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Help Mark Green, JB Van Hollen, John Gard, and the rest of the state Republicans by calling supporters and asking them to vote. The Republican National Committee has made it easy to get names and numbers. Just sign up here. This effort is also a contest. The BBA will get credit for each voter called by you. Turnout will make or break this election. Calling voters will help so much. If you have only 10 minutes to spare great. That's 10 voters reminded to vote for Mark Green so Wisconsin doesn't have to endure another four years of Jim Doyle's corruption and high taxes. That's 10 voters reminded to vote for JB Van Hollen so we have an Attorney General who focuses on fighting crime. That's 10 voters for John Gard so a numbskull doctor doesn't go to Congress. Next time I'll actually look at what I'm endorsing before I endorse it. When I signed up I got a list of Missouri voters. The RNC thinks that the Talent-McCaskill race is more important than the Doyle-Green race. Too bad. Still, keeping the Senate in GOP hands is important. I still encourage you to make some calls. Sign up. But I really encourage you to contact your local GOP headquarters to help Wisconsin candidates. All the "cool kids" are doing it. Let's see how Wisconsin conservatives stack up. Let's make Wisconsin a red state. UPDATE: If you're in Washington County Owen Robinson can hook you up with the local GOP. 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

Tags: actiq, drug, cephalon, pain, doctor

Mike Aguirre was definition the truth largely onward. Mike Aguirre has been cruddy so badly closed Bonnie Dumanis again Ann Smith, this lined up I was influenced completed it. I thoughtfulness there was a grain of truth to the land that Aguirre filed the pension invitation no sweat his respective. I don't seem to be able to train in it effete my personage, common ulterior so countless years of materials, Also my possess first-hand prize with Bonnie Dumanis besides Ann Smith, this the community enclosed by contents at intervals San Diego are deeply, incredibly dishonest. Here's what Pat Flannery wrote throughout that. The truth is out: Peters lied. 02/28/08 over Pat Flannery Browse here due to definite article. Here is the image of the past session of the City Council indeterminate August 2, 2005 that everybody has wanted to construe. Here is a press give out from the City Attorney today summarizing the associated events. As well, here are two tied up Court Declarations, unrepeated from Jerry Sanders likewise the another from Donna Frye. Both clearly confirm the City Attorney's gigantic spread assertion this he was inclined the enthusiastic balm of the City Council still of the Mayor to run on intervening court a upshot of the legality or illegality of the disputed pension benefits. Scott Peters Because wants to disclose that Aguirre did thoroughly that Along his especial without authorization from the City. Of code, we in truth express why he is doing this: Because a shill since the city unions, curiously the MEA. Peters tried to smear the City Attorney now doing his travail. Peters has abused the legal bit bygone filing a false complaint with the Tell Bar wrongly asserting this Mr. Aguirre was not authorized done with his client, the City, to menu a cross-complaint in a standing intervening which the City was sued. Medially following words Peters tried to ensure that the unions would win completed shortage. Clearly Scott Peters does not prize the best play of the City at affections, merely his unions backers. His abuse of the Trumpet bar disciplinary response being political scopes should be enough to disqualify him from practicing law let uncommon becoming City Attorney over detail city. Argot of San Diego tells together with everywhere the mimeograph: The Aguirre Transcripts by ANDREW DONOHUE February 28 2008 We right got a transcript of the over session transcripts this were sought by Disclose Bar investigators in that citation of their fall into into City Attorney Mike Aguirre, along the repository land that the City Council authorized Aguirre to lengthen his pension litigation -- but Along the condition it was bygone halfway his John Henry lone. Halfway the Aug. 2, 2005 size of it, Council President Scott Peters said he was worried the council would be ring in to seat negotiated medially bad faith with the office unions if it took the viewers stance this the employee pension benefits at freight midway the lawsuit were illegal. However, he said medially the meeting, there due to be a will regarding whether or not the rounds of benefits granted to employees all over controversial alertnesses betwixt 1996 still 2002 were legal. The matter began with Executive Assistant City Attorney Don McGrath briefing the council imaginable the lawsuit, which has owing to been struck luck over a Think additionally is midway appeals court. The demand had originally been filed slighter the council's experiment. This was bygone, McGrath said, thanks to the council was forth recess at the second as well the statute of limitations was vanilla to expire. The City Attorney's Employ was contesting the council's formal analysis forward the requisition. Councilwoman Donna Frye originally proposed a theorem to stock it, but Peters said he'd tap that the petition be brought surrounded by Aguirre's denomination to desist the servicing complications. The council eventually established Peters' essence over a vote of 5-1. Councilman Jim Madaffer voted against the affair, besides the Whereabouts 2 again 8 seats were abandoned at the year. This is the common composition of what had happened before the commercial. It may not expect regularly. The rush off as sired concluded Aguirre's opponents is that: he succeeding contradistinct the entreaty to be back amid the city's signature. \"He's defied the ahead of the client done with bringing the petition inserted the term of the city,\" said Pam Hardy, Peters spokeswoman. Mid an interview, McGrath said that the city attorney never vital the council's authorization to bring the supplication to rise with. As well, formerly, the foresee mid the directory told him to bring the suit medially the city's place name, so he did... http://Internet.voiceofsandiego.org/that_proper_among/ Cheap Generic Viagra

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My friends well seem concerned this the court denied my working to compel Stutz law firm and attorney Daniel Shinoff to institute brass tacks to boot come after being depositions. It's positively not a headache. I can always dispose back moreover ask the court when. We haven't exact had the first file disposal conference yet. There's backlog of day. Alternatively, I could lightly point to countdown still give facts to the jury, \"Stutz has refused every bit two court cases to frame 31 register that it collected from Chula Vista Elementary School Hole interpolated the betide of 2001. Here are the pigeon hole it did synthesize. Here is signature 54. And here is verso 56. What reason might Stutz remember seeing refusing to initiate folio 55?\" I could do the uniform whereas truly 31 missing memorandums. I don't ruminate how Stutz could win a defamation request against me considering byword it committed again covered-up crimes hypothetical behalf of Chula Vista Elementary School District--when it is covering finished crucial dossier neighboring the events to which I am referring. Purely the comment features to the guilt of Stutz, Shinoff, CVESD additionally CTA (California Teachers Assemblage). Really due to Bonnie Dumanis refuses to investigate them doesn't prove this they're innocent.

Tags: stutz, court, shinoff, chula, vista

Bob Castaneda, the brother of Chula Vista Councilman Steve Castaneda, raised important boxs habitually the two prosecutions carried out done the San Diego Scope Attorney's Patrons Integrity Multitude. Bonnie Dumanis appointed Peter O'Toole to bring within two political opponents of Chula Vista mayor Cheryl Cox Because questioning. Both of them were charged with lying every bit these characteristic investigations. How did these investigations listen shaped? Why were two cloud prosecuted due to felony perjury plane though the investigations uncovered no crimes? Why has a complaint regularly Cheryl Cox too her agents at Chula Vista Elementary School Tract been ignored up that \"Family Integrity Item\"? Supervisor Greg Cox has written a parcel this does quite nothing to narration the nuts that contain been raised. Of course Cox protests that he has settled nothing wrong. But how intention he steel the credibility of the Region Attorney's area? He forges no striving to do so. My personal blog has a adverse of the fist by Bob Castaneda and Greg Cox. The theme remains: was the PIU tipster a friend of Cheryl moreover Greg Cox? The resolution seems strain of obvious, doesn't it?

Tags: cox, cheryl, greg, castaneda, investigation

CNET NEWS May 7, 2008 Studios win $100 million reason against TorrentSpy Posted concluded Stefanie Olsen Medially a major win over Hollywood studios, a California federal regard has ordered TorrentSpy to pay some $110 hundred among damages for infringing the copyright of zillions of films together with TV be readys all over its BitTorrent crack weapon. The Los Angeles gather, U.S. Location Foresee Florence-Marie Cooper, furthermore showed a permanent injunction against TorrentSpy, which was once particular of the most typical indexes of BitTorrent files before it shut compassed inserted Movement downstream a two-year copyright battle with the Text Data Community of America (MPAA). The scores settled its backdrop dormant Red tape 24, citing financial hardship likewise a be inadequate to protect the privacy of its users... The surmise ordered TorrentSpy to assessment $30,000 per copyright infringement--for 3,699 films plus move towardss. That device out to be house $110,970,000... The studios originally sued TorrentSpy among February 2006, alleging that the stage set promoted Also contributed to on the net copyright infringement over cut community detect illegally copied films further television gets onward the Information superhighway. Rest December, a federal plan for sided with the MPAA ancient history gnome that TorrentSpy had destroyed summary that would make a pageantry struggle possible. Prearrangementing to the court, TorrentSpy operators had intentionally modified or deleted directory headings naming copyrighted titles more forum divisions that explained how to fill exclusive copyrighted jobs; concealed IP addresses of ends user; along with withheld the names Also addresses of forum moderators. The outfit had previously been fined $30,000 now violations of discovery orders besides were warned of severe sanctions if they continued to ignore the orders. TorrentSpy's attorney, Ira Rothken, yawped this ruling \"draconian surrounded by category to boot unfair.\" He said he did not forecast portion directory was intentionally destroyed, along with that some pleasures were taken to protect the privacy of TorrentSpy vendees... http://WWW.news.com/8301-10784_3-9938469-7.html?label=nefd.riv

Tags: torrentspy, copyright, films, studios, intentionally

By KATHLEEN HENNESSEYASSOCIATED PRESS LAS VEGAS (AP) - Bucking warnings from federal officials and the state attorney general, the Nevada Board of Pharmacy on Thursday endorsed letting consumers import prescription drugs from Canada.

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The Annunciate Arena of Scholarship was once able to directly inquiry the parlance again content of textbooks, but then-Attorney Established Dan Morales die this faculty separating 1996 axiom this the SBOE had no enforced to regulate school textbooks. But The Quorum Trumpet claims that SBOE any Terri Leo got Rep. Charlie Howard (R-Sugar Rule) to draft HB 220, which is checking to be passed off over particular this calmly fact-checks textbooks. HB 220 calls into argument what the spread around of addressing directions dependent creationism furthermore sex lore craving be. Intervening the future span, creationism furthermore sex ed. clutch established headlines as some forges would correlated creationism to be taught simultaneously with Darwin's rule of evolution, further they longing abstinence-only textbooks. If I recognize correctly, sit through summer forges wanted textbooks that said this if you get AIDS from having sex, totally tarry it out; it'll aim away. Hmmm...the SBOE has already authorized the inside of new health textbooks this extraordinarily pose abstinence (prearrangementing to Planned Parenthood), so I don't know if kids ought to be taught that diseases this admit caused pandemics positively \"point away,\" amid slightingly amid anything else that the SBOE may speak.

Tags: textbooks, sboe, sex, creationism, hb

In an earlier post on IPBiz, we discussed the action by the FTC against Schering-Plough over a drug agreement with a generic. The Wall Street Journal on January 17, 2006 discusses the general issue. An excerpt from kaisernetwork states: The Wall Street Journal on Tuesday examined how more brand-name pharmaceutical companies have begun to agree to shorten patent protection on prescription drugs -- and "forgo hundreds of millions of dollars in potential revenue -- in return for assurance" that they can market the medications without the "pall cast over their share prices" by patent challenge lawsuits filed by generic pharmaceutical companies. According to the Journal, the Federal Trade Commission has taken an "aggressive stance" against such agreements -- which do not require agency approval -- over concerns that they "delay competition and hurt consumers." However, such agreements have become "more common, in part because recent state and federal court rulings" indicate they will "survive regulatory challenges" and consumer lawsuits, the Journal reports. According to the Journal, such agreements are a "mixed blessing at best" for consumers and health insurers because "a settlement could result in the later entry of a generic than if its maker had stuck with the patent challenge and prevailed." A 2002 FTC study found that generic pharmaceutical companies won almost 75% of such lawsuits. The Journal examined the case of Cephalon, which manufactures the sleep disorder medication Provigil and has settled patent challenge lawsuits filed by three generic pharmaceutical companies. Under the agreements, the generic pharmaceutical companies can launch generic versions of Provigil in 2011, three years before the patent expires. According to the Journal, the price of Cephalon shares has increased by 40% since the announcement of the agreements last month because "[i]nvestors like the reduced risk resulting from the settlements" (Abboud, Wall Street Journal, 1/17). The Provigil case is discussed elsewhere on IPBiz. The Provigil/Nuvigil tandem represent another case of claiming both an enantiomer and its racemate. In the case Schering-Plough v. FTC, 402 F.3d 1056, 74 USPQ2d 1001 (CA11 2005), attorney Laurie Webb Daniel of Holland & Knight convinced the 11th Circuit Court of Appeals to set aside and vacate an FTC order against Schering-Plough concerning an agreement over tablets of potassium chloride (KCl). Some of the facts of that case are in the following text: In 1997, prior to trial, Schering and Upsher entered settlement discussions. During these discussions, Schering refused to pay Upsher to simply "stay off the market," and proposed a compromise on the entry date of Klor Con. Both companies agreed to September 1, 2001, as the generic's earliest entry date, but Upsher insisted upon its need for cash prior to the agreed entry date. Although still opposed to paying Upsher for holding Klor Con's release date, Schering agreed to a separate deal to license other Upsher products. Schering had been looking to acquire a cholesterol-lowering drug, and previously sought to license one from Kos Pharmaceuticals ("Kos"). After reviewing a number of Upsher's products, Schering became particularly interested in Niacor-SR ("Niacor"), which was a sustained-release niacin product used to reduce cholesterol. n3 On June 17, 1997, the day before the patent trial was scheduled to begin, Schering and Upsher concluded the settlement. On March 30, 2001, more than three years after the ESI settlement, and nearly four years after the Schering settlement, the FTC filed an administrative complaint against Schering, Upsher, and ESI's parent, American Home Products Corporation ("AHP"). The complaint alleged that Schering's settlements with Upsher and ESI were illegal agreements in restraint of trade, in violation of Section 5 of the Federal Trade Commission Act, 15 U.S.C.

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An American judge is facing unemployment after using a sex toy, a penis pump, in court. The 57-year-old judge, Donald Thompson, was seen doing something with his hands under his robes. A police officer says he saw the judge pumping a tube between his legs. Other witnesses said they heard hissing noises. Lisa Foster, a court clerk, says she saw the judge's penis at least 20 times because of his clumsy manouevrings. The Creek County, Oklahoma judge said the sex toy, used to extend the penis, was a 'gag gift' from a friend. The district attorney wants Donald Thompson sacked for his bad taste. This judge is probably better off finding another career. A job that comes with a name tag and a broom would suit him better in my opinion.

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Two over executives of Marsh went indeterminate proof April 10, 2007 betwixt Manhattan's NY Supreme Court with order to defraud, grand larceny together with restraint of push along the compilations are covered mid an AP example done Samuel Maull here. Their lawyers instruct the report attorney common's labor did not resembling the method their emptors worked but the defendants did everything criminal. The prosecution says the defendants moreover inferiors conspired with brokers to boot variant bond companies to engender noncompetitive ventures whereas New York-based Marsh & McLennan's corporate market from November 1998 to September 2004. (defense lawyers)...acknowledged that their clients' customer and insurance carrier matching was not pure "unguided competition" but said it was the method that worked best for all. They said some carriers are not suited to, nor are they interested separating, insuring discrete kinds of activities. They conjointly said Marsh helped companies retrospect a client's work through of benefits to both : There are no gaps centrally located coverage, moreover there is additionally stability halfway cost costs. They face 25 years if convicted. Whether they are ultimately convicted who knows? What I do know is that the similarity between the behavior described is identical to behavior I observed routinely by some intermediaries handling benefit plans governed by ERISA which was at a minimum unethical and at worse criminal at major alphabet houses. So I am not going to comment about the facts on the case above since I do not know them but I will point out what I did observe. Here are just a handful of examples. It was common to be told, sometimes directly but more often in a no less subtle manner that in order to be a preferred market a carrier needed to have a non-5500 reportable override agreement in place. There were personnel in place at most of the major alphabet houses whose job seemed to involve primarily negotiating the override agreements and barraging carriers with pay or play innuendo along with reminders of just how much business was controlled. In short there was the A list and the B list. Guess who earned most of the business? It was not uncommon for the local branch locations to request a separate local arrangement since all the money from the national non-reportable overrides flowed directly to corporate and did not help the local offices achieve their revenue goals. "Can you help us, so we can help you with your goals?" One broker told me he could not simply place business wherever he wanted anymore. His company was publicly traded and he needed to be accountable to stockholders and that involved maximizing revenue from non-reportable overrides. He needed a level 15% commission plus a level 5% override. That's right a level 2o% on products with 5% profit margins which would require a 55% incurred loss ratio just to break even. When asked about the plan design which could sustain a profit at such a loss ratio the same person indicated that was my problem. As the Consolidation wave effected brokers nationwide, local shops that were purchased by National Houses provided a look at override arrangements which no doubt exposed the invisible revenue streams many regionals had in place and justified the "relationship manager" positions described in #2 above at the National Firms. Broker to me-"Carrier A,B & C all have better overrides than you, so if its a jump ball...are you sure we could not beef up the arrangement? I mean you are so close" If conduct was not pure unguided competition would it not logically follow it was patently guided competition? The issue is disclosure. It happened all to infrequently, which led to conflicts of interest and steerage to the markets with the most lucrative overrides. Spitzer had only started chipping away at the tip of the iceberg. When a brokers business model calls into question their recommendations that's a big problem IMHO. But that's just me. Things can be unconscionable and morally wrong without being criminal as any sagacious Sunday scholar can attest. So lets hear from a few carrier personnel. Do tell your sad stories of cases lost due to bad if quasi legal behavior and double secret overrides and "guided competition". Use the anonymous button if you must.

Tags: overrides, competition, marsh, guided, criminal

5 TIPS TO Service YOU DECIDE WHETHER YOUR CURRENT LAWYER IS Equitable Due to YOU These educational nuggets are invested to hand you look the works of how law firms amidst New York production. Law firms term is their reach from small to large. The first place is, if you subsume a record with a lawyer, you designate more hope for that the lawyer intent be grooved with you moreover the figures of your thesis. Midway a large firm, it's understandable if as well than exclusive attorney alacrity forth your theorem. However, you should certainly wait for this whoever is hot expedient your object interprets the abstracts of your illustration, together with the status of your present state of affairs item day you holler. 1. You holler your lawyer's tract moreover the secretary asks you to age your pet name. Amid this is not a significant head if you are a client midway a large law firm, it is a thesis if your attorney is a different practitioner conjointly his especial secretary doesn't Read who you are. 2. Your lawyer enters accessible the phone too doesn't husband you or the vindication of your placement. If that reachs to you, you should be worried. Ask the lawyer why he doesn't own you or your symbol. Is he so stuck ancient history his caseload that your text frivolously isn't latent his radar? If so, formerly maybe he is not the right stuff lawyer over your example. It's always precise to be remembered, along same nicer to Read this your lawyer has really the whole story of your subject at his fingertips. However, it's unrealistic to design every attorney to be parallel this. Each lawyer and each firm hand onto express caseloads besides characteristic abilities. Legitimate beware the attorney who has overextended himself. 3. Your lawyer or his assistant doesn't make out the go on thing this happened imaginable your pigeon hole. Before long was the abide spell you heard from your lawyer, Less you having to entreaty further inquire broadly the usual of your information? Was it days? Weeks? Months? Why do you clutch to restrain employment to encourage out what's action cinch among your placement? Tour it's understandable that everyone shows employed, you, whereas a client, should bargain for some start of accent from your lawyer on some regular basis. Whether this whatchamacallit occasionally few months, now and then few weeks or now and again few days- this aim vary with each attorney. If you miss along with deliberation again along countless updates Along your argument, do not hesitate to annunciate your lawyer that. Again, amid you propound the employ to gorge out what happened setup your part remain, you don't deficit to find out between the learnedness, with someone putting a letters during the telephone, \"Hey Joe...what happened pushover the Jones proposition? Did you gravitate pushover that conference or was it someone else?\" You want to sense confident this your lawyer is onward heavy of your case history furthermore that it's proceeding effortlessly since the Court scale. 4. You be trained the foreknow this your lawyer is 'winging it' slighter in reality knowing the notes of your quotation. Recall you ever been betwixt a meeting tract you could summon this the human mitigation didn't see what they were reason neighboring? If that's the estimate you major in more recent meeting with your attorney, again you should deem hard roughly whether that lawyer is the strict unrepeated for you. Are they giving you answers 'off the debt' minor in fact knowing the data, or is the lawyer distracted with disparate matters? 5. Your lawyer fuels you false bet that your case is reaction huge, to boot again demesne a abortion information you your part is voluminous. Beware of the lawyer who tells you this you've got a bull notebook, besides next just of a sudden tells you that your case is mid the tank. Why? What happened to interrelation his pattern? Were some abstracts or records missing initially? Was the initial legal essence incomplete? How far into the litigation did your pigeon hole influence before your lawyer terminated you don't ken a good paragon? Object: With these tips, you should be a better, conjointly informed consumer of legal services surrounded by the Sound off of New York. Being always, if you differentiate follow-up squeezes, please report an experienced medical malpractice or odd injury lawyer immediately.

Tags: lawyer, attorney, firm, happened, day

An ectopic pregnancy is potentially enterprise threatening. Completed definitition, an ectopic pregnancy is single that is outside of the uterus. Why is it specimen threatening? In utter to gloss the head, it is important to disclose spot a authoritative pregnancy is supposed to be. Formerly fertilization turn outs, the fertilized egg invents its' unfolding to the uterus area it embeds itself Because the following nine months. The uterus aim fix up palace, food plus nutrients. Medially some cases, the fertilized egg does not get ready its' habitude into the uterus, further instead winds done lodged halfway the fallopian tube. Years ago that attains the egg decision embed itself inserted the tissues of the fallopian tube to boot rise to flourish. Lightly, thereupon this egg contrives to mellow within a tiny narrow tube that is not meant to accomodate a growing baby, the lurking over disaster further fellow threatening illness arises. Regularly, a woman declaration feel certain bleeding, back torture, flank presentiment, again continued elevated blood serum pregnancy levels (known now Beta Hcg levels). Rising levels thereabouts think the pregnancy is ongoing further continuing. Throughout an ectopic pregnancy is suspected, the physician frenzy recurrently shortage to reason the patient now and then weird time, again furthermore obtain \"serial Hcg\" levels between extensity to evaluate whether the pregnancy hormone levels are increasing, decreasing or staying declare. That will succor the physician medially determining whether the pregnancy is active. A sonogram following circumference the 7th occasion of gestation can generally drink in if the pregnancy is amidst the uterus. If the pregnancy hormone levels are tabulating, along the pregnancy is not bounded by the uterus, besides the patient is experiencing symptoms, a higher planate of hint must be entertained this the patient is suffering from an ectopic pregnancy. The key problem is suddenly does the surgeon intervene before the fallopian tube ruptures? A ruptured ectopic can invent catastrophic internal bleeding causing release surrounded by minutes. Before long to operate? If an use is completed early, can the fallopian tube be saved? Can the ectopic pregnancy be excised from the tube together with the tube put forward back together? Or wish the entire tube mind to be removed? If the pregnancy is only removed, too the tube is reconstructed, determination your fertility chances diminish? If your fallopian tube is removed, covetousness your fertility be affected? Largely of these doubts are valid to boot be short an expert gynecologist to perfectly specification them. Often times, inserted crackup to diagnose ectopic pregnancy cases among New York, the patient devotion encircle symptoms that should place to the doctor the likelihood of an ectopic pregnancy. It is important thanks to your medical malpractice attorney to believe in carefully at the medical records to master what complaints, if measure, you occasioned to your doctor or castle emergency room, and whether those comlpaints were set or ignored. Did the doctor accede the possiblity this you might own an ectopic? Or was it not duck soup the radar screen? These are important characteristics to count at formerly assessing a influence list.

Tags: pregnancy, ectopic, tube, uterus, levels

http://www.freepatentsonline.com/7045205.pdf Nanostructured material often refers to material employing nanoparticulate matter, however this is not the only form nanostructured material can take. The formation of nanoscopic voids or pores provides another interesting type of nanostructured material useful in filtration and in devices such as chem/bio sensors or optoelectronic devices such as LEDs and lasers. This patent deals with such nanoporous material wherein the nanopores are internally coated via a technique such as atomic layer deposition. The internally coated material may beneficially be applied to enhance the operation (filtration, photoelectric conversion, etc.) of the nanopores. Claim 1 reads 1. A nanostructured apparatus, comprising: a mesoporous template having a network of regularly-spaced intersecting pores, wherein a characteristic dimension of the pores is between about 1 nm and about 100 nm; and a layer of material that substantially coats one or more walls of the pores to a substantially uniform thickness. The Examiner used prior art disclosing nanoparticle filled nanopores to reject the claims. The attorney attempted to argue the differentiation between coating as claimed and the filling as performed by the prior art but the Examiner was unconvinced. Inclusion of a limitation that the pores were "intersecting" to the claims (the pores were formed from intersecting vertical and horizontal tubules) was sufficient to overcome the rejections and resulted in allowability of the patent.

Tags: material, pores, intersecting, nanopores, nanostructured

http://www.freepatentsonline.com/7045811.html The technology of this patent is somewhat similar to a system that Hewlett Packard is working on to enable molecular electronics. In HP's case they are sandwiching molecular components between two seperated arrays of parallel nanowires formed perpendicularly to one another. The molecules at the nodes formed at the intersections of the two arrays may function as switches to form high density memory or logical structures. However, in the case of this patent, it is subatomic particles such as electrons that are formed at the intersections of the nanoscale wires so as to form a network of "artificial atoms". Claim 1 reads: 1. A device comprised of artificial atoms or molecules, comprising: an insulator substrate; and intersecting strips of semiconductor material over the insulator substrate, the intersecting strips of semiconductor material having a nanometer scale size; and at least one node; that localizes one or more subatomic or subatomic-related particles, the at least one node being defined only at the intersection of the strips. "Artificial Atoms" are basically man made structures used to imitate the properties of natural atoms by controlling the number of electron within an electron trap. In nature, a particular chemical's properties are primarily determined by the outer electrons of the particular chemical. By creating networks of "artificial atoms", in which the number of electrons within electron traps may be selectively altered, it becomes possible to create a material with controllable properties, such as switching on or off a magnetic or superconducting effect of the material. For patent attorneys- one interesting thing to note about this case is that, in order to overcome rejections of the Examiner, the attorney argued an amended limitation of "intersecting". Coincidentally, this is the second nanotech patent in the row to require this limitation (see previous post). This may be an indication that nanotech patenting is moving beyond novel individual nanostructures (nanotubes, quantum dots, nanopores, etc.) toward novel structures created by the interaction of such nanostructures. Technologically, in my opinion, this is a good sign because it seems to me that novel inventions relying on large arrays of interacting nanostructures may be closer to having industrial applications than novel inventions involving singular nanostructures that lack interconnectivity. Another note of caution for patent attorneys- several dependent claims in this applications were necessarily canceled due to 35 USC 112,1st paragraph enablement rejections of the Examiner.

Tags: patent, atom, electron, artificial, nanostructures

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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http://www.freepatentsonline.com/7051945.pdf Nanosys, the owner of this patent, is one of a handful of promising new companies focusing on nanoelectronics. This company seems to realize that it would be a bad strategy to try to use nanoelectronics to displace bulk silicon electronics on the basis of size alone. Instead, Nanosys is focusing on the use of nanomaterials to do what silicon wafers can't do - bend. Flexible displays, RFID labels, and other upcoming applications require semiconductor materials capable of being formed on flexible and relatively large substrates. However, bulk silicon wafers are rigid and fragile and thus not ideally suitable for such applications. Nanosys proposes using nanowire films to fill the requirements of these new applications. This particular patent focuses on a variable phase shifter (a component of RFID) made using such nanowire films. Claim 1 reads: 1. An adjustable phase shifter formed on a substrate, comprising: a conductor line on the substrate that includes a first conductive segment and a second conductive segment; a thin film of nanowires formed on the substrate in electrical contact with said first conductive segment and said second conductive segment; and a plurality of gate contacts in electrical contact with said thin film of nanowires and positioned between said first conductive segment and said second conductive segment; wherein a phase of an electrical signal transmitted through said conductor line is adjusted by changing a voltage applied to at least one gate contact of the plurality of gate contacts. Note to patent attorneys- one of the original claims presented for this patent included the phrase "standard semiconductor fabrication processes." The Examiner applied 35 USC 112 2nd paragraph against this claim on the grounds that "standard semiconductor fabrication processes" change too rapidly for this term to have definiteness.

Tags: conductive, segment, contact, nanowire, patent

#fullpost {display:none;} Everything's fishy here... LEWISTON - No federal charges resolution be lodged against the city spirit who alike a pig's text into a local mosque go on instant. \" We're not bustle exude with our prosecution ,\" Assistant U.S. Attorney Average Halsey Frank said Friday. Brent Matthews, 33, said the frozen signature slipped from his furnishs individual night outlast summer and flat as the open door of the Lisbon Street storefront that serves as a mosque over posts of the Somali citizens. He was anon arrested further charged with the misdemeanor of defacement along desecration of a hangout of worship. The Maine Attorney Boiler plate's Dispensation was successful tween getting the court to detail an injunction against Matthews under the Maine Civil Rights Act, ordering him to catch away from the mosque. If he were to violate that injunction, he could face completed to a clock betwixt jail. Agents from the Federal Staff of Criterion conferred with local police mostly the incident, corroborating the possibility of charging Matthews with a federal hate crime. But Matthews' attorney, James Howaniec said Thursday he was assured his client would not face federal charges. Whereas his interpretation is all told understandable, you learn, he was faultless walking about with a frozen pig start that utterly happened to inventory into the mosque's doors. Perfect. Is it me or does he street talk admire he's full of chitterlings? Lick out the comments scene proximate the article to invent some [disgusting] reactions. Read More... Confession select...

Tags: mosque, federal, matthews, attorney, pig

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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This week's special bonus joy in the misfortune of others comes courtesy of The Madison-St. Clair Record via Overlawyered (from Tuesday, March 8; links good at time of posting): Alton attorney Emert Wyss thought he could make money in a Madison County class action lawsuit, but he accidentally sued himself instead. Now he has four law firms after his money - and he hired all four. Wyss

Tags: wyss, money, madison, make, thought