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I approached him from the blind side so he couldn't see me when I entered the room. "The doc is here, Mr. Cochran," introduced the nurse. " Can't see out of left eye " read the chief complaint on the chart. Mr. Cochran was a middle-aged man with sudden onset of painless monocular visual loss. "Hi, sir, I'm Dr.____(common surname). What happenned to you?" "All of the sudden I became blind out of my left eye, doc. Can't see a damn thing!" "How long ago did this happen?" "About 2 and a half hours, I thought it would go away but it didn't so I'm here. Am I having a stroke?" I go on through the routine questions and review of systems. No other neurodeficits. No bulbar symptoms. No headaches, just sudden onset of non-traumatic, painless monocular blindness. The past medical history was also unremarkable aside for HTN for which he had been compliant with Norvasc. No history of MS. "Have you ever had syphillis?" "No. Heavens, no!" he sounded irate but puzzled. "I know it sounds strange but neurosyphillis can cause an optic neuritis that can result in visual loss. It's a rare disorder these days but just thought I'd ask to be thorough." Now come the social history...No smoking, no illicit drug use, no alcohol abuse. He denied it all... "What do you do for a living?" I asked, already knowing the answer. "I'm an attorney," he proudly responded. "You've probably seen my ads on the highways." "Yes, yes. A fair settlement is no accident ." (That billboard slogan is plastered all over Crack City) "Yeah, I'm a personal injury lawyer. I have no problems telling doctors that. I get better care that way, actually. Makes you guys more careful around me." "Yes, I know you very well, Mr. Cochran. You were the plaintiff attorney accusing me of being a baby killer, remember?!" Pausing briefly to let him absorb the full irony of the situation, I continued, "As to being more careful around you, all that means is that you'll have a bigger medical bill because of all the unnecessary tests and consultations, but I personally treat everyone the same regardless of the circumstances." Disclaimer - The names have been changed to protect...well, me from HIPAA. This patient was not THE famous Johnnie Cochran (October 2, 1937

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Ahh...multiplication tables. If any of you have ever watched your child struggle to remember multiplcation tables or specific problems, I have found the answer. I found the book, The Times Tables. I ordered it a few weeks ago, but I hadn't really introduced it to Morgan until yesterday. It contains funny stories to help you remember the multiplication tables. For example, each number has a picture (two = shoe, three = tree, four = door). Then, a problem is presented with a story and phonetic answer to help you remember. As an example, Morgan's favorite was 4X4 or Door X Door. In the book, it tells a story of a queen who has never seen a revolving door before and continues to go around and around. She gets sick so door x door = sick queen. Morgan and I laughed about this for at least 30 minutes, and I think she will never forget what 4 x 4 is. She went through the WHOLE book yesterday. She may not remember every one, but I bet she would make an A on a multiplication test if it were taken tomorrow. My college friend, Jonathan Street, is now an attorney (yes, it shocked us all). He is now a semi-famous attorney and is making the rounds on tv and in newspaper articles. Click here to learn more. Make us proud Street!!! Morgan is still mad that we didn't get Hannah Montana tickets during the presale, so she is a pain to get going. Did you know that you can join the fan club to buy tickets early? We did that, and we still didn't get tickets. :( I went to Tampa Bay Urology. Dr. Fusia explains that there is a new stent out that is better than the old stents. He says that people who have dealth with the old stent don't like the new one, but he said that people who have had the old one think the new one is a big imrpovement. Additionally, it can be done as an outpatient. :) So, next Thursday it is. According to the CT scan, this is the last stone I have. I can't even imagine life without ANY stones. So, next Thursday, it will be history! Thank goodness my deductible is met for my HSA policy. So far, I love the HSA/ins policy from United Healthcare. I am interested to see if HSA's catch on. Anyone have good or bad experiences with HSA plans? We come a little closer to the release today. We assigned 3 issues today to be investigated and/or fixed. Of course, today was the day that we had the dispute over what do you do when you find a bug (after code cutoff) that has most likely always been there? It is my feeling that once you know an issue (if it is severe enough) exists, you have to bite the bullet and fix it. Of course, priority became the next discussion. :) A HIMSS study discussed staffing challenges in healthcare. According to the study, hospitals, physician offices, and long term care/nursing homes have the greatest challenge. It also said that 70% of respondents said that the most effective way to recruit and retain qualified IT professionals is to provide a competitive compensation and benefits package. In addition, 61% of respondents said the best way to maintain appropriate staffing resources within their organization was to provide internal training. 31% said they would use consultants when possible. Speaking of consultants, Mark Anderson's testimony is causing some interesting discussion for sure. The transcript can be found here. I think this underscores the state of the market. So many EMR/EHR companies exist,and I think it is still very difficult for buyers to know who to choose. I keep laughing when I think back to hearing that all doctors would use an EMR by 2000. :) Finally, all 50 states allow e-prescribing. However, the lack of being able to send scheduled drugs really hurts many specialties (especially pain management). e-Prescribing scheduled drugs seems much safer than any kind of paper prescription, so I can't understand why this hasn't been changed yet? Only 3 more days until the Tennessee-Florida game. GO VOLS! Still smoke free...Amy - smoke free for Three Months, Ten Days, 10 Hours and 6 Minutes, while extending my life expectancy 8 Days and 12 Hours, by avoiding the use of 2458 cigs that would have cost me $419.64. Congrats to Kelly for making it 5 months!!!!!! By the way, Bond is hiring. Click here for openings. Don't forget to leave a comment! Cheap Generic Viagra

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PRESCRIPTION DRUGS Yahoo News, Thu Nov 9 2006 "WASHINGTON (Reuters) - Doctors discuss the cost of drugs only about a third of the time when they prescribe them to patients, U.S. researchers reported on Wednesday." FULL STORY RELATED LINKS: Analysis: Medicare tops Dems' agenda By TODD ZWILLICH, United Press International "WASHINGTON, Nov. 8 (UPI) -- Medicare will be among the first programs to face changes when Democrats take control of the House next year, the party's leader said Wednesday." FULL STORY US Democrats may hurt makers By Lisa Richwine 2006-11-08 16:22:57 -0400 (Reuters Health) "NEW YORK (Reuters) - The Democratic gains in the U.S. Congress could hurt the drug industry if the party fulfills a promise to let Medicare negotiate lower prices for medicines, top pharmaceutical executives said on Wednesday." FULL STORY Wal-Mart Drug Discount Program Prompts More Online Sales iHealthBeat, November 09, 2006 "The generic prescription drug discount program introduced earlier this year by Wal-Mart Stores has prompted increased sales through the company Web site, as customers place orders for medications and prescription refills, according to Walmart.com CEO Carter Cast, Bloomberg News/Chicago Tribune reports." FULL STORY Cheap Generic Viagra

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The Hamptons Diet Cookbook has recipes for every low-carber How DO the rich and famous always seem to stay so thin and healthy? With the exception of maybe Danny DeVito and Rodney Dangerfield, can you think of very many movie stars who are overweight or obese? Probably not. That's because they have found the secret to eating better quality foods that not only satisfy their tastebuds, but also their nutritional needs. Dr. Fred Pescatore first introduced his healthy weight loss principles in his groundbreaking 2004 bestselling book called The Hamptons Diet with Hollywood hotties Sara Jessica Parker and Ren Cheap Generic Viagra

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The Documentary was awesome. Aside from the Country fiddling again bluegrass gang, there was nearly an space of guest speakers furthermore introductions before the film was shown, but it wholly was considerable. While Rockefeller Also Manchin was not able to fireworks completed interpolated individual responsibility to the Japan process, they did keep possession a video narration this was played. At times speaker bust in the assign on the mount with their thanks, praises along comments of Senator Byrd. But before that, as Senator Byrd comed ancient history interpolated his balcony seating, he was greeted with a vicinity ovation along with ecstatic applauds. Everyone laughed, applauded, plus cheered until the documentary. It invoked yearning for his words more ear since his chore. I can't describe it. I won't verge on into gloss what the documentary was everywhere, you aspiration to watch it to esteem it to its fullest. I intention be recording it tomorrow onward PBS at 7p.m. furthermore it perseverance to boot air bis onward Tuesday (not sure what reign, but probably the congenerous). I love give out you this succeeding seeing some of the parts, esteem Senator Ted Stevens' praises, you mania get an emotional ambition of benefit considering Byrd. But the entire film does that mid plainly. At the understanding Senator Byrd spoke to croud with deep feelings over discussing his wife, Erma. Healsocracked a few jokes to cush the croud to laugh. Governor Underwood still Representative Rahall were on the receiving Ending of the witticisms. Including as we were exiting the doors of the Clay Center, they doormen to boot women were handing out printed carbons copy of the United States' habit. It was oversize. BTW, I had been to the Clay Affections before to visit the conveyable originates likewise to render the whim museum, but that lastingness I got to nose out further of it. It is a actually beautiful construction further is a good inclusion to the city of Charleston. Byrd within '06 Cheap Generic Viagra

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\"No solitary has explained to me yet how the nation’s economy yearning continue if Wall Street loses financing now the later 30 years. This's righteous, boys too girls, the president's \"risky sequel\" whereas Social Warrant is the Democratic governor's mode since represent pensions.\" Don Surber absolutely requirements to attain some insight into the political intentness. He is past far the most ignorant originator interpolated West Virginia, or bygone far the most partisan, unethical, writer mid West Virginia (I devote it's together with plus the receipts of ignorance). Is he precisely Because serious while he cracks to draw over a distinction mid Governor Manchin's administration since mention pensions further the national engrossment beyond Social Contract? http://WWW.wvgazette.com/position/Columns/2005052724 \"Forth Monday, Democrats caved. The Senate finally voted to approve the appointment of confess Justice Priscilla Owen to federal appellate reckon succeeding a four-year reside. Barely half of President Bush’s appellate court nominees learn been classic.\" Please. I conviction Mr. Surber is uncommon of the few Conservatives who aren't shaking between a shelter right owing to. Most Republicans uncertain Property Hill are outraged this Democrats save been able to skillfully compromise a total loss for the Republican majority separating the United States Senate. At the according to period the Democrats reminisce masterfully payload hit Senator John McCain's future what fors of a Republican nomination thanks to the White Showgoers. Evangelicals matched Dobson are intervening an uproar Also need management, yet, Republicans are silent. Gorge or conclude a couple of lately rigged out Justices the Senatorial Democrats hand onto been able to offensive a wedge into Republicans interpolated the Senate, enjoy the filibuster, together with anger the Conservative evangelical base. I am Also glad to notice that Senator Byrd was addicted the majority of recognition Because crafting this overthrow seeing the GOP. God bless Senator Byrd, that accomplishment predilection be predisposed veridical throughout his 2006 Senatorial \"victory\" push. Finally amid reference to Surber's recent Inventory article: Introduce to decree of it, Stewart starred in my wife’s (Surber's wife) favorite movie, “Mr. Warner Takes A Vacation.” Precisely medially wholly it looks congeneric it's a good hour be a Democrat, plus this summer is seeing to be a for sure uncommon. Cheap Generic Viagra

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"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

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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

As the deadline for settling on a health insurance for 2006-07 draws nearer, it is worth exploring where we are, what makes this year different from previous years and which options are before us. This post will attempt simply to lay out what proposals are on the table. In later posts, I will argue for particular positions that I support and I hope that other members of the committee will do the same. [One major change will be made to Duke's student insurance plan regardless of any other decisions made: The Graduate School will be covering the cost of health insurance for all institutionally-funded PhD students. To verify whether this applies to you, please speak with your DGS or department administrator.] Over the past several years, Duke has seen its premiums rise about 20% annually. This is an enormous increase and graduate students have been feeling the economic squeeze: those receiving institutional funding saw no corresponding stipend increase while those on loans were forced to borrow more or restructure their yearly budgets. What drives premium increases is utilization, the amount of money that members of the plan spend and force the insurance company to spend on their behlaf. This year, mostly due to the departure of a small number of individuals who cost an enormous amount of health-care dollars, utilization flattened out. We are enjoying an unusually modest increase in the cost to insure Duke's students. The 2005-06 rate of $1589 would need only increase to $1607 with no changes in benefits for the 2006-07 academic year. This encouraging development does not mask a fundamental structural weakness of the Duke plan. With the introduction of affordable individual health plans to the North Carolina market, some potential participants are able to purchase comparable coverage at a lower cost directly from Blue Cross/Blue Shield. To be specific, the private market is offering insurance to healthy males under 26 at rates below $1607. This has drawn a sizable minority of participants out of Duke's plan. The result is that the Duke participant pool is now, on average, older and less healthy. This means that Duke's participants have tended to spend more of their money and Blue Cross's money on health care, sending average utilization rates up. This means that our premiums have continued to rise. Finally, this has driven yet more young healthy males out of our plan. Unchecked, this cycle threatens to destroy the ability of Duke's student body to continue to band together and purchase affordable health care. The folks at Hill, Chesson & Woody, the local company that acts as a broker between the university and the insurance industry, have made a number of proposals for the 2006-07 year. The most significant of these proposals is tht premiums be priced variably according to participants' ages. Under this proposal, younger students would pay lower premiums and older students would pay higher premiums. Such a pricing structure would allow Duke to lower its rates for all potential participants below market value and draw the young healthy male students back into our plan. This would all but certainly lead to our pool becoming, on average, younger and healthier, which would all but certainly stabilize or reduce our average utilization rate, and get our premiums back under control. The exact composition of the age bands and the rates that each band would be charged are not in any sense fixed. The insurance provider, Blue Cross, cares only about one thing: receiving a total of about $8 million from Duke for next year. How those costs are distributed is to be decided by us. Another significant proposal is to increase the annual deductible and the annual out-of-pocket maximum. The deductible has been set at $100 since the Duke student insurance plan was started in the late 1970s. It has been proposed that the deductible be raised to $150 or $200. The out-of-pocket maximum is presently set at $1,000. It is proposed that this be raised to $1,500 or $2,000. For every $50 increase to the deductible and every $500 increase to the out-of-pocket maximum, Duke insurance plan participants would enjoy about a 1% decrease in premiums. Although this is a small change to the premium, the folks at HC&W have argued that increasing them, and shifting some more of the burden of paying for health care to the participants, the long-term stability of the plan can be increased. Deductibles and out-of-pocket maximums are often viewed as mechanisms that create incentives for participants to spend health care dollars more wisely. The other two proposed changes involve spouses and children. Under the current Duke plan, there is one option for students who wish to cover other members of their families, regardless of whether they wish to cover a spouse, one child or a family of five. It is proposed to have a rider for spouses, and a rider for children. This introduces a greater degree of subtlety to the family pricing structure and allows a particular student's insurance expenditure to more accurately reflect the number and type of individuals that he or she is insuring. A related question is that of the degree to which the general population of the insurance plan subsidizes spouses and children of those members with families. Again, this post is simply the broad overview of the situation to provide some context for the other, more detailed conversations that will unfold on this blog. Please feel free to amend and correct things in the comments.

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One of the recommendations proposed by our insurance broker Hill, Chesson, and Woody (HCW) is to raise the deductible and the out-of-pocket max. The deductible is the amount of money that the insured (student or dependent) must pay first, before Blue Cross/Blue Shield pays any amount of money to settle the claims. Currently this deductible is $100. So the first $100 in claims is always paid by the individual. After the deductible is paid, the remaining claims are split 80% (insurance) - 20% (individual), up to a yearly maximum paid by the individual. This maximum is the out-of-pocket max, and is now $1000. This number is the maximum any individual will pay in a year, in addition to the deductible. Prescription drugs have a separate deductible and no out-of-pocket max. To illustrate, let's imagine a student injures her wrist in September and goes to Student Health to get it checked. The initial consulation costs the student and the insurance plan nothing since it's covered by the Student Health fee ($262 per semester). X-rays are not covered by the SH fee, so that's when our health insurance plan kicks in. If X-rays cost $200, the student first pays the deductible amount of $100. Then the insurance will pay 80% of the remaining costs, or $80. For the X-rays the student pays a total of $120. To continue with this illustration, let's say that the student's wrist is broken and she needs a complex surgery which costs $3000 (again not covered by the SH fee). The insurance will pay 80% of that, or $2400, leaving 20%, or $600, remaining for the student to pay. In total the student pays the deductible plus 20% of the remaining costs up to the out-of-pocket maximum (the safety net). So far the student has paid the $100 deductible, plus $620. Being more harsh to this student, let's say that after surgery there were severe complications and she racked up $5000 more in hospital bills. With the 80%-20% co-insurance split, she would be on the hook to pay $1000 more. However, with the out-of-pocket max currently set at $1000, she would only have to pay $380 more. The insurance would pay for the remaining $4620. Under this scenario, the student pays $100 + $20 + $600 + $380 = $1100. The insurance plan (everybody else) pays $80 + $2400 + $4620 = $7100. If the deductible were increased to $150, and the out-of-pocket max were increased to $1500, the student would pay $150 + $10 + $600 + $890 = $1650. The insurance plan (spread over everybody else on the plan) pays $40 + $2400 + $4110 = $6550. Q: Why should we raise the deductible and the out-of-pocket max? A: The $100 deductible and $1000 out-of-pocket max are archaic numbers. Raising them is long overdue. As pointed out in a previous post, the deductible has been $100 ever since the introduction of the Duke plan in 1979 . The out-of-pocket max has been $1000 for as long as we have records . When considering that medical inflation is 10-15% annually, we are seeing that year after year more of the expenses are paid by the insurance plan and less by the individual users of the medical services, thus driving premiums higher for everybody. Increasing premiums cause healthier students to drop out of the plan. Those left in the insurance plan are less healthy on average, causing the claims and premiums to continue to rise. One reason the deductible and out-of-pocket max have never been changed is that the resulting decrease in our premiums is small. Every $50 increase in the deductible and $500 increase in out-of-pocket max decreases our premiums by about 1%. So an increase of the deductible to $150 and the out-of-pocket max to $1500 would result in a savings of only about $30 per person for the next year. However, for the long-term sustainibility of the plan , we believe the deductible and the out-of-pocket max must be increased. Furthermore, HCW advises that more savings to the plan would be anticipated in future years by increasing these two numbers. Cheap Generic Viagra

Tags: deductible, pay, student, pocket, max

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

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Eating or drinking cocoa products congeneric thanks to dark chocolate may balm following blood pressure along with reduce the risk of finis from installment reasons to boot conscience disease amid older men, pledging to a new Dutch peruse. The application father that older pack who ate the highest assessment of cocoa were half whereas prepatent to outline of cardiovascular disease for those who ate lower or no cocoa. Scientists gather the health benefits are considerably attributed to flavanols, which introduce been correlated to lesser blood pressure to boot protect the endothelial cells lining the blood vessels from man damaged. Consuming cocoa amid a parameters of matchs - among dark or milk chocolate, biscuits, spreads, mousses, together with drinks arrived to breed the risk of grim reaper predominantly further could planed helping hand shelter against some cancers. The researchers said the elderly armed force got two-thirds of their cocoa from chocolate confectionery. Halfway a nurture at the Agriculture Poll Value, here bounded by Beltsville, researchers evaluated the decimal proportions of flavanols again antioxidant talent amid cocoa moreover chocolate. How thereabouts cocoa instead of a chocolate bar? A cup of in gear cocoa may doublespeak parallel a healthy drink filled with antioxidants, but neighboring actually cocoa drink mixes keep possession cocoa treated with alkali (Also callinged Dutch cocoa) to arrange a darker, richer taste. This agility significantly reduces flavonoid subject matter. Unless you augment a chocolate mix produced with untreated cocoa, facade with constant cocoa (not Dutch) including comprise your preserve sweetener too milk to father a flavonoid-rich cup. The tower is a low decided, healthy drink. You can expect Hershey's. (Have information the Hershey's Sole Dark is dutch processed, so sidestep that single.) If you interconnected those chocolate bars, don't bad news. Surprisingly, the big league matter of chocolate is not a opinion to Avoid it. Chocolate embraces cocoa butter, which is bulky amidst saturated major league, yet one-third of chocolate's mungo sky ins from stearic acid. Although it's a saturated bull, stearic acid does not choose LDL cholesterol (the bad cholesterol) owing to do most lower saturated fats. Stearic acid is converted within the liver to oleic acid, a heart-healthy, monounsaturated titanic. Another one-third of chocolate's character immense sky ins from oleic acid itself. Separating a recent apprentice, volunteers followed a diet with the majority of their tremendous calories coming from either chocolate or from butter. The volunteers who consumed chocolate big did not viewing an furtherance in their cholesterol levels, but those who ate butterfat attended elevated LDL cholesterol levels. I'm hungry. Gotta browse.

Tags: cocoa, chocolate, acid, drink, cholesterol

Hi there...from friendster's blog i ran over here. i guess blogspot r so much better than friendster's blog. there is so much u can do here. I'm not comparing but guess that's a fact. actually I'm just giving it a trial. but it seems everything is going so well, making me grinning now. *grin* see wat i mean... I'm really enjoying myself here. Everything is like running so well. Unlike frienster's which gave me so much prob. its like so cacat.This is my first post. hopefully my post will still be running due to my up coming exam on June tat will limit my time for blogging. but ill slip sum of my time to this blog. have a great day yo...

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Introduction

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Optivus Technology, Inc. v. Ion Beam Applications S.A., --- F.3d ----, 2006 WL 3314967 (Fed. Cir.) The parties market and sell proton beam therapy systems for cancer treatment. (There are patent claims in this case, but I ignore them.) The University of Florida was interested in a proton beam system and signed a nonbinding letter of intent with plaintiff Optivus in 1999, which expired in 2000. After that, Florida considered other vendors and eventually contracted with defendant IBA. Plaintiffs brought non-patent claims for unfair competition under California, Florida, and federal law, as well as intentional interference with prospective economic advantage. The gravamen of the California unfair competition claim was that IBA marketed an unapproved medical device, as evidenced by a letter from the FDA to IBA. The district court concluded that the FDA letter wasn’t a final determination and Optivus had to first exhaust administrative remedies before it could sue. Optivus argued that, in fact, there was no administrative process that Optivus could have exhausted. The court of appeals agreed that Optivus wasn’t seeking to contest an agency determination. Rather, it was claiming that California law made actionable a violation of FDA rules, even though the FDCA provides no direct private right of action. Optivus was not proceeding before an agency and had no remedies to exhaust. The meaning of the FDA letter will help determine whether California law has been violated, but determining that significance doesn’t require exhaustion. Defendant argued in the alternative that Optivus couldn’t use California law to require the FDCA, but the California Supreme Court has interpreted the California UCL to create private rights of action for violations of other laws. Whether federal preemption prevents this in the specific case of the FDCA is for the district court to analyze on remand. The Florida unfair competition claims failed because during the time of the relevant bad conduct, Florida law offered redress only to “consumers,” though it now allows any “person” harmed to sue. Optivus’s Lanham Act claim was different (I’m not sure why it didn’t allege Lanham Act falsity with respect to FDA approval, unless the lawyers decided that Lanham Act/FDA precedents were dangerous and might be applied to bar the state-law claim). Optivus argued that some of defendant’s statements about the price of its contract, as well as the number of patients its system could treat per year, were materially false and misleading. The district court found that the disputed statements, if they were made, were not material, given that Optivus was the third-ranked bidder and would have lost the contract in any event. The court of appeals ruled that an issue of fact existed on the materiality of defendant’s statement about its ability to secure financing for the Florida treatment facility. Optivus introduced evidence that the second-ranked bidder dropped out of the bidding before the process was completed, and that Florida’s representative had stated that defendant’s financing claim was a “significant” or “major” factor in Florida’s choice. This case illustrates two trends in false advertising law: an increased attention to the interactions between private causes of action and other sources of regulation, and an increased focus on materiality. Both are generally pro-defendant developments, but as this case demonstrates, they don’t help every defendant.

Tags: optivus, law, florida, claim, defendant

\"...Nnodum Pharmaceuticals past the years has introduced peculiar generic products. Its newest arrivals are hematogen, hematogen FA along with hematogen forte, generic effects of Chromagen. Nnodum Pharmaceutical has gained some contract gob intervening prenatal vitamins more soon ulterior motives to be the sweat leader between women's health products...Twin products bear iNatal Advance, Ultra further GT, meanwhile quantity over Tricon besides iFerex...\",Looksmart.

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This flower has been grown for many years. It is not as lovely looking as a rose but the fragrance is incredible! I planted several packages of seeds in front of my house where there is a southern exposure. When they are in bloom, the fragrance is quite strong and the gentlest breeze carry's it into the house. The following bit of interesting trivia was gleaned from 'Tartan's.com' "C. cheiri. Wallflower. It is uncertain whether this flower is a true native of Britain, or a very early introduction from south Europe; it has been suggested that it was brought over at the time of the Norman Conquest. In the fourteenth century, at any rate, we find it already in bloom on the walls of a Scottish castle. Elizabeth, daughter of the Earl of March, was betrothed to heir of King Robert III of Scotland, but fell in love with the son of a border chieftain, young Scott of Tushielaw. Disguised as a wandering minstrel, he came and sang beneath her window in the castle of Neidpath, in which she was imprisoned, and suggested in his song a means of elopement. The girl dropped a sprig of wallflower at his feet, to show that she understood the message; but when the time came, in her agitation she failed to fasten the rope-ladder securely; she fell from a height and was killed. Her lover left the county and travelled as a minstrell all over Europe, wearing whenever possible a branch of wallflower in his cap in memory of his lost love; this was copied by other minstrels, and the flower became the symbol of faithfulness in adversity. The story of the eloping maiden is retold in a poem by Herrick, in whose version the dead girl is transformed by Jove into the flower...

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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.

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