�The following is a summary of selected women's health-related web log entries.
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).
Reprinted with kind permission from hypertext transfer protocol://www.nationalpartnership.org. You can perspective the entire Daily Women's Health Policy Report, search the archives, or sign up for email speech here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
� 2008 The Advisory Board Company. All rights reserved.
More info
Wednesday, 3 September 2008
Sunday, 24 August 2008
FDA Requires Additional Information On DORIBAX For Treatment Of Hospital-Acquired Pneumonia
�Johnson & Johnson Pharmaceutical
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.
More info
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.
More info
Thursday, 14 August 2008
Whit Stillman Offers Praise for August Movies � and Might Finally Be Directing a New One
Stillman
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]
More info
Friday, 27 June 2008
Amy Winehouse arrested based on video
Amy Winehouse has been arrested on suspicion of drug possession, police and her spokesman said Wednesday.
Thursday, 19 June 2008
Kanye Booed at Bonnaroo
The Bonnaroo boobirds were out in full force for Kanye West this weekend.
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
Michael Jackson has avoided foreclosure on his Neverland Ranch after a company acquired the exisitng loan allowing him to keep ownership of the iconic property.The 2,700-acre ranch in Santa Barbara was set to be auctioned this Wednesday (May 14), however, the King of Pop released a statement saying that the outstanding loan was taken over by Colony Capital, LLC, a Los Angeles based private-equity firm. “I am pleased with recent developments involving Neverland Ranch," Jackson expressed. "And I am in discussions with Colony and Tom Barrack with regard to the Ranch and other matters that would allow me to focus on the future.”No further comments were made by either party at the time of writing. Photo courtesy of Sony BMG.
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