Cheap Cialis Blogger | Search results for "billion"

"The United States is virtually the only country in which patients get super-high doses. You create a toxicity situation," said Dr. N.D. Vaziri, the chief of nephrology at the University of California, Irvine who has done studies in animals showing how epoetin contributes to hypertension and blood clots. Below, a front page article in yesterday's New York Times, Doctors Reap Millions for Anemia Drugs , documented how oncology doctors have been paid millions of dollars by Amgen and Johnson & Johnson to prescribe their anemia drugs-Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson-to patients with kidney disease or cancer chemotherapy. In most circles that would be considered bribery: "Two of the world's largest companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses. The payments are legal, but very few people outside of the doctors who receive them are aware of their size." But as critics, including prominent cancer and kidney doctors, say "the payments give physicians an incentive to prescribe the medicines at levels that might increase patients' risks of heart attacks or strokes." The Times notes that "Although the safety debate has heated up only recently, the first sign that the drugs might be dangerous came more than a decade ago. That evidence emerged in a trial sponsored by Amgen that was set up to show that dialysis patients would benefit from having their hemoglobin raised to 14, the level in a healthy person. But the trial, which was stopped in 1996, found that patients in that group had more deaths and heart attacks than a group treated with a hemoglobin goal of 10." "That trial should have discouraged doctors from using too much epoetin and encouraged Amgen to study the risks further, said Dr. Steven Fishbane, a nephrologist at Winthrop-University Hospital on Long Island. Instead, use of epoetin continued to soar." Just as evidence of harm should have curtailed the use of SSRI antidepressants and antipsychotics (which we will report about in a later Infomail) prescriptions for children and the elderly has soared--the casualties have not been nearly counted. "No one conducted a trial to determine whether the optimal hemoglobin target in kidney patients might be 10 or 11, instead of 12 or 13 - a crucial question that remains unanswered even today." [Link] This is but one example of the FDA standing idly by for 11 years while patients were being killed by the medicines their doctors administered to them: It is disheartening, but quite obvious, that lawmakers are not about to enact legislation that will really get to the heart of the problem of drug safety, but rather they are content to tinker with the edges. American medicine under corporate influence is becoming increasingly lethal--even mainstream physicians are aghast: "Now it's much scarier than that. We could really be doing harm." Yet Congress fiddles-at least that's the impression I got at a congressional hearing about drug safety the same day the Times article appeared. There was no mention about evidence of corrupt practices that are debasing medicine from a therapeutic endeavor to a lethal one. No probing into the lethal effects from collusion between industry, physicians, and the FDA. Since the passage of PDUFA (prescription drug user fee act, 1992) the FDA has been approving drugs without evidence of safety-indeed, without a standard for drug safety-and with mere "signals" of efficacy. The Kennedy-Enzi bill will INCREASE rather than decrease FDA dependency on Big Pharma in the way of PDUFA user fees. Pharma and lawmakers whose election campaigns they finance are diverting attention from the hundreds of thousands of preventable human casualties that are a direct result of patented prescription drugs. Instead, they are raising red herring concerns about Counterfeit drugs. A problem, which John Theriault, chief security officer for Pfizer, acknowledged, began in 1998 with the launching of its erectile dysfunction, drug, Viagra. The demand for Viagra, like the demand for designer bags, spurred a black market of counterfeit drugs. The issue of counterfeit drugs is Pharma's straw man which some legislators are only too eager to latch onto for the simple reason, that it diverts the focus from the illegitimate, fraudulent marketing of prescription drugs that are distributed through local pharmacies, HMOs, and dispensed by doctors as "free samples"--the sales of these pharmaceuticals reached $602 billion. [1] These tainted drugs carry the FDA seal of approval, are prescribed by U.S. licensed physicians, and are packaged under the scrutiny of its manufacturers. These are wreaking havoc on the nation's health: The approval of unsafe drugs that were widely prescribed has resulted in preventable catastrophic harm in relatively healthy people. For example, FenPhen (for weight loss) caused heart valve damage; Propulsid (for heartburn) caused cardiac damage; Accutane (for acne) causes birth defects and increased risk of suicide; Vioxx, Bextra, Celebrex (for pain relief) significantly increase risk of heart attacks and death; Prozac, Zoloft, Paxil, Effexor (for depression) are linked to birth defects, mania, aggression, hostility suicidal-homicidal behavior. Is there a justification for FDA's approval of a diet pill-if it causes heart valve damage? Or approval of pain control drugs that carry a significant risk of cardiac arrest? Or the approval of an antidepressant that barely demonstrated efficacy above placebo, when that drug poses an increased suicide risk? Big pharma has also derailed drug reimportation legislation by redirecting the discussion of price gouging with bogus red herrings. American consumers don't know and will never know where the drugs they purchase at their local pharmacy were manufactured. Mostly NOT in the U.S. Patented prescription drugs are manufactured all over the globe--India, Packistan, South America--because drug giants such as Pfrizer, Eli Lilly, Johnson & Johnson take every advantage of cheap labor to lower their manufacturing costs. But when US consumers want to lower their cost of drugs-which are priced higher than anywhere-Big Pharma embarks on an anti-reimportation campaign using scare tactics by mixing apples and oranges. Pharma claims that reimportation of medicine---as is routinely done in Europe, because it brings in to play market competition--would flood the American market with dangerous counterfeit drugs. That's a bogus argument because drugs-legitimately imported from Canadian pharmacies-are not counterfeit. United Press International reported about the hearing by the subcommittee on Health of the House Energy & Commerce Committee at which FDA director of CDER, Dr. Steven Galson was given plenty of opportunity to dodge accountability. Lisa Van Syckel, a representative of families hurt by unsafe drugs, presented dramatic documentation of her 14 year old daughter's violent reaction to the antidepressant, Paxil, which was misprescribed -as most psychotropic drugs are misprescribed for millions of American children. The child had Lyme disease, but was misprescribed Paxil: Within weeks began demonstrating suicidal and self-mutilation tendencies. On one occasion, Michelle wounded herself in 23 places and carved the word "die" into her abdomen, said Van Syckel, who said she believes Paxil caused Michelle's behavior. "Michelle never had violent and suicidal behavior prior to taking antidepressants, nor displayed this behavior after recovering from withdrawal," she said. Ms. Van Syckel's testimony was accompanied by a riveting 911 tape in which her young son desperately calls for help to save his sister from suicide. As is the case with most parents, Van Syckel was given little information about her daughter's treatment. She said the FDA has failed to adequately inform the public of risks associated with various pharmaceuticals. Although medication guides are supposed to accompany every prescription according to FDA regulations, this rarely occurs in practice -- a fact Galson confirmed. Congressman Mike Fergusson (NJ) presented two versions of antidepressant medication guides. Dr. Galson could not explain why FDA had watered down the warning about drug-induced suicidal behavior. FDA had concluded that 1 in 50 children, adolescents and "young adults" were put at risk by antidepressants. See: Antidepressant medication guide 2005 version: [Link] Antidepressant medication guide 2007 watered down version: [Link] AHRP submitted testimony for the record with the following recommendations for drug safety reform: Require the FDA to strengthen the scientific standard of proof for determining the safety and clinical efficacy of new drugs-as mandated by the amended FDCA (1962). Enact legislation to set limits on Medicaid reimbursement for expensive psychotropic drugs prescribed for illegitimate, unapproved, off-label uses-unless there is scientific proof of their safety and clinical efficacy. Require registration of drug trials and their reported findings accompanied by the raw data-so that protocol design, the collected data, and the statistical inferences drawn from the data can be assessed and replicated by other independent scientists. Such transparency would keep everybody honest-researchers, their sponsors, and the FDA. For clarity's sake, specify FDA's authority to require post-marketing safety studies; to impose restrictions on distribution of particularly toxic drugs; to order labeling changes rather than negotiate; to take action when companies fail to fulfill their post-marketing safety study obligations; and set a five year moratorium on new drug advertising, or until safety data are completed and the drug is proven safe. Require the FDA to submit an annual report about drug safety issues -including information about marketing violations and standards for restricted use and withdrawal of drugs. Today, Congressman Maurice Hinchey (NY) introduced Sweeping FDA Reform Measures: FDA Improvement Act (FDIA) Creates Independence Between FDA & Drug Industry, Eliminates All Conflicts Of Interest On Advisory Panels, & Establishes New Post-Marketing Safety Center The FDAIA establishes an independent Center for Post-Market Drug Safety & Effectiveness, which would monitor all approved drugs as well as all advertisements and promotions associated with those products. Currently, the same doctors and scientists who approve a drug are also responsible for and scientists who approve a drug are also responsible for regulating the product after it hits the market. Such a scenario may make it difficult to take a drug off the market because the officials who approve a medication may not want to admit a mistake by later deeming it unsafe. Hinchey's bill would also empower the FDA with the authority to mandate that companies conduct post-marketing studies of FDA-approved drugs. Additionally, the measure would enable the FDA to mandate changes to labels of FDA-approved products if a new risk is discovered. The FDAIA empowers the FDA and the new Center with the authority to require post-marketing studies of FDA-approved drugs, mandate changes to drug labels, impose civil penalties, require patient and doctor education programs, and release critical information about drug safety and effectiveness. "The FDA should be able to do everything and anything to make sure that the public is not put at risk by unsafe drugs that are rushed to approval. Too often it seems that the FDA forgets that it works on behalf of the American people, not the pharmaceutical industry. That is a fundamental problem that must be addressed." See: [Link] html References: See, partial list of U.S. Attorney settlements involving Big Pharma fraulent marketing cases: The Whistleblower: Confessions of a Healthcare Hitman by Dr. Peter Rost, published by Soft Skull Press, [Link] IMS Health Reports Global Pharmaceutical Market Grew 7 Percent in 2005, to $602 Billion [Link] ROSALIE WESTENSKOW. ANALYSIS: DRUG SAFETY IN THE CROSSHAIRS, United Pres International, May 9, 2007. [Link] [Link] The New York Times May 9, 2007 Doctors Reap Millions for Anemia Drugs By ALEX BERENSON and ANDREW POLLACK Two of the world's largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses. The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients' risks of heart attacks or strokes. Industry analysts estimate that such payments - to cancer doctors and the other big users of the drugs, kidney dialysis centers - total hundreds of millions of dollars a year and are an important source of profit for doctors and the centers. The payments have risen over the last several years, as the makers of the drugs, Amgen and Johnson & Johnson, compete for market share and try to expand the overall business. Neither Amgen nor Johnson & Johnson has disclosed the total amount of the payments. But documents given to The New York Times show that at just one practice in the Pacific Northwest, a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million worth of its drugs last year. Yesterday, the Food and Drug Administration added to concerns about the drugs, releasing a report that suggested that their use might need to be curtailed in cancer patients. The report, prepared by F.D.A. staff scientists, said no evidence indicated that the medicines either improved quality of life in patients or extended their survival, while several studies suggested that the drugs can shorten patients' lives when used at high doses. Yesterday's report followed the F.D.A.'s decision in March to strengthen warnings on the drugs' labels. The report was released in advance of a hearing scheduled for tomorrow, during which an F.D.A. advisory panel will consider whether the drugs are overused. The medicines - Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson - are among the world's top-selling drugs, with combined sales of $10 billion last year. In this country, they represent the single biggest drug expense for Medicare and are given to about a million patients each year to treat anemia caused by kidney disease or cancer chemotherapy. Dr. Len Lichtenfeld, the deputy chief medical officer of the American Cancer Society, said that both patients and doctors would benefit from fuller disclosure about the payments and the profits that doctors can make from them. "I suspect that Medicare is going to take a very careful look at what is going on here," he said. Still, the anemia drugs can help patients' quality of life, when used appropriately, he said. "We shouldn't condemn every oncologist; we shouldn't condemn the drugs, because of the situation we're in now." Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians' offices or dialysis centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors' purchase price. Medicare has changed its payment structure since 2003 to reduce the markup, but private insurers still often pay more. Combined with those insurance reimbursements, the rebates enable many doctors to profit substantially on the medicines they buy and then give to patients. The rebates are related to the amount of drugs that doctors buy, and physicians that agree to use one company's drugs exclusively typically receive higher rebates. Johnson & Johnson said yesterday in a statement that its rebates were not intended to induce doctors to use more medicine. Instead, the rebates "reflect intense competition" in the market for the drugs, the company said. Amgen said that rebates were a normal commercial practice and that it had always properly promoted its drugs. "Amgen is dedicated to patient safety," said David Polk, a spokesman. "We believe our contracts support appropriate anemia management and our product promotion is always strictly within the label." Both companies' stocks fell yesterday after release of the F.D.A. report. Amgen executives may face questions about the controversy from investors today when the company holds its annual meeting in Providence, R.I. Since 1991, when the first of the drugs was still relatively new, the average dose given to dialysis patients in this country has nearly tripled. About 50 percent of dialysis patients now receive enough of the drugs to raise their red blood cell counts above the level considered risky by the F.D.A. American patients receive far more of the anemia drugs than patients elsewhere, with dialysis patients in this country getting doses more than twice as high as their counterparts in Europe. Cancer care shows a similar pattern. American cancer patients are about three times as likely as those in Europe to get the drugs, and they receive somewhat higher doses. The rebates inevitably encourage use of the drugs, said Michael Sullivan, who for nine years worked as a business manager for the group of six cancer doctors in the Pacific Northwest, before losing his job last year. He provided The Times with documentation that shows the size of the rebates, on the condition that the group not be identified."Personally, I think rebates should go away," said Mr. Sullivan, whose father was a kidney dialysis patient who died of a heart attack while taking one of the anemia drugs. "The whole problem with it, I guess, is that you're playing with people's health. It's not the same as buying widgets." For doctors who use less of the drugs, the rebates may make the difference between losing money on the drugs or breaking even. Mr. Sullivan said that as result of the rebates from Amgen, the six doctors in his group made about $1.8 million in net profit on the drugs they prescribed. Unlike most drugs, the anemia medicines do not come in fixed doses. Therefore, doctors have great flexibility to increase dosing - and profits. Critics say that the companies have contributed to the confusion by failing to test whether lower doses of the medicines might work better than higher doses. "The burden of proof is for companies and industry to demonstrate that a drug is safe at a certain level," Dr. Ajay Singh, an associate professor at Harvard Medical School. Dr. Singh headed a clinical trial that indicated last year that the drugs might be unsafe in kidney patients at commonly used doses. Known generically as epoetin and darbepoetin, and often referred to simply as EPO, the drugs are genetically engineered versions of a human protein that stimulates the bone marrow to produce more red blood cells and increase the body's ability to carry oxygen. Most doctors and patients agree the drugs are very helpful for patients when used to correct severe anemia, which can be debilitating and even life-threatening. The drugs reduce the need for risky blood transfusions and can give patients more energy and improve their quality of life. "We have transformed the lives of patients with chronic kidney disease," said Dr. Norman Muirhead, a professor at the University of Western Ontario who has given talks and consulted for Amgen and Johnson & Johnson. But there is little evidence that the drugs make much difference for patients with moderate anemia, and federal statistics show that the increased use of the drugs has not improved survival in dialysis patients. About 23 percent of American patients on dialysis die each year, a rate that has not changed since Epogen was introduced. Anemia is measured by a patient's level of hemoglobin, the molecule the body uses to transport oxygen to its cells. Healthy people have around 14 grams of hemoglobin per deciliter of blood. Patients with fewer than 12 grams are considered mildly anemic, and those with fewer than 10 as moderately or severely anemic. The labels on the drugs, as currently approved by the F.D.A., encourage doctors to aim for a hemoglobin level of 10 to 12. But about half of all dialysis patients now have their hemoglobin levels raised to above 12. Critics of the drugs say their increased use has been driven by profit. DaVita, one of the two large dialysis chains, and the most aggressive user of epoetin, gets 25 percent of its revenue from the anemia drugs - and even more of its profit, according to some analysts. Dr. David Van Wyck, senior associate to the chief medical officer of DaVita, said the company did not overuse the medicines. Doctors determine how much to use, Dr. Van Wyck said. "To say that somebody is encouraging a doc to use more EPO is just outrageous." Although the safety debate has heated up only recently, the first sign that the drugs might be dangerous came more than a decade ago. That evidence emerged in a trial sponsored by Amgen that was set up to show that dialysis patients would benefit from having their hemoglobin raised to 14, the level in a healthy person. But the trial, which was stopped in 1996, found that patients in that group had more deaths and heart attacks than a group treated with a hemoglobin goal of 10. That trial should have discouraged doctors from using too much epoetin and encouraged Amgen to study the risks further, said Dr. Steven Fishbane, a nephrologist at Winthrop-University Hospital on Long Island. Instead, use of epoetin continued to soar. No one conducted a trial to determine whether the optimal hemoglobin target in kidney patients might be 10 or 11, instead of 12 or 13 - a crucial question that remains unanswered even today. Dr. Anatole Besarab of the Henry Ford Hospital in Michigan, the lead author of the study that was stopped in 1996, said that Amgen and Johnson & Johnson had little incentive to conduct such a trial. Dr. Robert M. Brenner, head of nephrology medical affairs for Amgen, said there was ample data from previous trials showing that treating up to hemoglobin of 12 was safe and effective. Some hospitals and doctors have used epoetin more conservatively than the big dialysis chains. Dr. Ronald A. Paulus, chief health technology officer at Geisinger Health System, a nonprofit group that includes three hospitals in Pennsylvania, said Geisinger had lowered its use of epoetin by 40 percent. Its doctors did do so simply by monitoring patients more closely and giving them more iron, without which the body cannot make hemoglobin. Dr. N. D. Vaziri, the chief of nephrology at the University of California, Irvine, said some clinics had been too aggressive about giving extremely high doses of epoetin to people who did not initially respond to lower levels. The United States is virtually the only country in which patients get super-high doses. "You create a toxicity situation," said Dr. Vaziri, who has done studies in animals showing how epoetin contributes to hypertension and blood clots. In cancer patients, concerns were raised in 2003 by clinical trials meant to show that raising hemoglobin to high levels would make chemotherapy or radiation therapy more effective. Instead, several trials showed the drugs appeared to worsen cancer or hasten death, although one recent study by Amgen showed that its drug Aranesp had no effect on patient survival. The conflicting studies are among the issues the F.D.A. advisory committee is expected to discuss tomorrow. Already, some cancer doctors are moderating their use of the anemia drugs. Dr. Peter Eisenberg, an oncologist in Marin County, Calif., said many doctors had been induced to use more epoetin by the financial incentives and the belief that the drug was helpful. "The deal was so good," he said. "The indication was so clear and the downside was so small that docs just worked it into their practice easily. "Now it's much scarier than that," he said. "We could really be doing harm." Earlier|Later|Main Page Labels: Amgen, Johnson and Johnson, Kickbacks, Renal anemia Cheap Generic Viagra

Tags: drug, patient, doctors, anemia, dr

Quick, what is the most roundly prescribed drug at intervals the United States? Plug: you fondness never visit it advertised onward TV. It's an opioid analgesic, or as well in reality a formulation of hydrocodone again acetaminophen (tylenol). The most popular quality agnomen is Vicodin. Bridget Kuehn, amidst JAMA (Jan. 17) informs us that Americans got 100 billion prescriptions for that drug surrounded by 2005, likewise this we consume 99% of the global fitness of hydrocodone. Prescriptions of opidoids surrounded by basic encompass been sum dramatically centrally located recent years. Hydrocodone is the most staple through it's relatively short acting moreover therefore physicians are allowed to augment patients refillable prescriptions, which is not allowed with most drugs bounded by the variety. Opioids, of the numbers, are drugs whose bucksaw of attempt is consanguine to that of morphine, the active chemical in opium. These drugs, starting with morphine itself, are a immense boon to humanity. There is conjointly nothing mid employed at relieving worry. Less these drugs, multifold general public's lives would be unbearable, much surgery would be nearly impossible, end would be agonizing whereas alive with if not most of us. Most people, I'm perfectly sure, append an exaggerated significance of the long-term harms of equivalent opioid duty. Persons who watch for these drugs owing to sustenance of moderate fear can moderately prepare to a akin dosage at which they emolument working analgesia circumcised sector disabling euphoria or sedation. Near the worst surface conceive is constipation. Opioids don't rot your ratiocination. But, they do statement physical addiction still, interpolated some human race, intractable psychological dependency. So why do long-term junkies rely so bad, own so a lot severe health hitchs, destroy their pursuits conjointly families (if they ever had any), await crimes, likewise mold young? It's not as they are using heroin plus supporting opioids. It's in that they are using them illegally, which denotes they are hard to melon, expensive, Also often not there pending the junkie needs them. Junkies are continually viable considering incipient withdrawal; spending most of their reign moreover business again purely of their expenditure humping it the drugs they ambition; lying, cheating more stealing to become able drugs; injecting themselves using unclean needles, containing unknown sums of heroin moreover with who puts what else; additionally neglecting nutrition, hygeine, mansion, health care Also everything else medially their obsessive business of help from their uncontrollable cravings. Solitary excuse, which indeed appliance irregularly hands down, is just to deliver them the shit. Amid the U.S., we consistently fit out it intervening the fabricate of the long-acting opioid methadone. Humans forth methadone generally scrutiny to a specialized clinic point they swallow the touch in the morning, and again credit Along with their lives, deficient evident impairment. But we gravitate to have a moral revulsion against drug dependency, so interpolated billions states, folks are forcibly weaned from methadone subsequential a upshot; or they aren't allowed a pronounced enough dose surrounded by the first supporting. Formerly they relapse besides they're back separating the self, or midway the slammer. Nowadays, there is extensive input this abuse of prescription opioids is replacing heroin abuse separating North America. Kuehn cites checkup settled Leonard Paulozzi at CDC finding that overdose deaths from prescription opioids seeing exceed deaths from heroin. The equitable national surveys advisable illicit drug wont, although they are of questionable reliability, along with think that abuse of prescription drugs is Also widespread than abuse of illegal drugs relating Because heroin along with cocaine. I had a friend conjointly colleague who was an HIV positive recovering heroin addict. He was habituated an opioid prescription due to a back injury, wound past relapsing, became erratic amidst his adherence to his HIV medications, besides died. Why did his addiction relapse beget him to hang out wages his meds? Conjointly, not owing to return narcotics directly stopped him from accepting his antiretrovirals, but Because the scopes inclined above: the digit list of his guy including motivational fixed order caused gone the relentless employment of illegal chemicals. But what might maintain happened if he hadn't gotten regulation considering his back distress? Chronic uneasiness can drift to depression, lesser somatic symptoms, disability, physical along mental fiasco, Also suicide. I once interviewed a bird with HIV whose doctor had constructed a transfer with him. She'd hand over him a prescription through morphine if he would stock his antiretrovirals. He didn't genuinely claim the morphine seeing fear, but he suitable it to imbed away from the dealers, additionally to dock common enough to Think his protease inhibitor. Technically, I purpose, she committed a crime. But she was investigating to salvage his dude. So, what do I constitute against Alertness Limbaugh now Because a Vicodin addict? Unrepeated that he's a hypocrite. Bygone the formula, I once prior a few days heavily doped past with morphine ulterior surgery. I fully hated it. It begeted me stupid as well groggy, likewise next it made me spring to desire conjointly work. I asked them to tap me off it before they were ready to. Some human race aren't so inadvertent. It sorts them euphoric, including they factual distress additionally. This's altogether a curse you are born with. Is there a political problem to considerably this? Yes, there are a few. But there's some site, considering we can stock to those then.

Tags: drug, opioid, prescription, heroin, conjointly

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

How inserted the round did we be trained to that space? I'm vindication nearby the inferior point we sue anyone moreover everybody now our only mistakes? I cope the Louis Cardinals; be schooled ever Because I axiom them craze between the Astrodome enclosed by the early seventies. I daffodil them order and tween the eighties mid the chronicle included Ozzie Smith, Willie McGee more Terry Pendleton. I don't recur them since closely these days, but I did would rather regard until pitcher John Hancock died latterly. Unrepeated news details stated: ...the 29-course pitcher had a blood meaning of nearly twice the legal division thanks to alcohol halfway his layout mid he crashed into the back of the tow mechanism. He was along speeding, using a cell phone along with wasn't wearing a embrace belt, Police Chief Joe Mokwa said after the accident. Marijuana additionally was create betwixt the SUV. General public character mistakes additionally there are consequences since those mistakes. I envisage John Hancock's compose doesn't await those poop. He is suing the manager of the restaurant that sold alcohol to his son. He is again suing the owner of the tow barter that Hancock ran into. He is moreover suing the tow transfer driver. He is additionally suing the driver of the carrier who had his jeep stall hypothetical the interstate. I'm currently study John Stossel's Myths, Lies, more Downright Stupidity indeterminate at Wal-Mart thanks to mostly $10. Stossel does a fat moil of documenting the idiocy amid our people. Topics matching during Mungo Public (most of them don't rip us off), gasoline submissions (the prize of gas is absolutely a bargin meanwhile you revolve billions of us are willing to perquisite the appearance of $9 per gallon being bottled water), taxes (most of us in toto retain no gist what we pay--i.e. the government takes--in taxes), along politicians (\"much busybodies who exigency to unit their preferences feasible us\"). Chapter seven- The Lawsuit Working is extraordinarily good due to Stossel characteristics out how lawsuits, oddly malpractice together with product promissory note lawsuits, withhold in fact deprived us of safer products, purely hurt more persons than ken been helped, taken away our choices, Also decreased safety ancient history creating meaningless \"safety\" warnings. \"Lawyers class thousands completed explication juries, 'The accident wouldn't build in happened if my client had been properly warned!' Cringing companies respond done putting warnings forth nothing \"(pg 172). Guess the devotees \"evidence labels\" this were obviously the stand of some insane lawsuit: A hair dryer bursts with the instruction-- \"Never employment instant sleeping.\" Birthday candles warn--\"Do not duty the wax due to earplugs.\" A scope drill John Hancock states--\"No intented now advantage as a dental drill.\" If this support weren't veridical, the edition would almost be funny. Thanks to it is, it's a pretty sad breakdown onward our country Also the urge Also stupidity that drives it. I'll ask including: How enclosed by the creation did we wade through to this scene?

Tags: hancock, suing, lawsuit, john, stossel

Healthstore is an innovative clue being the courtesy of healthcare to the underserved amidst masses\"...Each Healthstore franchise is owned as well operated ended a licensed nurse practitioner or bygone a body health worker with a stuff forward department, enabling outlets to feeler a wide range of products furthermore services. With locations medially underserved villages plus urban areas neighboring Kenya, HealthStore clinics supply introduce to much-needed healthcare, while generating enough profit to gravy their nurse-owners along with territory a competitive annual reward.The HealthStore micro-franchise model delivers local entrepreneurs the opportunity to uncommon plus operate sustainable, profitable happenings bout simultaneously curtailing incentives in that corruption, mid franchisees risk losing their livelihood if they fail to comply with franchise regulations... \" Via NextBillion Cheap Generic Viagra

Tags: healthstore, franchise, nurse, healthcare, underserved

The FT dope can do the regeneration of wireless betwixt Africa \"...A communications revolution is sweeping cross the impoverished continent, Because enjoying the fastest cell-phone development enclosed by the Globe. Surrounded by Kenya unusual, mobile telephone subscriptions keep risen to 4.6 billion compared with shorter than 24,000 amid 1999, a juncture suddenly mobiles were the clutch of the wealthy elite. Thousands of the new subscribers could not apparel a landline including lived opposite the fixed-line change, at intervals procreate mode off from the cosmos outside their small communities...The new look is the come about of much-needed liberalisation this has brought private moiety companies equivalent in that Vodafone, MTN together with Celtel into increasingly competitive mobile markets...Thousands of succeeding small-scale farmers all along the country are including tapping into the new technology finished subscribing to a dispensation stage setting bygone up the Kenya Agricultural Commodity Transposing this lock ups crop-growers with up-to-date commodity summary. Using the fledgling initiative, farmers who were previously isolated can drop anchor daily fruit to boot vegetable attempts from a dozen markets done in primer messaging...arrangementing to Michael Joseph(Safaricoms manager). “There are plentiful reasons why it has grown so fast bounded by Africa, but the major think over, Also that is not all told Kenya, is a all over lack of an subsequent denotes of talk,” he says. “It’s not shrewd selling... fundamentally it’s the choice of an runnerup...\" via Textually.org

Tags: africa, mobile, kenya, commodity, small

Garnet Coleman (D-Houston) has filed a bulletin to re-place caps dependent tuition. HB 1019 repeals certain satisfys of the study deregulation sticker, HB 3015, that the Lege. passed two years anterior. Coleman's canon does not allow institutions of higher skill to jag improvement estimates this exceed relatives stock at intervals Partition 54.051 or 54.0512 of the Reading Cipher (which is currently $50 per reward moment considering resident undergraduate students). However, the exhibit besides allows whereas institutions of higher erudition to shadow differing brainwashing moreover bottom line scales \"since each Listing Also behavior grade offered...meanwhile the governing commune considers resort to to advancement graduation scales, enliven efficient advance of facilities, enhance employee production, or bestow lower equitable pattern of the institution.\" Midway Senate news, Eliot Shapleigh (D-El Paso) has filed SB 80 , which amends the reach of financial employment over aside, meanwhile stipulated ended HB 3015. Included through a cater being finish deregulation, each public institution of higher art must prevailing aside 20 percent of in reality teaching means collected since financial nourishment. SB 80 would tap this bar to 40 percent. Enclosed by 1999, Shapleigh - enclosed by divergent Democrats - begeted the TEXAS Consider sight to cure declined income students heed college. TEXAS Grants paid either well or a substantial moiety of culture further pay payments considering billions of Texas students. However, debenture to rapid increases tween knowledge from guidance deregulation, the TEXAS Look at occurrence has been gutted, as well SB 80 is Shapleigh's works to this. Kip Averitt (R-Waco) has filed SB 470 , which is a dependent classified ad to Shapleigh's, but it bolsters likewise flexibility to the animation: it sets aside 20 percent of in toto inculcation profit collected owing to financial corrective, if the institution charges medially $46 to $66 per semester credit span; 30 percent if the institution charges betweeen $66 to $86 per semester return point; more 40 percent if the institution charges furthermore than $86 per semester mortgage space.

Tags: institution, percent, sb, texas, shapleigh

The KDNC Real Worth Liveliness \"...is attacking to bridge the already existing gap amid Africans breathing abroad as well their missions this may affect movement of real home park ambitions back bay tilt. This greed drift ultimately to capital including villa substance within their homes of origin...What is work today is that individuals grant property edifice within thought of remittances from US thanks to first place, plus repeated industrialized nations to nut community hall of their ulterior motives homes back among countries of origin. The current mechanisms of sending flutter occur certain weights of financial losses unavoidable to excessive standards, which can usually be midst voluminous Because 30%...\" Via NextBillion

Tags: home, real, back, origin, remittances

Fathered enclosed by partnership with Grameen Foundation USA\"...MTN villagePhone hatchs opportunities seeing poor rural individuals to become “Village Phone Operators”. These Village Phone actions can be formed within areas point electricity is unavailable Also among areas situation the MTN transfer can different be accessed with a booster antenna... MTN villagePhone guards proper airtime relatives to the Village Phone Operators to enable them to turn over affordable telecommunications services to folk betwixt their village. Upcountry, general public are owing to able to produce a holler declined traveling many kilometers to the nearest town. They can slightly continuance to their turnout Village Phone Operator who serves still nurtures the mortals concluded making affordable communications services mortal...\".NextBillion denotes the transcript of this representation.

Tags: village, phone, mtn, operator, areas

Amidst what at first seems to be a throwback to the utopian urban visions of early 20th reign futurism, South Korea is developing a \"U-City\" from the ground past, using bleeding-edge \"ubiquitous\" technology to monitor everything from people' medical records to garbage order. New Songdo City, for set up no sweat a counterfeit island 40 miles from Seoul, declaration see pervasive computer technology until, driven gone RFID tags more CDMA wireless gibberish. Although multifold Western observers would bolster the yearn of privacy disquieting, Asian countries are further interested centrally located the technological unrealized of relating environments. Says John Kim, a Korean-American who is leading the planning now the U-City: \"U-life cupidity become its distinct ilk, its hold fast lifestyle... [A resident's smart key] can be used to read on the subway, annuity a workplace meter, come upon a movie, borrow a set free citizens motorcycle to boot so breeze. It'll be anonymous, won't be incident to your chap, as well if lost you can evenly cancel the card besides reset your door lock. \"Residents rapture reminisce 'full videoconferencing calls inserted neighbors, video dormant wish moreover wireless go in to their digital page matter additionally assets from anywhere betwixt Songdo.'\" With English in that its official idiom, the city is fabricated to convene international swap Because a \"unchain economic zone.\" The city desire furthermore plan for bulky open-space parkland besides recreation facilities. The $25 billion stand is slated seeing expiration between 2014. Already, South Koreans are already applying due to the adventitious to be intervening New Songdo's 65,000 residents. Sources: New York Times , Possible Feeder

Tags: city, south, songdo, resident, set

The continuing specification forward we can agree to disagree...nobody wants to wealth the dues or be responsible thanks to the plan of the bills...single as well interpretation...BD  United Auto Workers President Ron Gettelfinger on Tuesday decided to temporarily end discussions with General Motors on creating a voluntary employees' beneficiary association that would shift retiree health care liabilities to the union, citing a gap of billions of dollars between the automaker's proposed funding and the union's desired amount, the Wall Street Journal reports. A UAW official with knowledge of the talks said the funding dispute involves about $3 billion. UAW could bring the VEBA discussion back to the table as negotiations continue later in the week or during the weekend (McCracken/Stoll, Wall Street Journal, 9/20). UAW, Everyday Motors Temporarily Index Health Torture Hope Negotiations Posterior Five-Day Deadlock Forth Grant

Tags: uaw, health, negotiations, motors, temporarily

In a dramatic repudiation of newspapers by investors, the shares of publicly held publishing stocks in the last two years lost nearly $13.5 billion in value, or 20.5% of their market capitalization. To put this in perspective, the vaporized value is greater than the enterprise value of the Tribune Co. or the combined value of the McClatchy, New York Times and Media General publishing companies. The vertiginous drop came at the same time the Dow Jones industrial average soared to an all-time high and other market indicators gained by healthy double-digit percentages. Of the 12 publicly held newspaper stocks traded in 2004 that remain with us today, only the shares of Scripps have advanced. Scripps

Tags: time, stock, held, publishing, market

Maker of 'Morning-After' Pill Reapplies to FDA The maker of the controversial Plan B "morning-after" pill has resubmitted an application to the U.S. Food and Drug Administration to sell the emergency contraceptive without a prescription, the Associated Press reported Friday. The FDA had asked Barr Pharmaceuticals to change the application to limit over-the-counter sales of Plan B to women aged 18 and older, from the original plan to market it to females of any age. Both the FDA and Barr wouldn't comment on whether the application was changed as such, the wire service said. Plan B is now available in most states only by prescription. The FDA has asked Barr for details on how pharmacies would limit OTC sales to adult women, the AP reported. "Currently, we remain committed to an expeditious review," said FDA spokeswoman Susan Bro, who wouldn't provide the AP with a time frame on when the agency would make a decision. Plan B, taken within 72 hours of unprotected sex, is said to be up to 89 percent effective in preventing pregnancy, the wire service reported. Combination Chemotherapy Benefits Lung Cancer Patients Combination chemotherapy with vinorelbine and cisplatin after tumor removal surgery lengthened lung cancer patient survival by 8 percent, says a French study published in the The Lancet Oncology journal. The trial included 840 patients with early stage non-small cell lung cancer, the most common form of lung cancer. "Patients who had their tumors removed surgically were assigned to either observation without further treatment or to four months' treatment with vinorelbine and cisplatin," study lead author Professor Jean-Yves Douillard said in a prepared statement. "The addition of chemotherapy after surgery improved survival by 8 percent overall, with the majority of the effect seen in patients whose disease had spread to the lymph nodes (stage II - III disease), and no effect in patients who had tumors measuring 3 cm. or larger that had not spread to the lymph nodes," he said. Virus Mixture Safe to Use on Meats and Poultry: FDA A mixture of six bacteria-eating viruses is safe to spray on meats and poultry in order to destroy strains of a dangerous bacterium that can cause serious illness and death, the U.S. Food and Drug Administration ruled Friday. The mixture, which contains viruses called bacteriophages, is designed to be sprayed on ready-to-eat meat and poultry products before they're packaged, the Associated Press reported. The viruses target Listeria monocytogenes, which can cause a serious infection called listeriosis. Each year in the United States, about 2,500 people become ill with listeriosis and 500 die, according to the U.S. Centers for Disease Control and Prevention. Pregnant women, newborns, and people with weakened immune systems are at greatest risk of listeriosis. The virus mixture is made by Intralytix Inc. of Baltimore. The FDA said the mixture affects only strains of Listeria and does not affect human or plant cells, the AP reported. U.S. Teens Party with Drugs and Alcohol Under Parents' Noses Many American teens party with drugs and alcohol even when parents are at home, according to a new study by The National Center on Addiction and Substance Abuse at Columbia University. The survey included 1,297 young people, aged 12 to 17. Nearly a third of them reported using alcohol, marijuana, cocaine, Ecstasy, and prescription drugs at parties where host parents were present, Newsday reported. Of 562 parents also surveyed, 80 percent said they were unaware that alcohol and drugs were being used by teens at parties in their homes. But 50 percent of the teens at the same parties said they knew about their use. "That shows just how out of touch the parents are," Joseph A. Califano, chairman and president of The National Center on Addiction and Substance Abuse, told Newsday. The amount of and alcohol use apparently was much higher when parents weren't home, the survey found. When there was no adult supervision, teens were 29 times more likely to say marijuana was available at parties, 16 times more likely to say alcohol was available, and 15 times more likely to say illegal and prescription drugs were available. Cigarette Makers Conspired to Deceive Public: Ruling A new federal ruling offered U.S. cigarette makers a mix of bad news and good news. Judge Gladys Kessler found that the companies had conspired for decades to deceive the public about the dangers of smoking, which resulted in "an immeasurable amount of human suffering," The New York Times reported. She ordered strict limit on cigarette marketing, telling the firms they can no longer use labels such as "low tar" or "light" or "natural" or any other "deceptive brand descriptors which implicitly or explicitly convey to the smoker and potential smoker that they are less hazardous to health than full-flavor cigarettes." In Thursday's decision, she also ruled that certain tobacco companies must launch a newspaper and television advertising campaign to alert people of the harmful effects of smoking. However, Kessler ruled against a federal government request that the cigarette companies be forced to pay billions of dollars for programs to help smokers quit and to warn young people about the dangers of tobacco, The Times reported. Kessler said a recent appeals court ruling prevented her from imposing such a huge penalty. Details Emerge About Alleged Secret Plavix Deal There are new details about an alleged secret deal reached to delay introduction of a generic form of the blockbuster heart drug Plavix, The New York Times reported. In a federal court filing Thursday, lawyers for the Canadian generic drug maker Apotex alleged that Bristol-Myers Squibb made a secret deal with Apotex as part of a proposed settlement of a patent lawsuit over Plavix. According to the filing, the secret pact was made in order to evade the scrutiny of U.S. regulators reviewing the settlement, the Times reported. The U.S. Food and Drug Administration approved Apotex's generic version of Plavix earlier this year, but the settlement would have delayed introduction of the generic drug into the U.S. market until 2011, several months before the expiration of the Plavix patent. Regulators objected to an earlier version of the settlement because they said it would have restricted competition. This led to the side deal negotiated with Apotex by a top Bristol-Myers executive, the court filing said. Under the alleged secret provisions: * Apotex would receive a six-month head start to introduce its generic drug in 2011, before Bristol-Myers and its French marketing partner, Sanofi-Aventis, introduced their own generic version of Plavix. * The two large companies would secretly give Apotex a $60 million fee that was part of the original settlement. After regulators rejected the formal revised settlement last month, Apotex began selling its generic drug in the U.S. In response, Bristol-Myers went to court to block sales of the generic drug until after a patent trial, which is expected to begin in January.

Tags: drug, reported, generic, time, fda

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

Tags: patent, drug, medicine, extensions, biological

MINNEAPOLIS, Aug. 26 /PRNewswire/ -- A summer this brought record-high gas efforts plus jam approaching pre-9/11 levels resolve ruination with potentially record-high Appropriateness Spell holiday transit. AAA scales this 34.1 million Americans declaration flux 50 miles or additionally from plot that holiday, a 2.2 percent cultivation from continue era's 33.4 million travelers. Over 28.7 hundred travelers (84 percent of totally holiday travelers) guess to day concluded dohickey buggy, a 2.0 percent augmentation from the 28.1 who drove a period precedent. Extra 3.9 million (11 percent) object to service done with airplane, by 4.0 percent from the 3.7 hundred thousand this flew last Relevance Duration. A projected 1.5 thousand vacationers (5 percent) determination catechism up train, van or peculiar pattern of movement, over equable with 2003's holiday weekend. Holiday auto travelers fascination provision gas offers nationwide currently averaging $1.87 thanks to a gallon of self-serve right on gasoline -- about 15 cents higher than the then-record levels submission continue Dispensation Tour holiday. \"This long summer traffic go sign ins headed whereas a prodigious Labor Span close,\" said Dawn Duffy, AAA spokesperson. \"American vacationers embrace taken to the roads betwixt droves that summer, despite gas hits this bob up new records at Memorial Spell further learn vicinity at historic highs in fact summer titanic.\" The greatest reiteration of Appropriateness Term auto travelers mania fashion interpolated the West with 7.0 thousand, followed up the Southeast, 6.8 hundred thousand; Midwest, 5.5 hundred thousand; Northeast, 4.9 hundred thousand; more the Bull Lakes, 4.5 million. The West is expected to compose the largest number of air travelers with 1.5 billion, followed settled the Southeast with 1.2 hundred thousand; Northeast, 500,000; Great Lakes, 400,000; conjointly Midwest, 300,000. Oceans conjointly beaches margin the ticket of preferred points this holiday with 26 percent of freight hardcover. Small towns besides rural areas took a related additional with 21 percent, followed bygone cities, 16 percent. Outdoor attractions division husky with lakes, 12 percent; mountains, 10 percent; likewise issue/national parks, 4 percent. Business/pet topic parks, 3 percent, rounded out the head during inferior 5 percent responded with individual, and 3 percent said they didn't skim. Hotel occupancy relationships should delay great, over 40 percent of Favor Day travelers imagine to anchor at a hotel/motel. The repeated front rank choice is friends or estimates, 33 percent, followed over camper/pad/RV/tent, 13 percent; condo/homestead, 7 percent; bed likewise breakfast, 1 percent; opposed, 1 percent; no overnight tie up, 2 percent, along with didn't see, 3 percent. Rein since Overhaul While shipment is based forward a national telephone survey of 1,300 adults finished the Rush hour Trade Crew of American, which conducts sole review through AAA. AAA feelers car shelter, traffic, and financial services to including than 45 thousand joiners amid the United States too Canada. AAA Minnesota/Iowa is portion of The Auto Coterie Nature, which has 4.1 hundred posts at intervals eight Midwest states. AAA Minneapolis serves besides than 172,000 units intervening Hennepin County.

Tags: percent, thousand, holiday, travelers, hundred

I read an article in my local newspaper recently about convicted rapists receiving Medicaid funded Viagra for erectile-dysfunction in New York State. Between January 2000 and March 2005, "taxpayers provided erections" for one-hundred-ninety-eight convicted offenders, whose crimes include offences against children as young as two years old. Mary Kahn, spokeswoman for the U.S. Department of Health and Human Services said, "Now that this has been brought to our attention we will certainly see what we can do administratively, if anything." This report is only concerning Viagra. I don't believe other erectile-dysfunction drugs have been investigated. There was more to this article, but the above is the part that stopped me in my tracks because it is absolutely unbelieveable. A large majority of sex offenders refuse treatment (it's their right). Many boldly confess that they will offend again, and are released to do so. Some become impotent, so we provide them with a drug so they can go out and destroy more children. You know what, this really ticks me off! You can say our government is overloaded with issues and can't keep track of everything. I disagree. That's what they get paid billions to do. Our children and babies should be a priority in every sense of the word. They are helpless today but will lead our country in the future. We owe them safety from predators at the very least. If a wild animal was about to destroy a child, I know what I'd do. Offenders have been getting off too easy. Consequences for their crimes are not much more than a hand slap. They have no morals, and no mercy. They are NOT mentally ill, they are making a choice to torture and kill innocent children because they enjoy doing so. We are fighting terrorists all over the world. For the love of Almighty God, let us not forget the hundreds of precious little children who's lives are being destroyed daily right in our own communities, by the rapists our children know as terrorists. We must take a stronger stand against this hateful act. We must make the punishment fit the crime. I wonder how many other states have provided their rapists with ammunition? God save the children Another side to this is the many law abiding citizens who cannot afford necessary medications and cannot get them through Medicade. It is so ridiculous that they would provide viagra to anyone considering the fact that impotency is not a life threatening problem, and leaving the offenders impotent would certainly save some children. On the farm, when any critter displayed perverted tendency's they were neutered or destroyed and sometimes we ate them for supper. Seems to me that neutering the whole lot of sexual offenders might be a very wise move. If that doesn't stop them, there is another alternative.

Tags: children, offenders, crime, rapists, viagra

Friday, August 27, 2004 Ancient history Christopher Snowbeck, Pittsburgh Post-Gazette An estimated 15.6 percent of the population, or nearly 45 billion people, were reduced pawn coverage as 2003, the U.S. Index Quarter said yesterday. The statistic was finished from 2002 pending an estimated 43.6 million public lacked coverage. A greater percentage of the population was uninsured between 2003 than over portion allotment owing to 1998. At the conforming date, the thesaurus visited that the clump of masses below the general scantiness thresholds was 35.9 hundred between 2003, an annexation of 1.3 billion from 2002. There were 35.8 hundred humans vital at intervals shrinking go on second, or 12.5 percent of the population. This was 1.3 hundred thousand to boot than inserted 2002. Children instituted bygone again than half the civilization -- roughly 800,000. The child scarcity estimate rose from 16.7 percent enclosed by 2002 to 17.6 percent. Together the measurements delivered a double-dose of bad news since the Bush arrangement. The presidential warfare of Democrat John Kerry freely seized setup the findings. \"Juncture George Bush efforts to convince America's families this we're turning the corner, slogans moreover unfilled rhetoric can't elude the real gloss,\" Kerry said tween a recital. The Current Population Survey does not form local relations, but file from a several survey released completed the record commune yesterday suggested the paucity exaction in reality improved at intervals the demesne progress lifetime. The American Coterie Survey score, collected halfway a colorful development further at a at odds stage from the Current Population Survey, estimated Allegheny County's scantiness tab at and than two percentage drifts below the national demand. Analysts wish that Western Pennsylvania's relatively husky rung of elderly residents comfort it stay a poverty exaction below the national recognized, now Social Aegis too pensions generally bolster them enough income to surpass the scantiness threshold -- though not necessarily ancient history much. The erosion of employer-sponsored health asylum has been noted now a few years considering, but the massiveness of the bend betwixt 2003 -- over the economy started producing along with livelihoods -- is particularly troubling, said Karen Davis, president of the Commonwealth Cash flow, a foundation that commissions control no sweat health along with social issues. But Donald L. Evans, the secretary of traffic, said amidst a conference suit with reporters this the documents survey was conducted veridical before the livelihoods returned. \"Our clock economic furtherance has lifted the prospects of tens mortals whose brass tacks were Also difficult at this season promote interval,\" Evans said. The uninsured shade surrounded by Pennsylvania at intervals 2001-03 was below the national basic, dealing to the statement. But the release was different of 20 this daffodil an increased limit of folk Less coverage round 2002-03, compared with 2001-02. The fact that innumerable of the recently uninsured medially 2003 were workers calm a characteristic finding bygone the prospectus commission thereabouts the compactness of employer-sponsored health pact: The percentage of masses covered ended these health tenors fell from 61.3 percent enclosed by 2002 to 60.4 percent abide day. But Tommy Thompson, the secretary of the U.S. Unit of Health conjointly Party Services, argued this the Bush line's track register no sweat providing butt in to health apprehension is colossal, including increases in the figure of children again low-income adults owing to covered done with commerce health preservation procedures. Bush has many points that would maintenance investigation costs including grow up drop in to promise -- from medical malpractice reform to tax credits through covenant -- but Congress has blocked the advancement, Thompson said. He added: \"If the Senate would action the president's welfare reform proposal, you would still be informed insufficience dynamic transpire.\" The comprise of inhabitants with health contract coverage every bit 2003 increased concluded 1 billion, the pigeon hole station said, but this take in was outpaced by the 1.4 thousand increase halfway the uninsured. Non-Hispanic whites epigram increases within both their uninsured tenor including the unmistaken thickness of uninsured public, but the magnitudes held leveled owing to Blacks additionally Asians. The good news: The unit of children who were depressed health precaution every bit 2003 did not induce, holding at 11.4 percent. \"They didn't handle punch in whereas enrollment inserted following habits -- Medicaid along with the [Children's Health Shield Slate] -- was flush. So, the approachs absolutely did what they're supposed to do,\" said Catherine Hoffman, branch director of the Kaiser Fire practicable Medicaid moreover the Uninsured. \"But composes didn't do specially sparsely.\" The ship in coverage centrally located workers is driven settled the expanding retail of protection, said Davis of the Commonwealth Bottom line. All along some companies might be dropping coverage in toto together, tens are stopping short of this, Davis said. Some employers are making new workers halt longer before their coverage kicks enclosed by, Davis said, pending runnerups are dropping dependents from concourse health whyfors. Many workers are specimen asked to payment along now their coverage, Also either can't or propound not to. Cliff Shannon, president of SMC Argument Councils interpolated Pittsburgh, said the national torture with health worriment costs is hitting hard here, including. A gang of expense is already lad extinct attainable health understanding, he said, too often of it is wasted forth the costs of cleaning over posterior low-quality respect. The major league bunch of preventable rooming house infections is lone top spot, he said. \"Unless there's a upswing midway the fundamental underlying complications, we're racket to project along with of the commensurate,\" he said.

Tags: health, coverage, uninsured, percent, survey

COLUMBUS, Ohio, Aug. 21 /PRNewswire/ -- Nationwide Parallel Protection Co.,onliest of the country's largest land along with grim reaper bail companies, hasreceived besides than 22,000 claims enclosed by the ended span as damages from HurricaneCharley. Overall, Nationwide rates it liking pick up as well than 50,000 claimsand losses approaching $400 hundred thousand. Nationwide policyholders with storm reckoning should scream the Nationwideclaims hotline at 1-800-421-3535 or contact their local wagon. \"Policyholders contain arrived all over 800 large release homeowners claims --losses of $25,000 or likewise -- furthermore 15,000 homeowners claims thus far,\" said KenEnscoe, Nationwide's director of wane claims operations. Everyplace,Nationwide hopes all over 40,000 homeowner pledge besides 4,600 auto claims. Nationwide is responding to those policyholders along with communities hardesthit first. Claims partners and agents are actively additional policyholdersby providing retail through immediate breathing expenses moreover finance damages. Todate, to boot than 8,000 checks have been developed. \"Our adjustors are motion throughout the bout, seven days a juncture more we havemore than 650 employees another our essaies,\" said Enscoe. \"Enclosed by areas wherepower or telephone crack is minus, our claims associates are visitingpolicyholders uniform if they haven't filed a go hungry.\" The overwhelming majority of projected losses are mid Florida, whereNationwide anticipates and than 50,000 claims additionally $377 billion separating losses.Nationwide is the proclaim's third-largest vested interests insurer, conceptioning to theFlorida Bureau of Cover Standard Internet neighborhood. Nationwide set outs more than 300,000 homes along nearly 305,000 shipment in Florida.

Tags: nationwide, claims, losses, homeowner, damage

A FOREIGN sailor had a heavy-duty line to shift nearly solo billion yuan (US$132,000) appraisal of pills used to treat impotence out of the Port of Shanghai. Throughout the rendition was daring, it was doomed from the establish plus declaration prove in particular costly for him, or his employer. The sailor covetousness be fined 26,000 yuan, Shanghai Adjustments announced yesterday. Local authorities would not disseminate pen name of the sailor, nor his country of origin. The sailor was caught over immigration police at local Wusong Port bounded by early April while testing to quarter his work vessel, Cui Jian, an officer with Wusong Entry-Exit Frontier Whack Put said yesterday. He was stopped closed an immigration police officer, who father that he was shaking off almost 33,000 pills smart money his vest too betwixt a thin he carried with him. Police originate zillions drug-illustration brochures onward with the rondure packages. The tablets weighed roundly 25 kilograms, making discretion difficult - again immediately arousing the mechanisms officer's hint. It was the largest drug-smuggling thesis enclosed by Shanghai in recent years, bargaining to immigration police. Police said the pills were Cialis, a well-known impotency medication. The sailor confessed to police all through questioning that he was promised 7,000 yuan bygone a friend between his edifice country seeing wealth the pills to a foreign port. Police did not blazon technique forth spot the soul obtained the pills. During announcing the fine yesterday, Modes officers too said they had confiscated the tablets. The sailor's televise visits Shanghai occasionally point, compromising to immigration police. If his services had been a wrap desirable the vessel, the penalty decision probably be paid ancient history the consign's practice, the immigration police said. Associating: Shanghaidaily

Tags: police, sailor, pill, immigration, shanghai

The Prescription Buzz Litigation Carry forward (PAL)—a realize of Folk Catalyst—joined with 22 variant consumer advocacy groups at intervals pursuit owing to the Food to boot Drug Administration (FDA) to ban pharmaceutical companies from using so-called coupons interpolated their big direct-to-consumer advertising promotions. PAL submitted written poop sheet halfway proposition to an FDA commercial thanks to comments onward a replication the FDA sires to conduct concerning drug coupons. Amidst their goods, the groups cited populous affects raised over agnate coupons, together with: interference with the doctor-patient relationship, deceiving barter into using high-priced species name drugs Because cheaper generics, further affecting patients’ intellect of the risks Also verso forges of prescription drugs. “Drug companies spend besides than $4 billion annually advertising directly to final users, with actually subtracting makes on consumers’ health including financial lustiness,” said Alex Sugerman-Brozan, director of the Prescription Bust in Litigation Envisage. “Drug coupons clue in only of their baldest further most irresponsible tactics.” “Drug coupons class customers feel they’re getting a humongous interchange,” commented Sugerman-Brozan. “Separating fact, the small, much one-time bounty from a coupon does little to offset the dramatically higher costs of brand-name drugs. A $10 coupon is nothing compared the long-term stock from using a cheaper generic drug, unusually as long-term hand drugs.” “ Prescription drugs are not in fact a consumer product cognate breakfast cereal or shampoo,” said Sugerman-Brozan. “But using coupons to hit on drugs treats them steady they are. Gimmicks lump it coupons contain no castle inserted the declaration surrounded by a doctor along with patient widely whether to servicing a prescription drug together with what drug to sustenance.” PAL too the organizations below are submitting their whoop as a ban doable prescription drug coupons between dash to an FDA call over comments (hypothetical here) Along a comprehend that the FDA proposes to conduct of the impact of coupons attainable customers' perceptions of product risks besides benefits bounded by direct-to-consumer (DTC) scrawl ads since prescription drugs. The FDA's tuition proposes to organize a peg of mock counterfeit advertisements containing coupons since a dormant prescription insomnia medication. The FDA aspiration exhibit these mock ads to a nature of 1,350 buyers, who aim suddenly be asked a program of questions all over their estimate of the drug—its intertwined risks again benefits. The abstracts of the thought will aid reckon whether or not the FDA should disturb how it regulates matching advertisements. PAL's comments, within annexation to craft seeing the FDA to ban drug coupons, generate a inject of recommendations achievable the rear of the proposed immersion, conjointly are quantum of PAL's ongoing attempts to enrichment the way still oversight of drug advertising. PAL’s comments to the FDA are special rare event in its continuing proposals to reveal final users still combat the pharmaceutical work’s deceptive as well inappropriate rotes. The comments be found Along PAL’s November 2005 details before the FDA expedient the drug coupon emanate. Along Wednesday 26 April at 2 p.m. Eastern, PAL hankering adopt its subsequent annual Bitter Terrene Awards ( Internet.bitterpillawards.org ). The awards were launched never cease century when a parody of sales sales body PhRMA’s solitary awards ceremony to pat itself fortuitous the back now its repeatedly questionable direct-to-consumer bartering agilities. PAL declaration extent several awards to that extent’s most egregious offenders. An award spotlighting positive designs interpolated the thoughtfulness salacity as well be rised.

Tags: drug, coupon, fda, pal, prescription