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Архив за 22 сентября 2010

От плохого пап Тайна Коробки: Десять Клейма JJ Abrams проекта

от администратора на Sep.22, 2010, под Area 51

c32c4 20100915 jjabramsonset 190x190 From Bad Dads to Mystery Boxes: The Ten Hallmarks of a J.J. Abrams Project

Фото: Paramount Pictures

Через четыре сезона Felicity, пять сезонов Alias, Lost пилот "," Миссия невыполнима 3, Star Trek, бахрома, новое шоу сегодня Undercovers, и за ее пределами, творчество Джей Джей Абрамс была ослепительно разнообразной и плодотворной. Но это не имеет значения whethe г он имеет дело с любовью-запутанного студентов, путешествия во времени, или насмешливо SP х годов - определенные архетипы, стилистические заметки, творческие подходы, и тем REC Ура снова и снова. После тщательного просматривание всего тела Абрамс работы , Мы обнаружили следующие признаки десять его творчестве. И когда вы настраиваете я N сегодня вечером Undercovers, Вы обязаны видеть по крайней мере пять из них в PIL OT одиночку.

1. Папа вопросам. Производится сценарий Абрамс вторым, касается Генри, вокруг мужа и отца, так нарциссической, интимности-фобических, неэтично, и заинтересованы в его жену и дочь десятилетнего ребенка, что он принял выстрел в голову, чтобы заставить его пересмотреть свою позицию во главе dinne г таблице. Парад пап Абрамс в изгоев, которые следуют может сделать сирот очень повезло. Алкогольные Андрей Ковингтон (Джон Риттер) сделал схождение керлинг поступления на к серийным сжать его сын Фелисити Портер (Keri Russell) на Фелисити, и Ja CK Бристоу (Виктор Гарбер) занимает совершенно беспринципный подход к отцовству В первом сезоне Alias. Но как побледнел по сравнению с Lost "плохо-папа тройной выигрыш: презрительным призрак Бузер Джека папа (который может или не может были boink ING его дочь-в-законе за Абрамс-соавторстве сезона три нож); Сойер € ™ S homicid др. / суицидальных старика, и воровство поп Локка почек характер. Fringe центров на поводке , Оливия, определяющей детства момент был застрелил ее оскорбительные stepfathe г в нежном возрасте девяти лет, и каждую неделю он действует из драмы между ума так N (Джошуа Джексон) и сумасшедший гений отца (Джон Ноубл). И когда он был в свою очередь JJ перезагрузки S смолы Trek, он reimagined франшизу как космическая опера построена вокруг двух детей, Ки РК и Спок, оказавшихся в длинные тени пара мощных отцов.

2. Fing erprints везде. Как будто писатель-режиссер-постановщик уже не хватает дефис, почти смешно продуктивной Абрамс также пишет музыкальные темы T О Fringe, Alias, и Фелисити, и участвовал в создании открытия названия для Alias, пт Нге, и проиграл. (Это парадигматических дрейфующих буквами? Абрамс бросил, что от Дур ING звук-микс сессий для пилота.) Абрамс, чей дед владел компанией , которые сделали электронику наборы, всегда был одаренный, Tech-одержимый, NAT Урал-родился ремесленника. Он даже troubleshot визуальных эффектов для М: I3, зарабатывая последней перечисленных кредит в конце обход гораздо менее известные эффекты техников.

3. Чистый Пыток. Что-то должно быть нажата, когда Абрамс пишет щекотать пыток сцене г Мел Гибсон и характер подруга его в своих ранних спектр сценарий, навсегда Молодые. Потому что вещи только обострилась оттуда, с ним часто включения / а г меньше giggly способы сделать его герои говорят. В первые несколько секунд Al МСФО премьера, Гарнер голову Дженнифер была жестоко dunked в туалет. В М: I3, Том Круз, чтобы OK на экране shellacking (в комплекте с климатическими временное самоубийство и ад-L ibbed дефибрилляция), который представляет карьеры высокими для punishm характер Круиз ЛОР. Учитывая ключи к Trek франшизы Star, Абрамс reenacted Кита Угорь в terrogation от Гнев Хана, хотя в Клингонский Nero тюрьмы-лагеря пыток ESCA PE оказался на полу монтажной.

4. Кризис сейчас, объяснение позже. Абрамс любит, чтобы начать его фильмов (и пилотов), бросив нас прямо в середине некоторых хаотических опасности, создание напряженной тон, а затем резервного копирования, чтобы заполнить как W E получили там: и М: I3 (номинальная римейк пилот серии Alias) и звезды Tre К начать в полной драматических кипятить перед прошивкой назад (или вперед, в случае T РЭК), как все это началось. Мы встретились Alias ​​'S Сиднее середине утопление, то молнии к ней с экзамена в школе. Актерский состав Lost встретились и смешались для Впервые на фоне все еще ​​взрываются обломков рейса 815:. MI 3 ногами Долой пытки сцены, который разрешает пятью барабанами позже. Очень разные обречены полета вспыхнули в воздухе липкий апокалипсис в первые моменты Fringe. Показать Абрамс начинается с Chokehold, а не для рук. Он хватает вниманию Fi аудитория первого, и только после он установить, что на самом деле происходит.

5. Girl Power. В eightie S, Джеймс Камерон был чемпионом женщины герой действия, но в форуме он ма nned с Сэм Уортингтон. Теперь Абрамс (наряду с Джосс Уэдон) остается ди лучших сотрудников задницу-кикер друг. Женщины заботился о бизнесе в Alias, Lost, М. И. : 3, бахрома, и Undercovers, хотя в отличие от других показателей, девушка действовать жестко , Абрамс не нужно ремень ружья или значок на своих героинь, чтобы дать им силы. Будь студентка (Фелисити) или беглых (Кейт), девочки JJ's имеют власть и характер нюанс, чтобы сэкономить.

6. Время ничего не значит. В саге Абрамс, символ Характер прошлое не только несовершенным, Ита ™ с непостоянным. В год звезда последний путь перезагрузки, ABR AMS, Роберто Орчи и Алекс Курцман так искусно плетеных характер предыстории с сюжет путешествия во времени мести, что они полностью перезапуске франшизы, wipi нг чистой Библейской истории, которые стали безнадежно запутанным. Lost 'S мигает вперед, назад, вбок D создал жанр конкурирующих сетей плагиат транспортных средств (девять, D aybreak, Flash Forward), которая работала на скользких рельсов времени. Даже Фелисити попал с странной самомнение путешествия во времени, в котором она вернулась из будущего через заклинание ее гот соседа по комнате. Эй, вы чего-то начинать ...

7. МакДжи uffin тех пор, как Хичкок, "тайна окне" была основным кино, точили ей, что это шипение атомной ящика Пандоры в Kiss Me Deadly, ковчег в рейд ERS В поисках утраченного ковчега, или Pulp Fiction 'S светящиеся портфель. И, как объяснение Абрамс INED в его TED Talk мастер-класс на рассказ , концепция всегда fascin ated его. Наряду с клипами и PowerPoint слайды, Абрамс показал аудитории TED обломки окно Kleenex он скрывал в своем гостиничном номере и магии-S хоп Тайна Box как правило, на дисплее в своем кабинете, который остался нетронутым с Он купил его в детстве. И фильмография Абрамс комплектуется участка зарядки ING тайну коробки, тотемы, и Grails, являются ли они открыли намеренно (Lo 'St' S люк, Star Trek с красной материи), случайно (воздушный поток заморозить тело г в Forever Young, Area 51 коробки автомобиля в Super 8 прицепа), или не все ( 's Mystery Mae клад на шесть градусов, в соседа по комнате Фелисити Меган волшебный ящик, и, если серьезно, то, что "кролика ногой" в M: I3). Конечно, его навязчивая идея избавиться расслоений и раскрывает выходит за рамки фильмов и показывает себя, его вирусной кампании и myste rious тизеры создали его как одного из самых драматических шоуменов Голливуда. В руках Абрамса's, секретность-S hrouded проекты, как Монстро и Super 8 стать фан-щекочущее тайну окне ES, которые только развернул в день открытия.

8. Заговор Абрамс в упорной паранойи Большой Abou T правительствами, корпорациями, и темные учреждений бы Франц Кафка Pro уд, и он якорей многие его заговоров в весе зловещий миф и G ravity факта. Мило Рамбальди в Alias ​​комбинированных Винчи гений Da с Nostrad непроницаемой псевдо-AMuS в мистике. Lost 'S Фонд Хансо и Дхарма инициатива вызвала озадачивает й EW научно-магическое-духовного двойного пересечения ". S Fringe размерности spannin г правительственных тайной войны обязан как много Джозеф Кэмпбелл также Parallax Vie Вт. В следующем году Super 8 будет распаковать сценарий, который сочетает в армии США расстояние urbing практике реальные перемещения потенциально опасных грузов по железной дороге с слух S о чужеродных коллекцию аппаратных Area 51 в.

9. Поговорите с камеры. Абрамс и других в своей Bad Robot стабильной успешно торгуются на макет Doc троп F или лет, даже до точки, где Абрамс гостевой направлены эпизод Управления . Хотя фильм-школы Фелисити видео камера "docuvent" заговор устройство может деформации просмотра patie NCE столько, сколько он получил на нервы Sean Blumberg поставим-на друзей, гвоздика с использованием rfield "из Lo-Fi видео стал мастер-класс в травления малых реализма и непосредственность в G odzilla размер участка - все, помогая сохранить бюджет небольшой.

10. Грег Грюнберг , Вечный ролей За время его двадцатилетней карьеры восходящей траектории, Абрамс сделал забудьте сохранить знакомые лица для поездки, особенно хи ldhood другу Грюнберг, регулярно на псевдоним и Фелисити который выскочил в сом E емкости (от больших вспомогательную роль, чтобы голос за кадром) в поразил Bad Robot Pro ductions. Как и другие завсегдатаи Абрамс (такие, как актриса Аманда Форман, композитор М ichael Джаккино, и редактор Мэри Джо Марки), он, кажется, удачи шарм-S tatus, и, несомненно, будет продолжать формировать вселенной Абрамс, в любом количестве размеров и пространственно-временных континуумов.

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Фремонт студенты собираются для утренней молитвы

по администратора по Sep.22, 2010, под Area 51

Небо было еще темно, когда студенты начали сбор перед Фремонт средней школе сегодня утром.

Но, как небо облегченный, студенты пели хвалебные песни. L Атера, они собрались в круг вокруг полюса флага молиться. Около 100 студенты встретились в 7 часов утра для встречи на полюс - часть общенациональной событий в ходе которого молодежь молиться за свою школу, учителей и руководителей.

Более 2 миллионов студентов из всех 50 государств участвовать в мероприятии, которое началось в Техасе в 1990 году. Студенты я п более чем 20 стран принимают участие, заявил Увидимся на литературу полюса.

Студенты, собравшиеся в местной средней школе сегодня, начали утром спокойно петь такие песни, как "вечный Бог", "Blessed Be Ваше имя" и "Сегодня днем".

После формирования круга, студенты по очереди молятся в микро- телефона.

Второкурсник Райан Пеннингтон молился, чтобы Господь будет держать студентов-й Ронг и что люди будут видеть, что они были христианами их любви. Он поблагодарил й E Господа за что позволяет студентам объединяться.

"Это потрясающе, как мы можем прийти к нашей школе и хвала вам," он молился.

Тхи S исполняется 20 года для национальных события. Локально, студенты также могут принять годовых РТ в братство христианского исследования спортсменов Библии. И новые, во главе со студентами Bib Le исследование, названное района ಳ, началось также, сказал Тони Лесли, одной из молитвы лидеров для встречи на полюсе.

"У нас большой явки," он сказал по изучению Библии, отметив, что число участника S стали возрастать с 32 студентов приняли участие в первой.

"Люди слышат о нем и ENJ Oy его и пригласить своих друзей ", сказал Лесли.

Студенты на события сегодня утром сказал, почему они все понравилось.

"Я думаю, что это действительно здорово как куча дети могут собраться вместе, чтобы прославить нашего Создателя, "Джейк Хармс говорит.

Хотя Лесли и Хар MS являются пожилые люди, студенты сказали, что они считают underclassmen усиливают U р и возьмет на себя руководящую роль в следующем году.

Хармс считает события, как См. Yo и на полюсе хорошие ", так вы можете видеть, что другие люди имеют те же убеждения, как вы и что Вы не там один. "

Лесли отметил Кристиан студенты могут иногда испытывают чувство alonen ESS.

"Прогулка по залам в школе, он может чувствовать себя таким образом", сказал он. "Но в этом году, мы сделали много мероприятий, которые мы получили к Пуанкаре Т, где каждый раз, когда вы идете по коридору, вы видите кого-то (человек христианин).

"Это намного легче жить нашей веры, когда мы видим, мы не только там", добавил он.

Студенты также собрались на Фремонт средней школы для встречи на полюсе.

Увидимся на митинге полюс запланирован на 7 вечера Tod ау в евангелической свободной церкви, 2050 N. Lincoln Ave., в Фремонт.

Мероприятие включают музыку, молитвы, некоторые игры и угощения. Все студенты приглашаются.

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До-до-минутный Tracker всех Super 8 утечки, вирусных подсказки, новости, и спойлеры

по администратора по Sep.22, 2010, под Area 51

Каждый день чуть больше новостей сочится из о таинственных следующий Джей Джей Абрамс фильм, Super 8, из-летом следующего года и только начинает стрелять в настоящее время в Западной Вирджинии: Некоторые из этих самородков выступить против его воли, некоторые новости тщательно утечка, и некоторые из них вид загадочные вирусных намекает, что Абрамс и его компания, Bad Robot, А. Р. E известны озорно дриблинг в продвижение новых проектов. Мы считаем, что знаете основной сюжет (не благодаря Абрамс!): показатели указывают на это составляет около грузовой поезд из района 51 - который перевозил нечто чуждое и в живых "Сбой за пределами Среднего Запада малые города в 1979 году, и группа подростков, которые около pture это на пленку а возиться с кинокамерой дома. (Вы даже можете увидеть один из этих детей в флэш-кадра в конце прицепа.) Но мы голодны, чтобы найти больше. Таким образом, Vulture будет отслеживать все дразнилки, намеки, и спойлеры и обновление этого слайд-шоу, как они сочиться. (Не волнуйтесь: все спойлеры будут тщательно Помечено в.) Вот что мы знаем до сих пор ...

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Up-To-The-отелей Tracker всех Super 8 Утечки, вирусных подсказки, новости и спойлеры

по администратора по Sep.22, 2010, под Area 51

Каждый день чуть больше новостей из струйки о таинственных следующего фильма Джей Джей Абрамс, Super 8, из-летом следующего года и только начинает стрелять в настоящее время в Западной Вирджинии: Некоторые из этих nugge ts come out against his will, some news is carefully leaked, and some are the ki nd of cryptic viral hints that Abrams and his company, Bad Robot, are known for mischievously dribbling out in advance of new projects. We think we know the bas ic plot (no thanks to Abrams!): Indicators point to it being about a cargo train from Area 51 — which was transporting something alien and alive — crashing outside a small Midwestern town in 1979, and a group of teens who capture it on film while messing about with a home movie camera. (You can even see one of thos e kids in a flash-frame towards the end of the trailer.) But we're hungry to find out more. Как such, Vulture will be tracking all the teasers, hints, and spoilers and updatin g this slideshow as they trickle out. (Don't worry: all spoilers will be carefully marked.) He re's what we know so far …

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The Rise and Fall of Provigil – Part II

by admin on Sep.22, 2010, under insomnia symptoms

The Rise and Fall of Provigil – Part
II

A little over a year after the Volkow
study reported that Provigil (modafinil), affects the same
brain chemicals as stimulants and may be addictive, on July
20, 썚, in the Atlanta Science News Examiner, Kevin
Murn ane reported that research showed modafinil “produces
some effects that are similar to abused stimulants, such as
cocaine.”

In what may turn out to be the final nail in the
modafinil coffi n, rhesus monkeys were given modafinil prior
to undergoing behavioral, neurochem ical, and brain imaging
studies for a study led by Monica Andersen, conducted at
Yerkes National Primate Research Center at Emory University,
in the June 20 10, “Psychopharmacology” journal.

“Similar
to other stimulants, these researchers found that modafinil
increased movement or locomotion in their subjects,” Murnane
wrote. “Furthermore, an acute bolus of modafinil elicited a
Ретур n or reinstatement of cocaine self-administration that
had been previously dimin ished through extinction
training.”

“These behavioral effects are very consistent
with those of other stimul ant-type drugs,” he reported.

Mechanistically, the researchers found “using Positron
Emission Tomography (P ET) imaging that modafinil bound to
and occupied a protein in the brain called t he dopamine
transporter,” he explained. “This protein is the same one
that cocaine binds to.”

“Furthermore, they found that
modafinil i ncreased dopamine neurotransmission,” Murnane
сказал. “This is the same mechanism thought to mediate the
eupho ric and addictive properties of cocaine.”

He pointed
out that the findings “closely paralleled those of a st udy
by Volkow and colleagues in human subjects that was
published in the March 2 009 issue of the Journal of the
American Medical Association.”

“Collectively, these
studies show that modafi nil has similar behavioral and
pharmacological effects to stimulant-type drugs o f abuse,
such as cocaine,” he wrote.

“These data indicate that
modafinil has the potential to be abused or производить
dependence,” Murnane said. “Accordingly, closer monitoring
of the modafinil supply and abuse pattern s may be
warranted.”

In June 2010, when the European Medicines
Agency recommended restricting the use of modafinil for the
treatment of narcolepsy only, on Pharmalot, Ed Silv erman
said the issue to watch was what this meant for Cephalon's
Nuvigil. Для the moment, EMA may have given Cephalon a
boost, “especially since the FDA keeps delaying appr oval to
use Nuvigil for jet-lag disorder and studies for other
indications have either flopped or will take quite awhile to
complete,” he wrote.

“A similar step to restrict Nuvigil,
of cou rse, would make it harder to broaden the Nuvigil
market,” he pointed out, and noted that the d rug's label
states: “Psychiatric adverse experiences have been reported
in patients treated with modafinil. Modafinil and
armodafinil (NUVIGIL) are very closely related. Therefore,
the inc idence and type of psychiatric symptoms associated
with armodafinil are expected to be similar to the incidence
and type of these events with modafinil.”

However, the
Фрейзер , Pennsylvania-based firm's Annual Report for 2009,
does not show Nuvigil as approved for use in any other
country besides the US.

Unprecedented Price Gouging

О
November 18, 2008, Pharmalot reported that Cephalon had
raised the price on Provigil by 28% since March 2008.
drug was then 74% more expensive than four years earlier,
with an average wholesale price of Ű.71 per pill.


price hikes were in prepa ration for the expected launch of
Nuvigil in 2009. By sharply raising prices, Ce phalon hoped
to convert patients to Nuvigil before cheap generic versions
of Pro vigil came on the market.

A year later, Dow Jones
reported that in November 2009 , Cephalon had raised the
price on Provigil by 29%, to $13.62 a pill, and that t he
cost of Nuvigil, launched in June 2009, with patent
protection until 2023, wa s $8.98 per tablet. Five years
earlier, “Provigil's cost was $5.53 per pill,” Dow Jones
noted on December 22, 2009.

Nuvigi l Launch

In launching
Nuvigil, in addition to promotional efforts in the field,
Cephalon “initiated patient sampling programs, discount
programs for patients, a significant n umber of key opinion
leader/speaker presentations, and a contracting plan with
C ertain health care payers,” Bob Roche, of Cephalon's
Worldwide Pharmaceutical Operations, said in an August 4,
썙 Earnings Call, posted by “Seeking Alpha.”

Sampling
programs included regular distribution of samples to doctors
and a free 7-day coupon for patients to print out from an
online web сайт.

Cephalon also implemented a “Co-Pay
Assistance Program,” which provides up to $50 of co-pay
assistance per prescription. “To make things easier for
patients, this program is administered automatic ally in many
pharmacies, making co-pay assistance coupons or cards
unnecessary,” Roche said.

H owever, patients covered by
government plans like Medicare and Medicaid do not q ualify
for the co-pay assistance, CEO, Frank Baldino, pointed out
in the call.

C ephalon also developed a data base of
approximately 50,000 individuals who reque sted information
on Nuvigil and mailed “these people a launch kit, with a
free seven-day coupo n and information on our Co-Pay
Assistance Program,” he said.

The company also planned to
impl ement an online, “Wake Information Support and Education
Program,” as part of a professional education and s upport
campaign designed for doctors in the sleep/wake field, Roche
reported. “In addition to information on sleep and
wakefulness issues, physicians can, with just a click o f a
mouse get information on NUVIGIL, order samples, request
coupons, ask questi ons, or request to see a sales
representative,” he explained.

In the first quarter of
2010, Ce phalon also launched a Nuvigil shift work disorder
campaign. There are “15 million shift worke rs in the United
States and approximately 1/3 of them suffer from excessive
slee piness associated with shift work disorder,” Baldino
reported in a May 4, 2010 Earnings Call.

A non-branded
radio campaign was launched “in select markets where shift
work is a significant part of the working population,” said
Robert Repella in the call. We “expect to see the benefits
coming out of that as we move through the
year.”

Cephalon also started a program with We bMD in the
first quarter, he said. We've had “over 7 million visits to
their website related to either NUVIG IL or disease area
content.”

Today it's doubtful that shift workers in the
US make enough mo ney to pay for Provigil or Nuvigil. В
August 2010, one hundred 250mg tablets of Nuvigil cost
$1,080, or $10.80 per tablet, and the price for 100 tablets
of 200 mg of Provigil was $1,855, or $18.55 per pill, at
DrugStore.com.

If generic Pro vigil was to hit the market,
patients who converted to Nuvigil would likely be p ressured
by payers to switch back to a cheaper Provigil generic. В
the meantim e, the same drug, sold as Modalert, can currently
be purchased online from other countries for as low as $120
per hundred, at EuroDrugstore.

Off-Label Marketing
Схемы

Back on November 8, 2007, Ed Silverman's
Pharmalot reported that Ceph alon had struck a deal with the
US Attorney in Philadelphia to pay 蹉 million to settle
off-label marketing charges. He noted that the settlement
was no surpr ise because the firm had been under a microscope
for off-label marketing for som e time and had received an
FDA warning letter in February 2007, ordering an end к
promotional materials claiming Provigil could be used to
treat fatigue.

underlying lawsuits were filed in
2003, by three former employees, Bruce Boise, Майкл
Makalusky, and Lucia Paccione, and another whistleblower,
Joseph Piacent ile, in federal court in the Eastern District
of Pennsylvania, under the False C laims Act, arising from
false claims submitted to Medicaid, Medicare and other
F ederal insurance programs that do not provide coverage for
such off-label uses.

About six months after the
settlement became known, on April Ǿ, 2008, Cephalon
announced the hiring of Gerald Pappert, former Attorney
General of Pennsylvania , as Executive Vice President and
General Counsel. Pappert was First Deputy Atto rney General
from 1997 to 2003 and Attorney General from 2003 to
2005 год.

When he t ook over as attorney general, Pappert
“launched a vigorous fight to lower the cost of prescrip Тион
drugs for Pennsylvanians,” the AG's website states.


will ensure that prescription drugs are price d fairly, and I
will take action against those who defraud our Commonwealth
прога rams or cheat us through illegal pricing and other
schemes,” he promised, after being sworn in to office in
February 2004.

The same month, Pappert was appointed to
the Pharma ceutical Pricing and Prescription Drug Abuse task
forces, of the National Associ ation of Attorneys General,
“which were formed to ensure that pharmaceuticals are priced
fairl y and to prevent the illegal use and sale of
prescription drugs, respectively,” according to F ebruary 4,
2004 press release.

In May 2004, Pappert reported that
Cephalon's Actiq, a narcotic lollipop, was showing up in
illegal sales in Philadelphia under the street nick имя
“perc-o-pops,” according to the September 30, 2008
Philadelphia Inquirer.

In September 2004, the US at torney
in Philadelphia subpoenaed documents about Cephalon's sales
and marketing of Actiq, Pro vigil, and Gabitril, an epilepsy
drug, the Inquirer reported

During his tenure i n
Harrisburg, Pappert filed a lawsuit accusing 13 drug
companies of price-fixing in March 2004. “As Attorney
General, I am committed to doing everything I can to reduce
р rice of prescription drugs for the Commonwealth and its
citizens,” he said, in a March 10, pre ss release on the
suit.

He explained that many consumers purchase drugs,
либо by themselves or through a health plan or insurer,
and “are financially harmed when drug comp anies
intentionally raise the prices of their drugs to manipulate
the market.”

In part, the lawsuit accused the companies
of “the widespread practice of offering trips, con sulting
opportunities, seminars, gifts, meals and cash payments to
medical provi ders in return for prescribing their products,”
the press release noted.

“Several of the companies named
в my lawsuit,” Pappert wrote in a March 19, 2004, Oped,
“have already pled guilty to and/or agreed to settle federal
charges of having engaged in unlawful marketing and sales
practices with respect to certain of their prescription
drugs.”

“These companies have already paid more than $1
billion i n fines and civil penalties to the federal
government,” he pointed out.

“My pharmaceutical industry
иск focuses on the pricing practices, which I believe
are clearly illegal,” he told Insider. “If we ultimately
succeed, it is going to change the way the industry prices
pharmaceuticals, and stop the prices from continuing to
skyrocket, and reduce prices.”

About five months after
Па ppert went to work for Cephalon, on September 29, 2008,
the US Department of Jus tice announced that the firm would
enter a criminal plea to one count of “Distribution of
Misb randed Drugs,” and pay $425 million to settle federal
and state charges and resolve allegation s that it marketed
three drugs, Provigil, Actiq and Gabitril, for unapproved
использования С.

Pappert signed off on the agreement as Executive VP
and General Counsel of C ephalon.

The government's
investigation began in January 2003, when Bruce Boise, a
sales rep resentative in Ohio, contacted the FDA about
Cephalon's sales practices. Boise agreed to wear a wire to a
company sales conference to help the government gather
evidence, acc ording to his attorney, Peter Chatfield, in a
September 29, 2008 press release b y his firm, Phillips &
Cohen. In November 2003, another sales rep, Lucia Paccione
of Philadelphi a, filed the first lawsuit. The complaints
remained sealed until the settlement was announced.

“What
makes this case unique is that it's the first time, in the
absence of substantial kickb acks, that the federal
government has used the False Claims Act to go after a
рН armaceutical company for marketing drugs for off-label
indications for which the re were no credible published
scientific research supporting these drugs' safety or
effectiven ess,” Chatfield said. “Not only were these uses
marketed by Cephalon not approved by the FDA, there was
abso lutely no literature published in any medical compendia
that supported them.”

While federally funded healthcare
programs “often will pay for off-label use of drugs
supported by credible me dical research and prescribed based
on the medical judgment of physicians, Cepha lon's marketing
efforts pushed well beyond those constraints,” according to
the press release.

From 2001 thr ough 2006, “Cephalon
improperly promoted Provigil to treat sleepiness, tiredness,
decreased ac tivity, lack of energy and fatigue,” the DOJ
sentencing memorandum reports.

“Cephalon continued its
illegal promotional activities after January 2002, when the
FDA specifically directed t he company to stop promoting
Provigil for off-label uses,” it states. For instance, in
Novembe r 2002, a Cephalon manager accompanying a sales
representative on calls to physi cians, told the sales
person: “Your best call of the day was with Dr. [a
psychiatrist] … Informing the phys ician of the transition
that we have made with Provigil from narcolepsy to the
V ariety of areas in which it is currently being used was
also effective.”

“Cephalon had its sales representat ives
call on doctors who would not normally prescribe the
defendant's drugs in the course of the doctors'
practice,” DOJ states. In fact, during a February 15, 2007
progr am, ABC's “20/20,” revealed a copy of a sales report
that showed allergists, internists, pediatricians and even
dentists w ere prescribing Provigil off-label to people with
depression, MS, hyperactivity and cancer.

Celaphon
marketed directly to psychiatrists after concluding that
й ey respond to a “lower threshold of scientific proof” than
other doctors. “In other words, Cephalon targeted physicians
й at would least object to their promoting Provigil for uses
with little clinical support,” says a September 29, 2008
press release by Connecticut's attorney general.

В
December 2002, Cepha lon sought to expand Provigil's label
to cover excessive sleepiness, without r egard to the
patient's underlying medical condition. However, in
January 2004, the FDA approved only a narrow expansion for
excessive sleepiness associated wi th obstructive sleep apnea
and shift work sleep disorder.

Harvard professor, Dr
Charles Czeisler, chief of sleep medicine at Brigham and
Women's Hospital, was lead investigat or in the shift-worker
study, which showed Provigil kept participants awake 1.7
minutes longer than a placebo. In September 2003, Czeisler
went before the FDA t o lobby for approval to treat
shift-workers on behalf of Cephalon.

The FDA form союзник
approved it for shift work disorder on January 23, 2004.
Less than four mon ths later, on May 21, 2ዄ, Science
Magazine reported that Cephalon was providin g $2.75 million
to fund an endowed chair at Harvard Medical School to be
named a fter Cephalon's founder and CEO, Frank Baldino, and
that Czeisler would hold the chair. Baldin o was also on the
advisory board of Harvard, Science noted.

Czeisler
опубликовано a paper in the August񎧕, “New England Journal
of Medicine,” and claimed night-shift workers remained more
alert with Provigil. “I would characterize [Provigil] as the
treatment of choice with patient s with shift-work disorder,”
сказал он.

However, in an editorial in the same issue, Dr
Robert Ba sner, director of Columbia University's
Cardiopulmonary Sleep and Ventilatory Disorders Center , said
the researchers' data showed only slight improvements in
workers wakefulness and produc tivity with Provigil, and the
drug seemed to exacerbate insomnia symptoms for so me patients.

“That's not a very robust endorsement of the drug coming
from the investigators themselves,” Basner wrote. “This drug
is l ittle better than nothing in terms of making them less
sleepy during shift work at night.”

For the February
2007 program, “20/20″ wanted to find out how well Provigil
worked in studies n ot funded by Cephalon, which led them to
the sleep labs of the US Army and resea rch psychologist,
Nancy Wesensten, who studies drugs to help soldiers stay
бодрствующий .

In studying Provigil for the army, Wesensten
compared it to caffeine in terms of how well soldiers
performed on tests, how alert they were, and side effects.
“In our hands, at the dosages we tested, modafinil did not
work any better than caffeine,” she told 20/20.

Cephalon
arranged for “case studies to drive growth for off-label
uses such as multiple sclero sis, adult ADD and depression,”
the DOJ press release charges. And in fact, a literature
Реви w, by Dr Jacob Ballon and Dr David Feifel, for an April
2006 paper in the “Journal of Clinical Psychiatry,” was
conducted on PubMed, with the search term modafinil OR
Provigil, and shows a total of 397 articles for on and
off-label uses.

“Cephalon employed sales representatives
и retained medical professionals to speak to doctors about
off-label uses,” the press release s aid. “The company funded
continuing medical education programs, through millions of
dollars in grants, to promote off-label uses of its
drugs.”

“Cephalon sent doctors to “consultant”
meetings at lav ish resorts to hear the company's off-label
message,” the DOJ reports. According to a Cepha долгота
document, these meetings “proved incredibly effective in
driving prescription growth among the attendees,” the memo
Примечания.

“Cephalon trained its sales representatives on
techniques to prompt the doc tors into off-label
conversations,” and “had its sales representatives tell
doctors how to document their of f-label uses of drugs to get
these uses paid by insurers, who often will not pay для
off-label uses,” the DOJ reports.

The drug maker “also
structured its sales quota and bonuses in such a way that
sales representatives could only reach their sales goals if
they promo ted and sold the drugs for off-label uses,” the
press release notes.

According to the sentenci ng memo, for
over six years, the very top levels of the company knew and
approve d of these efforts.

Cephalon’s sales reports
show the success of the off-labe l campaigns, with Provigil
sales rising from $146 million in 2001, to $691 milli on in
2006, to more than $850 million in 2007. Sales increased
more than a 1,000 % from 2000 to 2007, according to
Connecticut's attorney general and the government found more
than 80% were for off-label use.

It's difficult to see
where the off-label marketing has en ded because Provigil
profits have never fallen. SEC filings show sales of the
Д-р ug exceeded $988 million in 2ወ, the year the settlement
agreement was signed, roughly $138 million more than
2007 год.

In 2009, Provigil sales topped the billion доллар
mark, and Nuvigil earned $73,391 million. Combined, these
two products ha d an 11% increase in sales over 2008, and
made up 51% of Cephalon's total net sales for 2009.

With a
doubling of Provigil sales in the first 6 months of 2010,
totaling $547,2 ȱ million, sales could potentially beat the
record set in 2009. In comparison, sales in first 6 months
of񎧙 were only $515,430 million. Nuvigil had sales of ,
$75,890 million in the first 6 months of 2010, compared to
$16,786 million in the first 6 months of 2009.

Since the
launch of Nuvigil on June 1, 2009, Cephalo n has been aiming
at approvals for additional indications, including people
с jet lag and traumatic brain injury, as well as
adjunctive therapy for schizophr enia and bipolar disorder,
and fatigue associated with cancer treatment. “We expect
NUVIGIL to be a much bigger drug than PROVIGIL ever was in a
long run,” CEO, Baldino, said in a February 11, 2010
Earnings Call.

However, in March 2010, the FDA nixed
approval for jet lag, which Cephalon was counting on because
it would have allowed sales reps to hit virtually every kind
of physician that might treat jet lag, instead of only
doctors who treat sleep disorders, according to market
analysts.

In the last wee k of June, Cephalon filed a
formal response to the FDA's non-approval. The FDA
“classified t he response as a class two resubmission
requiring a six-month review with a PDUF A date of December
30,” Baldino said in a July 27, Earnings Call.

Also, in
Июн e 2010, the results for a study of Nuvigil, in
conjunction with antipsychotics, for schizophrenia showed
the drug failed to meet its primary endpoint, and in th e
July 27, Earnings Call, Dr Lesley Russell, Cephalon's Chief
Medical Officer, said the compan y had “decided not to move
forward with cancer related to fatigue for
NUVIGIL. "

Hammered Again in Court

On the same day that
the FDA refused approval of Nuv igil for jet lag, a federal
judge refused to dismiss the antitrust lawsuits file d
against Cephalon by the Federal Trade Commission and
другие.

In 2005 and 2006, Cephalon entered into
settlements with the generic drug makers, Barr, Mylan, Te va,
and Ranbaxy, and agreed to pay the four companies a combined
total of more t han $200 million, in return for agreements
that would keep generic versions of P rovigil from coming on
the market until April 2012, instead of 2008.

In March
2 006, when announcing the settlements, CEO Baldino told the
Philadelphia Business Journal: “We were able to get six more
years of patent protection. That's $4 billion in sales that
no one e xpected.”

Later in 2006, a class of direct
purchasers (such as health plans and pharmacies) fi led a
lawsuit against Cephalon and the generic companies, followed
soon after by a class of end-payers of Provigil, and Apotex,
another generic firm. They all a lleged that Cephalon, and
the generic makers were engaged in anticompetitive con проток
in violation of the Sherman Antitrust Act.

Pay-For-Delay
Предложения

The so-calle d “pay-for-delay” agreements (also known
as “reverse payments”) are settlements of patent litigation
in which a brand-name company pays a potential generic
competitor to abandon a patent challenge and delay entering
the market with a generic.

Brand-name companies “can delay
generic competition that lowers pri ces by agreeing to pay a
generic competitor to hold its competing product off th E
market for a certain period of time,” the FTC explained in a
January 2010 report titled, “Pay-for-Delay: H ow Drug Company
Pay-Offs Cost Consumers Billions,” which summarized the
savings lost to US con sumers through such deals during the
previous six years.

The FTC found the numb er of
pay-for-delay agreements had increased from none in 2004, to
a record 19 i n the fiscal year of 2009. On average, these
agreements precluded generic entry for 48 months, the agency
докладов.

Most of the deals reached since 2005 were st ill
in effect, and were protecting at least $20 billion in
brand-name sales from generic competition. “These sweetheart
deals are being done on the backs of consumers,” FTC
chairman, Jon L eibowitz, told the New York Times in January
2010 год. “From the perspective of the Federal Trade Commission,
these deals are one of the worst abuses across the board in
health c are and should be stopped.”

The FTC estimates
the agreements currently cost A merican consumers $3.5
billion a year in higher prescription costs when they mis s
out on generic prices that can be as much as “90 percent
less than brand prices,” according to the study.

“Based on
PR eliminary analysis, already, in the first nine months of
FY 2010, there have bee n more brand-generic settlements
involving some sort of compensation – 21 – than in any prior
full fiscal ye ar,” Leibowitz reported in July 27, 2010
testimony before the House Judiciary Subcommittee on Суды
and Competition Policy.

Those settlements protect $9
billion in drug sale s from generic competition. "Это
almost an epidemic,” he told lawmakers, “and left untreated,
these types of settleme nts will continue to insulate more
and more drugs from competition.”

The FTC joined the
Cephal on antitrust litigation on February 13, 2008, by
filing a lawsuit against Cephal on, but not the generics
makers, alleging violations of the Federal Trade Commis sion
Act. Cephalon's anticompetitive scheme “denies patients
access to lower-cost, generic v ersions of Provigil and
forces consumers and other purchasers to pay hundreds of
millions of dollars a year more for Provigil,” the agency
stated in a press release the same day.

On March 29, 2010,
a federal judge in Philadelphia denied a defense motion к
dismiss the FTC €™s case (and related cases) against
Cephalon. The case is no w in the discovery phase, according
to the FTC. However, nobody better look for a resolution and
cheap generic Provigil anytime soon because Cephalon has
каждый intention of dragging out this litigation as long as
possible and is geared up f or round two of delay and motion
filing.

In a May 4, 2010 Earnings Call, Georg e Pappert,
the former champion of lower drug prices for citizens of
Пенсильвания , informed listeners that the discovery process
“will take us to roughly the middle of񎧛.”

“And then
we will be filing our dispositive motions, our motions for
summary judgment,” he said. “I believe the court has a
schedule se t for July of 2011, and then the court will
consider those motions at that time.”

Being the fi rst
batch of motions took years to resolve, generic Provigil
will likely enter t he market in 2012, exactly as specified
in the pay-for-delay deals, and long bef ore the litigation
ends. Providing the drug is still allowed to be sold at all
T hat is.

Also see The Rise and Fall of Provigil: Part
Я

*************

Evelyn Pri ngle
epringle05@yahoo.com

(Evelyn Pringle
is an investigative journalist focused on exposing
corruption in government and corporate
America)

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Right Now More>>

by admin on Sep.22, 2010, under political contributions

DETROIT, Michigan – General Motors is handing out political contributions contributions to both political contributions parties, but so far incumbent Ohio Goveror Ted Strickland is not one of those candidates.

In fact, federal election records show that GM's political contributions action committee has donated five-thousand dollars to republican candidate for S enate Rob Portman, who's running against democrat Lee Fisher.

Those records also show a two thousand dollar contribution to incumbent Ohio Democratic Senator Sherrod Brown who faces GOP c hoice Mike DeWine.

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GM Resumes Campaign Contributions

by admin on Sep.22, 2010, under political contributions



By Josh Mitchell

General Motors Co. has resumed contributing to political contributions campaigns, lifting a self-imposed ban on political contributions spendin g adopted during the auto maker's bankruptcy restructuring last year.

GM gave $90,500 to candidates running in the November elections, Federal Election Commis sion records show. The beneficiaries include midwestern lawmakers, mostly Democr ats, who have traditionally supported the industry’s legislative agenda on Cap itol Hill, including Sen. Debbie Stabenow and Rep. John Dingell of Michigan and Sen. Sherrod Brown of Ohio.

The list also includes House Republican Whip Eric Ca ntor (R., Va.), who would likely assume a top leadership post if Republicans win control of the House in November.

While it's hardly unusual for big companies like GM to make political contributions contributions, GM's situation is diff erent because it is majority-owned by the US government. GM is planning to ret urn to the public stock markets later this year, allowing the US to begin to s ell off its roughly 61% stake in the company.

GM spokesman Greg Martin said the company stopped making political contributions contributions in spring 20ǩ to f ocus on its taxpayer-financed bankruptcy reorganization.

“As we've emerged a sa new company, weâ ™re not going to sit on the sidelines as our competitors an d other industires who have PACs are participating in the political contribution s process,” Martin said. He said the company's politcal action committee is “an effective means for our employees to pool their resources and have their c ollective voice heard.”

He said the company has supported members of both part ies who “approach issues thoughtfully € and “support a strong auto industry ".

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Crist can keep GOP campaign contributions — for now

by admin on Sep.22, 2010, under political contributions

By Robert Samuels, Miami Herald

In Print: Wednesday, September 22, 2010


NAPLES — Gov. Charlie Crist can continue spending millions of do llars in contributions he received as a Republican Senate candidate, a judge rul ed Tuesday afternoon.

But the saga over the $7.5 million Crist raised before lea ving the GOP and turning independent is not yet over.

Circuit Court Judge Jack S choonover said he needs more time to decide whether a suit from former Crist sup porters, who want their contributions returned, can become a class-action suit f or thousands of other donors to Crist's campaign.

That decision could be costly to Crist becau se the governor raised more than half of his campaign money as a Republican. His total war chest is about $12.4 million, about $5Ǡ,000 less than Republican riv al Marco Rubio and $5 million more than Democrat Kendrick Meek.

The attorney pus hing for the class-action suit wants the case tried as quickly as possible. He a rgued that allowing Crist to continue spending money is unfair and an infringeme nt of the free-speech rights of donors, who contributed to Crist because they th ought he spoke for them as Republicans.

“Now that Charlie Crist is not Republican, he's different,” said Tom Grady, a lawy er and state lawmaker from Naples who represents the disgruntled donors. “And because he's different, he is not meeting the terms of the agreement that he entered into (with his donors).”

Grady had aske d Schoonover to stop Crist from spending campaign dollars until a final decision was rendered. But Schoonover rejected the request, allowing Crist to continue s pending freely with the money raised between May 2009 and May 2010, when Crist b ecame an independent candidate.

The judge said he had to review more than 400 pa ges of additional research and evidence he received from lawyers. He doesn't expect to make a decision on the class-action request until the end of the week.

Scott Weinstein, the attorney representing Crist, said he thought it would be impossible to reso lve the issue before the Nov. 2 election.

“If he rules against us, we will appeal,” Weinstein said. “This will continue lo ng after the election's over.”

In court Tuesday, Weinstein argued that it was unreasonable to lump the 8,000 contributors in question as a single class of people. Some might not have liked Crist, in particular, but donated to all candidates. Some might want their mone y back because he's not a sure-fire winner. Others may still support him.

A class-action suit, Weinstein said, would be forcing the people who don't want to be involved in the case “to take an action th ey don't want to take.”

The case started in June, when donors Linda Morton of Naples and former US Ambassa dor to the Bahamas John Rood of Jacksonville sued Crist, claiming their support hinged on his political contributions affiliation. Morton had contributed $500; Rood, $4,8 00.

Weinstein added these claims cases should be tried individually, in small cl aims court.

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Charlie Crist can keep GOP campaign contributions — for now

by admin on Sep.22, 2010, under political contributions

NAPLES, Fla. —
Gov. Charlie Crist can continue spending millions of dollars in contributions he received as a Republican Senate candidate, a Collier County judge rul ed Tuesday afternoon.

But Collier County Judge Jack Schoonover said he has no t decided whether a suit from former Crist supporters — who want their contributions returned — can become a class-action suit for thousands of other donors to Crist's campaign.

Donors Linda Morton o f Naples and former US ambassador to the Bahamas John Rood of Jacksonville sue d Crist in June, claiming he should not be able to use campaign contributions ma de when he was running for the US Senate as a Republican.

Cri st received about $7.5 million in contributions before he broke with the party a nd became a no-party affiliation, or independent, candidate.

Crist's attorney, Scott Weinst ein of Fort Myers, says the proper venue for Morton and Rood would be small clai ms court if they want to recover the $5,300 they collectively gave to Crist.

Asking for refunds on behalf of all donors, Weinstein contends, is merely a plo y by the Republican Party to further the campaign of their candidate Marco Rubio by tying up funds during the campaign's final weeks.

Rep. Tom Grady, R-Naples, a Naples at torney representing the two plaintiffs, is trying to turn the complaint into ac lass-action lawsuit that could include some 8,000 additional contributors.

Gr ady, who resigned as Crist's regional campaign chairman after his former political contributio ns ally jumped ship, said class-action status is needed to reimburse donors who gave money to one candidate only to find he had morphed into another.

Judge Ja ck Schoonover said he expects to make a ruling on the class-action request by Th ursday.

The News Service of Florida contributed to this story.

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Political Funding Process in Ohio Has Just Been Changed Dramatically!

by admin on Sep.22, 2010, under political contributions

A Contributor Perspective: Federal Court Agreement Says Campaign Contributions from Corporate Entities is Now Unlimited!

NEWBURY, Ohio — Recently in a Federal Cou rt in the State of Ohio the ban on corporate and labor union spending for politi cal contributions causes has been lifted by an agreement made in federal court o n September 16th 2010.  This case was brought by the Ohio Right to Life Societ y against the Ohio Elections Committee. In this case the Right to Life group p osed that the ban on this type corporate spending went against our first amendme nt rights.

The entire foundation of this important ruling has been that many peo ple believed the original “political contributions spending ban” had opposed the “right to free speech” portion of the First Amendment t o the United States Constitution, which is a part of the Bill of Rights. The F irst Amendment covers many aspects of the peoples freedoms and rights, one of wh ich gives us the right to express our political contributions views and opinions publicly with no fear of recrimination.

From Statements made on their website b y Mike Gonidakis the Executive Director of the Right to Life Society, in Columbus Ohio, Based on this ruling corporation s can now engage in what is called “independent advocacy” where a corporation can use their own funds to cam paign either for or against a specific candidate. “This consent decree does not authorize di rect contributions to or coordination with candidates, it simply protects the fr ee speech rights of corporations, labor organizations, and advocacy groups, like everyone else, to tell people the candidates they support and why” said Mike Gonidakis.

Для over a hundred years now there has been a ban on corporate spending for politica l contributions campaigns in the State of Ohio. This ban was designed to preven t the corruption of political contributions parties and elections in the State o f Ohio. Regular campaign funding process will still be handled in the same man ner as before, and this ruling has no bearing on that process. The removal of restrictions could prove beneficial for all parties involved in the political co ntributions campaign process in Ohio.

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