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Posts Tagged ‘cancer’

FDA Approves Lazanda – First Fentanyl Nasal Spray – for the Management of Breakthrough Pain in Cancer Patients

Posted by 4love2love on July 24, 2011

FDA Approves Lazanda – First Fentanyl Nasal Spray – for the Management of Breakthrough Pain in Cancer Patients

“Lazanda is an important new option for patients with cancer who experience excruciating breakthrough pain,” says Jeffrey H. Buchalter, chief executive officer of Archimedes Pharma. “Lazanda, which uses our patented PecSys® drug delivery system, is designed to deliver medicine in a rapid, but controlled manner, and provides patients with an effective alternative to manage their breakthrough pain.”

Breakthrough pain in cancer (BTPc) is an intense, sudden pain that is often unpredictable and debilitating and occurs despite otherwise appropriate opioid therapy for background pain. BTPc has a different profile from background pain. BTPc often has high intensity, a rapid onset, usually reaching maximum intensity within five minutes, and a short duration, lasting between 30 and 60 minutes per episode. On average, BTPc affects more than half of patients with cancer and often interferes with patients’ health and ability to engage in daily living activities.

“As the first fentanyl nasal spray in the U.S., Lazanda provides a new approach to managing the often debilitating and inadequately-treated episodes of breakthrough pain that many patients with cancer experience,” said Donald Taylor, M.D., director at Taylor Research LLC., and clinical investigator for Lazanda. “Current treatment options typically utilize short-acting oral opioid medications that cannot provide pain relief with an onset of action or duration of effect that matches the time course of a BTPc episode. Lazanda’s rapid and controlled availability is a much better match for the nature of an episode of breakthrough pain, giving physicians a new and powerful tool for treating cancer breakthrough pain.”

Lazanda will be available in the second half of this year through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction, overdose, and serious complications due to medication errors. Under the Lazanda REMS program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to dispense, distribute, and prescribe Lazanda.

“We fully support the FDA mandate to implement a REMS program for Lazanda as an important way to provide patients, healthcare providers, and pharmacists with the information they need about the appropriate and safe use of Lazanda,” said Buchalter. “Archimedes Pharma looks forward to working closely with health care professionals to ensure safe and consistent access to Lazanda for the patients who are seeking relief from unbearable episodes of breakthrough pain in cancer.”

About Lazanda (fentanyl) nasal spray

Lazanda contains fentanyl, which is a Schedule II controlled substance, and uses Archimedes Pharma’s patented drug delivery system, PecSys®.

Lazanda, incorporating PecSys technology, delivers fentanyl in a rapid, but controlled manner and is designed to deliver a fine mist spray to a mucus membrane, in this case the nasal membrane. Each spray of Lazanda forms a gel when it contacts the nasal mucosa; the active ingredient is then rapidly absorbed across the mucus membrane and directly into the blood stream.

The efficacy of Lazanda for the management of breakthrough pain in adult cancer patients was established in a double-blind, placebo-controlled clinical study in which Lazanda showed a statistically significant improvement compared with placebo on the primary endpoint, the sum of the pain intensity difference at 30 minutes (SPID30). More than 500 patients evaluated in the clinical trial program (which included three phase III clinical trials) contributed to the understanding of the tolerability and safety profile of Lazanda. The most common adverse events associated with Lazanda were consistent with opioid treatment and included vomiting, nausea, pyrexia (fever), and constipation.

Important Safety Information

Warnings: Potential for Abuse and Importance of Proper Patient Selection

Lazanda contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Lazanda can be abused in a manner similar to other opioid agonists, legal or illicit. Consider the potential for abuse when prescribing or dispensing Lazanda in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Schedule II opioid substances, which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Serious adverse events, including deaths, in patients treated with other oral transmucosal fentanyl products have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of Lazanda for any other fentanyl product may result in fatal overdose.

Lazanda is indicated only for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg of oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

Lazanda is contraindicated in opioid non-tolerant patients and is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients treated with other fentanyl products. When prescribing, do not convert patients on a mcg per mcg basis from another fentanyl product to Lazanda. Patients beginning treatment with Lazanda must begin with titration from the 100 mcg dose. (see Dosage and Administration)

When dispensing, do not substitute a Lazanda prescription for any other fentanyl product. Substantial differences exist in the pharmacokinetics of Lazanda compared to other fentanyl products that could result in clinically important differences in the rate and extent of absorption of fentanyl and could result in fatal overdose.

Special care must be used when dosing with Lazanda. If the breakthrough pain episode is not relieved, patients must wait at least 2 hours before taking another dose of Lazanda. (see Dosage and Administration)

Lazanda is intended to be used only in the care of opioid tolerant patients with cancer and only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain.

Patients and their caregivers must be instructed that Lazanda contains a medicine in an amount that can be fatal in children, in individuals for whom it is not prescribed, and in those who are not opioid tolerant. Lazanda must be kept out of the reach of children at all times. (see Patient/Caregiver Instructions)

The concomitant use of Lazanda with cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations and may cause potentially fatal respiratory depression.

Because of the risk for misuse, abuse, addiction, and overdose, Lazanda is available only through a restricted program, required by the Food and Drug Administration, called the Lazanda REMS (Risk Evaluation and Mitigation Strategy) program. Under the Lazanda REMS program,healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program to prescribe, receive, dispense, and distribute Lazanda, respectively. [see Warnings and Precautions]. Further information is available at http://www.LazandaREMS.com or by calling 1-855-841-4234.

Contraindications

  • Lazanda is contraindicated in the management of pain in opioid non-tolerant patients, because life-threatening hypoventilation could occur at any dose in patients not already taking around-the-clock opioid therapy.
  • Lazanda is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room.
  • Lazanda is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl. Anaphylaxis and hypersensitivity have been reported in association with the use of other oral transmucosal fentanyl products.

Warnings And Precautions

  • Patients must not be converted to Lazanda from other fentanyl products because it is not equivalent to other fentanyl products on a mcg per mcg basis, and such substitution could result in a fatal overdose; do not substitute Lazanda for another fentanyl product when being dispensed.
  • Serious or fatal respiratory depression can occur even at recommended doses in patients using Lazanda. Respiratory depression is more likely to occur in patients with underlying respiratory disorders and elderly or debilitated patients, in opioid non-tolerant patients, or when opioids are given in conjunction with other drugs that depress respiration.
  • Lazanda could be fatal to individuals for whom it is not prescribed and for those who are not opioid tolerant.
  • Patients and their caregivers must be instructed that Lazanda contains medicine in an amount that could be fatal to a child and thus must keep both used and unused bottles in their child-resistant container and out of the reach of children at all times and all residual fentanyl must be emptied before disposal.
  • Patients on concomitant CNS depressants must be monitored for a change in opioid effects and adjust the dose of Lazanda.
  • Concomitant use with potent cytochrome P450 3A4 inhibitors may increase depressant effects including hypoventilation, hypotension, and profound sedation. Monitor and consider dosage adjustment if warranted.
  • Cautiously adjust the dose of Lazanda in patients with chronic obstructive pulmonary disease or preexisting medical conditions predisposing them to respiratory depression.
  • Administer Lazanda with extreme caution in patients particularly susceptible to intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness.
  • Patients taking Lazanda must be warned that opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery).
  • Use Lazanda with caution in patients with bradyarrhythmias.
  • Lazanda is not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.

Drug Interactions

  • Potential interactions may occur when Lazanda is given concurrently with agents that affect CYP3A4 activity. Monitor patients for signs of opioid toxicity who begin therapy with, or increase the dose of, inhibitors of CYP3A4 or stop therapy with, or decrease the dose of, inducers of CYP3A4.Monitor patients who are taking vasoconstrictive nasal agents to treat allergic rhinitis for potentially impaired pain management.

Use In Specific Populations

  • Safety and efficacy below 18 years of age have not been established.
  • There are no adequate and well-controlled studies of Lazanda in pregnant women. Do not use Lazanda during labor and delivery or in women who are nursing.
  • Lazanda should be administered with caution in patients with impaired renal or hepatic function and titrated to clinical effect in patients with severe renal or hepatic disease.

Adverse Reactions

  • Most common adverse events during titration (frequency greater than or equal to 5%): nausea, vomiting, and dizziness.
  • Most common adverse events during maintenance (frequency greater than or equal to 5%): vomiting, nausea, pyrexia, and constipation.

Please see the accompanying full Prescribing Information including boxed warning. For more information please see http://www.lazanda.com.

About Archimedes Pharma

Archimedes Pharma is an international specialty pharmaceutical company providing novel and advanced treatments to address unmet needs for people living with serious or life-threatening chronic and debilitating illnesses. Archimedes Pharma markets a diverse portfolio of speciality products and has operations in the U.S. and throughout Europe. Archimedes Pharma U.S. Inc. is a subsidiary of Archimedes Pharma Ltd. For more information, please visit: http://www.ArchimedesPharma.com.

Lazanda®, PecFent®, and PecSys® are registered trademarks of Archimedes Development Ltd.

SOURCE Archimedes Pharma Ltd.

Posted: June 2011

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FDA MedWatch Alert – Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication – Modified Dosing Recommendations

Posted by 4love2love on July 24, 2011

June 24, 2011
Epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp)

ISSUE: FDA notified healthcare professionalsthat new, modified recommendations for more conservative dosing of Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic kidney disease (CKD) have been approved to improve the safe use of these drugs. FDA has made these recommendations because of data showing increased risks of cardiovascular events with ESAs in this patient population. The new dosing recommendations are based on clinical trials showing that using ESAs to target a hemoglobin level of greater than 11 g/dL in patients with CKD provides no additional benefit than lower target levels, and increases the risk of experiencing serious adverse cardiovascular events, such as heart attack or stroke.

BACKGROUND: ESAs treat certain types of anemia by stimulating the bone marrow to produce red blood cells and by decreasing the need for blood transfusions. The manufacturer has revised the Boxed Warning, Warnings and Precautions, and Dosage and Administration sections of the labels for the ESAs to include this new information.

RECOMMENDATIONHealthcare professionals should weigh the possible benefits of using ESAs to decrease the need for red blood cell transfusions in CKD patients against the increased risks for serious cardiovascular events, and should inform their patients of the current understanding of potential risks and benefits. Therapy should be individualized to the patient and the lowest possible ESA dose given to reduce the need for transfusions. See the Drug Safety Communication for additional information including a table of key trials and other supporting references. Treatment with ESAs in CKD was discussed at the Cardiovascular and Renal Drugs Advisory Committee, held October 18, 2010. For summary minutes of that Advisory Committee, see link below.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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NY Times – American Artist Who Scribbled a Unique Path

Posted by 4love2love on July 6, 2011

CY TWOMBLY, 1928-2011

Michael Stravato for The New York Times

Cy Twombly with his painting “1994 Untitled (Say Goodbye Catullus, to the Shores of Asia Minor),” at the Menil Collection in Houston in 2005. More Photos »

By 
Published: July 5, 2011

Cy Twombly, whose spare, childlike scribbles and poetic engagement with antiquity left him stubbornly out of step with the movements of postwar American art even as he became one of the era’s most important painters, died on Tuesday in Rome. He was 83.

The Art of Cy Twombly

His death was announced by the Gagosian Gallery, which represents his work. Mr. Twombly had battled cancer for several years.

In a career that slyly subverted Abstract Expressionism, toyed briefly with Minimalism, seemed barely to acknowledge Pop art and anticipated some of the concerns of Conceptualism, Mr. Twombly was a divisive artist almost from the start. The curator Kirk Varnedoe, on the occasion of a 1994 retrospective at the Museum of Modern Art, wrote that his work was “influential among artists, discomfiting to many critics and truculently difficult not just for a broad public, but for sophisticated initiates of postwar art as well.”

The critic Robert Hughes called him “the Third Man, a shadowy figure, beside that vivid duumvirate of his friends Jasper Johns and Robert Rauschenberg.”

Mr. Twombly’s decision to settle permanently in southern Italy in 1957 as the art world shifted decisively in the other direction, from Europe to New York, was only the most symbolic of his idiosyncrasies. He avoided publicity throughout his life and mostly ignored his critics, who questioned constantly whether his work deserved a place at the forefront of 20th century abstraction, though he lived long enough to see it arrive there. It didn’t help that his paintings, because of their surface complexity and whirlwinds of tiny detail — scratches, erasures, drips, penciled fragments of Italian and classical verse amid scrawled phalluses and buttocks — lost much of their power in reproduction.

But Mr. Twombly, a tall, rangy Virginian who once practiced drawing in the dark to make his lines less purposeful, steadfastly followed his own program and looked to his own muses — often literary ones, like Catullus, Rumi, Pound and Rilke. He seemed to welcome the privacy that came with unpopularity.

“I had my freedom and that was nice,” he said in a rare interview, with Nicholas Serota, the director of the Tate, before a 2008 survey of his career at the Tate Modern.

The critical low point probably came after a widely panned 1964 exhibition at the Leo Castelli Gallery in New York. The artist and writer Donald Judd, who was hostile toward painting in general, was especially damning, calling the show a fiasco. “There are a few drips and splatters and an occasional pencil line,” he wrote in a review. “There isn’t anything to these paintings.”

But by the 1980s, with the rise of neo-Expressionism, a generation of younger artists like Jean-Michel Basquiat found inspiration in Mr. Twombly’s skittery bathroom-graffiti scrawl. Coupled with rising interest in European artists whose work shared unexpected ground with Twombly’s, like Joseph Beuys, the newfound attention brought him a kind of critical favor he had never enjoyed before. And by the next decade, he was highly sought after not only by European museums and collectors, who had discovered his work early on, but also by those back in his homeland who had not known what to make of him two decades before.

In 1989, the Philadelphia Museum of Art opened permanent rooms dedicated to his monumental 10-painting cycle, “Fifty Days at Iliam,” based on Alexander Pope’s translation of “The Iliad.” (Mr. Twombly said that he purposely misspelled Ilium, a Latin name for Troy, with an “a,” to refer to Achilles.) That same year, Mr. Twombly’s work passed the million dollar mark at auction. In 1995, the Menil Collection in Houston opened a new gallery dedicated to his work, designed by Renzo Piano after a plan by Mr. Twombly himself. Despite this growing acceptance, Mr. Varnedoe still felt it necessary to include an essay in the Modern’s newsletter at the time of the retrospective, titled “Your Kid Could Not Do This, and Other Reflections on Cy Twombly.”

‘It Does Not Illustrate’

In the only written statement Mr. Twombly ever made about his work, a short essay in an Italian art journal in 1957, he tried to make clear that his intentions were not subversive but elementally human. Each line he made, he said, was “the actual experience” of making the line, adding: “It does not illustrate. It is the sensation of its own realization.” Years later, he described this more plainly. “It’s more like I’m having an experience than making a picture,” he said. The process stood in stark contrast to the detached, effete image that often clung to Mr. Twombly. After completing a work, in a kind of ecstatic state, it was as if the painting existed but he himself barely did anymore: “I usually have to go to bed for a couple of days,” he said.

Edwin Parker Twombly Jr., was born in Lexington, Va., on April 25, 1928, to parents who had moved to the South from New England. His father, a talented athlete who pitched a summer for the Chicago White Sox and went on to become a revered college swimming coach, was nicknamed Cy, after Cy Young, the Hall of Fame pitcher. The younger Mr. Twombly (pronounced TWAHM-blee) inherited the name, though he was much more bookish than athletic as a child, with stooped shoulders and a high ponderous forehead. He read avidly and, discovering his calling early, he worked from art kits he ordered from the Sears Roebuck catalog. As a teenager, he studied with the Spanish painter Pierre Daura, who had left Europe after the Spanish Civil War and settled in Lexington. Daura’s wife, Louise Blair, studied cave paintings and may have sparked Mr. Twombly’s early interest in Paleolithic art.

In 1947 he attended the Boston Museum School, where German Expressionism was the rage, but Mr. Twombly gravitated to his own interests, like Dada and Kurt Schwitters and particularly to Jean Dubuffet and Alberto Giacometti, two important early influences. He moved back to Lexington in 1949 and studied art at Washington and Lee University, where his talent impressed teachers. By 1950, he was in New York, the recipient of a scholarship to the Art Students League. Later in his life, he cited visiting Willem de Kooning’s studio and seeing an Arshile Gorky retrospective at the Whitney Museum of American Art as important moments in his young painting life. But he also came to New York at the heyday of the New York School and was exposed to the work of almost all its giants in the city’s galleries. He turned down an offer for a solo show of his paintings at the Art Students League in 1950, saying that he felt it was too early for him.

He met Rauschenberg, a fellow student at the league, during his second semester, and Rauschenberg later persuaded Mr. Twombly to enroll at Black Mountain College in North Carolina, which had become a crucible for the American avant-garde, with John Cage, Merce Cunningham, Ray Johnson, Dorothea Rockburne and John Chamberlain among its faculty and students. Mr. Twombly, who studied with Ben Shahn, stayed at the college only briefly and was a bit of an outsider even then. As he told Mr. Serota: “I was always doing my own thing. I always wondered why there are books with photographs of all the artists of that period and I was only in one! I thought: ‘Where was I?’ ”

In the summer of 1952, after receiving a grant from the Virginia Museum of Fine Arts, Mr. Twombly traveled to Europe for the first time and met up with Rauschenberg. The two wandered through Italy, North Africa and Spain, an experience that later yielded some of the first paintings to be considered a part of Mr. Twombly’s mature work. “Tiznit,” made with white enamel house paint and pencil and crayon, with gouges and scratches in the surface, was named for a town in Morocco that he had visited, and the painting’s primitivist shapes were inspired by tribal pieces he saw at the ethnographic museum in Rome, as well as by artists like Dubuffet, de Kooning and Franz Kline.

The painting, along with another based on tribal motifs, was exhibited in 1953 at Eleanor Ward’s Stable Gallery on West 58th Street along with monochromatic paintings by Rauschenberg. The show was generally savaged. (Early this year, the Museum of Modern Art acquired “Tiznit,” along with another early work, which Mr. Twombly had kept in his personal collection.)

Mr. Twombly was drafted and spent more than a year in the Army, where he was assigned to cryptography work in Washington. On weekends and leaves, he continued to paint and draw, sometimes at night with the lights out to try to lose techniques he had learned in art classes and to express himself more instinctively. After receiving a medical discharge and teaching for a time in Virginia, Mr. Twombly returned to New York and worked in a studio on William Street, near both Rauschenberg and Johns, who helped choose titles for his paintings during this period.

Mr. Twombly tried without success for several months to get a grant to go back to Europe and in 1957, with Ward’s help, he spent several months in Italy, where he met Tatiana Franchetti, a portrait painter and member of a storied family of Italian art patrons. They were married in 1959 at City Hall in New York and their son, Cyrus Alessandro, was born that year. She died in 2010. Mr. Twombly is survived by his son; two grandchildren, and by Nicola Del Roscio, his longtime companion.

In Love With Italy

Mr. Twombly fell in love with Italy, which reminded him of the faded grandeur of Lexington. (“Virginia is a good start for Italy,” he once said.) He rented an apartment facing the Coliseum in Rome and began to work on larger scale paintings, which were increasingly spare, incorporating scrawled words and doodle-like shapes on a smudged off-white background, establishing a lifelong reputation as a high-art graffitist that generally irked him. He told Mr. Serota that while early paintings made visual reference to ancient graffiti, his intentions were “more lyrical” and his inclusion of phalluses and female body parts were often just ways to evoke male and female presences in the work. If his aspirations were toward any period, he later said, it was an early neo-Classicism, like that of Poussin, whom he said he would have liked to have been. (In his final days, he at least communed with his hero’s spirit; the Dulwich Picture Gallery in London opened a show on June 29 pairing his works with Poussin’s.)

In 1958, Mr. Twombly left Ward’s Stable Gallery and began to show at Leo Castelli, which represented Rauschenberg and Johns and was establishing them as presences in the New York art world. Mr. Twombly continued to live and work in and around Rome, but he traveled extensively, to the Sahara, Greece, Egypt and Turkey. In 1964 his work was included in one of the first exhibitions to explore the ideas of Minimalism, “Black, White and Grey,” at the Wadsworth Athenaeum in Hartford, with a roster of rising stars like Agnes Martin, Frank Stella and Andy Warhol.

But the same year, Mr. Twombly’s “Nine Discourses on Commodus,” an ambitious painting cycle he made after the assassination of President John F. Kennedy, based on the life and death of the Roman emperor, received scathing reviews in a show at the Castelli gallery. In addition to Judd’s condemnation, other critics dismissed the work as nostalgically backward-looking or barely there; one described paintings of “indecisive pinkish scrawled areas floating across each other at the edges.” According to the catalog for the Tate Modern show, the criticism damaged Mr. Twombly’s career and caused him to paint less for several years. His aversion to the press might also have been cemented at this point; not long after the Castelli show, Vogue magazine ran a piece about Mr. Twombly, lavishly illustrated with pictures by Horst P. Horst of his elegant Roman apartment. The article noted archly that his wealth and comfort had led to “Twombly being suspected of having fallen for ‘grandeur’ ” and to a view among American critics that he had “somehow betrayed the cause.”

In the 1960’s, he began to work for periods of time back in Lexington and in New York, where he used the collector and curator David Whitney’s loft and then rented space on the Bowery. In 1972, he began working on one of the largest canvases of his career, a painting inspired by Burton’s “Anatomy of Melancholy,” which would take him 22 years to complete and is now installed in the Twombly gallery at the Menil Collection.

With the opening of that gallery Mr. Twombly fully entered what might be called the Old Master stage of a career that had taken a long time to arrive there, though his presence is still muted in the narrative of postwar art told by many American museum collections.

In 2010, the Louvre unveiled a ceiling painting it commissioned by Mr. Twombly, a 3,750-square-foot work in the museum’s Salle des Bronzes, next door to a ceiling triptych created more than half a century before by Georges Braque. The work is as calm and classical as his many of his early paintings were stormy and scatological: a listing of Hellenic sculptors against a deep blue background with planet-like discs. Characteristically, Mr. Twombly said little about the work.

Just before the retrospective at the Modern opened in 1994, he submitted reluctantly to an interview with The New York Times, sounding more agitated by the attention the show directed his way than vindicated by the recognition.

“I have my pace and way of living,” he said, in his hillside house in Gaeta, south of Rome, “and I’m not looking for something.” Of reputation and artistic acclaim, he added: “It’s something I don’t think about. If it happens, it happens, but don’t bother me with it. I couldn’t care less.”

 
© 2011 The New York Times

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Reuters – Judge blocks testimony from Casey Anthony fiancé

Posted by 4love2love on June 29, 2011

By Barbara Liston

ORLANDO, Fla | Tue Jun 28, 2011 9:01pm EDT

(Reuters) – The former fiancé of accused child killer Casey Anthony testified on Tuesday that she claimed she once woke up to find her older brother standing over her, staring at her while she slept.

Judge Belvin Perry called Jesse Grund’s testimony impermissible hearsay evidence, and said he won’t allow the jury to hear it unless defense lawyers persuade him otherwise with sufficient legal arguments.

Grund said Casey told him about her experience with her brother after Grund asked her why she didn’t want her daughter Caylee to be around Lee Anthony.

Prosecutors say Casey, 25, smothered 2-year-old Caylee on June 16, 2008 so that she could “live the good life” free of the demands of motherhood. They say Casey stored the child’s body in her car trunk, then dumped it in woods near her home.

Defense attorney Jose Baez told jurors in his opening statement that Caylee accidentally drowned in the Florida family’s backyard pool, and the death went unreported.

Baez said Casey was sexually abused, and that explained why she partied and seemed inappropriately carefree after her daughter’s death.

But Baez has yet to produce evidence of the alleged abuse during Casey’s murder trial, now in its sixth week.

Casey’s father, George Anthony, has denied molesting her. Earlier this month, Perry scolded Baez when he asked a witness whether Lee could be Caylee’s father.

Much of the testimony on Tuesday came from Roy Kronk, the water department meter reader who discovered Caylee’s remains in a swampy part of a wooded area near the Anthony home in the Orlando area.

Kronk said he called the sheriff’s department three times in August 2008 to report he found what looked like a small skull.

At the time, a nationwide search was underway to find Caylee, who Casey claimed was kidnapped by a nanny. Special phone lines were created to handle the thousands of tips and leads sent to authorities.

But detectives were zeroing in on Casey, who they knew had lied extensively about Caylee’s disappearance.

Kronk said no one took him seriously until December 11, 2008, when he stopped at the location again and verified the object was in fact a skull. His supervisor alerted authorities, who arrived at the site and found Caylee’s remains.

MAJOR DISCOVERY

Kronk is a key witness for the defense. Baez has insinuated that Kronk played some sort of role in the disposal of Caylee’s body. The lawyer told jurors Kronk had sole “control” of Caylee’s remains during the intervening four months and claimed he was motivated by a $225,000 reward.

However, the reward money was offered to anyone who found Caylee alive.

“I just simply tried to do the right thing,” said Kronk, who noted he received $5,000 from the crime tip line.

Kronk testified he first spotted what looked like a skull on August 11, 2008 while taking a break with two co-workers, and called a crime tip line later that night to report the object.

Kronk said he called the Orange County Sheriff’s Office again on the evening of August 12 and the morning of August 13 before finally getting deputies to meet him at the location.

Two deputies came but neither went into the woods nor asked him to show them the skull-like object, Kronk said.

One deputy walked as far as a flooded area, quickly looked from side to side, slipped on mud on his way back to the roadside, and then berated Kronk for 30 minutes for wasting his time, the meter reader testified.

Kronk’s co-worker, David Dean, confirmed Kronk’s account of discovering the skull. Within a few weeks, Dean testified, a tropical storm deluged the area with rain.

Prosecutors have suggested one reason no one saw the remains during subsequent searches in the area was because it was under water.

George Anthony took the stand briefly again on Tuesday, denying assertions by Baez that he had an affair with search volunteer Krystal Holloway. George testified he only went to Holloway’s condominium to comfort her after learning she had cancer.

“I never had a romantic affair,” George said.

He denied ever telling Holloway that “Caylee’s death was an accident that snowballed out of control.” He also said he never told her that he grabbed Casey by the throat, threw her against a wall and demanded Casey tell him where Caylee was.

“She (Holloway) is not a good person,” George testified.

(Editing by Colleen Jenkins and Jerry Norton)

© Copyright 2011 Thomson Reuters

 

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MedicineNet.com – Skin Changes, How to Spot Skin Cancer

Posted by 4love2love on June 26, 2011

It wasn’t too long ago that my grandmother had to have a mole removed because it had become malignant. We had a relative die years ago from skin cancer, and recently, my mother had to have a melanoma removed from her arm. I am now facing my own fear of skin cancer related to multiple small growths that have started to increase in appearance on my face. So, I thought to help other people to be aware of skin cancer and how to spot it. Remember that if you notice any signifigant skin chances, please see your doctor right away!

 

Medical Author: Melissa Stoppler, M.D.
Medical Editor: William C. Shiel, Jr, MD, FACP, FACR

Picture of skin cancerAccording to the American Academy of Dermatology, one in five Americans will develop some form of skin cancer in their lifetime. Sun exposure is the leading cause of skin cancer, and people with fair skin and light eyes whose skin has a tendency to burn easily in the sun are most susceptible to the damaging effects of the sun’s UV rays. Fortunately, most skin cancers can be detected in their early stages since skin tumors are more visible than tumors of the internal organs.

Three types of cancers account for virtually 100% of skin cancers. The nonmelanomatous skin cancers include basal cell carcinoma and squamous cell carcinoma. Malignant melanoma is the third, and most deadly, type of skin cancer.

Basal cell carcinoma is by far the most common type of skin cancer, accounting for 80% of cases. These slow-growing tumors occur most commonly on areas of the body that are exposed to sun and may take several forms. A raised, reddish, pearly nodule is the most common appearance of basal cell carcinoma, but it may also appear as a pink or red scar or area of irritated skin. Basal cell carcinomas metastasize (spread via the bloodstream or lymphatic channels) very rarely; instead, they grow invasively into surrounding tissues and can cause localized tissue destruction when not completely removed.

Squamous cell carcinoma is the second most common type of skin cancer, representing about 16% of all skin cancers. As with basal cell carcinoma, squamous cell carcinoma occurs most often in sun-exposed areas and in elderly people. Its appearance is similar to a chronic ulcerated area of the skin or a crusty or scaly skin lesion. Unlike basal cell carcinomas, squamous cell cancers metastasize to other parts of the body when they are not detected and removed at an early stage.

The deadliest skin cancer, melanoma, accounts for only 4% of skin cancers. This type of cancer often spreads to the lymph nodes and internal organs. While melanomas have a variety of physical appearances, they are most often pigmented lesions greater than 0.6 mm (about the size of a pencil eraser) in diameter. They may show a range of colors and generally have an irregularly-shaped, asymmetrical border. Melanoma can be cured by surgical removal if detected before spread to other organs has occurred. About 95% of melanomas can be cured when the cancer is limited to the outermost layer of the skin, but the prognosis is poor when melanoma has spread to other parts of the body.

Other, rare types of skin cancer make up less that 1% of all skin malignancies. Examples of these rare tumors include Paget’s disease of the skin, Merkel cell carcinoma, and cutaneous lymphoma.

Early detection is essential for successful treatment of skin cancers. You should consult your doctor if you have any suspicious skin changes or lesions including:

  • moles that have changed in appearance, bleed, or become itchy
  • new moles or sores
  • ulcers that do not heal
  • moles that have grown or exhibit unusual changes

Avoidance of sun exposure and use of appropriate sunscreen products are the best ways to prevent all skin cancers.
Last Editorial Review: 12/26/2006

 

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WebMD – Why Some Smokers Have a Harder Time Quitting

Posted by 4love2love on June 25, 2011

Study Shows Variation in Brain May Give Some Smokers More Pleasure From Nicotine
By Denise Mann
WebMD Health News
Reviewed by Laura J. Martin, MD

smoker and double helix overlay

May 16, 2011 — Quitting smoking is never easy, but some smokers have an even harder time kicking the habit, and now new research suggests that they may derive more pleasure form nicotine.

The new study, which appears in the Proceedings of the National Academy of Sciences, may also help foster the development of more effective quitting strategies for certain smokers.

Researchers used PET scans to capture images of the number of “mu-opioid receptors” in the brains of smokers. Smokers with greater numbers of these receptors seem to derive more pleasure from nicotine, and as a result may have a harder time quitting.

“The brain’s opioid system plays a role in smoking rewards, and quitting smoking and some of the variability in our ability to quit among smokers is attributable to genetic factors,” says study researcher Caryn Lerman, PhD, director of Tobacco Use Research Center at the University of Pennsylvania in Philadelphia.

“The ability to quit smoking is influenced by a number of psychological, social, and environmental factors, but also genetic factors,” she says. “For some people, genetic variations may make it more difficult to quit than for someone else who smokes the same amount for same amount of time,” Lerman says.

The study findings are more applicable to quitting smoking than becoming addicted in the first place, she says.

New Quitting Strategies/Tools Needed

There may be a role for personalized medicine when it comes to smoking cessation, Lerman says.  Personalized medicine takes the trial and error out of matching treatments by making decisions based on genetic profiles.

“Based on a person’s genetic background, we can select the optimal treatment,” she says. “It is a two-pronged approach of developing new medications and being able to make the best choice for a particular person based on existing options.”

Importantly, even diehard smokers should not take these findings to mean they can’t quit, she says.

“Don’t become fatalistic,” she says. “You may need particular approaches tailored to you,” she says. Going forward, “we hope to study this pathway in more detail to understand whether examining genetic background and the numbers of brain receptors can help us choose the right treatments for the right individual.”

Raymond S. Niaura, PhD, an associate director for science at the Schroeder Institute of the American Legacy Foundation, an antismoking group based in Washington, D.C., says that “there are genetic influences involved in becoming addicted to nicotine and tobacco and on how hard it is to quit smoking.”

The new findings provide “a peek into the genetic and underlying brain processes responsible for nicotine addiction,” he says.

Daniel Seidman, PhD, assistant clinical professor of medical psychology and the director of Smoking Cessation Services at Columbia University Medical Center in New York City, agrees.“There are a lot of smokers and everybody gets lumped together, but there are a lot of patterns like with other types of addiction.”

This paper “points to a biological or genetic substrate which predisposes some people to have a hard time,” he says. Quitting smoking can be emotionally charged, he says. Symptoms typically include irritability, anger, and sad mood. “Some people are able to rally more and some may not bounce back as well because they have a harder time finding alternative sources of pleasure,” he says.

Agreeing with Niaura, Seidman says that some smokers seem to need nicotine replacement for longer periods of time. “When they come off nicotine patches or gum, it doesn’t feel right and it may be related to this subtype,” he says. “This is not a problem because nicotine replacement doesn’t cause cancer or go into yourlungs.”

People with this particular genetic variation may benefit from extended treatment, he says. “They may have a certain kind of sensitivity to nicotine, which could explain why they became addicted in the first place and why they may need to use nicotine replacement for a longer time than others.”

 

© 2011 WebMD, LLC.

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Reuters – Heart risks lower in men who get enough vitamin D

Posted by 4love2love on June 24, 2011

Amy Norton Reuters3:22 p.m. EDT, June 24, 2011

NEW YORK (Reuters Health) – Men who consume the recommended amount of vitamin D are somewhat less likely to suffer a heart attack or stroke than those who get little of the vitamin in their diets, a large U.S. study suggests.

Following nearly 119,000 adults for two decades, researchers found that men who got at least 600 international units (IU) of vitamin D each day — the current recommended amount — were 16 percent less likely to develop heart problems or a stroke, versus men who got less than 100 IU per day.

There was no such pattern among women, however, the researchers report in the American Journal of Clinical Nutrition.

The authors say the findings do not prove that vitamin D, itself, deserves the credit for the lower risks seen in men. So they should not start downing supplements for the sake of their hearts.

“The evidence is not strong enough yet to make solid recommendations,” said lead researcher Dr. Qi Sun, a research associate at the Harvard School of Public Health.

On the other hand, the apparent benefits were linked to vitamin D intakes near what’s already recommended: Last year, the Institute of Medicine (IOM), a scientific advisory panel to the U.S. government, bumped up the recommended dose to 600 IU for most people. Adults older than 70 were told to get 800 IU.

So these latest findings may encourage more people to meet those guidelines, Sun said.

But as far as whether vitamin D cuts heart disease and stroke risk, the jury is still out.

Sun said that more answers should come from an ongoing clinical trial that is looking at whether a high dose of vitamin D (2,000 IU per day) can cut the risk of heart disease, stroke and other chronic diseases.

Clinical trials, wherein people are randomly assigned to a treatment or a placebo, are considered the “gold standard” of medical evidence.

So far, there have been few such randomized clinical trials testing vitamin D’s health effects.

A flurry of studies in recent years has linked higher vitamin D intake to lower risks of everything from diabetes, to severe asthma, heart disease, certain cancers and depression.

The problem with those studies is that were “observational” — researchers looked at people’s vitamin D intake, or their blood levels of the vitamin, and whether they developed a given health condition. Those kinds of studies cannot prove cause-and-effect.

The current study was also observational, based on data from two long-term projects that have followed two large groups of U.S. health professionals since the 1980s.

Out of 45,000 men, there were about 5,000 new cases of cardiovascular disease over the study period. These were defined by an incident of heart attack, stroke, or death attributed to cardiovascular disease.

After accounting for a range of factors — like age, weight, exercise levels and other diet habits, such as fat intake – Sun’s team found that men who got at least 600 IU of vitamin D from food and supplements had a 16 percent lower risk of heart attack and stroke compared to men who got less than 100 IU of vitamin D per day.

For women, though, there was no correlation between vitamin D intake and cardiovascular health.

It’s not clear why that is, Sun said. One possibility is that women may have less active vitamin D circulating in the blood; vitamin D is stored in fat, and women typically have a higher percentage of body fat than men do.

But more research is needed, Sun said, to know whether real biological differences underlie the current findings.

In theory, vitamin D could help ward off heart disease and stroke; lab research suggests that it may help maintain healthy blood vessel function and blood pressure levels, reduce inflammation in the blood vessels, and aid blood sugar control.

But until clinical trials help show whether vitamin D works, Sun advised people to stick with the tried-and-true ways of protecting their hearts: maintaining a healthy weight, getting regular exercise, eating a well-balanced diet and not smoking.

“There are many established ways to lower your cardiovascular disease risk,” Sun said. “People can focus on those measures.”

As for vitamin D, the sun is the major natural source, since sunlight triggers vitamin D synthesis in the body. Food sources are relatively few and include fatty fish like salmon and mackerel, and fortified dairy products and cereals.

SOURCE: http://bit.ly/irO9Xe American Journal of Clinical Nutrition, online June 8, 2011.

Copyright © 2011, Reuters

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