot tea, and just to add some edge, a fine line of mild orange zest ran through it all, well balanced and adding to the overall lusciousness of the product.
The palate, which is where I spent most of my time, was excellent, though perhaps a little more restrained…some attention had to be paid here. The brutal aggro of a rum bottled at 60%-plus had been dialled back, pruned like a bonsai, and left a poem of artistry and taste behind: more honey, nougat, nutmeg, brown sugar water, and calming waves of shaved coconut and the warmth of well-polished old leather, cumin, and anise, with that same light vein of orange peel still making itself unobtrusively felt without destabilizing the experience. At the close, long and aromatic aromas simply continued the aforementioned and quietly wrapped up the show with final suggestions of rose tea, almonds, coconut and light fruit in a long, sweet and dry finish. Frankly, it was hard to see it being the same vintage as the Velier Courcelles 42% which was tried alongside it, and was better in every way – the 54% was an excellent strength for what was on display and I enjoyed every minute of it.
There's a streak of contrariness in my nature that seeks to resist flavour-of-the month rums that ascend to the heights of public opinion to the point where their makers can do no wrong and every issuance of a new expression is met with chirps of delight, holy cows and a rush to buy them all. But even with that in mind, quality is quality and skill is skill and when a rum is this good it cannot be ignored or snootily dismissed in an effort to provide "balance" in some kind of perverse reflex action good only for the personal ego. Velier, even when nobody knew of them, showed great market sense, great powers of selection and issued great rums, which is why they're just about all collector's items now. The Demeraras and Caronis and collaborations with other makers showed vision and gave us all fantastic rums to treasure…but here, from the dawn of Luca's meteoric career, came a now-almost-forgotten and generally-overlooked rum that came close to breaking the scale altogether. It is one of the best rums from the French islands ever issued by an independent, a cornerstone of my experience with older rums from around the world…and hopefully, if you are fortunate enough to ever try it, yours.
The Courcelles distillery in Grande Terre (one of the two "wings" of Guadeloupe island) was established in the 1930s and closed way back in 1964 when the then owner, M. Despointes, transferred the inventory and equipment to another distillery, that of Ste Marthe. They continued using Courcelles's pot still and distilled this rum in 1972. This is probably the last year any Courcelles was made – I've never been able to find one made more recently.
Distilled in 1972 and set to age in 220 liter barrels until 2003 when it was decanted into "dead" vats, and then bottled in 2005. I chose to call it a 31 year old, not a 33.
The profile does not suggest an agricole, and since Guadeloupe is not AOC compliant, it may derive from molasses…or not. If anyone has definitive information or a link to settle the issue, please let me know.
I'm not an avowed fanboy of agricoles: yet this one may be the best I've ever tried, and certainly among the top tier of rums made anywhere, by any method. Rare, old, powerful, excellent, pricey and, well … yeah it's worth it.
Holy sweet mother of God, where has this rum been sitting? A snarling, awesome 58% beefcake of an agricole (I have my suspicions about this, see below), aged 37 years and one of the best of its kind I've ever tasted. This is where I get up on my soapbox and demand that rum makers start going stronger, higher, more powerful, and move off from the self-imposed limit of 40% ABV. Just tasting this one would tell you how much more intense everything is when you dial it up a few notches.
On my last day in Berlin in August 2012, I popped over to the Rum Depot and asked for whatever they had that was old, unique and preferably rare (this was on top of the eight rums I had already bought that were exceptional in their own way and unavailable in Canada). The co-manager (whose name I have regrettably not written down and have now forgotten, my apologies to the gentleman) trotted out this 500ml bottle from Guadeloupe from his personal stash, and purely on the strength of the tasting, I immediately bought the 47% version, which is the same age, but packing a shade less oomph in its trousers.
The Rhum Vieux Domaine de Courcelles Grande Reserve was distilled in 1972 on the French Caribbean island of Guadeloupe (home of Karukera) and bottled in 2009, and let me tell you, it's phenomenal. It did not have any AOC or terroire marked on the bottle – Guadeloupe has never been quite as intense as Martinique in getting the designation – but frankly, after a careful nosing and even more careful sip (or four), I didn't give a damn. The amazingly strong (yet soft) nose billowed out at me without fuss or complaint, as assertive and friendly as an insistent St. Bernard coming to you over the snow to provide a well-needed dram. Scents of cinnamon, marzipan, breakfast spices and brown sugar melting in the tropical heat argued genteelly for attention, none dominant, none rough, none out of balance with any other. Indeed, I spent an inordinate amount of time simply nosing the thing, and even among all the other tastings I did that day, this was the one to which I continually returned.
All these scents and more carried over to the palate of the medium bodied, straw-coloured rum. The marzipan almost mischievously flirted with turning into a minty flavor (but not quite, otherwise I might have been sourly muttering about toothpaste the way my Dad, the Hippie or the Maltmonster would), the cinnamon added nutmeg, brown sugar, honey and floral notes and for a 58% strength rum, the Grande Reserve was unbelievably deep and even a bit smooth – not without a little sting, mind, yet not raw or uncouth, not the bitchy scratch of rum-claws that made you hunt for your tonsils in Albania, more like the dark heat of strong, well-brewed tea. To call it glorious is to undersell it. It barks. It gurgles. It snarls. It loves you. It makes you shake your head and smile and thank whoever it was for inventing rums because this, by God, is what a rum should taste like. And the finish was nothing short of exceptional – long, lasting and mellow, with closing notes of warm ground after a fresh rain, a shade dry and with a last exclamation point of leather and pipe tobacco.
The Courcelles distillery in Grande Terre (one of the two "wings" of Guadeloupe island) which was established in the 1930s when rum was in its heydey, closed way back in 1964 when the then owner, M. Despointes, transferred the inventory and equipment to another distillery, that of Ste Marthe. They continued using Courcelles's pot still and distilled this rum in 1972 as noted above. What a shame there is so little of it to go around. Note my suspicion that this is not an agricole: even taking into account the pot still origin, it seems a little too heavy and flavourful to come from cane juice, and since Guadeloupe has a history of using rather more molasses than juice to make rum (unlike Martinique where the opposite is true), I feel my take is reasonable…feel free to point me right if you have evidence the the contrary, though.
Premium or true vintage rums are a secondary enterprise for those who make them. Rums live and die at the mid-range and low-end, places and price-points that have never been welcoming to either old-timers or eccentrics. The hoi-polloi sneer at the past and don't bother about the future, aimlessly seeking pleasure only in the amorphous now. Great and well-known legends in other genres have an easier go of it (like whiskies do), and gradually some older rums are finally getting their due. But no matter how reviewers like me flog the alternative, aged, unusual stuff, we know in our hearts that they will always represent a niche market, and be unappreciated by most – and if you doubt me, look no further than dusty Renegade rums gathering spiders webs of neglect in the liquor stores of Alberta.
A rum like this shows up the weakness of that one-size fits all mentality, because if you think about it, rums made for "everybody" (and which sell by the truckload precisely because of that) are actually made for nobody in particular. On the other hand, rums about specific styles, with a complex palate done to exacting standards, with great blending, great artistry and (dare I say it?) great love … these are magical; they make no attempt to seduce us; they are serenely, happily themselves. When you try the Rhum Vieux Domaine de Courcelles Grande Reserve 58% with its amazing profile, you'll understand why it's important we should agitate for more of such exceptionalism, even if it is just for the few remaining barrels of some long-defunct distillery that none but us rum lovers now recall.


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The work, which is reported in this thesis, is concerned with the photochromic processes, or light induced changes of colour displayed by the hexaaryl bi-imidazolyl system.
The thesis includes a study of the solid state photochromic decay reaction, in which the colour change is brougnt about by the dimerisation of triphenyl imidazolyl radicals. Equipment, used in conjunction with a U. V. /visible spectrophotometer, was assembled to allow the process to be followed at various temperatures and from the data accrued a kinetic scheme, based upon a diffusion controlled reaction involving a radical-dinier complex species, has been suggested.
Investigations were also carried out into. the photochromic processes of the bi-imidazolyl system in benzene solution. Based on earlier observations, the work included the study of the effect of variation of the parent dimer concentration upon the generation and decay kinetics of the triphenyl imidazolyl radicals and the related radicals fluorinated on the 2 phenyl ring. Kinetic schemes, most of which have necessarily involved a postulation of radical-dimer complexes of some sort, have been formulated for each radical system at each dimer concentration used. Rate constants for the reactions have been given.
The electron spin resonance spectra for the three fluorinated derivatives of the triphenyl imidazolyl radical have been reported. Assignment of the splitting constants was attempted by use of simple Hückel molecular orbital calculations but this proved largely unsuccessful. Accurate theoretical reproduction of the experimental spectra was thus not achieved. It was decided, that Hückel was in too many ways unsatisfactory for the system, and work on an alternative, more complete molecular orbital approach (that of Pople, Pariser and Parr) was initiated. A computer program was obtained to permit such calculations to be made, and although not all problems had been overcome by the end of the time allowed for this thesis much headway had been made, and guide lines for further work have been suggested.


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This modern, stylish and tranquil two-bedroom FREEHOLD villa sits on 355 sqm of land and is hidden between the beautiful Umalas rice fields. Situated in a complex with 3 other villas, there is a security area and wide parking area available for the complex.
At the time you enter the villa you will be greeted by beautiful garden and large swimming pool. This stunning villa offers you two large en-suite bedrooms on second level, featuring fully equipped kitchen, cozy dining and living room on first level boasting the swimming pool and garden. The property comes fully furnished with modern appliances which make you wont to miss the opportunity to see this property.
Umalas is a great area to be – it still offers beautiful views of rice fields and its blissfully tranquil beaches still maintain its original raw beauty. Located only 5 minutes away from Seminyak and 1.5km from the beach and famous surf spots, Canggu (10 minutes) and Berawa beach (7 minutes).


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95% of All Digital Music Downloads are Still Illegal
It has been reported that 95% of all digitial music downloads are illegal. The Digital Music Report stated that people are buying more music, but the damage caused by piracy will cost until 2015 more than a million creative jobs.
Australia Music Sales in Heavy Decline Across the Board
It seems like the music industry in Australia is in complete free fall. The Australian Recording Industry Association (ARIA) has reported that recording sales dropped 13.9 percent in 2010 by value (complete PDF here). Physical unit sales tanked by 19.5 percent.
EMI Think Apple Has Too Much Control in the Music Industry
UK major label EMI this week railed against Apple's iTunes in the body of its latest annual financial statement. EMI are unanimous in their praise for Apple's achievements in online music sales, but resent the huge slice of the music sales market the company has carved out.
IFPI – New Research On Music Buying Habits
Another new survey conducted in the EU argues that music sharers buy less music over the course of a year than those who are classified as online or physical only buyers. http://www.ifpi.org/content/library/Jupiter_Research_study_on_online_piracy.pdf Oddly iPod owners aren't…
UK Digital Music Market Trends
The UK has seen record levels of digital sales in 2009, with 10 trading weeks and the Christmas period still to come. 117 million singles have been sold so far, with 98.6% of these sales…
Digital Music Store Focus – Recordstore.co.uk
London based company Digital Stores Limited has been building online shops for various high profile clients for the best part of a decade (they were incorporated in '97), and have put up their own record…
Digital Music Store Focus – Napster 2.0 <
Napster originated as a peer-to-peer music service in 1999, one of the first that gained widespread popularity. Unlike modern bit-torrent services it provided a connection between users through a central server, and this direct involvement…
Digital Music Store Focus – iTunes
No prizes for recognizing that logo, this is the biggest music store on the web. The store isn't available using a normal web browser, only by installing Apple's proprietory iTunes software, relentlessly updated to include…
Digital Music Store Focus – Insound
Insound is a minor player with a lot of heart involved in its operation. They essentially act as a blog and record label, picking up and supporting new acts that are to their taste, promoting…
Digital Music Store Focus – iMesh
iMesh is a peer-to-peer platform that has survived the legal harrow of the recording industry. The RIAA brought a copyright infringement case against them, which they settled out of court, and after which they changed…


text:
Chrysolina banksii (Fabricius, 1775)
Subgenus:
CHRYSOMELOIDEA Latreille, 1802
CHRYSOMELIDAE Latreille, 1802
CHRYSOMELINAE Latreille, 1802
DORYPHORINI Motschulsky, 1860
Chrysolina Motschulsky, 1860
The subgenus Chrysolina s.str. includes only 5 species of which 3 are Canary Island endemics, C. staphylea (Linnaeus, 1758), the type species of the genus, is Holarctic, and the present species which is western Mediterranean in distribution extending south to North Africa and north to the U.K.. There is also a population in the Himalayas. Several regional variations, sometimes considered as subspecies, occur; a metallic bronze-green form, chlorizans Weise, 1884 is widespread, ibezensis Bechyne, 1950 from the Balearic Islands, ausonia Schatzmayr, 1941 from central Italy and peloritana Schatzmayr, 1941 from Sicily, the nominate form is widespread and occurs in the U.K. Here it is a local species of coastal or near coastal occurrence from Hampshire to North Wales, including Anglesey and the Isle of Wight, and very local further north; there are a few central and eastern records, mostly from Essex and Kent. The typical habitat is open grassland, heaths, dunes, wooded margins and salt marsh. Adults generally occur year-round, although in severe winters they may fail to survive, overwintering in moss and tussocks etc. near the host plants and becoming active in the spring. New generation adults appear in May and June and feed for a few weeks before they aestivate during the summer, they resume feeding in September and begin oviposition soon after. Eggs are laid in small batches on the underside of host leaves; in the U.K. both adults and larvae feed mostly on ribwort plantain, Plantago lanceolata, but a range of hosts have been recorded including various Lamiaceae e.g. Calamintha ascendens, Lamium, Galeopsis, Marrubium vulgare and Ballota nigra, Asteraceae including Cynara sp. and Apiaceae including species of Foeniculum. Larvae emerge in the autumn and develop quickly, passing through four instars, before overwintering at the base of plants; they resume feeding in the spring and pupate in the soil during April and May. Although local the beetle may be common where it occurs.
Chrysolina banksii 1
A large and dark species; dark brown to bronze, with a distinct metallic reflection and pale, non-metallic appendages. 8-11mm. The head is broadly visible from above in normal setting, the eyes generally hidden within the produced anterior angles of the prothorax. The antennae are pubescent from the seventh segment, and the terminal segment of the maxillary palpi is truncate. Pronotum strongly and evenly narrowed from the base to the apex, the lateral grooves are deep and strongly, often confluently, punctured, and the sublateral suface is strongly convex. The disc is very finely punctured to impunctate. The elytra are a little wider at the base than the base of the pronotum, weakly rounded to subparallel and with scattered strong, almost foveate, punctures and sparse micropunctures. The wings are variously developed but it seems the species rarely flies. The pro- and meso-tarsi are strongly dilated in the male.
In the U.K. the only confusion might be with C. staphylea but this is generally smaller, 5-8.5mm, lacks a metallic reflection and has the pronotum more or less parallel-sided in the basal half.


text:
Chris Dickerson ist der Name folgender Personen:

* Chris Dickerson (Bodybuilder) (1939–2021), US-amerikanischer Bodybuilder
 Chris Dickerson (Baseballspieler) (* 1982), US-amerikanischer Baseballspieler

redpajama_set_name: RedPajamaWikipedia


Happy to discover your blog, Lara.
Yes, I went right to the Jamaica pictures and was rewarded with a feast of gorgeousness. No wonder you love it.
Barbara! Thank you for coming over & visiting. So glad that you enjoyed my pictures from back home – I am longing for another trip!


Cole's momma, daddy, and big brother Carter brought him into our downtown sioux falls studio recently to hang out, and to capture some awesome pics! With a dump truck used for his brothers newborn portraits, and gear from his families tree trimming service; we got so many adorable pictures I can't even stand it!!
Check out the love Carter already has for Cole - melts my heart!
Now booking newborn portrait sessions in our downtown Sioux Falls studio for June, July, and August!


Have you discovered that money has been taken from your credit card from Top Collar Box?
Often customers of Top Collar Box have no knowledge that they have been signed up for a subscription that automatically renews and takes money from your credit card. So that leaves the question: How can you get your money back from Top Collar Box? It can often be extremely difficult and frustrating trying to get the money back once Top Collar Box has taken them from your account.
In many cases, we typically manage to get customers their money back from Top Collar Box within 3-4 days. We know the process and have dealt with Top Collar Box before. We, of course, cant work for free, we charge a fee of 5 EUR for us to process the case. However, we only charge that fee if you actually manage to get your money back!


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Book traversal links for 4.3 Justification and evidence
The recommendation in this section addresses the following question:
PICO question 10 (MDR/RR-TB, 2020): In XDR-TB patients or patients who are treatment intolerant or with non-responsive MDR-TB, does a treatment regimen lasting 6–9 months composed of bedaquiline, pretomanid and linezolid safely improve outcomes when compared with other regimens conforming to WHO guidelines?
This is a new recommendation for a defined patient group; it is to be used under operational research conditions, and thus does not apply to routine programmatic use. Given these limitations, this recommendation complements other WHO recommendations on the use of longer regimens for patients with MDR/RR-TB (see Section 3) because individuals with MDR/RR-TB and additional fluoroquinolone resistance would usually receive a longer regimen comprising medicines from Groups A, B and C, according to their drug susceptibility profile and other parameters. Several conditions are therefore necessary for the implementation of this new recommendation on BPaL, and these are described in Section 4.5.
Treatment of XDR-TB presents multiple challenges to clinicians and NTPs, because of the limited range of medicines available and the life-threatening nature of the disease. Patients with MDR/RR-TB and additional fluoroquinolone resistance have typically experienced poor treatment outcomes since XDR-TB was first described in 2006 (90). Based on data reported by Member States to WHO, for the cohort of XDR-TB patients who started treatment in 2016 (and for whom treatment outcomes were available in 2018), only 39% completed treatment successfully, while 26% died, treatment failed for 18% and an additional 17% were lost to follow-up or were not evaluated (1).
Evidence base and analyses. The pressing need for more effective treatment regimens for patients with extensive drug resistance, including fluoroquinolone resistance and more extensive drug-resistance profiles, has been the driver for a number of studies and initiatives to test more effective and novel treatment regimens, including newer and repurposed medicines. One such study is the Nix-TB study, conducted by TB Alliance. The Nix-TB study was a one-arm, Phase III, open-label observational cohort study that assessed the safety, efficacy, tolerability and pharmacokinetic properties of a 6-month BPaL treatment regimen, extendable to 9 months for those who missed doses, or who remained culture positive or reverted from culture negative to positive between months 4 and 6 of treatment (89). The study was conducted between 2014 and 2019 at three study sites, all in South Africa, with the first patient enrolled in April 2015. Eligible patients were aged 14 years and above, weighed at least 35 kg, had a documented HIV result and had bacteriologically confirmed sputum culture positive XDR-TB or bacteriologically confirmed MDR/RR-TB, but were treatment intolerant or non-responsive to previous MDR/RR-TB treatment. A number of other inclusion criteria were applied (Box 2).
Patients were followed up for a period of up to 24 months after completion of treatment. The primary outcome measure was the incidence of bacteriological failure, relapse or clinical failure (including TB-related deaths) through follow-up until 6 months after the end of treatment. Secondary outcome measures comprised:
• incidence of bacteriological failure or relapse or clinical failure through follow-up until 24 months after the end of treatment (as a confirmatory analysis);
• time to sputum culture conversion to negative status through the treatment period;
• the proportion of subjects with sputum culture conversion to negative status at 4, 6, 8, 12, 16 and 26 or 39 weeks;
• linezolid dosing (actual) and efficacy;
• change from baseline in TB symptoms;
• change from baseline in patient reported health status; and
• change from baseline in weight.
The Nix-TB study regimen comprised pretomanid administered at 200 mg once daily, bedaquiline administered at 400 mg once daily for the first 2 weeks of treatment (days 1–14) and then 200 mg three times a week thereafter, and linezolid commenced at 1200 mg per day (additional information on linezolid dosing is included in Section 4.5) (89). Close microbiological, clinical and adverse event monitoring were features of the Nix-TB study (89).
The evidence to inform PICO question 10 was derived from the Nix-TB study, and included information on 108 patients. The total study population was 109 patients, but one patient withdrew informed consent to participate in the study; this person was included in safety analyses but not in the analyses for effectiveness. These data were compared to a subset of data from the IPD, which overall included 13 273 individual patient records from 55 different studies or centres in 38 countries. For the primary analyses, the comparator group included patients from the IPD on longer treatment regimens (with a mean duration of treatment of 21.0–25.5 months), who received both bedaquiline and linezolid as part of the regimen (no patients received pretomanid in the IPD). This comparison group included data of 456 patients reported from Belarus, India, France, Russian Federation and South Africa, and from one study in a group of countries.⁴⁹ The intervention and comparison groups were matched exactly for XDR, MDR and fluoroquinolone resistance, and for HIV status, with propensity score matching for the variables of age, sex, baseline culture result, extent of disease (determined by baseline AFB smear or chest X-ray findings of cavitation or bilateral disease if the AFB smear result was missing) and country income level (using the World Bank Atlas method (91)). Treatment outcomes used in these analyses comprised the investigator-defined outcomes for the intervention group (i.e. for the Nix-TB study) and those largely based on WHO definitions⁵⁰ for the comparator group (i.e. for the patients included in the IPD). To allow an equal opportunity for treatment outcomes to occur from the start of treatment when comparing the two groups, all outcomes were included from the start of treatment to 24 months after the start of treatment. Thus, in the intervention group, these outcomes occurred after completion of treatment and in the comparator group the outcomes were end-oftreatment outcomes (because patients in the IPD received a longer regimen and were not followed up after completion of treatment). Three other comparator groups from the IPD included patients on longer treatment regimens who received one of the following: a regimen that included bedaquiline, a regimen that included linezolid, or a regimen that included neither bedaquiline nor linezolid. The GDG's initial intention was to assess the intervention regimen against all three comparison groups; however, during their deliberations, the panel agreed that the judgements should be based on the comparison group who received bedaquiline and linezolid as part of their regimen, because these patients most closely resemble patients who would receive currently recommended longer regimens composed with medicines from Groups A, B and C. However, a direct comparison of BPaL with alloral longer regimens constructed according to the most recent WHO recommendations issued in March 2019 was not possible, because these regimens may have only been in use since mid-2019, so treatment outcomes for these patients are not yet available. Based on an assessment of the certainty of the evidence, carried out using predefined criteria and documented in GRADEpro, the certainty of the evidence was rated as very low.
Additional data reviewed by the GDG relevant to PICO question 10 were a cost–effectiveness analysis, a study on the acceptability and likelihood of implementation of the BPaL regimen, modelled pharmacokinetic data based on the development of a pharmacokinetic toxicodynamic model, and a summary review of preclinical and early clinical data on pretomanid. The cost–effectiveness analysis, acceptability study and modelled pharmacokinetic studies were conducted along with the Nix-TB study and were sponsored by TB Alliance.
The aims of the cost–effectiveness study were twofold:
• to estimate the cost–effectiveness of a new regimen (BPaL) compared with the standard of care at a given price; and
• to estimate the maximum drug price at which the BPaL regimen could be considered cost effective or cost neutral in each setting.
There were two patient populations: XDR-TB patients; and XDR-TB patients combined with MDR-TB patients who failed treatment or who were treatment intolerant. The comparison treatment regimen was the standard of care in Georgia, the Philippines and South Africa, and the main outcome of interest was the incremental cost per disability adjusted life year (DALY) averted. A health service perspective was taken.
The objective of the acceptability study was to assess the acceptability and likelihood of implementation of the BPaL regimen as anticipated by key stakeholders based on a number of criteria including perceived benefits and challenges of implementation of BPaL and also longer individualized treatment regimens and other practical requirements of implementation. The study was a mixed-methods, multicountry, cross-sectional study conducted in 2018–2019 among stakeholders in Indonesia, Kyrgyzstan and Nigeria. A total of 188 participants offered their views; they included caregivers, programmatic stakeholders (including national and international programmatic stakeholders and patient advocacy groups), and public and private laboratory stakeholders.
Additional evidence presented included modelled pharmacokinetic data based on the development of a pharmacokinetic toxicodynamic model designed to quantify the relationship between pharmacokinetic features of linezolid and toxicity as part of a 6-month BPaL regimen. Modelled data from 88 patients who received linezolid as part of the Nix-TB study were presented. This patient population included information on seven patients who had died. A total of 21 individuals from the Nix-TB study were excluded from these analyses – 16 because they had incomplete dosing histories (i.e. they were receiving ongoing treatment at the time of analysis) and five because they had an unverifiable dosing history.
Additionally, the GDG was presented with an independent summary review of the preclinical and early clinical data on pretomanid. This review included background information, preclinical data and early phase clinical data detailing safety and efficacy, including data submitted to the United States Food and Drug Administration (US FDA) as part of the original new drug application or as supplemental information.
GDG considerations. The GDG considered the desirable effect of treatment success, which was higher in the intervention group than in the comparator, for all four treatment outcomes assessed. Overall, when comparing treatment success versus failure or recurrence, the treatment success rate was 97.0% in the Nix-TB study and 91.7% in the comparator group (resulting in 6 more outcomes of treatment success per 100 patients). For the comparison of treatment success versus death, treatment success was 93.2% in the Nix-TB study and 91.9% in the comparator group (resulting in 1 more outcome of treatment success per 100 patients). For the comparisons of treatment success versus failure, recurrence or death, and treatment success versus all unfavourable outcomes combined (i.e. failure, relapse or death, and loss to follow-up) the proportions of patients with treatment success in the intervention and comparator groups were 90.5% versus 84.8% (6 more outcomes of treatment success per 100 patients) and 88.9% versus 82.2% (2 more outcomes of treatment success per 100 patients), respectively. Based on these figures, the primary analysis yielded adjusted odds ratios of 3.3 for treatment success (versus the combined outcome of failure and recurrence; 95% Cl: 0.8– 13.7), 1.0 for success versus death (95% Cl: 0.1–8.2), 1.8 for success versus failure, relapse or death (95% Cl: 0.7–4.4), and 1.2 for success versus all unfavourable outcomes (95% Cl: 0.5–3.1), with a mean duration of follow-up of 24 months (range 21.0–25.5 months), when BPaL was compared to longer regimens containing bedaquiline and linezolid. The GDG considered lower rates of loss to follow-up as a desirable effect; the proportion of patients who were lost to follow-up was lower in the intervention (BPaL) group (1.8%) than in the comparison group (3.1%); however, this difference was not considered by the panel to be large. The panel also considered that a shortened duration of treatment and less drug exposure were desirable effects of the intervention, and that both of these were components of the overall burden of a given MDR/RR-TB treatment regimen, which may not be wholly reflected in rates of loss to follow-up alone. Subgroup analyses could not be undertaken because of the small sample size.
The BPaL regimen was also associated with a high rate of adverse events, relative to the study drugs, which was a concern for GDG members. Of the 109 patients in the Nix-TB study, 28 (25.7%) experienced at least one serious adverse event. This included one (0.9%) death related to acute haemorrhagic pancreatitis, 29 (26.6%) other serious adverse events including hospitalizations and lifethreatening events, and two (1.8%) adverse events that resulted in persistent or significant disability or incapacity. A total of 53 (49%) patients experienced at least one Grade 3–4 adverse event considered to be related to the study drugs; these comprised 25 with peripheral neuropathy (11 resolved), 16 with increased hepatic transaminases (13 resolved), nine with haematologic adverse events (all resolved), eight with increased pancreatic enzymes (7 resolved) and two with optic neuritis (both resolved). This led to all three drugs being discontinued in one patient, and linezolid (initial dose 1200 mg/day) being discontinued in another 35 (32%) patients. Only 20 (18%) patients completed a full course of linezolid at 1200 mg/day. The GDG discussed the difficulty of comparing these adverse event rates with other studies, owing to major and important differences in ascertaining, assessing and reporting adverse events. However, in the IPD studies (where 90% of patients received a linezolid dose of ≤600 mg/day), the pooled rate of permanent discontinuation of linezolid was 17.9%, and in the endTB observational study (where all patients received a linezolid dose of ≤600 mg/day), the rate of linezolid discontinuation was 13.1%. In both of these studies, more than 80% of patients received a starting dose of linezolid of 600 mg per day. In preliminary analyses of the endTB observational study, nine patients out of 1094 (0.8%) died of an adverse event that was possibly or probably drug related, including two individuals with sudden cardiac death; these two patients were receiving bedaquiline, clofazimine, capreomycin and p-aminosalicylic acid, and both had hypokalaemia.
Information from the independent review on the preclinical and early phase clinical data highlighted that pretomanid possesses activity against replicating and non-replicating bacilli that is both concentration and dose dependent. Safety signals were comprehensively described, many of which were observed at exposures that are higher than would be used in humans; however, safety signals of note included liver toxicities (hypertrophy of hepatocytes, transaminase elevation and increased liver weight, observed at higher doses in rodents and lower doses in monkeys) and reproductive toxicities in males observed in animal (murine and simian) models, which appear to be both time and dose dependent. The observations in monkeys may have been due to the general decline of health in these animals; however, the same signals were observed in rodent models, with some evidence that these effects may be irreversible. In mouse models, these effects were observed at exposures that would be used in humans, and in females, reproductive toxicities were also observed.
Additional information on adverse events presented to the GDG included the results of a pharmacokinetic toxicodynamic model (Savic R, unpublished data, University of California, San Francisco, November 2019). Based on these data, it was concluded that the pharmacokinetics of linezolid are nonlinear in XDR-TB patients, and that individual linezolid concentration–time profiles are the best predictor of toxicity. Higher toxicity rates were observed at higher total daily doses, with comparable toxicity rates for BID (twice a day) and QD (once a day) dosing schedules. The results of the modelled data highlighted that anaemia can be managed by closely monitoring changes in haemoglobin over the first 4 weeks of treatment (in particular, changes in haemoglobin >10% decrease from baseline should trigger a reduction in the dose of linezolid; haemoglobin levels recover well after dose reductions). Thrombocytopenia was not a major concern. The study investigators recommended that peripheral neuropathy should be closely monitored; based on the modelled data, when peripheral neuropathy did occur, for most patients, it was reversible within 3 months. The GDG was concerned that the two studies had different findings with regard to reversibility of peripheral neuropathy (i.e. one study found that it was largely reversible, the other study had different findings).
The panel considered at length the desirable and undesirable effects, and the balance of these effects, noting the very low certainty of the evidence and acknowledging the efforts to match patients in the intervention and comparator groups (through exact and propensity score-based matching). Overall, the GDG agreed that the BPaL regimen showed high rates of treatment success when used in XDR-TB patients in South Africa, and they noted the additional positive treatment outcomes resulting from the use of the regimen when compared with patients receiving longer regimens with bedaquiline and linezolid. However, there were important residual concerns about the likelihood and severity of adverse events, possible reproductive toxicity signals in the preclinical data, limitations in the study design and the overall very low certainty of the evidence. The GDG was concerned that the Nix-TB study was a one-arm study with no in-study comparison group, including 109 participants overall recruited from one country setting (South Africa), with the inclusion of a group of patients who were sputum culture negative at baseline, and many patients receiving second-line treatment of variable duration before being enrolled on BPaL. The GDG agreed that this might limit the generalizability of the study findings to all populations and to all regions.
The GDG was concerned about issue of serious adverse events, particularly those related to linezolid, and pretomanid-associated potential safety signals related to male infertility observed in animal models (murine and simian). They highlighted the potential difficulties in monitoring infertility in a programmatic setting. Additional human sperm studies recommended by the US FDA will be carried out by TB Alliance; however, these data were not available for the GDG to consider at the time of the meeting. The GDG determined that infertility is a serious issue because it affects both patients and their families. The GDG also acknowledged that, at the time the Nix-TB study started, treatment options for patients with MDR-TB and additional fluoroquinolone resistance were limited in South Africa, with an associated high case fatality rate, which meant that patients may have placed a different value on potential male infertility at that time than they might now. The judgement about the balance of the desirable and undesirable effects was therefore assessed as not favouring the intervention or the comparison.
With regard to how much patients might value the outcomes, no research evidence was available for the GDG to consider. Although no research evidence was identified, the GDG felt that there was possibly important uncertainty or variability in how much people would value the main outcomes. Fertility was raised as an outcome for which there is less information at the present time. The GDG thought that this issue would increase the complexity of the judgement about how much people would value the outcomes. They discussed the fact that there are other safety outcomes (e.g. other adverse events, including peripheral neuropathy) that may vary, and that people may value these outcomes differently. The GDG considered indirect evidence in the form of a separate qualitative study conducted among 16 drug-resistant TB patients from high burden countries (which informed the judgements on PICO question 2, described in Section 2). The aim of the study was to determine the most acceptable treatment regimen for drug-resistant TB from the patient perspective. Based on the results of this study, the preferred MDR/RR-TB treatment regimen from the perspective of the patients who were interviewed was a short, injectable-free regimen with few to no physical or mental health side-effects, and a low pill burden.
The cost–effectiveness study determined that the use of BPaL for the treatment of XDR-TB is likely to be cost saving at the proposed price (US$ 364 per treatment course for pretomanid), in the settings in which it was studied. The study found that cost savings are a function of the cost of care and the magnitude of XDR-TB burden, and are about US$ 4490 (not including ART costs) in South Africa, US$ 4060 in Georgia and US$ 3860 in the Philippines. In high HIV-TB prevalence settings, such as South Africa, related future costs such as those from the HIV programme (ART costs) reduce the magnitude of expected cost savings to US$ 1400 per patient. Overall, when BPaL is introduced to a larger population (including MDR/RR-TB treatment failure and people with MDR-TB who are treatment intolerant), the GDG observed an increase in the incremental benefits, both in terms of deaths and DALYs averted, and incremental costs. The study investigators concluded that the impact of BPaL on costs and DALYs averted will depend on the overall performance of the NTP (e.g. considering rates of loss to follow-up or mortality). The GDG noted that food costs were not included in the cost– effectiveness analysis, and would need to be considered when BPaL is implemented. During the Nix-TB study, all study medications were administered with food (attributable to the administration of bedaquiline, which will also now feature as a core medicine in longer treatment regimens for MDR/ RR-TB). The GDG noted that the cost–effectiveness analysis was not specific to the other evidence that was presented; most importantly, the undesirable effects were not considered according to the GDG's judgements. This made the cost–effectiveness analyses informative, but not directly based on the evidence that the GDG was assessing.
Although no research evidence was identified on equity, the GDG felt that the impact on health equity would be a probable increase, given the option of a shorter regimen that could be available to all patients, globally. The GDF identified a price for pretomanid and stated that it will make the BPaL regimen available to NTPs, depending on the recommendation from the panel. Children and pregnant women were ineligible for inclusion in the Nix-TB study, and therefore will not be an eligible population for BPaL at the present time.
Acceptability was higher for BPaL than for the longer MDR-TB regimens in six of the seven acceptability categories assessed (ranging from patient friendliness to treatment safety monitoring), with the exception of treatment safety monitoring, where the difference was negligible. The main drivers of the acceptability of BPaL were the shorter duration, absence of injectables, lower pill burden, anticipated patient preferences and lower financial burden for patients, anticipated higher treatment success, lower costs for the health system, minimal additional requirements for diagnostic processes, and a lower anticipated per patient burden to TB laboratories for bacteriological treatment monitoring. The GDG thought that the intervention was probably acceptable to key stakeholders. There were residual concerns about the acceptability of the intervention, given the potential reproductive toxicities (which were not specifically discussed with study participants because they were not known to the study investigators at the time) and the comparator that was used in this study (which was not the same as the comparator assessed by the GDG). Therefore, the GDG felt that the acceptability study was informative, but was not based directly on the evidence that was assessed.
In line with the overall high acceptability of the BPaL regimen, the likelihood of implementing the BPaL regimen as a standard of care for the treatment of patients with XDR-TB and MDR-TB treatment failure or persons with MDR-TB who are treatment intolerant scored at 88%; only 1% of the 166 participants scored the implementation as "unlikely", and 11% had a neutral opinion. The likelihood of implementation was similar for the BPaL regimen as a standard of care for MDR-TB patients with fluoroquinolone resistance, with a score of 84%, regardless of additional resistance to second-line injectables. This indicated that those interviewed generally felt that it may be feasible to implement the regimen.
The GDG noted that more research studies are needed in the future, which may allow a more closely aligned comparison group, with less potential for residual confounding and more certainty in the evidence overall. The GDG also emphasized that it will be necessary for WHO to review, revise or update this guidance, as additional substantive data on the efficacy and safety of the BPaL regimen become available. Therefore, as the evidence base on the use of BPaL increases, researchers and NTPs are encouraged to make these data available for international policy-making.
Unpublished data. After the GDG meeting, the TB Alliance shared with WHO an additional report (unpublished and confidential at the time of the release of the current guidelines) that included comparison of data from the Nix-TB study with a cohort of patients with XDR-TB, treated at one of the study sites. The comparison group in these analyses comprised 102 XDR-TB patients treated in a programmatic setting in South Africa, between November 2013 and April 2016. All patients in the comparison group had laboratory-confirmed XDR-TB, with TB isolates resistant to rifampicin, isoniazid, ofloxacin and amikacin. About half of the patients in the comparison group had HIV infection (51.0%). These comparative analyses were carried out by a data analyst under contract to the TB Alliance, who used a methodology that differed from that used for the analyses that informed the WHO recommendation on the use of BPaL presented in these guidelines, and no IPD were provided. Thus, the comparative analyses are not directly comparable to the analyses presented in Annex 3. Although this report could not be considered by the GDG during the November 2019 meeting (given that is was not made available until after the meeting), it was reviewed by the WHO Guideline Steering Group and the GDG before finalizing the guidelines document. The comparison in this report reinforces the positive treatment success rates that have been observed with the use of the BPaL regimen. In these analyses, the treatment success rate for patients receiving BPaL was 89.9% (98/109) versus 66.7% (56/84) for patients receiving another XDR-TB regimen that also contained bedaquiline and linezolid, yielding an adjusted risk ratio of 1.31 (95% Cl: 1.11–1.55, P=0.0012). The detailed data that supported this comparison, together with the results of operational research in other settings, may be useful for informing policy recommendations on the use of BPaL in the future.
⁴⁹ China, Philippines, Republic of Korea, Russian Federation, Thailand.
⁵⁰ These treatment outcomes conform to the definitions outlined in the paper by Laserson K.F. et al. (2005) (93) or in the WHO publication: Definitions and reporting framework for tuberculosis – 2013 revision (94).