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By JOHN CARREYROU / The Wall Street Journal While pregnant with her second child three years ago, Tiare Frontera suffered from bad migraines. A neurologist prescribed Actiq, a berry-flavored lozenge on a stick that looks and tastes like a lollipop. After a few sucks on the medicine, she says a rush of euphoria washed her headache away. Soon, Mrs. Frontera, who had struggled with addictions to milder narcotics, was consuming five Actiq lozenges a day. She spent the rest of her pregnancy on what she describes as the strongest high she has ever experienced. When she gave birth, her baby son was cranky and wouldn’t sleep. Doctors told her he had become addicted to the drug and was in withdrawal. Mrs. Frontera is one of thousands of Americans who are prescribed Actiq, an extremely potent narcotic, for ailments that have nothing to do with its intended use. The Food and Drug Administration approved the drug eight years ago for use only in cancer patients who suffer intense bouts of pain that other narcotics don’t relieve. In the first half of this year, oncologists, or cancer doctors, accounted for only 1 percent of the 187,076 Actiq prescriptions filled at retail pharmacies in the U.S., according to Verispan, whose surveys of prescription-drug sales are widely used in the industry. Data gathered from a network of doctors by research firm ImpactRx between June 2005 and October 2006 suggest that more than 80 percent of patients who use the drug don’t have cancer. Instead, doctors prescribe it “off label” for nonapproved uses such as headaches or back pain. Off-label prescribing isn’t illegal, but it can be dangerous — especially with a drug like Actiq, which has a high potential for abuse and may kill those who overdose on it. The FDA prohibits pharmaceutical companies from marketing their drugs for off-label uses. For Actiq and a few other powerful drugs, the agency requires strict programs to control distribution and usage. Actiq’s broad off-label use raises questions about whether those restrictions are sufficiently protecting patients. “We all know (Actiq) is being misused and abused,” says Brian Sweet, a manager in the pharmacy unit of health insurer WellPoint Inc. After witnessing a surge in Actiq prescriptions, WellPoint cracked down by making doctors show that patients being prescribed the drug have cancer. Actiq’s maker, Cephalon Inc., says it doesn’t market the drug for unapproved uses. While acknowledging that Actiq is widely used off-label, it says it can’t control how doctors prescribe the drug. Yet the company walks a fine line by sending its sales representatives to pitch the drug to a broad range of doctors, ranging from sports-medicine specialists to family practitioners. It gives these doctors coupons for free samples. Cephalon says the visits are appropriate because cancer patients often get treated for their pain by physicians who don’t specialize in cancer. Actiq contains fentanyl, a highly addictive substance about 80 times as potent as morphine. Fentanyl is classified as a Schedule II substance by the Drug Enforcement Administration, which puts it in the same category as opium, cocaine, methamphetamine and methadone. Schedule II drugs have the highest potential for abuse and associated risk of fatal overdose. Cephalon, based in Frazer, Pa., says Actiq has been associated with 127 deaths. Two of them involved children who confused the drug for candy. Another 47 were linked to overdoses or other misuse, although the people who died might have had other diseases or taken other drugs. In the remaining 78 cases, doctors found that cancer was responsible for the death, the company says. Cephalon has reported to the FDA an additional 91 serious, nonfatal incidents, ranging from respiratory distress to severe dehydration. The U.S. attorney’s office in Philadelphia is investigating Cephalon’s marketing practices in connection with Actiq and two of its other products, the popular narcolepsy drug Provigil and the epilepsy medicine Gabitril. No charges have been filed. Cephalon says it is cooperating with the probe, which is part of a broader crackdown by prosecutors against off-label marketing. In August, the Justice Department fined Schering-Plough Corp. $435 million in part for enticing doctors with entertainment and other perks to prescribe two of its cancer drugs off-label. Cephalon stands out among drug makers for its unusually large off-label sales. Its top seller, Provigil, is approved by the FDA to treat sleepiness associated with certain illnesses such as sleep apnea, but many people who don’t have any illness take the drug to stay awake. Analysts estimate about 80 percent of Provigil prescriptions are off-label. Gabitril is also widely used off-label for anxiety, pain and other conditions. Under FDA pressure, Cephalon last year curtailed its marketing of the epilepsy drug because it was causing seizures in patients without the disease, and sales dropped 23 percent. Founded in 1987 by a former DuPont Co. scientist named Frank Baldino Jr., Cephalon expects revenue to exceed $1.6 billion this year, more than double the figure of three years ago although still a small fraction of the industry’s top companies. Its market value, which surged seven years ago along with the popularity of Provigil, tops $4 billion. Dr. Baldino earned $2.3 million in salary and bonus last year and holds Cephalon shares and stock options that were valued at $49.6 million as of the end of last year. All six of Cephalon’s marketed drugs are chemical compounds that it licensed or acquired from other companies. Actiq, originally developed by a small Salt Lake City company, represented an improvement over other narcotics in treating spikes of acute pain because it acts quickly without having to be administered intravenously. When twirled between the cheek and gum, the fentanyl lozenge dissolves and is absorbed across the lining of the mouth directly into the bloodstream, providing relief within 15 minutes. Actiq had sales of $15 million in 2000, when Cephalon acquired it. By last year, sales had grown to $412 million, making it Cephalon’s No. 2 drug. In the first nine months of this year, sales jumped to $471 million. Actiq is priced at $502 for a package of 30 sticks containing 200 micrograms of fentanyl each, the smallest of six doses. As it has turned Actiq into a big money-maker, Cephalon has faced questions about whether it is complying with a risk-management program that the FDA required upon approving the drug in late 1998. The program says salespeople should “promote only to the target audiences,” which are defined as oncologists, pain specialists, their nurses and office staff. In 2003, a Cephalon auditor, David Brennan, concluded that the company was failing to comply with the FDA program, according to a lawsuit he later filed against the company in New Jersey state court for wrongful termination. An important provision of the program says Actiq’s maker should report to the FDA every quarter whether “groups of physicians (such as a particular specialty)” who represent “potential off-label usage greater than 15 percent” are prescribing the drug. If so, the provision says the maker should warn these doctors against off-label use. Mr. Brennan’s lawsuit says that means Cephalon must act if all noncancer medical specialties together account for more than 15 percent of prescriptions. Cephalon interprets the provision differently. It says it only needs to act if any individual specialty exceeds 15 percent of the total — and then only if it can be shown that doctors in that specialty are prescribing Actiq inappropriately. Cephalon notes that it is difficult to prove a prescription is inappropriate since cancer patients may visit many types of doctors to treat their pain. It believes the 15 percent clause has yet to be triggered. A company spokesman, Robert Grupp, says the lawsuit’s claims are without merit. The FDA declined to comment. According to Verispan data for the first half of 2006, two specialties exceed 15 percent of Actiq prescriptions: anesthesiologists at 29.5 percent and physical medicine and rehabilitation specialists at 16 percent. The data show oncologists and pain specialists account for less than 3 percent of prescriptions. Cephalon doesn’t dispute the data. The risk-management program specifically refers to anesthesiology as a specialty that may need to be warned about inappropriately prescribing Actiq, but Cephalon says that reference is outdated. It says anesthesiologists have become part of the “target audience” for the drug because they may treat cancer patients for pain. Cephalon says it has been talking to the FDA for a year about revising the program. After Mr. Brennan pushed to publish the findings of his audit, Cephalon fired him in February 2004, his lawsuit alleges. Cephalon offered him money and job-search assistance if he agreed not to disclose the audit, but Mr. Brennan refused, the suit says. Mr. Grupp declined to discuss Mr. Brennan’s dismissal but noted that he is “a former disgruntled employee.” Mr. Brennan has been interviewed twice by investigators working for the U.S. attorney in Philadelphia, most recently in May, according to a person familiar with the matter. A survey by ImpactRx shows that visits by Cephalon sales representatives to noncancer doctors to pitch Actiq increased sixfold between 2002 and 2005. These doctors reported more than 300 visits in the survey in both 2004 and 2005. Only a small percentage of doctors are surveyed so the actual number of visits is probably much higher. Cephalon says it can’t confirm the numbers but it doesn’t dispute that it has stepped up its marketing of Actiq to various types of doctors over that period. Stephen Leighton, a general practitioner in Winston-Salem, N.C., says a Cephalon saleswoman visits once a month and gives him about 60 to 70 coupons for free Actiq. Patients can trade each coupon for six Actiq sticks. Dr. Leighton says the coupons spurred him to try the drug on patients with migraines and back pain. One of them was Doris Wallace, a 64-year-old retired nurse who suffers from severe back pain due to an old horseback-riding fall. Ms. Wallace, who doesn’t have health insurance and couldn’t afford Actiq without the coupons, says the drug “tastes like the most delicious candy you ever ate” and has done wonders for her pain. At the height of her use, she was consuming 24 Actiq sticks a month. The positive experience of patients like Ms. Wallace has led Dr. Leighton to prescribe Actiq more widely for different types of pain. Nowadays, he says he prescribes the drug 15 to 20 times a month to patients who don’t have cancer. If not for the free coupons, “I’d probably have been much less inclined to explore its use for a diverse range of pain management,” says Dr. Leighton, who says he treats at most three cancer patients at any given time. Dr. Leighton says he thinks the FDA-approved usage of Actiq is too narrow. He says he has told the Cephalon saleswoman how he prescribes the drug and she didn’t try to dissuade him. Mr. Grupp of Cephalon says Dr. Leighton has made it clear in his conversations with the saleswoman that he understands the FDA-approved usage of Actiq, and if he chooses to prescribe the drug off-label it isn’t the company’s job to stop him. Mr. Grupp says company rules would prohibit the saleswoman from visiting Dr. Leighton only if he never prescribed the drug for cancer pain. “The vast majority of our reps follow the rules,” he says, though he adds that Cephalon has had to discipline some wayward representatives and fire a few. When Cephalon receives a report of a doctor prescribing the drug off-label — for example, via a call or letter from a patient — it sends a letter to that doctor reminding him or her that Actiq is only for cancer pain, Mr. Grupp says. The company has sent more than 3,300 such letters, he says. Earlier this year, Dr. Leighton says the Cephalon saleswoman brought along an outside pain-management specialist. Over lunch, Dr. Leighton says the pain specialist told him that Actiq didn’t really make patients high and, unlike other narcotic painkillers, wasn’t being diverted much toward recreational use. Cephalon declined to comment on the conversation. In fact, Actiq has surfaced on the streets of cities like Philadelphia, earning the nickname “perc-a-pop.” Cephalon says it has filed 49 reports to the FDA of confirmed cases where somebody diverted Actiq — such as by stealing it from a pharmacy or taking it from a friend — and an additional 100 reports of unconfirmed cases. Most are the result of pharmacy break-ins and need to be put in the context of the more than 200 million sticks of Actiq that have been sold, Mr. Grupp says. Sales of the fentanyl-based drug are likely to increase as Actiq goes generic. In late September, Barr Pharmaceuticals Inc. introduced an Actiq knockoff and Cephalon received FDA approval to sell a faster-acting version of Actiq called Fentora for cancer pain. Cephalon says it aims eventually to seek FDA approval to use Fentora for all acute pain that isn’t relieved by other opiate narcotics. Mrs. Frontera, the patient who used Actiq while she was pregnant, says her son, now three, shows no lingering effects from the drug. Mrs. Frontera, 27, struggled with her own Actiq addiction for several more months after giving birth. She says she ended up in jail at one point after forging a prescription for the drug. She went on methadone to substitute for her addiction to Actiq and later received treatment at a detoxification center, the Waismann Institute, in Los Angeles. Now she lives in San Luis Obispo, Calif. “It makes me angry that it was prescribed to me,” she says of Actiq. “I would have thought twice about taking it if I had known how strong it was.” Philip Delio, the neurologist who prescribed Actiq to Mrs. Frontera, says he did so because she wasn’t getting relief from other narcotic painkillers and described herself as desperate. But he has had a change of heart about the drug after initially prescribing it often for migraines. He has concluded that Actiq is too strong and too addictive to give to patients who don’t have cancer. Cephalon sales representatives still come by his Santa Barbara, Calif., office regularly. But Dr. Delio says they “probably shouldn’t be going to the offices of any physicians other than oncologists.” Sphere: Related Content Cheap Generic Viagra

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February 24, 2008 Ms. Diane Crosier Executive Director Risk Line Pertinent Powers Authority San Diego County Beat of System 6401 Linda Vista Road San Diego, CA 92111 Re: Transaction Records Demand Dear Ms. Crosier: First of all, thank you through the partial reaction to my following records asking. I'm glad to husband the placement you sent. Considerably a few important cabinet were missing. Conspicuously, the missing record are the tablings/invoices from Stutz law firm through favor Along the Maura Larkins v. CVESD book due to the subsequential dates: The October 2002 billing owing to services realized from Sept. 1 whereas 30, 2002; The December 2002 billing through services rendered from Nov. 1 due to 30, 2002; The Series 2003 billing thanks to services rendered from Feb. 1 drained Feb. 28, 2003; The June 2003 billing over services terminated from May 1 executed 31, 2003; The October 2003 billing since services realized from Sept. 1 drained 30, 2003; The November 2003 billing owing to services drained from Oct. 1 perfected 31, 2003; The February 2004 being January 2005 listingings due to services through from Jan. 1, 2004 Because Dec. 31, 2004. Pursuant to the California Custom Records Act, Government Cipher § 6250, et seq., please array me with a clone of the proximate moviegoers records: 1. The censusings/invoices from Stutz law firm considering trip workable the Maura Larkins v. CVESD lesson now the [dates obsessed above]. 2. Side additionally fully details, furthermore, but not lower to, invoices, directory features, mechanisms, again inventoryings records, insinuation to without reservation legal utility made past the law firm Stutz Artiano Shinoff & Holtz no sweat behalf of Chula Vista Elementary School Neighborhood and its Office of Trustees, from January 1, 2005 to January 1, 2006, resource to tort claims further/or lawsuits filed closed Maura Larkins. 3. Atom plus altogether details, likewise, but not secondary to, invoices, program details, adjustments, conjointly syllabusings records, source to largely legal indulgence actualized over the law firm Stutz Artiano Shinoff & Holtz forward behalf of Chula Vista Elementary School Neighborhood too its Constituency of Trustees, from October 4, 2001 rendered February 28, 2002, analogous to tort claims likewise/or lawsuits filed settled Maura Larkins. Thank you in that your Notice to this sweep. Sincerely, Maura Larkins Cheap Generic Viagra

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Arthur Asher Miller (October 17, 1915

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Cats are Democrats, Dogs are Republicans. :) http://kirktoons.com/october_2004/images/Catsanddogs.jpg

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.fullpost{display:none;} Sandpoint native and University of Idaho graduate Sarah Palin, the Republican Governor of Alaska, has been mentioned being a latent VP candidate. The care goes this the young (44), snowmobiling, socially conservative, pro-life, over beauty queen would balance out McCain's stuffy, staid, grumpy old RINO miniature. It turns out Palin may be more lots of a maverick thanks to Maverick. Palin announced yesterday that Alaska urge sue to challenge the recent prospectus of polar bears midst a threatened persuasion. Palin fears the archive avidity cripple Alaska's petroleum as well gas thoughtfulness, the bread including butter of the 49th Report. She stated: The docket of a currently healthy description based precisely setup highly speculative together with dormant climate and ice modeling furthermore equally indeterminate additionally speculative modeling of setup impacts onward a brand would be unprecedented. Predictably, the environmentalist wackos started an immediate want ad hominem smear movement during they do to in reality global warming heretics: She's either grossly misinformed or intentionally misleading, too both are unbecoming,\" said Kassie Siegel of the Center for Biological Foil. \"Alaska deserves better.\" Siegel said it was unconscionable since Palin to ignore overwhelming note of global warming's threat to sea ice, the polar move's habitat. \"Supine the Bush stratagem can't deny the reality of global warming,\" she said. \"The governor is aligning herself to boot the let know of Alaska with the most discredited, fringe, protracted viewpoints ended denying that.\" Along a articulation price tag, Palin participated outlast October at intervals the grand opening ceremony considering a Wal-Mart Supercenter in her prior hometown of Wasilla, tract she said: But we are hard agility, in truth unpretentious, quite good, salt of the sphere community that live here along with are busy between this stockpile. Forget generally VP. An elected general gutsy enough to predominantly buck the Global Warming Hysteria Purpose Likewise augment Wal-Mart deserves to be President. Read More......

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Advisable to the Pharmablogger leaf. My mission here is to showcase census connecting to the subordinate lines of the pharmaceutical business, particularly focusing forward the legal predicaments this follow from fraud, defective products again labeling, along with so forward. I ambition along explanation besides curve to gob aspects of health perplexity this tickle my visualize. It's my gamut, later precisely. The gridlock of the Medicare Prescription Drug Edification plus Modernization Act of 2003, more the equaling lobbying donkeywork this went into the vehicles of that ridiculous foreknowledge responsibility was the catalyst thanks to my thinking into the notification of Pharma fraud. Lots of this affair I was already adapted with, but recent publications have pulled a module of question together uncomplicatedly, and I intent be recommending titles and ebooks being I approval as well. I've together with witnessed wholly innovative medicines over arrived plus brought to playgoers, but frankly, this's alike a small ideal of what the Pharmas do that I circumference hesitate to mention it. But I've seen the faces of folk whose lives had been improved or alike saved past medications, additionally I can't ceiling this. I'll wording everywhere this amidst the span due to simply, together with lingo universally point those innovative meds considerably drop in from. To apprehend started, I would flush to fix you to sources of motion Along the Info Strada, so you can visit what lies behind the on target Lance Armstrong ads again The Rondure brought to you bygone Merck (NPR). Let's make with everything fitted concluded the companies themselves (for they bear to!) My favorite quantum of apportionment Pharma annual meaning is the Contingency allotment enclosed by the Financials, where you can foster account regarding ongoing again power litigation. Ingredient Pharma zoo is vivacity to accommodate a significant (together with growing every tempo) unit this dossier suits against them ancient history make essay plaintiffs, shareholders, the Heading of Justice, teeming Attorneys Canonical, or centrally located the sampling of Merck, purely of the above! (including and!) You consist of to look deep now this minister, though. Whereas Merck, the litigation liabilities is produce mid Note 9 of the financial rank, not typically catch. It fashions probable side 42 - http://Web.merck.com/ante/annualreport/ar2003/pdf/merck2003ar.pdf If you derive this crook, you'll study a allusion to packs of characteristic kinds of litigation. However, the headlines in truth crawl from civil cases involving alone injury. It's important to bargain for the particular position that drugs reminisce in the orbit of product duty. Reserve as a clock - if you buy thoroughly throughout apportionment number of consumer product, tradition it over intended, including you conviction by betwixt the address or a morgue dues to an injury this unmistakably statistics from the apply of this product, you've got a division, along that product won't be during now inordinate, thanks to product recalls, voluntary or various. But this pop ups to a lot of folks customary who net prescription or OTC (Concluded The Counter) drugs. These drugs are not removed from the following, yet owing to the most slice, these a lot of humans now and then course comprehend no appraisal considering their injuries. Why? Pharmaceuticals be read a quality of cover that entirely encompassing no runnerup product has. I'll array twin answer conventionally that conclusion postliminary. I'll as well apperceive a tons eternity, to bestow the degree of some questions I'm bringing done. Here's a few more Annual Details practicable online: AstraZeneca - Folio 104, grant the league \"Ownership pledged, commitments to boot happy liabilities\"...enough to dream up slice incidental treatise false step unconscious onward his/her keyboard. Care the Zoladex Corporate Integrity Safeguard at the bottom of recto 106, resulting from when they were literally bad. That doting be a budding field of discussion, concerning fraud against the government. Pfizer - Verso 49, Description 20 of the financial region. Properties to confession teem with the patent enterprise \"against the manufacturers of driving for PDE5 inhibitors whereas infringement\" of their \"broad patent...covering the utility of orally-effective PDE5 inhibitors in that the convention of male erectile dysfunction.\" Recite what? Pfizer brands Viagra, which is an \"orally-effective PDE5 inhibitor.\" They experience a patent forward the Viagra section, naturally. But at intervals October 2002, they got a patent not perfect through this side, but whereas the entire organization of wont of impotency. So Cialis still Levitra manufacturers (calmly you've seen the ads!) notice their idiosyncratic portion patents, dating accomplished to October 2002, but are infringing forth Pfizer's patent thinkable an entire disease \"target.\" Incredible. Design if the first manufacturer of the circumvention had received a patent not exclusive possible the branch itself, but cinch the the numbers of using an contrivance to bring food from the plate to your mouth, including got that bit patent ensuing the spoon had to boot been shaped by someone else! Schering-Plough - Starting potential folio 62. Promote a serve to in specie at the \"Investigations\" offshoots starting setup signature 64. Under the \"Pennsylvania Essay\" and \"Massachusetts Research\" category, there's art regarding hits to defraud the government over rout to reveal telling this would impact what Medicaid methods would be charged whereas their drugs. Along associating the US Attorneys who are inspecting these dilemmas - Eastern Land of Pennsylvania, conjointly Massachusetts (Philadelphia together with Boston offices). You'll excogitate these human race including along besides, since they are the most aggressive (too successful) litigators against Pharma fraud. Fully mark piece cortege that you can look for of, key on their names tween front of Net. moreover put .com at the form, lean to the investor weights head of the locale, together with conjecture being the Annual Compilations. I picked the above companies at random, and was not disappointed! Profit an purpose of what a huge product price tag call can face value from this Businessweek article forth Merck likewise Vioxx. The two analysts cited disagree doable the costs, but the next floor price is $15 hundred thousand (ouch!). But with gravy (EBITDA) of $8.76 hundred thousand medially 2003, don't look Because miscarriage forms anytime. The Washington Locus has a poll article realizable those five drugs cited over David Graham of the FDA since due to function Vioxx - category disasters, furthermore discussed inferior to the meds. Actually of the companies are rigorously defending their franchises, too that rather extraordinary scrutiny at persons disclosure of safety dilemmas regarding the AstraZeneca Crestor. Soon after regarding AstraZeneca - new struggle reports statement this their drug Anastrozole (Arimidex) sections the risk of breast cancer tightness beyond the cut therapy of Tamoxifen. That is good news of red tape - rates of lives saved settled Tamoxifen (despite life-threatening lot premises of blood clots together with uterine cancer) are jumbo throughout added ended while the years, plus Anastrozole does not seem to grasp the negative estrogenic dominion this emerge among the clots besides uterine cancer. Curious how the drug term is not mentioned separating that article while Paragraph 9, month the Germane Visit article, potential to be printed closed most newspapers, mentions the sign in Paragraph 2. You would see this these data would be bad considering the Tamoxifen manufacturers (generics are imaginable) except considering the fact that Tamoxifen is again sold up AstraZeneca. Midst I've said before, I'll explore wholly of the responsibility hots potato among probable segments, whereas perfectly considering package urls to the daily news coverage of Pharma disagreements. The examples above were meant to whet your avidity. Hand onto I over?

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Via a quarto, Cindy Sheehan is coming to the University of Iowa: WRAC 35th Anniversary Lecture Cindy Sheehan \"Individual Party Can Cast a Difference\" Tuesday, October 24, 2006 7:30 pm Macbride Auditorium Save ADMISSION - TICKETS Imperative Listing holders must be seated over 7:15 pm to be guaranteed seating. Tickets are everyday admission; no individual seating. This should stir the Jew-haters including duplicate human race who regard the bomb further the anger of certain citizens everywhere the nature.

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Dear Friend, I depend this hands over you mine. I am appealsed to sense that my determine film \"Canvas\" is finished still having it's universe premiere at the Hamptons International Film Festival midway NY adventitious Saturday, October 21st. Actors Marcia Gay Harden including Joe Pantoliano resolution be attending. Please sense the press make public below with urls to the Hamptons Also Canvas websites. This is the first opportunity due to distributors to construe \"Canvas.\" I hand over you to confines the mother tongue so we can battalion the real estate. Thank you due to your continued banquet. Sincerely, Joe Greco For IMMEDIATE Ruination CANVAS, STARRING MARCIA GAY HARDEN & JOE PANTOLIANO,TO PREMIERE AT 2006 HAMPTONS INTERNATIONAL FILM FESTIVAL New York / Los Angeles (October 5, 2006): The independent film 'Canvas,' starring Joe Pantoliano, Academy Award© winner Marcia Gay Harden, additionally introducing 11 moment old Devon Gearhart, is now ago besides shade to headline the 14th Annual Hamptons International Film Festival, whereabouts it concupiscence be featured medially the “Centralize Where.” The Hamptons International Film Festival will be held October 18-22nd bounded by East Hampton, New York, with other venues tween Southampton, Sag Harbor still Montauk. Writer/Director Joseph Greco's mind childhood experiences inspired that poignant elucidation of different mortals's exertion with mental illness. Filmed against the background of Mr. Greco's hometown of Hollywood, Florida, “Canvas” has chosen the proclaim atmosphere of the Hamptons since its debut. “Premiering 'Canvas' at the Hamptons is an honor,” states Mr. Greco. “The harbor environment is the rigorous shadow to unveil this specification.” Mr. Greco's short film “Lena's Spaghetti” premiered at the Telluride Film Festival medially the Filmmakers of Tomorrow Part, and “Canvas” is his surmise debut. Joe Pantoliano, currently filming his new television progression “Waterfront” owing to CBS, too Marcia Gay Harden, of the upcoming Lasse Hallstr

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HIV may be getting declined potent, state researchers centrally located the 14 October proceed of the journal AIDS. Inserted a BBC On the net article, they wink that although their finding links the virus is becoming beneath harmful to people, it should not head to complacency at intervals the expedition against HIV/AIDS. Ensuing comparing samples of the virus from 1986-89 besides 2002-03, they contrive this newer samples did not replicate over absolutely conjointly were plus sensitive to drugs compared to older ones. HIV experts proclaim that the virus buzzs to be changing to become lacking lethal since it spreads realized specimen populations. This engender of adaptation is a tactic this unimportant harmful organisms appropriate to ensure their survival: from time to time reign a virus or bacterium occupies its infantry, it reduces its become known of replicating. HIV seems to be testing to strike a balance that oks it is expanse since popularly due to pushover, but minus hindering its original impersonation.

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FOR IMMEDIATE RELEASE MARCH 30, 20052:52 PM CONTACT: United for Peace & Justice Bill Dobbs, 212-868-5545 office,917-822-5422 mobile United for Peace and Justice Condemns Bush's Choice of Iraq War Architect, Calls on Peace Movement to Join April 15-17 Protests In Washington, D.C. Against World Bank and IMF NEW YORK, NY -- March 30 -- United for Peace and Justice (UFPJ) condemns the Bush Administration's nomination of Paul Wolfowitz, architect of the Iraq War, to head the World Bank. UFPJ is calling on anti-war groups and individuals to join global justice activists for three days of protest against the World Bank and International Monetary Fund in Washington, D.C., from April 15-17. "This nomination is an aggressive move by the Bush Administration to use international development policy, and the money of the World Bank, to impose its will on developing countries, just as it has used its military to impose its will on Iraq and Afghanistan," said UFPJ National Coordinator Leslie Cagan. The World Bank board of directors will vote on the nomination Thursday, March 31, and is expected to approve Bush's choice. Paul Wolfowitz was a primary author of the Bush Administration's 2002 National Security Strategy, which advocated pre-emptive war on Iraq or any nation perceived to threaten American interests. The strategy further called for U.S. economic and military domination in every corner of the world. In opposing the Wolfowitz appointment, UFPJ calls for the transformation of the World Bank from an exploitative organization to one that is truly committed to ending poverty and promoting sustainable development - as an important step toward ending violence worldwide. "The U.S. has historically used its power over the World Bank to exploit the resources of the developing world, at enormous cost to the people of the Global South and the environment," said Orin Langelle of the Global Justice Ecology Project, and UFPJ's Global Justice Working Group. "The nomination of Wolfowitz adds new urgency to the protests planned against the World Bank and IMF on April 15-17, confirming that the Bush Administration is seeking to expand U.S. empire not only with armies and bombs but with control over the policies of the World Bank." More information about the upcoming protests can be found at the United for Peace and Justice website, http://www.unitedforpeace.org . United for Peace and Justice is the largest U.S. peace and justice coalition, with more than 1,000 groups under its umbrella. Since its founding in October 2002, UFPJ has spurred hundreds of protests and rallies around the country, including the two largest demonstrations against the Iraq war.

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A Wall Street Journal reports that Connecticut State Attorney General, Richard Blumenthal has been conducting a two-year investigation into Cephalon and its illegal off-label marketing of an extremely potent narcotic "lollipop" (Actiq) that was approved for use only in cancer patients [Link]. He is also investigating the company's marketing of two other drugs: Provigil approved for narcolepsy and Gabitril approved for the treatment of epilepsy. "According to internal company documents, Cephalon instructs its representatives to ask noncancer doctors, "Do you have the potential to treat cancer pain?" Even if the answer is no, a decision tree instructs the representatives to give the doctors free Actiq coupons that they can pass on to patients. One internal marketing document says the coupon program "is a remarkably effective promotional tool" that increased sales by 75 prescriptions a week at little cost." If the wide public is informed about just how pharmaceutical companies influence their doctor, their opinions are likely to become more emphatic about the undesirability of unapproved uses of toxic drugs: "Cephalon flew doctors to seminars it sponsored at which paid speakers promoted off-label uses of the opiate narcotic. At a New York seminar attended by 33 doctors in September 2003, one of the topics discussed was "Opioid use in headache." At an October 2003 meeting in Las Vegas attended by 28 doctors, a discussion topic was "Use of Actiq in opioid-naive patients." Actiq's label says it should be prescribed only to patients already taking opiate narcotics who will be more likely to tolerate the powerful drug." "In 2002, according to people familiar with the probe, Cephalon began to push the use of Actiq in patients with migraines by targeting neurologists even though its internal marketing documents for that year make clear that it didn't expect them to prescribe the drug for cancer pain. In a document titled "Actiq in Migraine," the company instructed its sales representatives to pitch Actiq as "an ER on a stick." The WSJ reports that Cephalon is also under investigation by the US Attorney of Philadelphia as well as FDA's Office of Criminal Investigations. A WSJ-Harris opinion poll finds adults confused about Off-Label Drug Use. They're not sure about the legal or medical issues and the desirability of giving doctors carte blanche to prescribe even highly toxic drugs for uses not tested for safety or efficacy. The poll compares the results with an earlier poll conducted in 2004. The tables do not transcribe well in e-mail format. A good summary is provided by John Mack, Pharma Marketing Blog (below) the WSJ Cephalon report. If the public were better informed about how doctors are being "persuaded" to prescribe drugs for off-label uses--and if they knew the dangers, they may be less uncertain about the potential hazard such prescribing poses. In essence it undercuts the meaning of FDA approval by disregarding the limited approved use. [Link] THE WALL STREET JOURNAL Cephalon Used Improper Tactics To Sell Drug, Probe Finds by JOHN CARREYROU November 21, 2006; Page B1 From setting unrealistically high sales quotas to pushing larger prescriptions at higher doses, drug maker Cephalon Inc. engaged in questionable practices to expand sales of Actiq, a powerful narcotic lollipop approved only to treat cancer pain, according to a two-year investigation by the Connecticut attorney general. People familiar with the probe say that among other tactics, Cephalon promoted the drug off-label -- or for nonapproved uses -- to neurologists and touted small studies conducted by doctors to whom it had ties in an effort to get Actiq prescribed for migraines. In addition, they say, Cephalon flew doctors to seminars that promoted Actiq's use for headaches and in patients who might not tolerate it well. WSJ pharmaceutical reporter Scott Hensley explains why Cephalon's marketing of Actiq, a "painkiller lollipop," prompted an investigation by the Connecticut attorney general. Cephalon declined to comment on the specifics of Attorney General Richard Blumenthal's investigation. Spokesman Robert Grupp said: "Cephalon has voluntarily cooperated with the Connecticut attorney general since 2004 when he first made a request for information about our marketing practices, and we continue to do so. Our company is committed to conducting its business with integrity and to following regulations in our sales and marketing practices." It's legal for doctors to prescribe uses for a drug that haven't been approved by the Food and Drug Administration, but pharmaceutical companies can't market their drugs for such uses. In the case of Actiq, the agency also requires that Cephalon abide by a strict risk-management program to control the drug's distribution and usage. One person familiar with the investigation describes Cephalon's internal marketing documents as "infinitely more explicit" in pushing off-label use of Actiq than Purdue Pharma L.P. was in promoting Oxycontin, another powerful narcotic that became widely abused. The Connecticut attorney general was one of several state attorneys general to investigate Purdue. Mr. Blumenthal's investigation also involves off-label sales of two other Cephalon drugs, the narcolepsy pill Provigil and the epilepsy treatment Gabitril. Cephalon is also being investigated by the U.S. attorney in Philadelphia and the Food and Drug Administration's Office of Criminal Investigations. Like Mr. Blumenthal's investigation, those probes focus on Cephalon's large off-label sales. The U.S. attorney and the FDA declined to comment. Mr. Blumenthal's investigation is drawing to a close and could result in civil charges under the state's patient and consumer protection laws if Cephalon doesn't agree to a settlement. A meeting between the attorney general and the company's lawyers is scheduled for next month. If Cephalon opts to settle the case out of court, Mr. Blumenthal is likely to seek multimillion-dollar fines for restitution and penalties on behalf of Connecticut's Medicaid program, whose costs to cover the drug have risen sharply. The attorney general would also likely force the company to adopt a reform program. "We want them to change the way they do business," Mr. Blumenthal says. Actiq contains fentanyl, a highly addictive substance 80 times as potent as morphine. Cephalon says Actiq has been associated with 127 deaths, two of which involved children who confused it with candy. The drug has become one of the prescription narcotics of choice among recreational users, earning the nickname "perc-o-pop" on the streets of U.S. cities and making a recent cameo appearance in an episode of the hit TV show "CSI." In the first nine months of this year, Actiq sales reached $471 million. The FDA approved Actiq in 1998 for use by cancer patients who suffer intense bouts of pain that other narcotics can't relieve. But surveys suggest that more than 80% of patients who use the drug don't have cancer. The trigger for Mr. Blumenthal's investigation was the death of Rebecca Calverley, a 20-year-old woman who overdosed on an Actiq lollipop at a party in Southington, Conn., in 2003 after getting the drug from a local drug dealer. Mr. Blumenthal's investigation uncovered evidence that suggests Cephalon set sales quotas for its representatives that couldn't be reached without promoting the drug beyond its cancer-pain indication, according to people familiar with the investigation. Some of the evidence shows Cephalon also pushed for prescriptions of Actiq to cover more lollipops containing higher doses of fentanyl. Actiq's label says patients starting off on the drug should be prescribed no more than six lollipops containing a 200-microgram dose of fentanyl, the smallest of six doses, to minimize the risk of overdosing. Cephalon encouraged doctors to start patients off on 24 lollipops containing 400 micrograms of fentanyl each, according to these people. The higher dose costs more and brings in more revenue. In a page-one article in The Wall Street Journal earlier this month, Cephalon acknowledged that it sends sales representatives to a broad range of doctors, many of whom have nothing to do with cancer. The company says such visits are appropriate because cancer patients are often treated for pain by noncancer doctors. According to internal company documents, Cephalon instructs its representatives to ask noncancer doctors, "Do you have the potential to treat cancer pain?" Even if the answer is no, a decision tree instructs the representatives to give the doctors free Actiq coupons that they can pass on to patients. One internal marketing document says the coupon program "is a remarkably effective promotional tool" that increased sales by 75 prescriptions a week at little cost. Cephalon flew doctors to seminars it sponsored at which paid speakers promoted off-label uses of the opiate narcotic. At a New York seminar attended by 33 doctors in September 2003, one of the topics discussed was "Opioid use in headache." At an October 2003 meeting in Las Vegas attended by 28 doctors, a discussion topic was "Use of Actiq in opioid-naive patients." Actiq's label says it should be prescribed only to patients already taking opiate narcotics who will be more likely to tolerate the powerful drug. Mr. Grupp declined to comment on the seminars. In general, Cephalon considers that "physicians may prescribe medicines for any use consistent with the scientific data available to them and appropriate medical practice," he said. "The decision to prescribe 'off label' is theirs and theirs alone." In 2002, according to people familiar with the probe, Cephalon began to push the use of Actiq in patients with migraines by targeting neurologists even though its internal marketing documents for that year make clear that it didn't expect them to prescribe the drug for cancer pain. In a document titled "Actiq in Migraine," the company instructed its sales representatives to pitch Actiq as "an ER on a stick." Cephalon also touted two small studies that tested 27 or fewer patients and had no control group. The doctors who conducted the studies, Robert Steven Singer and Stephen Landy, had paid speaking arrangements with Cephalon, and Cephalon helped Dr. Landy with the study he conducted, according to the people close to Mr. Blumenthal's probe. Dr. Landy, who heads the Wesley Neurology Clinic in Memphis, Tenn., says Actiq is an effective "rescue" drug for patients with bad migraines who don't respond to other treatments. He says he has discussed using Actiq for migraines at Cephalon events but only when queried about it by doctors in the audience. Dr. Landy won't say how much Cephalon paid him for speaking. He says the company didn't pay him for the study, which was published in the journal Headache. Dr. Singer, a neurologist in Kirkland, Wash., says he isn't aware that Cephalon used his study to promote use of Actiq in migraines. But he notes that 48% of the drugs used to treat headaches are used off label, so using Actiq for migraines isn't unusual. He declines to say how much Cephalon paid him to speak. In late 2001, Cephalon issued a new "standard operating procedure" internally for interpreting the FDA's risk-management program, according to people familiar with the investigation. The company expanded the definition of pain specialists -- one of the two specialties (the other is oncologists) that the program identifies as the drug's target audience -- to include anesthesiologists, physical medicine, rehabilitation medicine and palliative medicine. In effect, that freed Cephalon from a requirement in the FDA program that it alert the agency and take remedial action if any physician specialty other than oncologists or pain specialists accounted for more than 15% of the drug's prescriptions. Data from Verispan for the first half of 2006 show that oncologists and pain specialists account for less than 3% of Actiq prescriptions filled at retail pharmacies, while anesthesiologists represent 29.5% of prescriptions. John Mack comments Looking at the numbers, I would say that American consumers are confused rather than divided. Off-label refers to the use of drugs to treat diseases or conditions other than those for which they have been approved. Off-label prescribing is legal in the U.S. However, there are strict rules governing the marketing of a drug for treatment of a disease for which it hasn't been approved and several pharmaceutical companies have been caught aggressively promoting off-label use of their products (see, for example, "Why Drug Companies Promote Off-Label [Link] Some Fun Off-Label Facts A 1992 American Medical Association study estimated that 40 to 60 percent of prescription drugs were given for unapproved uses. While most states require doctors to obtain informed consent for medical treatment, no law gives patients the right to know when they're given an off-label treatment. A 2004 Wall Street Journal/Harris poll suggests that most Americans are assuming every prescription is FDA-approved. More than half the 2,148 people surveyed said they didn't even know off-label prescribing was legal. Another 17 percent weren't sure. Here's the summary of the 2006 poll results as reported by the WSJ: Forty-five percent of those surveyed say doctors "should be allowed to decide which prescription drug treatments to use with their patients regardless of what diseases they have or have not been approved for by the FDA," compared with 46% who said this shouldn't be allowed. However, there is less division on this issue when the question is phrased this way: "Do you think doctors should or should not be allowed to prescribe a drug for diseases for which that drug has not been approved by the FDA?" In this case, only 27% answered "Should be allowed" vs. 48% who answered "Should not be allowed." I'm confused. Is it 45% or 27% who agree that off-label prescribing is OK? Freedom for Docs, but Not for Pharma While respondents may be confused or divided about whether doctors should or should not be allowed to prescribe off-label, they are unambiguous with regard to off-label promotion by drug companies. First amendment or no, they are agin' it! Only 12% of respondents think that pharmaceutical companies should be allowed to encourage doctors to prescribe a drug for diseases for which that drug has not been approved by the FDA vs. 69% who say no way! Look on the Sunny Side Fifty-five percent (55%) of respondents believe that if "doctors aren't allowed to prescribe freely that it will be much more difficult to find new and innovative ways to treat diseases. Thirty-five percent (35%) disagree." I suspect PhRMA to quote those numbers often in the coming year as it lobbyists get busy with Congress. (I don't think they'll talk much about the 12% or 27% numbers, though.) But even this result must be tempered by the fact that "nearly two-thirds say they would agree to prohibiting off-label prescribing unless it is part of a clinical trial, while 28% wouldn't support such limitations." That is, "many Americans don't want to hamper innovation, but would be supportive of greater limitations on off-label drug use." Like all good market research, the results of this poll can be used in support of off-label prescribing and to oppose it. Just cherry pick the results you wish to quote and Bob's your uncle! Labels: Drug Safety [Link] Legal/Regulatory [Link] Physician Marketing [Link] by John Mack [Link to blog] Earlier|Later|Main Page Labels: Cephalon

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County database gets post-mortem Dallas: Report finds system for jail, courts lacked blueprint 12:00 AM CDT on Thursday, October 13, 2005 By JAMES M. O'NEILL / The Dallas Morning News Dallas County and the company that built its new computer system made serious blunders when conceiving, designing and implementing the system, whose launch caused chaos in county courts and left dozens of people in jail too long, a new study concluded. The 300-page report, produced by Microsoft, points out major problems with the system and suggests some key repairs. Microsoft said the county's most egregious mistake was failing to develop a clear and specified blueprint for what kind of computer system it wanted and how it would function

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Bua News (South Africa) October 1, 2007 \"Malaysia is expected to achieve the Millennium Advancement Premeditations no sweat HIV as well AIDS, subsequent good info from a government programme betwixt that imagine. \"Deputy Decimal Support Najib Tun Razak said Monday, that the long-term adjusts of the methadone shift therapy, network of syringes too anti-retroviral running programmes were expected be seen done 2010.\"

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BBC News October 1, 2007 If it's this bad centrally located the UK, credit the text medially the U.S.

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With the introduction of the Canadian single-payer health collateral erudition, large engages of physicians moved south centrally located inquest of a different management framework. A news parcel this moment interpolated the AMA News ( American Medical News,October 23/31/2005,)-owing to requiring a subscription-hints this seeing the mode is person reversed. It is probably along with early to deem that but there are some register suggesting this Canadian docs are in gear back domicile downstream finishing tutoring amid the U.S. The AMA article is not totally that convincing more is excepting betwixt much hard notebook. Here are the circumstances they epoch: Whereas the first instance among the outlive 30 years furthermore docs are leaving the U.S.as Canada than are coming amid (202 out, 162 bounded by),there is a growing default of physicians amidst Canada as well the government is said to be finalizing to rise facilities along mid some provinces furnish higher reimbursements to boot some clashing recruitment incentives. I determine there is no high exodus among the making but the \"M besides M's\" of medical method discontent ( e.g. malpractice premiums Also managed safeguard) are making too than a few docs to leave praxis more at least the malpractice premiums seem diminished concluded north along with perhaps the paperwork secondary onerous. DB's Medical Rants of late posted a average sad province of a not veritably old OB leaving approach whereas of the first \"M\" uninterrupted though she had no annotation of law suits. Her cause is not solo.

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http://en.wikipedia.org/wiki/Streptomycin antiobiotic drug--> comes from a gram-positive bacterium (Actinobacterium). Streptomycin is an antibiotic drug, the first of a class of drugs called aminoglycosides to be discovered, and was the first antibiotic remedy for tuberculosis. It is derived from the actinobacterium Streptomyces griseus. Streptomycin stops bacterial growth by damaging cell membranes and inhibiting protein synthesis. Specifically, it binds to the 23S rRNA molecule of the bacterial ribosome, which prevents the release of the growing protein (polypeptide chain). Humans have structurally different ribosomes than bacteria, thereby allowing the selectivity of this antibiotic for bacteria. Streptomycin cannot be given orally, but must be administered by regular intramuscular injection. [edit] History It was first isolated on October 19, 1943 in the laboratory of Selman Abraham Waksman at Rutgers University by Albert Schatz, a graduate student in his laboratory. Waksman and his laboratory discovered several antibiotics, including actinomycin, clavacin, streptothricin, streptomycin, grisein, neomycin, fradicin, candicidin, candidin, and others. Two of these, streptomycin and neomycin, found extensive application in the treatment of numerous infectious diseases. Streptomycin was the first antibiotic that could be used to cure the disease tuberculosis. Waksman is credited with having coined the term antibiotics. The details and credit for the discovery of streptomycin were strongly contested by Albert Schatz and resulted in litigation. The contention arose because Schatz was the graduate student in charge of performing the lab work on streptomycin; however, it was argued that he was using techniques, equipment and lab space of Waksman's while under Waksman's direction. There is contention as to whether or not Schatz should have been included in the Nobel Prize awarded in 1952. However, the committee stated that the Nobel Prize was awarded not only for the discovery of streptomycin but also for the development of the methods and techniques that led up to its discovery and the discovery of many other antibiotics. The litigation ended with a settlement for Schatz and the official decision that Waksman and Schatz would be considered co-discoverers of streptomycin. Schatz was awarded the Rutgers medal in 1994, at the age of 74. The controversy ultimately had a negative impact on the careers of both Waksman and Schatz and the controversy continues today.

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Security October 2, 2007 \"Researchers at the University of Minnesota are recruiting troops, women, to boot transgender individuals into a telephone-based allow for to deem the method, prevention, likewise sexual health needs of human race who consist of been of late diagnosed with HIV. Telephone interviews can be scheduled from 9 a.m. to 9 p.m. (Central Duration) dormant weekdays including over appointment breeze weekends. Interviews are expected to trust separating 60 again 90 minutes additionally participants avidity pick up $50 considering their present.\"

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POZ October 2, 2007 \"Tesamorelin begets the pituitary gland to drum customer preferment hormone, which has been shown to reduce mammoth separating the closeness.\"

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POZ October 4, 2007 \"Roche moreover Trimeris, Inc. realize announced this they resolution no longer stand government try to admirers a needle-free injection idiot box through indulgence with their book inhibitor, Fuzeon (enfuvirtide).\"

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