Wednesday, 3 September 2008
Blogs Comment On New HHS Regulation, Election Issues
HHS Regulation
~"American Board of Obstetrics and Gynecology Calls Out Secretary Leavitt for Misrepresenting Certification Issues in Support of Proposed Regulation," Our Bodies Ourselves: HHS Secretary Mike Leavitt's most recent mailing on his professional blog about the proposed regulation reflects that he "continues to either misunderstand or deliberately fudge the credential issue as a master argument for the introduction of the proposed regulations," the blog post says. According to the submission, the American Board of Obstetrics and Gynecology, the certifying organization for ob/gyns, has "clearly stated since at least March of this class that refusal to do or look up for miscarriage would take no bearing on issuance or replenishment of supplier certification." The blog references a alphabetic character sent on Aug. 22 by ABOG to Leavitt in response to the proposed ordinance. The letter challenges Leavitt to provide any evidence that this is a real justification for the regulation, which he has "thus far failed to provide" ("Our Bodies Ourselves," 8/25).
~"HHS Proposal Says Doctors Can Refuse Abortions, Referrals," Feministing: Leavitt's insistence that the American College of Obstetricians and Gynecologists "issued guidelines that could shape board certification requirements and necessitate a doctor to perform abortions to be considered competent" is a falsehood that "HHS is using [to] create the illusion that providers' rights are under vicious attack, when in reality the regulations ar the criminal offence, blatantly ominous our procreative freedoms -- particularly for uninsured and low-income women," the blog post says. In gain, the entry says that although the regulation does not define contraception as abortion, the American Civil Liberties Union thinks in that location could be "some wriggle room" ("Feministing," 8/22).
~"The Department of Health and Hallowed Services," Cristina Page, Birth Control Watch: While Leavitt is "attempting to take place off his new rule as protecting health caution providers world Health Organization, for reasons of conscience, don't want to shoot part in abortion services," for those "schooled in the fine print, the regulation might be described as a love letter to extremists," Page writes in a blog entry. According to Page, in that respect already own been trey laws passed in the last 30 years that protect individuals who do not want to participate in abortion services. Page adds, "Leavitt does non claim that these pentateuch are unequal; he does not point to whatsoever violations of them. He seems to want us to trust that he is just underscoring longstanding laws." Page concludes that "[i]f Leavitt's intention is as broad as his loosely worded rule to evoke, your right-hand to health care -- all health care -- will be determined by the sensitivities of almost every person in a white gabardine, and level perhaps others. Your dr. may non have a problem giving you that prescription, simply will the pharmacist fill it? And, if so, will the pro-life cashier ring it up? Women have had to run an obstacle course to get procreative health care in recent years. If we leave it to Leavitt, the number of obstacles will grow" (Page, "Birth Control Watch," 8/22).
~"Proposed HHS Regulation Could Still Block Access to Contraception, Other Health Services," Jessica Arons, RH Reality Check: Arons writes that although most of the regulation "limits the scope of allowable moral objections to training, performing, counseling or referring for abortion and sterilization," its allowance for objections based on whatever personal moral convictions or religious beliefs "is much broader than traditional scruples clauses." Arons adds that the regulating would extend protection from physicians and nurses "to just about anyone wHO might come into middleman with a patient, and even some who might not," final, "[b]y that logic, an ambulance driver, a receptionist and even the person wHO processes health insurance forms might be able to refuse to perform their jobs if related to a wellness care armed service they recover morally objectionable. Volunteers ar explicitly protected, too" (Arons, "RH Reality Check," 8/22).
Election Issues
~"McCain Surrogate Falsely Suggests McCain Does Not Want to Overturn Roe," Think Progress: According to the blog entrance, in a new advert for Republican presidential candidate Sen. John McCain (Ariz.), Debra Bartoshevich, a self-described "proud Hillary Clinton Democrat," announces that she opposes Democratic presidential candidate Sen. Barack Obama (Ill.) and will vote for McCain. The blog reports that at a press league, Bartoshevich made this statement: "Going back to 1999, John McCain did an interview with the San Francisco Chronicle saying that overturning Roe v. Wade would non make whatever sense, because then women would receive to get illegal abortions." The brand adds that McCain supporter Carly Fiorina -- world Health Organization also attended the press conference with Bartoshevich -- has perverted McCain's posture on choice in the past. "Newsweek magazine reported" that Fiorina "told women in Columbus, Ohio, that McCain 'has never gestural on to efforts to overturn Roe vs. Wade,'" the web log says ("Think Progress," 8/25).
~"Biden -- a Moderate?" ProLifeBlogs: The blog entry examines vice presidential candidate Sen. Joseph Biden's (D-Del.) balloting record on such issues as Roe and abortion rights. According to the blog entree, "[g]iven his radical support for abortion, the news that" Obama chose Biden as his running mate is "not often of a surprise. What is a surprise is that some actually weigh Biden to be tame on issues related to the dignity of human" life ("ProLifeBlogs," 8/23).
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Sunday, 24 August 2008
FDA Requires Additional Information On DORIBAX For Treatment Of Hospital-Acquired Pneumonia
Research & Development, L.L.C. (J&JPRD) announced that the U.S. Food
and Drug Administration (FDA) requires extra information before it
will approve the company's New Drug Application (NDA) for DORIBAX(TM)
(doripenem for shot) for the treatment of hospital-acquired pneumonia,
also known as nosocomial pneumonia (NP), including ventilator-associated
pneumonia (VAP).
In response to the J&JPRD lotion seeking approval for DORIBAX for
the additional indication of the treatment of NP, including VAP, the FDA
issued a Complete Response varsity letter outlining the actions necessary to
address outstanding issues.
J&JPRD is reviewing the agency's letter and volition work to resolve whatever
outstanding questions. The NDA for DORIBAX for the treatment of NP,
including VAP, was submitted to the FDA in June 2007.
The NDA for DORIBAX for the handling of NP, including VAP, was the
subject of a July 16, 2008 U.S. Food and Drug Administration Anti-Infective
Drugs Advisory Committee. Based on information presented from two turgid nosocomial
pneumonia trials, the committee voted that five hundred mg of DORIBAX at both the
one-hour and four-hour extract regimens were safe (85) and effective
(7-6) in the treatment of NP, including VAP. The committee did non agree
that the non-inferiority margin for the DORIBAX NP trials was befittingly
justified, nor did it agree on the appropriate margin for NP trials in
general. J&JPRD is confident in the NP data submitted and will work with
the FDA to address the issues raised in the Complete Response letter.
DORIBAX is an endovenous (IV) antibiotic drug for hospital use, and belongs
to a class of antibacterial drug drugs called carbapenems. Carbapenems are
of import antibiotics to treat serious -- and sometimes grave --
infections caused by a broad range of bacteria, which are characterized as
Gram-negative and Gram-positive, based on a categorization process that is
used to identify the specific type of bacteria.
DORIBAX was approved in the U.S. in October 2007 for the treatment of
complicated intra-abdominal infections (cIAI) and complicated urinary tract
infections (cUTI), including pyelonephritis, due to susceptible bacteria,
and is marketed by Ortho-McNeil, Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc. DORIBAX besides is approved in Europe and Russia for
cIAI, cUTI and NP, including VAP. Doripenem is licenced from Shionogi &
Co., Ltd.
INDICATIONS
DORIBAX is indicated as a single federal agent for the treatment of:
complicated intra-abdominal infections caused by susceptible strains of E.
coli, K. pneumoniae, P. aeruginosa, B. caccae, B. fragilis, B.
thetaiotaomicron, B. uniformis, B. vulgatus, S. intermedius, S.
constellatus or P. micros, and for the treatment of complicated urinary
tract infections, including pyelonephritis, caused by susceptible strains
of E. coli, including cases with concurrent bacteriaemia, K. pneumoniae, P.
mirabilis, P. aeruginosa, or A. baumannii.
To reduce the development of drug-resistant bacterium and keep the
strength of DORIBAX and other antibacterial drugs, DORIBAX should be
ill-used only to treat infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibleness information
ar available, they should be considered in selecting and modifying
bactericide therapy. In the absence of such data, local epidemiology and
susceptibility patterns may put up to the empiric choice of therapy.
IMPORTANT SAFETY INFORMATION
DORIBAX is contraindicated in patients with known life-threatening
hypersensitivity to doripenem or other carbapenems or in patients world Health Organization have
demonstrated anaphylactic reactions to beta-lactams.
Serious and occasionally fateful hypersensitivity (anaphylactic) and
serious skin reactions have been reported in patients receiving beta-lactam
antibiotics. These reactions are more likely to occur in individuals with a
history of sensitivity to multiple allergens. If an hypersensitized reaction to
DORIBAX occurs, discontinue the drug. Serious acute anaphylactic reactions
require emergency discourse with adrenaline and other emergency measures,
including atomic number 8, IV fluids, IV antihistamines, corticosteroids, vasoconstrictor
amines and airway management, as clinically indicated.
Carbapenems may reduce serum valproic acid concentrations to
subtherapeutic levels, resulting in loss of capture control. Serum valproic
acidulous concentrations should be monitored frequently after initiating
carbapenem therapy. Alternative antibacterial or anticonvulsant therapy
should be considered if serum valproic acid concentrations cannot be
maintained in the remedial range or seizures occur.
Clostridium difficile-associated diarrhea (CDAD) has been reported with
use of nearly all antibacterial agents and may range in severity from mild
diarrhoea to fatal colitis. CDAD must be considered in all patients who
introduce with diarrhoea following antibiotic drug use. Careful medical history is
necessary since CDAD has been reported to occur o'er two (2) months after
administration of antibacterial agents. If CDAD is suspected or confirmed,
ongoing antibiotic use not directed against C. difficile may need to be
discontinued.
When DORIBAX has been used investigationally via inhalation,
pneumonitis has occurred. DORIBAX should not be administered by this route.
Safety and effectiveness in pediatric patients have non been
established.
The to the highest degree common adverse reactions (greater than or equal to 5%)
discovered in clinical trials were headache, nausea, diarrhea, efflorescence and
phlebitis.
Please see the DORIBAX Full Prescribing Information by visiting
http://www.DORIBAX.com
Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.,
is committed to providing innovative, superiority prescription medicines
and resources in the areas of bacterial contagion and cardiovascular
disease for healthcare providers and their patients in hospitals and other
care facilities. For more information, visit hypertext transfer protocol://www.ortho-mcneil.com.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is
part of Johnson & Johnson, the world's most broadly based producer of
healthcare products. J&JPRD is headquartered in Raritan, NJ, and has
facilities throughout Asia, Europe and the U.S. J&JPRD is leveraging drug
discovery and do drugs development in a assortment of sanative areas to address
unmet medical of necessity worldwide.
FORWARD LOOKING STATEMENT
(This press release contains "innovative statements" as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If fundamental assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from the Company's expectations and
projections. Risks and uncertainties let in general industry conditions
and competition; economic conditions, such as interest rate and currency
exchange rate fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development, including
obtaining regulatory approvals; domestic and foreign health care reforms
and governmental laws and regulations; and trends toward wellness care cost
containment. further list and description of these risks, uncertainties
and other factors can be plant in Exhibit 99 of Johnson & Johnson's Annual
Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of
this Form 10-K, as well as subsequent filings, are available online at
http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. The Company
does not undertake to update any forwards looking statements as a result of
new information or future events or developments.)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
http://www.jnj.com
View do drugs information on Doribax.
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Thursday, 14 August 2008
Whit Stillman Offers Praise for August Movies � and Might Finally Be Directing a New One
If, like us, you've been wondering what on earth Whit Stillman has been doing since 1998, and when he might direct another movie, check out his interview with Karina Longworth at Spoutblog. The director of urbane and beloved nineties indie comedies Metropolitan, Barcelona, and The Last Days of Disco says that he's finally preparing to shoot a movie set in Jamaica in the sixties called Dancing Mood. (He described the movie to "Page Six" last year as being "about the gospel church and the music scene from pre-reggae days, including ska," which sounds, um, awesome.) Here's hoping this actually turns out to be true!
But Stillman also has something pretty interesting to say about a recent favorite Vulture topic, the August Movie � and how the crappiness of other August movies has both helped his films and (in the case of August anti-classic 54) hurt them.
Stillman points out that August has been a fertile time for his diminutive movies to be released, since they stand out well against the tote up crap that's out in that location most previous summers:
Metropolitan came out the first weekend in August. It was just a wonderful clock time to follow out. We got a lot of good attention. Barcelona was the final weekend in July. So, that had always been a great time for us.
But when The Last Days of Disco, Stillman's delightful comedy starring Chlo� Sevigny, Kate Beckinsale, and Robert Sean Leonard came out in 1998, it was released earlier in the summer, in order to stave off disco-related contest from � the notoriously Augustine 54. "It was just a disaster," Stillman says now:
Normally, if you are an independent film coming kayoed against be big studio blockbusters, you are the �good� kind of programming. Normally, [your competition] are just sort of stupid action movies or �shoot-them-ups� or whatever. But, in our case, the big summer movies were as well critical favorites and Oscar favorites. So, we came out against Truman Show, Saving Private Ryan. The independent films were likewise very substantial - The Opposite of Sex, Henry Fool. There were just so many things just at the same time. Even the Soderbergh cinema, I think, it was Out of Sight? Everything that came out was not exclusively a dear film, simply a critical favorite � We just got run over. I mean, it initially did well. We had great weekends in the cities. But, we were steamrolled.
The good news show? There's password a Criterion edition of Disco power be coming out shortly, which would make a nifty double feature with a moonshine copy of the Pansexual Ryan Phillippe edit of 54.
Anti-Populism and Indie Antiquity: Interview with Whit Stillman [Spoutblog]
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Friday, 27 June 2008
Amy Winehouse arrested based on video
Thursday, 19 June 2008
Kanye Booed at Bonnaroo
The Grammy winner walked onto the festival stage nearly two hours past his scheduled 2:45 a.m. performance time...
Thursday, 12 June 2008
Friday, 6 June 2008
Michael Jackson Avoids Losing Neverland Ranch
Thursday, 29 May 2008
Forgotten Tomb
Artist: Forgotten Tomb
Genre(s):
Metal: Doom
Metal: Death,Black
Discography:
Negative Megalomania
Year: 2007
Tracks: 5
Love's Burial Ground
Year: 2004
Tracks: 9
Springtime Depression
Year: 2003
Tracks: 6
Songs To Leave
Year: 2002
Tracks: 5
Obscura Arcana Mortis (EP)
Year: 1999
Tracks: 5
 
Excruciation
Monday, 28 April 2008
MIMOBOT(R) Brings Pop Culture to USB Ports with MIMOZINE(TM) Issue 2; Partners with VBS.tv, IODA, and HackTone Records
MIMOBOT(R) Brings Pop Culture to USB Ports with MIMOZINE(TM) Issue 2; Partners with VBS.tv, IODA, and HackTone Records
Hub of the Universe, April 18 -- Military issue 2 of MIMOZINE(TM) digital
magazine by MIMOBOT(R) released today, preloaded on Mimoco's fresh
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from Planet Blooh.
For their arcsecond publication, working with IODA, the lead digital
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Andy Jefferson Davis, Chikita Violenta, Curumin, The Wedding Show, and Target Rae of
Yes King, wHO wholly performed at IODA's 4th annual opening day event. Too in
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supplies.
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of Media Development and the man responsible for the MIMOZINE. "Workings
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Player
Saturday, 26 April 2008
TRINA
TRINA
Still Da Baddest (Slip-N-Slide/EMI): B
Few female rappers have enough swagger to rock a mike while showing enough sensitivity to be endearing. On her fourth album, Miami rapstress Trina alternately details sexual exploits in terms that would make a porn star blush and laments over a love jones, proving that nasty is still a major part of her repertoire but not the totality of it. Some topics wear out fast - the size of Trina’s assets, how much better than you she is - but it’s still more entertaining than what most of her male counterparts have to say.
Download: “Hot Commodity.”
Coen Bais
Los Angeles Philharmonic plays French works
Los Angeles Philharmonic plays French works
For a while, conductor Jacques Alexandre Cesar Charles Dutoit made the Los Angeles Symphony orchestra sound like a French orchestra Thursday at Walt Walter Elias Disney Concert Hall.
The effect wasn't due simply to the plan: works by Run and Saint-Saëns surrounding Grieg's Pianoforte Concerto in A kid, with nattily dressed French piano player Jean-Yves Thibaudet as the soloist.
It had a great handle more to do with a form of integrated sound, a special transparency and peculiarly a long-lined approach to phrasing.
The transparence suited Ravel's "Ma mère l'oye" (Mother Goof) Rooms, unity of the composer's most economical and magical slews, which opened the concert. The work manages both to inhabit a earth of childhood innocence and to convey an adult's nostalgia for its deprivation.
Dutoit opened the suite with breathless gentleness; allow the little Empress of the Pagodas have her noisy, entertaining bath and modest Turandot-like processional; and tenderly showed Beauty and the Creature negotiating their slenderly awkward waltz.
In the concluding section, "The Fairy Garden," he conveyed a development sense of something wondrously about to chance combined with a recognition that the precious moments of childhood would soon be doomed eternally. It was uncanny and unforgettable.
Among the spiritualist soloists were concertmaster Alexander Treger, principal violist Dale Hikawa Silverman, principal violoncellist Peter Stumpf and harper Lou Ann Neill.
Grieg's concerto was long a staple of the repertory until it became something of a victim of its own popularity. Although it ne'er quite vanished -- audiences would not permit that -- it appeared less and less oftentimes on serious subscription programs and to a greater extent much as region of summertime outdoor series, where its scintillating sense of North Germanic language iciness offered more or less relievo from an evening's heat.
Lately, though, there get been signs of a modest revival. Norwegian piano player Leif Ove Andsnes recorded it twice and performed it with the Symphony orchestra under Esa-Pekka Salonen at Disney Asaph Hall in 2005.
Thibaudet shoemaker's last played it with the Philharmonic under E. O. Lawrence Foster at the Dorothy Chandler Marquee in 2001. At Walt Disney, his blindingly fast octaves set the tenor of his approach. Edvard Grieg looked as difficult to perform as Rachmaninov.
Not that Thibaudet had any difficulties. The speed, lucidness and magnate of his playing were jaw-dropping. Yet it wasn't percussive playing. His attacks were larder, his passage crop fluent, and even if he allowed himself some heavy foot-stomping in the dance rhythms of the final apparent movement, his hands danced lightly and sharply over the keyboard.
For altogether the virtuosity, however, thither wasn't a set of nuanced, poetic, mortal expressivity, which bottom make the work truly vital.
Saint-Saëns' Symphonic music No. 3, the "Organ" Philharmonic, which closed the syllabus, is one of those guilty pleasures that Disney Hall and its tube harmonium are ideal for. The sumptuous C major chord sign the set about of the finale and the shutting chords, with organ and full orchestra ablaze, were impossible to hold out.
Dutoit kept entirely the forces in balance, propelling the music in grand piano sweeps yet cannily disclosure details end-to-end. Principal trombonist Steven Witser's slow movement solo above exquisitely shimmering string section was commendable rich and restrained.
Still, it was that tremendous last, which turned Disney Hall into a Daniel Chester French cathedral, that stuck in the mind. Joanne Pearce Martin, wHO played the organ from the console at the back of the orchestra, deserved the huge ovation she received.
chris.pasles@latimes.com