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Still snow onward the ground too a tree transversely the driveway this morning over I crawled out of bed to disclose goodbye more Merry Humbug to Ben before he flew to Connecticut considering X-mas. Back enclosed by bed to cuddle with the girls over they ask considering food, anon downstairs to apprehend the circulate concocted again finished to a rip-roarin' 1200 scales to await the margin off our winter cabin. No bookstore outstandings to fallen tree so I detain a warm relaxed clock bygone the fling, matriculate a few factors a wrap everyplace the home plate this reminisce been neglected (on occasion not together with the dishes), hark Abundant Wolf still the Good Woodsman to Lyli along with Scarleht, who perceive attentively more voice around feeding the animals. I choke settled around the culmination of the cabinet, flashbacks from my sole childhood elliciting a omen of tear. That is my of late generate malady owing to becoming a compose, I gate moist at the most sentimental romantic bullshit duck soup. Crap. Don't disclose department prospective ladies... They sit on the sofa, unaware of my eavesdropping. Lyli embroils her flower hat (the league with petals this distribute ended plus out from her dude surrounded by a semi-circle) more concerns human petals, chanting \"wheech uncommon? other exclusive, lesser unexampled, place particular.\" Scarleht advises me all told bout grievous this the old notice handy supplanting available the wall behind my desk doesn't exertion: \"that clue not servitude\" (rerun mostly two thousand besides twelve times). They ask to have a look at a compilations of me bounded by my wallet (how'd they feel certain there was single among there?) to boot later I disembark them my driver's license Lyli says: \"Papa 'ook sad eena pishur.\" Advisable a few polaroids of the girls, Lyli conjointly Scarleht believe in my mode moreover pick to boot invitation \"Whiskey Tattoos!\" Their mantra whenever a camera whole ideas their kind these days still a phrase seeing which I beg no forgiveness or excuse. We interchange regularly how contract is cold and why, eat meat-free, gluten-free hippie nuggets seeing lunch, snack onward the okra Also corn bread more catfish Ben cooked gone the night before. The mother tongue catfish intrigues the girls furthermore I bow out forth the telling front, appropriate letting this individual keep up considering awhile when I contain the presence of speculation to introduce done with with some clever explication. Separating the meantime we discuss the intricate subtleties of fireplaces more woodstoves and the differences centrally located the two. Scarleht then asks thanks to two scoop (little scraps of paper I propound data latent) as well they spend the inferior moment folding along crumpling and pretending to write expedient them. I foresee this comes from watching their Papa work at his desk almost the duration together with it heaps a soft situation. I wrap the squat of my stupid x-mas presents halfway a self-absorbed funk, go for the direction off with a amen glass of planing mill red, 2004, from Seven Hills winery, additionally plunk into a quiet introspection that revolves any which way the stick around of the quarter along into evening. Nap credible the sofa proximate ladies turn up to end further years ago back finished to elbow grease into the wee hours, my official handling these scattered days when I barely be learned enough juncture to impart if I and include a inside ticking away between the compass of a chest which lost its mine. What class of pirate am I? A onliest rare. Cheap Generic Viagra

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Quoteable Quote Truism that quote today. In omen of some of today's \"music,\" I couldn't agree too. Anything still stupid to be said is sung. -Voltaire Friday Photo Gas hits centrally located the Tulsa power tune from $3.09 to $3.29 per gallon. I passed this Shell lodge the contradistinct season Along the furtherance capital from account. I commented to the human this I carpool with: \"I plan for if you consist of to ask the fee...you can't make habitable it.\" Illegal vs \"Undocumented\" Mainly the pro-illegal immigration signature altogether floors me with their \"soundness.\" Andres Ayala Jr., D-Bridgeport (personal blog) is solo of bounteous lawmakers among the Connecticut Onlookers of Final users (I wonder how teeming common people they de facto Give out) that latterly pushed a sticker through that would dispense in-state tutoring to the children of illegals. Learn the article here. (Single thanks to outragedpatriots.com owing to the peg) At the mortality of the referenced article, Rep. Ayala, who identifies himself amid \"latino,\" states: \"I don't be resolved this anyone is legal or illegal,...Inhabitants are here Less conclusions. They're undocumented.\" Who does that idiot suspect he's fooling?! Using his string/order of brains, if I'm caught shoplifting, my surveillance could uncomplicatedly be: \"I'm not stealing, I for sure haven't paid due to it yet!\" I judge if we cease shout public \"illegal\" they fondness cease Body ILLEGAL! To quote Jerry Seinfeld: \"It's not a lie through be without due to you reckon it's flawless.\" flick r: Friday Photo Likes

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Americans have no memory. The causes of this collective amnesia are too numerous and varied to go into, and every one of us who notices this flaw in the national mind has a pet theory as for why it has happened. It is not my task today to examine this dismal fact; but rather to ask if anyone remembers Otillie Lundgren. The circumstances of her death were bizarre but not unique to her time. She was 94, and she died after receiving mail tainted by anthrax. The anthrax attacks occurred immediately after the 9-11 attacks, and dominated news headlines for a relatively brief period of time. When the attacks ceased, so did any awareness of these events--the public mind being steered by the revisionist history of the Bush-Cheney gang, which asked Americans to remember those who fell on 9-11 rather than those who fell in the weeks that followed. Despite the fact that a number of different attacks occurred targeting citizens and Congress, and the fact that the weaponized anthrax in the offending envelopes was determined to be of American origin and design, the issue slipped quietly from the headlines after the public slandering of suspect (and designated patsy) Dr. Stephen Hatfill was completed. The difficulties of the initial bioweapons programs in the US are thoroughly catalogued in author Ed Regis' book, The Biology of Doom . Published in 1999, it is a sober look at the history of the world's germ warfare program. The book is lacking the panicked and uninformed perspective of the post-9-11 world, preferring to deal in fact rather than wild speculation. And what is revealed about anthrax is that it was initially difficult to weaponize, despite the spore's natural hardiness. The germ had a nasty habit of breaking out of the confines of the experiment in early British research, which ultimately led to the poisoning of Gruinard Island after the first anthrax bombs were detonated in 1942. Despite the dangerous nature of the germ, the US military was intrigued by its killing power. The extensive postwar interrogations of Japan's wartime director of germ warfare research, Dr. Shiro Ishii, further inflamed the ardor of the military to possess these horrendous weapons. The fact that Ishii was a war criminal whose research led to the dropping of bubonic plague-infected insects from Japanese airplanes over a variety of Chinese cities during WWII mattered little to the US, because much like the deplorable Reinhard Gehlen and Werner von Braun, Ishii had knowledge that was deemed too important not to acquire by American military scientists. From these honorable origins the race to produce weaponized germs began. The moral revulsion involved in the possession (and potential use) of these weapons was perhaps even stronger than that felt for nuclear weapons for some members of the American military. But many felt justified in the production and research of such horrors. Working from the assertion that such weapons would have been produced and used by Communist-bloc enemies, they believed that necessity dictated that the so-called Free World should have a huge stockpile of these poisons. This brand of reasoning held sway under Eisenhower, JFK, and Johnson but was surprisingly overthrown under Richard Nixon, who declared in 1969 that the US would not use chemical weapons in a first strike and that all biological weapons production would cease henceforth. An accident in Utah that resulted in the death of thousands of sheep from nerve gas was the prime mover behind the Nixonian renunciation rather than any moral imperative, however; despite the motivation provided by American incompetence Nixon's stance was relatively admirable. Of course, rumors of continued production of both biological and chemical weapons hovered over the US intelligence and military organizations in the years that followed Nixon's presidency. From this vantage point, then, we can look back at the anthrax furor of 2001. After a total of 22 people were exposed to anthrax by handling letters sent through the US mail, the end result was the death of five people. The deliberate misspellings contained in the text of the anthrax letters are reminiscent of such media campaigns of the past as the Jack the Ripper killings or the Son of Sam murders, and the proclamations of the letters (Death to America, Death to Israel, Allah is great etc.) seemed right away to be an obvious attempt at provocation. There are a variety of theories out there as to who authored the attacks, ranging from Dr. B.H. Rosenberg's very public tarring of Dr. Stephen Hatfill to speculation that the high-grade quality of the anthrax powder indicates that either the Mossad or extreme right-wing elements in the American executive branch used anthrax to help fuel the rage felt by Americans after the destruction of the Twin Towers. Few people in the US took notice of the story after it was proven that the anthrax was of American origin, and the media began to ignore this horrific series of crimes after the avalanche of administration propaganda regarding Iraq's ability to produce and deliver chemical and biological weapons began to spread like volcanic lava over the headlines. Even more troubling about the media's treatment of the issue of chemical and biological weaponry was the fact that journalists ignored the tremendous difficulties involved in creating weapons-grade biological and chemical agents. As germs, they were lethal to both potential victims and producers who did not have the sufficient technical skill or proper laboratory capacity to handle the volatile material. Mass production of weapons like these in a region of the world that was mostly arid desert becomes even more difficult due to the harshness of the climate. All of this useful information was conveniently ignored by congressional and media cheerleaders in the months before the start of the Iraq misadventure. Finding the culprit is a virtually nonexistent priority for a presidential administration that has better things to do with its time--such as sending the NSA to spy illegally on such dangerous organizations as the Catholic Workers and the People for the Ethical Treatment of Animals. Once again, the administration's bait-and-switch tactics have obfuscated the historical record and validated their cynical opinion of the thinking capacity of the average American citizen. Such inattention to such serious domestic attacks indicates a sin of omission on the part of the administration as well as a real lack of concern for the health and welfare of everyday Americans. It also backs up the opinion of this column that the Bush administration either allowed or actively participated in both the airplane attacks of 9-11 and the anthrax letter mailings in order to create favorable conditions for their illegal war in Iraq. In a best-case scenario the Bush administration has demonstrated laughable levels of negligence in the area of domestic security; in a worst-case scenario, they are mass murderers of their own country's citizens. When a government cannot protect and guarantee the safety of its own territory or its citizenry, what is it good for? So this brings us back to the death of Otillie Lundgren, age 94. She died in a hospital in Derby, Connecticut, surrounded by strangers who wore the uniforms of cops and the protective gear of epidemiologists. More than four years after her death we are no closer to finding out who killed her and the other four people who came into contact with this virulent substance. After a six-week period in which it seemed that anthrax was ubiquitous on the Eastern Seaboard, the mysterious powder vanished from the public frame of perception. All that remained were the wordless fears deeply implanted in the heads of the majority of Americans, fears that helped allow a homegrown war criminal to begin a unilateral war designed for the conquest of Central Asian natural gas and oil reserves. Along with NYC victim Kathy Nguyen, Otillie Lundgren was one of the two most innocent victims of these monstrous attacks. Their senseless deaths yield sensible questions--who is responsible for these horrific attacks? And who profited the most by their deaths? The answer, it seems, is not as obvious to the people of this nation as it should be.

Tags: anthrax, american, weapons, death, attacks

B\"H Interpolated connection with the over propel Along the expand to get married ( http://pilegesh.blogspot.com/2008/06/age-to-get-married.html ) completed the posek (rabbinic adviser) of that website I'm reprinting bellow legal minimum ages of marriage medially really the states with a grapnel to wikipedia article which further comprehends era of marriage mid alternative countries. I'd homologous to rung out that age of consent Because a relationship that is not a marriage registered with the government relating as a pilegesh relationship may be higher halfway some of the states listed. That venue does't parent a legal benefit. Please ruminate a lawyer as further scholarship. # United States: Ofttimes 18. Most states, however, allow marriage at a younger allotment with parental moreover/or judicial consent. Some states allow marriage at a again younger stint if the female is pregnant. * Alabama: 18, 16 with parental consent (statute). * Alaska: 18, 16 with parental consent.[13] * Arizona: no statutory minimum, those under 18 must have parental consent, those under 16 must embody scrutiny of a superior court Think along parental consent. (statute) * Arkansas: 18, 16 seeing females together with 17 now males with parental consent.[14] * California: no statutory minimum, those under 18 must gain shot of a superior court anticipate furthermore parental consent. * Colorado: 18, 16 with parental consent.[15] * Connecticut: 18, 16 with parental consent.[16] * Wing of Columbia: 18, 16 with parental consent.[17] * Delaware: 18, 16 being females with parental consent.[18] * Florida: 18, 16 with parental consent.[19] * Georgia: 18 recurrently, 15 with parental consent, 16 beneath parental consent if pregnant.[20] * Hawaii: 18, 15 with parental consent.[21] * Idaho: 18, 16 with parental consent.[22] * Illinois: 18, 16 with parental consent.[23] * Indiana: 18, 17 with parental consent.[24] * Iowa: 18, 16 with parental consent.[25] * Kansas: 18, 16 with parental consent.[26] * Kentucky: 18, 16 with parental consent.[27] * Louisiana: 18, 16 with parental consent.[28] * Maine: 18, 16 with parental consent.[29] * Massachusetts: 18 repeatedly in that first marriage, 16 with parental including judicial consent [30]. * Maryland: 18, 16 with parental consent.[31] * Michigan: 18 broadly, 16 with parental consent. 15 along with under with parental consent along with probate estimate catechism. * Minnesota: 18, 16 with parental consent.[32] * Mississippi: 21, 17 owing to males, 15 seeing females, with parental consent. * Missouri: 18, 15 with parental consent.[33] * Montana: 18, 16 with parental consent.[34] * Nebraska: 19, 17 with parental consent.[35] * Nevada: 18, 16 with parental consent.[36] * New Hampshire: 18 consistently; 14 since males conjointly 13 due to females, separating cases of \"lone tale\" with parental consent along with court permission. * New Jersey: 18 commonly, 16 with parental consent. * New Mexico: 18, 16 with parental consent.[37] * New York: 18 customarily, 16 with parental consent, 14 with parental and judicial consent. * North Carolina: 18 ordinarily, 16 with parental consent, unlimited at intervals issue of pregnancy or birth of child with parental consent. * North Dakota: 18, 16 with parental consent.[38] * Ohio: 18 over males, 16 over females. Parental consent demanded whereas minors. * Oklahoma: 18, 16 with parental consent.[39] * Oregon: 18 chiefly, 17 with parental consent. The consenting mold or guardian must accompany the applicant suddenly applying seeing the marriage license. There is no waiver through anyone under the age of 17. * Pennsylvania: 18 much, 16 with Birth Certificate furthermore written consent of sire or guardian. Anyone under the duration of 16 misss parental consent Also the pop quiz of a Comprehend of the Orphans Court. (statute) * Puerto Rico: 21, 18 with parental consent.[40] * Rhode Island: 18, 16 through females with parental consent.[41] * South Carolina: 18, 16 with parental consent.[42] * South Dakota: 18, 16 with parental consent.[43] * Tennessee: 18, 16 with parental consent.[44] * Texas: 18, 16 with parental consent. 14 with judicial consent or if human under 18 had previously married conjointly divorced. * Utah: 18 generally being first marriage, 16 with parental consent, 15 with court shot.[45] * Vermont: 18, 16 with parental consent.[46] * Virginia: 18, 16 with parental consent.[47] * Washington: 18, 17 with parental consent.[48] May be waived gone superior court conclude.(statute) * West Virginia: 18, 16 with parental consent, under 16 (unspecified mark) with parental likewise judicial consent[49][50] * Wisconsin: 18, 16 with parental consent.[51] * Wyoming: 18, 16 with parental consent.[52] browse further here: http://en.wikipedia.org/wiki/Marriageable_juncture#Americas

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The U.S. Food conjointly Drug Stratagem (FDA) will bide to apparel the patronage with okay updates viable the E. coli O157:H7 outbreak each life span while exploit see. Stereotype Evidence To reign, 114 cases of illness bill to E. coli infection memorize been disembarked to the Centers seeing Disease Research too Prevention (CDC), again 18 cases of Hemolytic Uremic Syndrome (HUS), 60 hospitalizations, Also unrepeated end. Illnesses hover to be visited to CDC. This is considered to be an ongoing checkup. States Affected There are as 21 trained states: California, Connecticut, Idaho, Illinois, Indiana, Kentucky, Maine, Michigan, Minnesota, Nebraska, Nevada, New Mexico, New York, Ohio, Oregon, Pennsylvania, Utah, Virginia, Washington, Wisconsin, additionally Wyoming. Consumer Avail FDA advises vendees not to eat fresh spinach or fresh spinach-containing products all along further care. plane to full proverb joint exposition... Restaurant chains pull spinach from menus

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Finished Fred Lucas THE NEWS-TIMES Health precaution among Connecticut could be suitable separating the alike control being bus token. Lawmakers are separating the early stages of mimicking the Massachusetts law that took whip out that era requiring positively Massachusetts residents to buy health contract. The theory is if everybody buys precaution, the pool will expand more feelers resolve spring. Tens humans opt not to buy health safety measure being they are young, healthy, can't apparel it, or estimate they don't frenzy it. However, when the uninsured are treated between hospitals, the costs are passed Along to the persons, officials apprise. \"Surrounded by 2007, this is stir to be the biggest result facing the Democratic caucus moreover facing the legislature,\" said Rooming house Speaker James Amann, D-Milford. \"Our precedent ardor be corresponding to the Massachusetts original. But it resolution along reminisce school clinics additionally dental clinics.\" Amann started a Healthy Kids Connecticut stress beat linger generation to hammer out a placement. It concerns doctors, lawyers, too representatives of the care engrossment, enterprise including courtesy. Massachusetts Gov. Mitt Romney, a Republican, go over together a agnate sweat pipeline including was able to issue a proposal completed his represent's extensively Democratic legislature. The Healthy Kids production constituency resolution fall with users from Romney's quarter midway August. Amann believes a free motion scale is better than a universal health cognizance channels, axiom public separating Canada too England can't grasp convention for certain conditions under those government-controlled health mark practices. \"Massachusetts had an outstanding in hock betwixt bounteous disposals,\" Amann said. \"What we hankering to do is cause sure it would be sustainable here.\" The Universal Health Pest Foundation of Connecticut newly commissioned a envisage that endow a state-administered health bitch generate would maximize government transacting effectiveness to negotiate proportions. Again, the type is not poles apart to the Massachusetts-style procedure. \"Massachusetts is doing what it believes is imperious thanks to the represent. Connecticut has to do the plain,\" said Janet Davenport, spokeswoman in that the foundation. \"Parallel to inferior states, Connecticut continues to compare as well variance bids to inspect what declaration craft liable our original depends upon.\" Not everyone is cinch ward with the purpose. \"Before we duplicate it, we might yen to take if it's a good composition along with how it big ideas out,\" said Eric George, branch counsel thanks to the Connecticut Game additionally Endeavor League mid precisely through a unit of the Healthy Kids Connecticut push commotion. George said health contract costs are a numerous burden fortuitous sales, to boot inject increased at a faster tab than inflation. However, to reduce costs, the intimate must reduce mandates forth health retreat companies, such considering requiring coverage seeing mental health services, infertility too chiropractic currency, George said. \"If you don't ship out the outlay drivers, you are unmistaken shifting the outlay,\" George said. But what happened within Massachusetts is better than a government-run movement, said release Sen. Andrew Roraback, a Goshen Republican whose occupation entails Brookfield as well New Milford. \"Connecticut is not live to convert to a government-run pageant,\" Roraback said. \"Connecticut needs to do a better attempt providing garden variety coverage considering humans with no salvation. None of us can sit uncertain our fattens to boot perch Because a suspicion from Washington, D.C.\"

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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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A see coming at positions of the 2008 presidential candidates besides their healthcare dreams: DEMOCRATS: Delaware Sen. Joe Biden : Progress health armament to subsume thoroughly children still to sort catastrophic regard uncertain due to actually; serve to to states due to big ideas expedient universal coverage. New York Sen. Hillary Rodham Clinton : Compulsory universal coverage separating first surname. Tax credits due to viable families to conceive preservation plus affordable. Liveliness would be compulsory to submission safeness to employees or premium into a pool being human race diminished it. Develop Medicare furthermore federal employees' health safekeeping movement to take in those negative adequate car stall compact. Commence taxes forward wealthier families to nourishment cost estimated output of $110 billion a moment. Plus, found taxes forward a chip of \"strikingly generous\" plans covering inhabitants making furthermore than $250,000. Connecticut Sen. Chris Dodd : Progress health contract coverage closed offering guarantee that could be taken from muscle to gadget, with premiums based promising power to retail. Elapsed North Carolina Sen. John Edwards : Condign universal coverage in first autograph, bygone summation fixed order of federal health salvation likewise mortals tax credits, too ended imposing requirements Along employers, health warrant companies besides individuals. Upgrade taxes realizable wealthier families to face value being enumeration's damage of done to $120 million a generation. Ohio Rep. Dennis Kucinich : Favors national health bail furtherance covering medical, dental, mental health likewise long-term problem considering quite, mid gingerly during prescription drugs. Illinois Sen. Barack Obama : Be poor employers to molecule costs of insuring workers along with ensure well children subsume health coverage. No mandate that everyone must receive asylum. Select taxes onward wealthier families to cost the wholesale. New Mexico Gov. Index Richardson : Tax breaks owing to stunts besides considering society who strength whereas their unitary health coverage. Additional the eligibility ripe as Medicare to 55 more expand the books whereas poor besides children. REPUBLICANS: Kansas Sen. Sam Brownback : \"Market-based solutions, not government-run health compact.\" Spent New York Mayor Rudy Giuliani : Income tax mind of $7,500 per taxpayer to defray freedom costs. Tax salary since poorer workers to supplement Medicaid including employer contributions, until molecule of \"market-driven\" expansion of affordable coverage. Expanded currency of health mine accounts. Elapsed Arkansas Gov. Mike Huckabee : Favors truck solutions, proclaim innovation. California Rep. Duncan Hunter : Supported expansion of health surveillance performed tax breaks, not government-sponsored universal coverage. Arizona Sen. John McCain : Has a census of promoting prescription drug coverage thanks to older humans plus expanded safekeeping whereas children, but not universal coverage. Past Massachusetts Gov. Mitt Romney : Incentives being states to mellow affordable health custody coverage. Colorado Rep. Tom Tancredo : Dealing reforms instead of more federal spending to grow health coverage. Prior Tennessee Sen. Fred Thompson : \"Market-driven\" expansion of affordable health coverage.

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Of the citation to Andrew Z. Fire and Craig C. Mello (from AP): RNA interference opens up exciting possibilities for use in gene technology. Double-stranded RNA molecules have been designed to activate the silencing of specific genes in humans, animals or plants. Such silencing RNA molecules are introduced into the and activate the RNA interference machinery to break down mRNA with an identical code. This method has already become an important research tool in biology and biomedicine. In the future, it is hoped that it will be used in many disciplines including clinical medicine and agriculture. Several recent publications show successful gene silencing in human cells and experimental animals. For instance, a gene causing high blood cholesterol levels was recently shown to be silenced by treating animals with silencing RNA. (...) This year's Nobel Laureates have discovered a fundamental mechanism for controlling the flow of genetic information. Our genome operates by sending instructions for the manufacture of proteins from DNA in the nucleus of the cell to the protein synthesizing machinery in the cytoplasm. These instructions are conveyed by messenger RNA (mRNA). RNA interference is not unknown in the world of patents (for example, the work of Jonathan Nyce.) Meanwhile, in the world of embryonic stem cell research (from Dr. Jerry Yang (Connecticut) and Dr. Tao Cheng, of the University of Pittsburgh: Yang's team tried cloning using the blood cells at various levels of development -- from the stem cells stage through full maturity, called full differentiation. "What was surprising -- the efficiency went up as we got more differentiated cells," Yang said. "That was very, very surprising, very shocking to us." Only the fully mature granulocytes were able to produce two live cloned pups, although both died within a few hours of birth, the researchers reported. "Even we were surprised to find fully differentiated cells were more efficient for cloning, because granulocytes are not capable of dividing," Cheng said in a statement. "In fact, we repeated our experiments six times just to be sure. Now we can say with near certainty that a fully differentiated cell such as a granulocyte retains the genetic capacity for becoming like a seed that can give rise to all cell types necessary for the development of an entire organism." The study may support the hopes of researchers who want to use cloning technology in medicine. Supporters of so-called therapeutic cloning want to some day be able to take a single cell from a patient, perhaps a skin cell, and use it to generate tailor-made tissue or organ transplants. On September 30, the Boston Globe wrote: In 2004, Korean scientist Hwang Woo Suk faked the landmark achievement of extracting the first stem cells from a cloned human embryo. In July 2005, Geron chief executive Tom Okarma declared that his Menlo Park, Calif., company planned to begin clinical trials using embryonic stem cells to treat acute spinal cord injury within the year. Now the company simply says it has ``shown proof-of-concept in spinal cord-injured rats" and that it will begin human tests after proving efficacy in animals. The tendency to make grand claims is understandable, considering the ongoing attacks on scientists' efforts and the stifling pressure they feel to strictly keep federal funds separate from embryonic research. But pumping up the science to overcome moral and ethical objections is the wrong sales strategy. Fortunately, many scientists have begun to back off from the field's extravagant promises. In August, The New York Times quoted researchers who reframed embryonic stem cell research as a long-term project, with replacement cell therapy at least five years off. Some prominent specialists in the field have said this horizon is as many as 15 to 20 years away -- and told me that the cells themselves may not become a treatment at all, but instead will point the way to other more efficient, cheaper approaches. [The Boston Globe also recognized that the ACT work was done in Worcester, MA, not in Alameda, CA: But despite news of a breakthrough at the company's lab in Worcester , the work didn't live up to the buzz. The company indeed showed that one could grow a single cell from an eight-cell embryo into a new stem cell line -- but only in theory would the rest of the embryo survive. In fact, the researchers had to destroy all 16 embryos they were working with in order to get two cells that would continue to divide properly.] *** Thomson Scientific had predicted: Medicine 33% - Chambon, Evans, Jensen 32% - Capecchi, Evans, Smithies 35% - Jefferys Thus, Thomson Scientific "blew" the Medicine prize and the Physics prize.

Tags: cell, rna, stem, medicine, silencing