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"Cooperation is the thorough conviction that nobody can get there unless everybody gets there." Virginia Burden "If you tell the truth you don't have to remember anything." Mark Twain (1835 - 1910) "A lot of senators are so worried about convention and how they look that they wouldn't let their hair down if they had any." Ben Nighthorse Campbell , former Senator from Colorado, is 73 today. "Ultimately, love conquers all, and gay or straight, don't we all want to believe that? I would that if this was to happen to me, and one of my kids had come and told me he or she was gay, I would say: If that's the only way you can live, then I love you." Paul Sorvino , actor, is 67 today. "We are all born mad. Some remain so." Samuel Beckett , from Waiting for Godot (1955). The Irish-born author, critic, and playwright was born on this date in 1906 and died in 1989. He won the 1969 Nobel Prize for Literature. Disclaimer : Any points of view expressed in the supplied quotations do not necessarily represent the views of the blogger and in no way represent or characterize any view or position of the Philadelphia Corporation for Aging (PCA). Cheap Generic Viagra

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Lawyer found naked with girl in courtroom gets prison (The Pantagraph) PHILADELPHIA -- A defense attorney who was found naked with a 14-year-old girl in a courthouse pleaded no contest Monday to charges of sexually assaulting her and five other girls. http://us.rd.yahoo.com/dailynews/rss/search/penis+pumps/SIG=12gq76nie/*http%3A//pantagraph.com/articles/2007/09/12/news/doc46e69f0eb987d361443017.txt penis enlargement pump penis pump demonstration penis vacuum pump video Erectile dysfunction: What to expect during your doctor visit (Mayo Clinic) You may feel reluctant to talk with a doctor about erectile dysfunction — but treatment can help. Find out what kind of questions and tests to expect. http://us.rd.yahoo.com/dailynews/rss/search/penis+pumps/SIG=121g4jkbu/*http%3A//www.mayoclinic.com/health/erectile-dysfunction/MC00060 judge penis pump penis pump do they work penis pump photo Sunday Mirror - SEX DOCTOR: DESPERATE FOR CHRISTMAS LIFT December 24, 2006 -- Dear Dr Cath ALL I want for Christmas is an erection. I am 55 and haven't been able to get one for three years. Now I've met a new partner and have been enjoying getting to know her. But I http://findarticles.com/p/articles/mi_qn4161/is_20061224/ai_n17074696 penis pump demo bigger penis pump discount penis pump Independent, The (London) - SLEEPING AROUND: Three can be my magic number October 4, 2005 -- My first threesome happened, at least in part, because there was nothing good on television. It started by accident: I had been out dancing with a female friend from university and a mutual male f http://findarticles.com/p/articles/mi_qn4158/is_20051004/ai_n15641438 medical penis pump how to make a penis pump penis and ball pump Men's Fitness - The hottest nitric oxide product of 2005! October 1, 2005 -- Remember that time in the gym when everything was perfect? You were as strong as an ox, the weights felt lighter than normal, each rep and set was effortless, ... http://findarticles.com/p/articles/mi_m1608/is_8_21/ai_n15674748 penis pump surgery penis pump cum does penis pump really work New Life Journal - Taoist art of cultivating male sexual energy September 1, 2005 -- Since ancient times, Taoists have sought to tap the power of sexuality to heal the body, deepen love relationships, and achieve elevated states of enlightenment. http://findarticles.com/p/articles/mi_m0KWZ/is_9_6/ai_n15394266 penis pump result gay penis pump penis pump Men's Fitness - The hottest Nitric Oxide product of 2005! June 1, 2005 -- Remember that time in the gym when everything was perfect? You were as strong as an ox, weights lighter than normal, each rep and set was effortless, ... http://findarticles.com/p/articles/mi_m1608/is_5_21/ai_n13779046 cheap penis pump penis pump for erectile dysfunction free penis pump Pocket Doc (Chicago Flame) Dr. George Q. Is there any non-surgical way to enlarge a penis or a breast? A. The desire to enlarge a man's penis has become one of the great targets of the unscrupulous marketer-as the spam in your e-mail can attest. Hardly a day goes by without claims of "unbelievable growth,""amazing results,""male enhancement," or "greater satisfaction. http://us.rd.yahoo.com/dailynews/rss/search/penis+pumps/SIG=12ed11j87/*http%3A//www.chicagoflame.com/news/2007/09/03/Pulse/Pocket.Doc-2947320.shtml penis pump instructions best penis pump penis pump warm water Men's Fitness - Nitric Oxide supplement buyers guide: review on the hottest Nitric Oxide product of 2005! May 1, 2005 -- Remember that time in the gym when everything was perfect? You were as strong as an ox, the weights felt lighter than normal, each rep and set was effortless, ... http://findarticles.com/p/articles/mi_m1608/is_4_21/ai_n13648657 implant penis pump buy penis pump penis pump gallery Art in America - In a liquid medium: better known in Europe than in the U.S., Richard Jackson has been testing the confines of painting for over three decades. Recent shows September 1, 2005 -- I've been fascinated by Richard Jackson's work for years without ever seeing any of it in person. Poring over photographs in exhibition catalogues and ... http://findarticles.com/p/articles/mi_m1248/is_8_93/ai_n15379632 penis pump pic before and after penis pump for sale penis pump technique Cheap Generic Viagra

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HEALTH CARE REFORM By Jon Hurdle Yahoo News, Wed Jan 17, 5:20 PM ET "HARRISBURG, Pennsylvania (Reuters) - Pennsylvania became the fifth U.S. state to seek universal coverage for its citizens on Wednesday when it unveiled a plan to provide medical insurance for some three-quarters of a million residents who currently have none." FULL STORY RELATED LINKS: Governor Rendell Announces Plan to Provide Health Care Coverage for All Pennsylvanians Pennsylvania Health Law Project - News Release, 1/18/07 "On January 17, 2007, Governor Rendell announced his 'Prescription for Pennsylvania: Right State. Right Plan. Right Now.' At a briefing at the Governor's Residence in Harrisburg on January 17th, PHLP learned the following..." FULL RELEASE Rendell: 47 ideas to cut health costs: His sweeping proposal covers insurance, hospital mistakes, nutrition and smoking. And it won't hurt the budget, aides said. Reaction was subdued By Amy Worden and Josh Goldstein Philadelphia Inquirer, Thu, Jan. 18, 2007 "HARRISBURG - In a proposal that could have profound effects on the multibillion-dollar health-care industry and touch virtually every Pennsylvanian, Gov. Rendell announced yesterday that he wanted to drive down the spiraling costs of care while improving its quality and expanding access for all." FULL STORY Cheap Generic Viagra

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"Anyone who proposes to do good must not expect people to roll stones out of his way, but must accept his lot calmly if they even roll a few more upon it." Albert Schweitzer "The only safe thing is to take a chance." Mike Nichols , director, is 75 today. "Inside prisons, hospitals, and schools, a society's vision and morality are on vivid display against the backdrop of its ideals." David K. Shipler "You may search my time-worn face, You'll find a merry eye that twinkles. I am not an old lady; Just a little girl with wrinkles." Edythe E. Bregnard "My agent said, 'You aren't good enough for movies.' I said, 'You're fired.'" Sally Field , actress, is 60 today. Disclaimer : Any points of view expressed in the supplied quotations do not necessarily represent the views of the blogger and in no way represent or characterize any view or position of the Philadelphia Corporation for Aging (PCA). Cheap Generic Viagra

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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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"The mind is its own place, and in itself can make a Heaven of Hell, a Hell of Heaven." John Milton , poet, was born on this date in 1608. He died in 1674. "No matter how old you get, if you can keep the desire to be creative, you're keeping the man-child alive." John Cassavetes , actor and film director, was born on this date in 1929. He died in 1989. "Starting Jan. 1, [2006] every 7.7 seconds a baby boomer will turn 60." Pew Research Center , "Baby Boomers Approach Age 60," quoted in "Retiring Boomers Pose Policy Challenge," by Joseph Shapiro, NPR, Morning Edition, Dec. 9, 2005 [See link to this report below]. "Life is like a B-picture script! It is that corny. If I had my life story offered to me to film, I'd turn it down." Kirk Douglas , actor, is 89 today. "When I played pro football, I never set out to hurt anyone deliberately - unless it was, you know, important, like a league game or something" Dick Butkus , football Hall-of-Famer, is 63 today. "We need a president who's fluent in at least one language." Buck Henry , actor-writer, is 75 today. Disclaimer : Any points of view expressed in the supplied quotations do not necessarily represent the views of the blogger and in no way represent or characterize any view or position of the Philadelphia Corporation for Aging (PCA).

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A new survey closed Nielsen/NetRatings wraps up this netizens who listen online news are further the on the net versions of their local newspapers. Bounded by perfectly of the major metropolitan markets except Because unrepeated (Philadelphia), readers cited their city's on the net newspaper until their example choice as news (Philly readers favored USAToday.com perfected their native Philly.com). However, separate single on the internet paper (WashingtonPost.com) was favored bygone again than 30% of its local trade. Medially the when of sagging newspaper circulation and readership, the survey has some good news seeing newspapers... or since their on the web invitations at least. Revenues being on the internet newspapers are be afraid to arise smoothly a wrap 2008. It would be interesting to dream of if on the net newspaper loyalty remains exact between smaller markets, along part diverse local news sources on the web (equaling over TV news websites) smoke into the mix. Including, is readership seasonal? Local news websites, considering occasion, are indispensable for eliminating dependent school exchange omegas midway the winter. Stating: eMarketer

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Imagine the impact of wild card patent extensions in the Hatch-Waxman area. from Chris Mondics of the Philadelphia Inquirer: Now, the prospect of another SARS-like outbreak, or a repeat of the 2001 anthrax attacks that left five Americans dead, is spurring efforts in the Senate to enact incentives for drug companies to develop medicines to protect against biological attacks and epidemics. Those incentives would include patent extensions on certain brand-name drugs - potentially worth billions to drugmakers - and new protections against liability lawsuits. Sen. Judd Gregg (R., N.H.), Senate Majority Leader Bill Frist of Tennessee, and Sen. Rick Santorum (R., Pa.), all key Senate players, are sponsoring one bill. In the coming weeks, Sens. Joe Lieberman (D., Conn.), the former vice presidential candidate, and Orrin G. Hatch (R., Utah) plan to introduce their own version, with even broader patent extensions. The useful patent life on a medicine is about 10 years. Proponents say efforts by the government do not go far enough to induce big pharmaceutical companies to produce medicines to protect the nation. "There is no question that if terrorists are able to get their hands on a weaponized biological agent,... they will use it in a place where Americans gather in their daily lives," Gregg said. "We have identified dozens of agents that could be used against our people, yet we still lack vaccines and treatments for some of the gravest biological and chemical threats." Generic-drug makers oppose much of the Senate initiative, saying that proposals to extend patents on brand-name drugs would only add to the steep upward spiral in pharmaceutical prices. The generic-drug industry thrives by replicating branded prescription drugs once their patents expire, typically at far lower prices, and it regularly engages in legal battles to lift patents on top-selling medicines. "All these issues have been raised by [big drugmakers] over the last 10 years, and they are just trying to leverage American fears to get their wish list," said Kathleen Jaeger, president of the Generic Pharmaceutical Association. "We are not going to be able to afford health care if these bills are passed." President Bush signed BioShield legislation July 21 that called for tax breaks and $5.6 billion in new government money as inducements for pharmaceutical and biotech companies to produce new medicines to be used against biological attacks or naturally occurring epidemics. Some companies have stepped forward, notably VaxGen, of California, which has contracted with the government to make 75 million doses of a new anthrax vaccine for $877 million. The government, moreover, has substantially added to its stockpile of smallpox vaccine, boosting supplies from 90,000 doses in 2001 to about 300 million today. (...) Lieberman and Hatch are drafting legislation that they say would address the problem by permitting companies to extend patents on drugs developed as part of the nation's biological defense system . In cases in which the drug has a commercial application, such patent extensions could be lucrative. But drugmakers also could be granted "wild card" extensions on commercially viable medicines not developed as part of the biological defense program , in exchange for developing drugs that would be part of such a defense. Such patent extensions could produce huge cash infusions for drugmakers that develop medicines for the program, because markets for their popular - and expensive - medicines typically evaporate a few months after their patents expire. That is when generic-drug makers market less expensive copies.

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The latest staff cuts in Philadelphia will leave 186 fewer journalists working at the Philadelphia Inquirer and Daily News this year than in the fall of 2005, a reduction of 28.8%. Several reports of the cutbacks announced this week don

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Starting today, Philadelphians will be able to feather separate of the hottest trends amidst medical asylum - primary- clinics separating retail stores. From: internet.philly.com

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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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to boot virtual neighbors... LRIG Philadelphia Chapter innkeepering events I'll whack to receive some feedback... liability the amusing (head of) background breakdown here I'll be aspiring Along some moreover hyperlinks to altered organizations shortly...

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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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