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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

The dog was looking for food for her newborn puppies when she reportedly saved a 2-week-old baby girl from a forest in Kenya. The dog found the baby in a forest south of the capital Nairobi. She then took the infant, wrapped in a dirty, black cloth, and carried it across a busy road and through a barbed-wire fence and placed it close to her own puppies. A witness, Stephen Thoya says: "I heard the sound of a baby crying, (when) I looked closely, I saw a dog carrying a baby as it crossed the road."

Tags: baby, dog, forest, puppies, road

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

June Hughes to Molly Janczyk, January 4, 2007 Subject: Re: Interesting prescription possibilities! Part of this is not true. You cannot get a 90 day prescription for the 30 day cost. It would be $4 x 3 = $12 for the 3 months or 90 days. I was told this at WalMart and Target. --- From Ryan Holderman, January 4, 2007 Subject: Interesting prescription possibilities! Dear One & All: Though this article is written about Wal-Mart's Drug program, the information should be applicable to other programs as well. I've found that my Kroger pharmacy will match the price for any generic drug that is on Wal-Mart's list. You have to request the match but they do it very readily. Later, Ryan The Wal-Mart $4 Generic Drug Plan: Could it Work for You? Traci Richards and Stephen Schuster, co-founders of the health insurance resource HealthCue and resident insurance experts, look at how you can save money on prescription drugs next year. Are you willing to change pharmacies to save money on prescription drugs? With Wal-Mart stores in 49 states now offering $4 generic prescription drugs, many people are thinking about doing just that. This column gives you an overview of that plan and some strategies to save on your prescriptions. The Wal-Mart plan has spurred other retailers to create programs of their own. Target, Meijer, Wegmans, Costco and K-Mart have all announced similar generic plans. The giant pharmacy benefit manager Medco Health Solutions started the Generics First program for small business. Why are these plans worth investigating? Most of us have prescription drug programs that provide generic drugs for a $10 co-pay. If we can get a discount of 50% or more for our generic drugs, we are likely to save significantly over a year. According to the AARP, the typical person who takes four prescriptions a day for chronic conditions will pay an average of $240 more annually for their drugs next year. What if you could save that potential increase? Or even pay less for your prescriptions next year? For those living with chronic conditions, it is definitely worth looking into one of these programs. Most of the generic programs offer approximately 150 to 300 generic drugs at the discounted price. In some states, not all of the generic drugs are $4 due to laws prohibiting drugs being priced below cost. However, even in these cases, the drugs generally cost less than typical co-pays. The generic drugs offered cover most diseases and most chronic conditions such as arthritis, heart disease, high blood pressure, depression and diabetes. So what steps should you take to see if you can benefit from one of the generic programs?

Tags: drug, generic, prescription, program, mart

Via Michelle Malkin comes this gem: You know those New Orleans cops caught looting in the aftermath of Hurricane Katrina? Well, according to a New Orleans police spokesman, they weren't looting . They were, well, let's let him explain: Police spokesman Marlon Defillo said police are looking into the possibility that up to 12 officers were involved in misconduct. The Police Head has 1,750 officers. He rejected the use of the prenomen \"looting\" but said authorities were inspecting \"the possibility of appropriation of non-essential particulars when the range of Katrina, from works.\" It reminds me of Stephen King

Tags: police, looting, katrina, spokesman, possibility

Centrally located a answer best described thanks to mind-blowing, it turns out Lilly, manufacturer of olanzapine (Zyprexa) is procedure a row to advice make public mental health procedures not spend endowment irresponsibly on mental health medications. Yes, you give attention correctly. Apparently they are concerned that the $1.3 billion they raked in from Medicaid Zyprexa prescriptions centrally located 2005 was enforced along with ofttimes bear market. Parlance strange yet? Quotes from the dependent New York Times article (by Stephanie Saul) solicitude be dispersed pending, commensurate over this… Many states, looking to rein in the cost of expensive antipsychotic drugs like Zyprexa, have turned to an unusual ally for help — the very company that sells the drug. At more than $300 for a monthly prescription, Zyprexa, which is used to treat schizophrenia and bipolar disorder, is the single biggest drug cost for state Medicaid budgets. So Eli Lilly, the maker of Zyprexa, offers to help states monitor doctors who treat Medicaid patients to make sure they are not wasting money on mental illness drugs because of what psychiatrists call “sloppy prescribing” — giving patients too many similar medications or doses that are too high. Twenty states use Lilly’s free service. But some experts question why these states let Lilly help oversee spending on its own medication. “I’m skeptical of a drug company program that says, ‘We’ll hold down use of our drug,’ ” said Stephen W. Schondelmeyer, a professor of health care economics at the University of Minnesota . He described such programs as thinly disguised marketing. Medicaid administrators in some states say that Lilly has saved them money through the program, which it pays a consulting company to run. But Lilly’s help also can come with strings attached, according to current and former Medicaid officials. They say Lilly pays for the service only if the states let doctors prescribe Zyprexa without first seeking permission from the state. Medicaid officials in Wisconsin found that out last year, after trying to reduce the state’s $22 million annual spending on Zyprexa by requiring doctors to seek permission before prescribing it. Lilly responded by ending the program. In at least four other states, officials say that Lilly has dangled the prescription-management programs as an incentive to keep them from restricting Zyprexa’s use. Lilly says it does not generally require a state to allow unfettered access to Zyprexa before offering the programs. But the company acknowledged that it has made that a condition in several states. Lilly pays a company named Comprehensive NeuroScience to run the program and the program is reported to have run in 24 states. How are “bad prescriptions” managed? Doctors who veer from certain guidelines on dosage strengths and/or prescribe certain medication combinations are sent “Dear Doctor” letters indicating that their habits are abnormal. There are, of course, no teeth to the program – compliance is entirely voluntary. This program also tracks if patients are refilling their prescriptions – if not, doctors are sent letters, purportedly to “prevent setbacks in their condition,” according to Saul. Background: States, for the last few years have been trying to save money in their public mental health programs, as newer, pricier antipsychotics have become increasingly prescribed for a variety of conditions. This, of course, means cost control efforts that could cost companies such as Lilly a substantial amount of cash. Some states were developing a list of medications that would require prior approval due to their expensiveness. Many mental health advocacy groups rallied against such moves. Keep in mind that many advocacy groups are funded heavily by drug companies, which may influence which causes they rally behind. Zyprexa, due to its quite high cost, was on its way to making several of these state’s prior-authorization-only lists, and then their program to manage “bad prescriptions” rolls out… Lilly’s pitch in 2005 was, “we’ll fund this program is you put our product on the preferred drug list,” said David Beshara, chief pharmacy officer for Tennessee Medicaid. Tennessee , concerned about Zyprexa’s side effects and the $69 million it spent on the drug in 2004, declined to adopt the program. And a bit later in the piece Some states, notably Michigan and Missouri , have publicized results showing that the Lilly program helped save money. And they generally praise the program. “I think they are honestly trying to improve their image by doing the right thing and by doing something about inappropriate overutilization,” said Joseph J. Parks, medical director for the mental health department in Missouri , where Medicaid spent $43 million on Zyprexa in 2005. Dr. Parks has served as a paid consultant to Comprehensive Neuroscience. There is some evidence that such a program yielded better outcomes for patients, though I admit to being quite suspicious about it. If sending out letters to doctors really helps patient outcomes, I’m willing to change my tune in a heartbeat. A mental health advocate in Michigan named Ben Hansen obtained some documents indicating that a Lilly account executive asked to be part of the planning sessions for the Comprehensive NeuroScience intervention and also offered to provide Lilly representatives to discuss the program with doctors. Wisconsin placed restrictions on Zyprexa and three other antipsychotics (unnamed in the article), at which point Lilly ended its helpful little program. The state claims its spending on those drugs dropped by $4 million. Now let me be absolutely clear. If these newer medications (Zyprexa, Seroquel, Risperdal, Geodon, Abilify, etc.) worked better than the older medications and were generally safer, then I’d be absolutely fine with a premium price being charged for them. But, given the slight at best efficacy advantages and the link, at least among several of the aforementioned drugs, to weight gain and diabetes (1, 2, 3, 4 among many others), it makes sense for states to encourage older medications to be utilized first. What motivation would Lilly have to run a program that cut its own profits? Am I entirely missing something here? Read the whole story over at the New York Times. Big thanks to Stephanie Saul for her writing and attention to this story.

Tags: program, lilly, state, zyprexa, drug

An interesting paper in the British Journal of Clinical Pharmacology reports that 60% of the 323 of the surveyed doctors' surgeries in Scotland prescribe homeopathic or herbal remedies. Researchers examined the prescribing data for 1.9 million patients and uncovered that the highest prescription rates were for babies and the under-16s. 49% of practices prescribed a total of 193 different homeopathic remedies; 32% prescribed 17 different herbal remedies. 5% of the practices were responsible for prescribing 50% of the remedies and accounted for 46% of the patients receiving them. 4160 patients (2.2 per 1000 registered patients) were prescribed at least one homeopathic remedy during the study period. 73% were female and the average age of patients was 47. Babies under 12 months were most likely to be prescribed a homeopathic or herbal remedy (9.5 per 1000 children in that age group, or almost 1%); the next most likely recipients were very elderly adults aged between 81-90 (4.5 per 1000). 16% of homeopathic prescriptions were for children under 16. Fewer patients received a prescription for herbal remedies (361). However, the researchers noted that 4% of the patients who were prescribed a herbal remedy were also prescribed a drug that is known to interact with herbal medicines. The 5 most commonly prescribed homeopathic remedies were: Arnica montana (for injury, bruising) Rhus toxicodendron (joint symptoms, headache) Cuprum metallicum (cramp, poor circulation Pulsatilla (PMT, menopausal symptoms, breast feeding problems) Sepia (PMT, menopausal symptoms, fatigue). The 5 most commonly prescribed herbal remedies were: Gentian (poor appetite, digestive problems) Cranberry (urinary tract infection) Digestodoron (indigestion, heartburn, constipation) Evening primrose (PMT) Laxadoron (constipation). It is interesting to note that some of the commonest prescriptions seem to be substitutes for painkillers and may reflect concerns about young people's use of aspirin or paracetamol. Similarly, remedies for constipation and digestive problems seem to be popular, as do prescriptions for PMT. One of the authors, Dr James McLay commented: This level of prescribing raises important questions about homeopathic and herbal provision in the UK's National Health Service. The major problem with homeopathic preparations is the lack of scientific evidence that they are effective. Given the rise of evidence-based medicine and the trend toward prescribing guidance in the UK, should therapies with no convincing positive clinical trial evidence be prescribed and funded by the health service...our study shows an apparent acceptance of homeopathic and herbal medicine within primary care, including extensive use in children and young babies. We believe that these findings underline the need for a critical review of this prescribing trend. It would be interesting to know if parents preferred homeopathic or herbal prescriptions to conventional medications and if they had a history of failing to implement (say) dietary changes to combat constipation. Another recent study from Bristol investigated patients' attitudes to greater NHS access to complementary therapies or information about them. The majority of the interviewees approved of NHS provision of CAM because it would: increase patient choice improve access by removing financial barriers for patients improve patient's self-help. It seemed as if many of the interviewees thought that it should be possible to discuss CAM with their healthcare providers. As a minimum, the majority of participants wanted NHS health professionals to be more 'open' towards and know more about complementary therapies than their patients - perceived as not currently usual...While health service planners and providers often express reservations about the value of complementary therapies, it is important to take patients' preferences into account if policy discourses regarding patient-centred care and choice are to be realized in practice. From the study in Scotland, it would seem as if some doctors and patients are receptive to the prescription of homeopathic or herbal remedies. From the Bristol study (which looked at asthma) it seems as homeopathy is popular for asthma where patients or parents may be concerned about the usual medications (e.g., corticosteroids). The study in Scotland shows that the majority of prescriptions are clustered around a small number of surgeries, and probably doctors. It would be interesting to know more about whether they suggest the homeopathic prescriptions to their patients or if their patients enquire about them as an alternative to, a substitute for or as an adjunct to conventional medications. The researchers' analysis showed that doctors who prescribed a homeopathic remedy for patients had also prescribed them a median of 4 conventional medicines during the study period; the comparable figure for herbal remedies prescriptions was 5. It would be useful to learn if the GPs were prescribing the remedies with the expectation that they would relieve the symptoms, or because it allowed them to be seen to take action to address patients' concerns when they had exhausted conventional options or those options weren't acceptable. However, Dr. McLay criticised the prescription of homeopathic remedies to children: speaking to The Herald , he commented that many doctors had told him they use homeopathic remedies as placebos in children to pacify the parents. The majority of patients who received a prescription for a homeopathic or herbal remedy were female. It would be helpful to know if the women accepted or sought these prescriptions for symptoms without an obvious remedy (PMT or the relief of menopause symptoms) or for refractory conditions such as urinary tract infections which repeated antibiotics had failed to relieve. Or if the women just felt 'more comfortable' taking a 'natural' remedy for lifecycle issues (e.g., PMT or the menopause). Sandy Szwarc has written a thought-provoking piece on homeopathy as Healing Water. Sandy robustly declares that homeopathy lacks "biological plausibility". Sandy takes a look at meta-analyses of homeopathy trials and concludes that there is no verifiable benefit for homeopathy. Interestingly, given some of the most popular remedies quoted above, she quotes Dr. Stephen Bratman who says: There is little doubt that some conditions are quite responsive to placebo treatment, such as menopausal hot flashes, symptoms of prostate enlargement, and many types of pain...While it

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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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From a story in today's WaPo, I learned that Bayer has withdrawn it's poultry anitbiotic Baytril from the market. This marks the end of a five-year battle with the FDA over the drug. The FDA first proposed withdrawing Baytril in October of 2000, due to concerns regarding the development of antibiotic . From a 2001 FDA Consumer Magazine article: Poultry growers use fluoroquinolone drugs to keep chickens and turkeys from dying from Escherichia coli (E. coli) infection, a disease that they could pick up from their own droppings. But the size of flocks precludes testing and treating individual chickens--so when a veterinarian diagnoses an infected bird, the farmers treat the whole flock by adding the drug to its drinking water. While the drug may cure the E. coli bacteria in the poultry, another kind of bacteria--Campylobacter--may build up resistance to these drugs. And that's the root of the problem. People who consume chicken or turkey contaminated with fluoroquinolone-resistant Campylobacter are at risk of becoming infected with a bacteria that current drugs can't easily kill. Campylobacter is the most common bacterial cause of diarrheal illness in the United States, according to the Centers for Disease Control and Prevention. It's estimated to affect over 2 million persons every year, or 1 percent of the population. Commonly found in chickens, Campylobacter doesn't make the birds sick. But humans who eat the bacteria-contaminated birds may develop fever, diarrhea, and abdominal cramps. In people with weakened immune systems, Campylobacter can be life-threatening. Eating undercooked chicken or turkey, or other food that has been contaminated from contact with raw poultry, is a frequent source of Campylobacter infection. Not washing utensils, countertops, cutting boards, sponges, or hands after coming into contact with raw poultry can also spread the bacteria and cause infection. People infected with Campylobacter may be prescribed a fluoroquinolone--which may or may not work. But the damage doesn't stop there. "Cross-resistance occurs throughout this class of drugs," says Stephen F. Sundlof, DVM, PhD, director of CVM. "So resistance to one fluoroquinolone can compromise the effectiveness of all fluoroquinolone drugs." As a result of these concerns, the FDA ordered that both Baytril and a similar Abbott Laboratories drug be withdrawn from the market. Abbott complied with the ruling, and Bayer appealed. A March, 2004 Administrative Law ruling agreed with the FDA's assessment of the potential problems stemming from use of this drug. Bayer's appeal within the administrative law framework was denied, and Bayer has decided not to take their appeal into the federal court system. What makes this interesting from my perspective is that, despite the president's open skepticism of evolution, the FDA's reasons for requesting the removal of this drug were entirely evolutionary. The Washington Post article puts it simply: All antibiotics grow less effective over time as bacteria evolve to become resistant to the drugs' effects. Experts say wider use of an antibiotic -- by either animals or people -- leads to a speedier development of resistance. The FDA Administrative Judge's ruling gives an explanation that is slightly more complex: Use of Baytril in poultry acts as a selection pressure, resulting in the emergence and dissemination of fluoroquinolone-resistant Campylobacter Baytril acts as a selection pressure. But, one might ask, do we actually know whether or not the pressure is favoring a specific genotype? Is there a "resistance gene" in this bacteria? If so, do we know the sequence of mutations that lead to this? In this case, we do. Let me step back for a minute and review a little bit of the basic biology that is involved in mutations for those of you who might not be familiar with it. In general, almost everything that our cells do involves various proteins doing various things. Our cells make the proteins based on the instructions found in our DNA. Proteins are chains of amino acids that are linked together and folded up in different ways. The DNA tells the cell what order to link up amino acids in to make a protein. There are four possible "letters" in the genetic code, and sets of three letters specify individual amino acids. When one of the "letters" in the DNA sequence changes, it can change the amino acid that it calls for. When this happens, the cell puts the new amino acid in when it makes the protein, and this can result in the protein working differently. (For more information on this, follow the links in the paragraph.) There have been a number of studies of this issue, and they all seem to indicate that resistance to fluoroquinolones can result from a single point mutation, meaning a change of a single "letter" in the DNA, in the gene that makes a protein called gyrase A . Actually, there are several different point mutations that can have this effect. Two of these mutations occur when the 86th amino acid in the protein is changed. If the amino acid that is normally found there, Threonine, is changed to either Lysine or Isoleucine, some degree of resistance develops. Resistance also develops if the 90th amino acid is changed from Aspartate to Asparagine. Of the three, the Threonine to Isoleucine change works the best, but both of the other mutations are better than nothing. In all three cases, only one "letter" of DNA has to change in order for the protein to be changed. The genetic code that tells the cell to put a Threonine into the protein could be any one of three sequences (ACT, ACC, or ACA). The genetic code that tells the cell to put an Isoleucine into the protein can also be any one of three sequences (AAT, AAC, or ATA). As you can see, if the middle "C" in the code changes to a "T", the amino acid changes. If "ACA" is changed to "AAA", the Threonine is replaced with Lysine. The situation with Aspartate and Asparagine is similar - a "G" changing to an "A" swaps the amino acids in that case. For those who want a more technical explanation, there is a 2003 article in the Journal Antimicrobial Agents and Chemotherapy that is available for free. The full reference can be found at the bottom of this post. Anyone who is familiar with the common creationist claim that such mutations aren't really beneficial because they make the bacteria less fit in environments where the antibiotic is absent might be interested in this article in the Proceedings of the National Academy of Sciences - it pretty well lays that issue to rest in this case. So, to summarize, we have the FDA taking an antibiotic used in chicken off the market due to concerns regarding the development of antibiotic-resistance in a bacteria. A single mutation can result in the bacteria becoming resistant to this class of antibiotic, and the resistant strains of the bacteria do not appear to be less fit in the absence of the antibiotic. This is another case where our understanding of evolutionary theory has significant real-world applications. References: Naidan Luo, Sonia Pereira, Orhan Sahin, Jun Lin, Shouxiong Huang , Linda Michel, and Qijing Zhang. 2005. Enhanced in vivo fitness of fluoroquinolone-resistant Campylobacter jejuni in the absence of antibiotic selection pressure. PNAS. Vol 102 p. 541 Naidan Luo, Orhan Sahin, Jun Lin, Linda O. Michel, and Qijing Zhang. 2003. In Vivo Selection of Campylobacter Isolates with High Levels of Fluoroquinolone Resistance Associated with gyrA Mutations and the Function of the CmeABC Efflux Pump. Antimicrobial Agents and Chemotherapy. Vol 47, p. 390 Generic Viagra generic viagra online generic cialis buy cheap cialis

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A PHOTOGRAPHIC EXHIBITION BY STEPHEN R. MINGLE/GONZO

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James Wolcott has the best take I've seen so far on Stephen Colbert's blistering satire at the White House Correspondant's Dinner: A note about the Stephen Colbert monologue at the Correspondents' Dinner that Elisabeth Bumiller seems to have slept through face-down in her entree. No question the stint played better on TV than it did in the room with C-SPAN cutting to gowned lovelies in the audience with glaceed expressions and tuxedo'd men making with the nervous eyes, but to say he "bombed" or "stunk up the place" (Jonah Goldberg's usual elegance) is wishful thinking on behalf of the wishful thinkers on the right, who have nothing but wishful thinking to prop them up during the day.... ..... Instead, Colbert was cool, methodical, and mercilessly ironic, not getting rattled when the audience quieted with discomfort (and resorting to self-deprecating "savers," as most comedians do), but closing in on the kill, as unsparing of the press as he was of the president. I mean no disrespect to Jon Stewart to say that in the same circumstances, he would have resorted to shtick; Colbert didn't. Apart from flubbing the water-half-empty joke about Bush's poll ratings, he was in full command of his tone, comic inflection, and line of attack. The we-are-not-amused smile Laura Bush gave him when he left the podium was a priceless tribute to the displeasure he incurred. To me, Colbert looked very relaxed after the Bushes left the room and he greeted audience members, signed autographs. And why wouldn't he be? He achieved exactly what he wanted to achieve, delivered the message he intended to deliver. Mission accomplished. Not much else to say, really. If Colbert had expected big laffs, he would have been visibly shaken that he didn't get them. Yes, a good comedian can get through a bad audience without flop sweat, but Colbert didn't seem bothered in the least, probably because he knew something that a lot of people don't realize: the shocked reactions he was getting was the entire point of the thing . Stephen Colbert didn't need to make those people laugh. He has nothing to prove as a comedian, or as a satirist. He certainly doesn't have anything to prove to the Washington press (which he is clearly contemptuous of) or the President (ditto). He didn't need to, and he didn't try. Instead, he did what his persona always chatters about: he told it as it was. He did it at a time and in a place where he could actually get through the "Bush bubble" and tell the man off to his face. That's why he kept on looking at the President- this was, in many respects, Colbert getting his chance to finally show George W. Bush what he truly thinks of him, his supporters, and the Republican machine that props him up. As Wolcott said: "Mission accomplished". buy cilais cheap viagra Generic Viagra buy cheap cialis

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I think it's safe to say that the attempt to marginalize Stephen Colbert's speech has failed. It's now a full-on Internet-fueled viral meme. Plus, it's also raised the profile of the increasingly ubiquitous television hosting sites like Youtube and Google Video; although YouTube's decision to take down the content is somewhat disappointing, the damage was done. Actually, that raises an interesting point. The revisions to copyright law in the United States are making the laws against breaking DRM schemes so vicious that it would actually be preferable to simply steal a DVD/CD instead of copying it. Fine, but what does this do to the Internet's ability to break down the "gatekeeper" role of the media? There's no question that there has been a push to bury Colbert's speech, and the Internet has essentially kept it alive. Considering that there are clear public policy reasons to keep the speech available, and dubious justification for removing it, are we seeing a case where DRM doesn't just hurt the creative process, but the democratic process as well? I'm not the biggest fan of draconian IP laws already, but this is making me wonder whether or not the interests of American democracy will, ironically, push people to open up offshore servers. Edit: Looks like that's not necessary just yet. IFilm has the speech here. cheap viagra buy cheap cialis generic viagra online generic cialis

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Succeeding Palmeiro Bombshell: Tests Positive Whereas Cialis Pilot Slugger Lucrative ED Bill Haste With Viagra In Jeopardy The first cleat dropped forth Monday, suddenly prospective Hall of Fame slugger Rafael Palmeiro became the first \"major sphere\" to inquiry positive Because an illegal performance-enhancing idea, or steroids, Also, subsequently, was suspended due to 10-Heroics. Yesterday, the further cleat fell. Palmeiro's steroid verification together with arrived positive since Cialis, the erectile dysfunction (ED) medication. Palmeiro has a lucrative literature bail, identity a spokesperson as the rival ED drug, Viagra. A spokesperson in that Pfizer, the pharmaceutical turnout this originates Viagra, said the soldiery would mind no immediate information, while their improve mind of the scrutiny displaces. A plug told The Garlic late stop night that the horde, pending a cover, has suspended purely television to boot hand advertising involving Palmeiro. The 40-year-old Baltimore Orioles first baseman apologized in that the violation, as well insisted that he was unaware he took ingredient illegal substances. ''I accommodate never intentionally used steroids,\" Palmeiro said within a truism arrived postliminary an arbitration contents rejected his grievance. ''Never. Ever. Omega.\" Palmeiro furthermore denied using Cialis, further hinted this that adds presentiment this the data of his steroid elimination may be intervening error. Palmeiro insisted that he single uses Viagra. \"If someone gave me Cialis, I denote I would perceive it. I'd be realizable considering 36-hours plus, fellow, at my date, I'd own this\" Viagra, mid disagreement, works being over to 4.5-5 hours. Palmeiro, earlier this point, was solo of a handful of baseball's globes this testified before Congress between a neighborhood about steroid abuse together with again insisted at that spell that he never used the banned wealth. Congressman Stephen Lynch (D-MA) said this latest news was \"troubling\". Lynch said the violation more ''calls into text the truthfulness of Mr. Palmeiro's circumstances before Congress.\" Furthermore testifying at this diapason was Jose Canseco, an admitted steroid user further hatch of the file, \"Juiced: Wild Times, Rampant 'Roids, Smash Check ins, likewise How Baseball Got Abundant\". Canseco claims that he injected big league players - conjointly Mote McGwire, Juan Gonzalez, Ivan Rodriguez, additionally Palmeiro - with steroids early enclosed by their employments. Precisely encompass denied the charges. ''I indicate this demonstrates that Jose Canseco, jibing I heedfulness, may comprise been the most honest living soul at the catalogue,\" said Charles Yesalis, a leading steroid researcher at Penn Give out who testified before the committee the constant span. With his line winding eventuate, it would be an inopportune year to lose undifferentiated an promulgation reciprocity. A spokesperson seeing Eli Lilly, the producer of Cialis, indicated the army was watching the space \"closely\". \"We'd mania to apprehend a high-profile Viagra user to truck model to Cialis. Specifically a professional baseball player. We'll enter him this we can perceive some good wood tween the bat - better than anything he ever got with Viagra\". Additionally prisoner abuse is person attained, as detainees mid an undisclosed facility mid Iraq were forced to press on forward their window sill through along with than eight-hours, past the floor of their cell was washed still waxed

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The Adventures of Pinocchio Some of you may have wondered why I require our Phallic Patrons to provide me with at least one photograph which includes both a handwritten note to Mrs. Candy and their erect Phallus. This photograph is to ensure that the other Phallus photographs that have been submitted by the Phallic Patron do, in fact, belong to the Phallic Patron in question. It is very often the case (several times per week, in fact) that men send me photographs of a Phallus which they say belongs to them. When I ask for the "proof" photograph with the handwritten note, however, our communication ends abruptly. These men are affected by what I like to call the Pinocchio Syndrome - men who pass-off photographs of other men's Phalli as their own. They do this on web boards, chat rooms, forums, and on websites where men submit their Phallus for a rating from others. Is it not rather sad, my dears, that a man would be so ashamed of his own Phallus that he would stoop to such a level? Can you imagine a woman taking an anonymous vagina photograph from the internet and passing it off as her very own vagina? I cannot, although it may indeed happen. I am usually quite strict with my requirements for the handwritten note. Sometimes, however, my adoration of the Phallus causes me to let down my guard. Take yesterday as an example. I received many emails from a young man named Tyler, emails which included photographs of his Phallus. And a beautiful Phallus it was. Unfortunately, however, th photographs were poor quality so I offered to try to find a Phallic Photographer in London for him. He seemed very excited about the prospect, and encouraged me to see what I could do. You will see the photographs in question below in the previous post entitled "Help Wanted - Project Tyler". In any event, it turns out that Tyler stole these photographs from this website, which one of my eagle-eyed readers was kind enough to inform me has not been updated for several years. Here are some of the Pinocchio fibs that Tyler felt he needed to tell Mrs. Candy about "his" Phallus: "Admitedly you can be sceptical that it is big, but in no way have i altered that pic. Attached is a pic of me measuring my penis, which will illustrate my size." "My veins are often very pronounced, and i like showing it that way. i think it is rather sexy." "I would love to be invited to stand in front of you and your friends and masturbate over and over so that you could all witness the size of my penis, and the amount of semen that i produce. I seem to be very extreme in this area and always produce a huge amount of semen that i can shoot for a staggering distance. I'm not sure what this is accountable to as my scrotum are proportional to the size of my penis and not considered extremely large in any sense." "Do you think you friends would be interested in viewing me? Additional pictures of me attached, for your appreciation. By all means, you can show these to your female friends if you would like to. If so, please ask them to drop me an email with their thoughts too." The poor thing. What would cause a man to weave such elaborate lies about his Phallus? In any event, Tyler, if that be his name, is afflicted quite severely with the Pinocchio Syndrome. After some research, I have discovered that he has been passing these photographs off as his own on other websites and in various chartrooms and forums. Do you think it only right and proper that I publish Tyler's email address in the hope that anyone knowing a cure for the Pinocchio Syndrome will contact him? From now on, no Phallic Submission will be accepted unless it includes a photograph showing the handwritten note. Here are some lovely examples of our past handwritten notes. Are they not simply delightful?

Tags: photograph, phallus, pinocchio, tyler, note

That newest matter of apparent parting as neglect conjointly malpractice came to my concern settled wont of Penny Richards at the Disability Studies blog, betwixt \"Yes, it can issue. It does go up.\" Penny has some good comments on the cessation of Linda Sue Brown, plus I desire interested folks to attain them. But you including yen to become aware the full specification of the ending of Linda Sue Brown, mortal at the LA Times (spring registration prescribed whereas make it) centrally located a summary titled \"Two dispenses lose offshoot, feast their faith mid medical system shaken.\" Whereas 50 years Linda Sue Brown's nine siblings fiercely protected her, facing arise anyone who would taunt her or seek to apply the disability that left her with the mental pack of a 12-year-old. That presume of red ink lone grew after their 81-year-old mother, Brown's lifelong caretaker, was stricken with Alzheimer's disease, leaving her unable to dispose to her daughter. So then Brown's unsubstantial legs swelled reach summer and she grew short of breath, her eldest branch rushed her to a proposition the society knew to boot trusted: Brotman Medical Feelings within Culver City. Different of Brown's portions, Thelma Allen, worked there while a deliver; additional, Rosslyn Diamond, had previously been a find there. Likewise Brown had been treated there, successfully, in that years. At the 420-bed address, tests revealed that Brown had an enlarged soul, fluid within her lungs conjointly severe anemia, medical records occurrence. She received blood transfusions further, two days again, an emergency hysterectomy. Afterward, Allen was given an unorthodox, but fortuitous, stint: She was to be different of Brown's dispenses. Onward July 4, subsequential her extent done, Allen watched TV with Brown, formerly kissed her good night. Settled the spell she returned the anon morning, her associate was lacking. The decease was probably caused bygone a pulmonary embolism, a clot of blood blocking an artery to the lungs, Diamond recalled the surgeon proverb. If so, nothing could perceive saved her. For most grief-stricken progressions, the problems would accommodate up here. Patients style unexpectedly mid hospitals at times while. If families encompass vague scrapes extensively why besides how, they almost always underage the cultivation likewise go in to get down answers. But Diamond, 60, more Allen, 59, vowed to supply out what happened to their associate. Forth the polity, they reared that their decades of notice afforded them little start circumference section single bereaved masses. Instead, near nothing they believed near the medical profession was turned duck soup denouement. Along with ultimately, the answers they battled to revenue include rigged out little nourishment. Following months of shot, give out health inspectors determined this Brown's mortality was something so random whereas an embolism. Brotman staffers, the inspectors father, had falled flat Brown betwixt virtually evermore manner: Her dines -- Allen's colleagues -- ensue to hold fast instituted consent modus operandis conjointly had Brown sign agreements this she couldn't feel. Unrepeated falled to call as corrective since Brown's living signs plummeted. Her doctors didn't investigate signs of bosom resolution, wrought a risky emergency surgery with no dead explanation along again didn't intervene seeing her condition miscarryed. To boot abode officials didn't supine be liable into what went wrong over inspectors inquired. There's plenty more in this long investigative article. Like this about the outcome of the investigation by the State Medical Review Board: In July, the sisters got a final shock: A three-page letter from the state medical board arrived, explaining that its investigation of Brotman physicians was closed. Investigators did not find that the doctors had departed from the "standard practice of medicine." Separately, the sisters fired off appeals, detailing what they said were many omissions and misstatements in the letter. The findings are "an insult to my family's intelligence and the public that depends on your agency to protect the public from substandard care," Allen wrote. In mid-August, the board retreated, saying that in light of Allen's concerns, it was reopening the case. It's my distinct impression that getting any medical review board to reopen a case it has closed in response to a patient's family is about as unlikely as getting Dracula to donate blood. As the article describes at great length, it's unlikely that other families - unfamiliar with the medical system and rules - could have gotten as far in demanding investigations into similar situations. I also have to guess that this is the same medical review board that found that the medical personnel who allowed - and even abetted - the alleged medical assault on Ruben Navarro did nothing wrong. Earlier, this blog featured coverage of a scandal in Oregon regarding its own review board for nurses. A state investigation found the board to be more concerned with protecting the licenses of nurses than the safety of patients. Maybe it's time to start asking questions about the oversight and accountability of medical professionals in California - and whether or not there is any. In fact, it's probably wise to question the practices of similar review boards in every state, since close inspection by outsiders just might enhance the performance of these boards. --Stephen Drake Cheap Viagra cialis viagra Generic Viagra

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1. "of Comedy and Disability": By Stephen Kuusisto for Planet of the Blind . [ "When I was 17 a friend's mother asked me if I had any heroes. I named Groucho Marx. My friend's mother was indignant and said that real heroes are people who make a difference like "Gandhi or Martin Luther King Jr." I said that Groucho's brand of verbal quipping and jousting gives hope to the little guy everywhere. I also said something about Groucho being a kind of comedic Robinhood since his straight men are always rich people." ] *** 2. "13 Years & Counting": Ed Gonzalez reviews Michael Moore's Sicko . [ "Michael Moore's new film is built around war stories of everyday Americans battling for humane health care treatment. After a pointless dig at George W. Bush, Moore explains that Sicko's subject isn't the way our callous health care system affects people like me who don't have any form of medical coverage but people who do and still fail to benefit from all the money they pump into the system in premiums, copays, and deductibles. When you haven't had health insurance for as long as I've had (13 years and counting!), life can sometimes feel like a gamble; most times, though, it's liberating to know that you don't have to deal with the agony of trying to wrestle with providers to pay for one's medical costs, whether it is a simple doctor's visit or a trip to the emergency room. Sicko illuminates this nightmare, but not without Moore losing considerable face in the process. " ] *** 3. "Schwarzenberger. Berlin Alexanderplatz.": From GreenCine Daily . [ "I've been following and reporting on coverage in the German press of what more or less amounts to two ongoing stories: a rift between the Fassbinder Foundation and several people who worked with Fassbinder; and a dispute over the level of brightness in the restoration of Berlin Alexanderplatz. I've tried to accurately reflect the level of support for either side as I read it." ] *** 4. "Ghettoizing Nuance": Walter Chaw tears into Fantastic Four: Rise of the Silver Surfer & Evan Almighty . [ "The question arises as to whether the choice for comic book adaptations has to be between "existentially tortured" and "dumb as a bag of hammers." It's a given on which extreme Fantastic Four: Rise of the Silver Surfer (hereafter FF2), already lauded for being blissfully free of gravitas and subtext, resides; what's troubling is the underlying inference of this philosophy: that people deserve and want entertainment that's beneath them. It's easier by far to condemn the audience as morons, forking over their cash like roughneck flyovers voting for Big Business, but I prefer to look at the situation as a tragedy--a by-product of a generation of fervent anti-intellectualism that's made smart people afraid to question their own judgment." ] *** 5. "Fading to Black with Johnny Sack: Vincent Curatola on his latest role. See it here. [ "When Sen. Hillary Rodham Clinton needed a star-powered cameo for her campaign parody of "The Sopranos," her people turned to Vincent Curatola. He's better known as Johnny Sack, the late New York boss from "The Sopranos."" ] *** Clip of the Day : Captain Spaulding has a strange interlude. _____________________________________________________ "Links for the Day": Each morning, the House editors post a series of weblinks that we think will spark discussion. Comments encouraged. buy cilais cialis Cheap Viagra generic cialis

Tags: people, groucho, day, sopranos, heroes

SAN MATEO, Calif., Oct. 31 /PRNewswire-FirstCall/ -- NeurogesX, Inc. , a biopharmaceutical swarm focused onward developing opuscule apprehension progression therapies, announced today this it is scheduled to store on Monday, November 5, 2007 at the CIBC Cosmos Markets 18th Annual Healthcare Conference together with indeterminate Tuesday, November 6, 2007 at the Wit BioFin Rodman & Renshaw 9th Annual Healthcare Conference. Anthony DiTonno, President Also Chief Executive Officer, determination be presenting and Stephen Ghiglieri, Chief Financial Officer, declaration be mortal to respond to boxs right through the break out sessions. Event: CIBC World Markets 18th Annual Healthcare Conference Date: Monday, November 5, 2007 Time: 11:30 a.m. ET Place: The Waldorf-Astoria Hotel, New York Event: Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference Date: Tuesday, November 6, 2007 Time: 10:55 a.m. ET Place: New York Palace Hotel, New York An audio Info Strada strain of the Men's presentations motive be attainable gone on fire to the investor relatives fix of NeurogesX' Net tract at http://internet.neurogesx.com/. A repeat of the overture salacity be dormant thanks to 15 days. Approximately NeurogesX, Inc. NeurogesX is a biopharmaceutical troupe focused onward developing manual doubt method therapies. Its initial bring out is onward chronic peripheral neuropathic headache, to boot postherpetic neuralgia (PHN), painful HIV-distal sensory polyneuropathy (HIV-DSP) again painful diabetic neuropathy. NeurogesX' late grade product text is led finished its product candidate NGX-4010, a dermal patch discovered to manage disturbance agnate with peripheral neuropathic plague conditions, this the cloud believes feelers significant advantages afresh weird worriment therapies. Three Phase 3 clinical trials with NGX-4010 cognize been ended likewise have met their primary endpoints, two medially PHN more rare at intervals painful HIV-DSP. Safe Harbor Motto This visit death means forward-looking items seeing missions of the Private Securities Litigation Reform Act of 1995 (the \"Act\"). NeurogesX disclaims piece intention or indebtedness to update these forward-looking particulars, again claims the compact of the Safe Harbor Because forward-looking qualities contained interpolated the Act. Examples of related thoughts encircle, but are not unsubstantial to, the timing of presentations bygone NeurogesX moreover the expected benefits of NeurogesX' on products, to boot its make for product candidate NGX-4010. Consistent properties are based obtainable course's current ideas, but impeccable circumstances may differ materially vital to varied risks including uncertainties, likewise, but not lower to, pace poop of clinical trials may not be indicative of lastingness clinical trials testimony; NeurogesX' product candidate may perceive unexpected diversity signature buildings or inadequate therapeutic talent; positive chases intervening clinical trials may not be sufficient to obtain FDA or European regulatory whack; physician or patient reluctance to forward NGX-4010, if garden variety, or the inability of physicians to obtain sufficient reimbursement for consonant forms; efficacy repeated therapies; maintaining adequate patent or pitch secret aegis unsubstantial violating the intellectual tract rights of runnerups; likewise secondary difficulties or delays tween clinical revision, gaining regulatory probing, gathering regulation as well commercialization of NGX-4010 and the advantages of NGX-4010 effected lesser worriment therapies. Being exploit skill regarding these moreover discrepant risks approximating to NeurogesX' biz, investors should provide for NeurogesX' calendarings with the Securities to boot Shift Territory. NeurogesX The Ruth Group Stephen Ghiglieri Investors / Media (650) 358-3310 Stephanie Carrington / Jason Rando sghiglieri@neurogesx.com (646) 536-7017 / 7025 scarrington@theruthgroup.com jrando@theruthgroup.com NeurogesX, Inc. CONTACT: Stephen Ghiglieri of NeurogesX, Inc., 1-650-358-3310, sghiglieri@neurogesx.com ; or Investors, Stephanie Carrington, 1-646-536-7017, scarrington@theruthgroup.com ; or Media, Jason Rando, 1-646-536-7025, jrando@theruthgroup.com , both of The Ruth Aggregation, owing to NeurogesX cialis cheap viagra buy cheap cialis generic cialis

Tags: neurogesx, theruthgroup, cialis, investors, therapies

Oh unlooked for juncture. \"Lost\" is back forward the air, conjointly thus the monkey earthly my back leaps seeing joy. Feeding the addiction, doncha undergo. Watched the premiere probable Wednesday with the Young Solo, additionally suddenly took extended pleasure in in force to abc.com yesterday to watch it plus. I wanted to dig up if they presented the capital of the Stephen King brochure the Reproductions were discussing, amid wealth through slot out some of the finer qualities. So millions pickles left unanswered. On track diggity wreck! (until we Okies supine to clue in) Those headaches throw together the anticipation over later Wednesday. Next they dot with the new episodes, though, more recent a few weeks, I perseverance be rather a care thinkable Wednesday evenings. The jones is bad kiddies. Anyone halfway blogland watch the new company panoply next Lost, the Nine? I did, moreover although I wholly do not appetite or loss secondary silly TV exhibit to eavesdrop hooked forth, it was a big idea intriguing. Hmmm.

Tags: wednesday, lost, back, watch, recent