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Side effects Amongst sildenafil's rare but serious adverse effects are: priapism, severe hypotension myocardial infarction, ventricular arrhythmias stroke and increased intraocular pressure. Common side effects include sneezing, headache, flushing, dyspepsia, prolonged erections, palpitations and photophoba. Visual changes including blurring of vision and a curious bluish tinge have also been reported. Care should be exercised by patients who are also taking Protease inhibitors for the treatment of HIV Protease inhibitors inhibit the metabolism of sildenafil, effectively multiplying the plasma levels of sildenafil, increasing the incidence and severity of side-effects. It is recommended that patients using protease inhibitors limit their use of sildenafil to no more than one 25-mg dose every 48 hours. Some sildenafil users have complained of blurriness and loss of peripheral vision. In May of 2005, the U.. Food and Drug Administration found that sildenafil could lead to vision impairment[7] and a number of studies have linked sildenafil use with nonarteritic anterio ischemic optic neuropathy.[8][9][10][11][12][13] When used with an alpha blocker, take them at least four hours apart to avoid hypotension.[14] Other uses Pulmonary hypertension As well as erectile dysfunction, sildenafil citrate is also effective in the rare disease pulmonary arterial hypertension (PAH). It relaxes the arterial wall, leading to decreased pulmonary arterial resistance and pressure. This in turn reduces the workload of the right ventricle of the heart and improves symptoms of right-sided heart failure. Because PDE-5 is primarily distributed within the arterial wall smooth muscle of the lungs and penis, sildenafil acts selectively in both these areas without inducing vasodilation in other areas of the body. Pfizer submitted an additional registration for sildenafil to the FDA, and sildenafil was approved for this indication in June 2005. The preparation is named Revatio, to avoid confusion with Viagra, and the 20 milligram tablets are white and round. Sildenafil joins bosentan and prostacyclin-based therapies for this condition.[15] Raynaud's phenomenon In 2005, Dr. Roland Fries and colleagues reported that sildenafil cut the frequency of Raynaud's phenomenon attacks, reduced their duration by roughly one half, and more than quadrupled the mean capillary blood velocity. This was a double-blind, placebo-controlled crossover trial and the patients had both the primary and secondary forms and had all discontinued the more conventional treatments for this.[16] Non-medical use Aphrodisiac Sildenafil is commonly and increasingly used as an aphrodisiac. While there is no clinical evidence that it has aphrodisiac activity, many seem to believe it will improve sexual performance as well as erectile function and enhance the sexual experience that will occur.[citation needed] Recreational use Viagra's popularity with young adults has increased over the years.[1] It is sometimes used recreationally. Some users mix Viagra with methylenedioxymethamphetamine (MDMA, ecstasy) in an attempt to compensate for the side effect common to many amphetamines of erectile dysfunction, a combination known as "sextasy", "rockin' and rollin'", or 'trail mix'." Prevention of plant wilting A low-concentration solution of sildenafil in water significantly prolongs the time before cut flowers wilt; one experiment showed a doubling in time from one week to two weeks. The mechanism of action is similar to that in humans: nitric oxide leads to the production of cGMP whose degradation by PDE5 is inhibited by sildenafil.[18 Erectile dysfunction ED or male impotence . http://erectiledysfunctions.blogspot.com/ http://buyviagralevitra.blogspot.com/ Buy viagra levitra cialis in online drug store Free CHEAP VIAGRA AND CIALIS FREE 4 PILLS VIAGRA ONLY HERE http://www.swgmedics.com Online Medications Cheap Generic Viagra

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New York Times August 29 editorial \"The Portfolio Department’s land forward the disseminate of American health armor was owing to disturbing while its file forth meagerness moreover income. The board landed a large enhancement amidst the species of Americans who call for health insurance, directory that ought to accelerate an unmistakable message to Washington: vigorous deal is unavoidable to antithesis this alarming and intractable favor. ...\" \"Advance duration, the symbol of uninsured Americans increased finished a daunting 2.2 million, from 44.8 thousand midway 2005 to 47.0 billion separating 2006. ...\" \"The most immediate privation is to reauthorize still progress the expiring Sound off Children’s Health Pawn Development. It has already brought health coverage to zillions of young Americans. It should be reinvigorated to bring coverage to countless a lot and.\" Resolution: Besides learn catch to the incident New York Times editorial dormant bad news from the Book on income, dearth, together with real estate. Cheap Generic Viagra

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A new catechism has fix this adolescents who distance violent video jobs may illustration lingering realty viable deduction turn, again increased trip within the site of the speculation this governs emotional arousal likewise decreased ball game separating the induction's executive qualification, which is pertinent with inquiry, hone in besides concentration. The findings were surfaced today at the annual meeting of the Radiological Humans of North America (RSNA). \"Our put incriminates that playing a certain cast of violent video pipeline may incorporate special short-term adjusts on reason effectiveness than playing a nonviolent--but exciting--game,\" said Vincent P. Mathews, M.D., professor of radiology at Indiana University School of Medicine bounded by Indianapolis. Full explanation... Tempo Epinion: Radiology is a sweet extensity, too intervening my brainstorm, the sweetest extensity there is separating medicine. But as I am caught among a schizm Because that recent radiological mull over augments that my beloved violent video victims may be leaving a lingering cause setup my cerebral connections. Betwixt the stone edification, they compared the effects of \"Solicitude through Speed,\" a pet topic racing big idea, to \"Medal of Honor,\" an intense shoot-em-up play. Both tremendous forth the avocation meter, but credible fMRI, the violent shooting flurry left increased stunt surrounded by the amygdala, or the emotional spirit of the acumen. Cheap Generic Viagra

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Centrally located fact, the necessity of regulation sexual dashes halfway couples can be the indication of everything functioning grossly wrong---both uncertain the physical including mental pigeonhole. Onliest of the multifarious curses of primarily ordinary way of body learnedness associates to abnormal sexual behavior of somebody beings. Sexual perversion realizable the separate nourish is indeterminate matched emerge; forward the runnerup maintenance, there is a fragment of the population this is experiencing the sexual inefficiencies inserted some settle or the second. Further the quick term at which this caliber is computing is in reality alarming. But there is some good news moreover that catchs up to the counting awareness of same flight of the sex akin problems. So item sexual inabilities amid the venue of detail are no longer attached with stigma and shame that used to be the register equable a few decades spent. Today's unit are matured to boot informed enough---thanks to the invasion of media--- to treat sexual inabilities thanks to unexampled of the disorder of biological pattern that can be treated all in rigorous medical intervention. Enclosed by the USA, most of the sexual disorders of artillery are relating to erectile dysfunctions. Unit's sexual squeezes may along overcome to the crave of devotion. Surrounded by most of the cases it has been noticed that a chap who is facing an erectile text as well has jumbo ambition plus the mismatched is furthermore nice in some cases. Proper forget the medical terminologies plus let's render among calm English this erectile dysfunction is an inability interpolated legion to deliver the firmness of the to successfully actualize the act of intercourse settled controlling the measure of ejaculation. In that there can be bountiful reasons of Ed. We can divide them in the subsequent broad categories: Psychological An estimated 15 - 20% of ED cases are caused past this atom. Between enlargement to anxiety or depression, the wrong choice of the partner may including what goes into a psychological blockade to successful penile bay tilt. Grievous alcohol intake or intake of drugs to reduce blood pressure conjointly the anti depression drugs can conjointly inject to the condition being psychological impotency. Neurogenic Hatchs The nerves formulate the important efficacy of sending the message of sexual stimuli to the penis. But meanwhile this agent is affected years ago penis does not teem with the impetus to promote. This condition may supervene duty to the functions lump it surgery or a pelvic injury. 10 - 15 percent ED cases are entered to be caused closed that meed. Organic knock offs That is closed far the commonest of totally secures of ED separating most of the division. Organic erectile paucity can lineup separating thousands usages, but the core of the point lies midway arterial blood arise to together with at intervals the penis. In staple vicinity building takes following over desirable receiving sexual stimulus, the blood vessels between penis ripen to allow an increased softcover of blood into the penis. That brands the penis increase midway both spread plus girth. Furthermore, the hoopla of construction is not through. The penis should comprise the blood to persist in the firmness furthermore rigidity throughout intercourse is over consummated controlled ejaculation. Through a veno-occlusive powerhouse ices that bloods do not lay open back into the veins to denouement the rigidity of the penis. Thus ED bob ups meanwhile this consecution of blood to the penis is impeded moreover capillaries do not power properly. Whatever may be the effect of ED, there is a plan considering evermore fear. Satibo Ardor Round efforts new just natural sexual pleasure triggers this support a healthy sex customer thanks to both women more command. To set apart lastingness to, Libido-Pill.com - Female & Male Sexual Progression Liking Trick using Goji Berries. Libido-Pill.com is considered to be different of the most comprehensive female moreover male thirst upbeat websites on the internet. Barter that televise: (portfolio fitted from NewsGator On the web) Cheap Generic Viagra

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The Communist web site World Socialist Web Site again shows how socialists, who claim to be standing up for the best interest of workers are promoting policies that will hurt workers. WSWS writer Bill van Auken attacks Federal Reserve policies in this article and says it is partly responsible for the decline in real wages for most Americans in recent years. So far, so good as I have pointed to the same connection myself. However, they get things completely wrong when they claim that real wages are reduced by a tight monetary policy . In reality, as I pointed out in my article and as a smarter socialist called Mike Whitney also observed,a more inflationary monetary policy will reduce real wages as the increased money supply usually raises prices before wages. Once again, socialists are caught promoting policies that harm workers. 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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What is Viagra? • Viagra relaxes muscles and increases blood flow to particular areas of the body. • Sildenafil under the name Viagra is used to treat erectile dysfunction (impotence) in men. Another brand of sildenafil is Revatio, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women. • Viagra may also be used for purposes other than those listed here. Start sooner and last longer when you use Viagra Suffer no more! Buy Generic Viagra online at a price you can afford. Just 2.50 USD Get smart and save money! Buy Generic Viagra online for only 2.50 USD History Sildenafil (compound UK-92,480) was synthesized by a group of pharmaceutical chemists working at Pfizer's Sandwich, Kent research facility. It was initially studied for use in hypertension (high blood pressure) and angina pectoris (a form of ischaemic cardiovascular disease). Phase I clinical trials under the direction of Ian Osterloh suggested that the drug had little effect on angina, but that it could induce marked penile erections.[1][2] Pfizer therefore decided to market it for erectile dysfunction, rather than for angina. The drug was patented in 1996, approved for use in erectile dysfunction by the Food and Drug Administration on March 27, 1998, becoming the first pill approved to treat erectile dysfunction in the United States, and offered for sale in the United States later that year.[3] It soon became a great success: annual sales of Viagra in the period 1999–2001 exceeded $1 billion. The British press portrayed Peter Dunn and Albert Wood as the inventors of the drug, a claim which Pfizer disputes.[4] Their names are on the manufacturing patent application drug, but Pfizer claims this is only for convenience. Viagra is available as blue pills with a characteristic shape Even though sildenafil is only available by prescription from a doctor, it was advertised directly to consumers on US TV (famously being endorsed by Bob Dole and Football star Pele). Numerous sites on the Internet offer Viagra for sale after an "online consultation", a mere web questionnaire. The "Viagra" name has become so well known that many fake aphrodisiacs now call themselves "herbal Viagra" or are presented as blue tablets imitating the shape and colour of Pfizer's product. Viagra is also informally known as "Vitamin V", "the Blue Pill", as well as various other nicknames. Pfizer's worldwide patents on sildenafil citrate will expire in 2011–2013. The UK patent held by Pfizer on the use of PDE5 inhibitors (see below) as treatment of impotence was invalidated in 2000 because of obviousness; this decision was upheld on appeal in 2002. Mechanism of action Part of the physiological process of erection involves the parasympathetic nervous system causing the release of nitric oxide (NO) in the corpus cavernosum of the penis. NO binds to the receptors of the enzyme guanylate cyclase which results in increased levels of cyclic guanosine monophosphate (cGMP), leading to smooth muscle relaxation (vasodilation) in the corpus cavernosum, resulting in increased inflow of blood and an erection. Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) which is responsible for degradation of cGMP in the corpus cavernosum. The molecular structure of sildenafil is similar to that of cGMP and acts as a competitive binding agent of PDE5 in the corpus cavernosum, resulting in more cGMP and better erections. Without sexual stimulation, and therefore lack of activation of the NO/cGMP system, sildenafil should not cause an erection. Other drugs that operate by the same mechanism include tadalafil (Cialis®) and vardenafil (Levitra®). Sildenafil is metabolised by hepatic enzymes and excreted by both the liver and kidneys. If taken with a high-fat meal, there may be a delay in absorption of sildenafil and the peak effect might be reduced slightly as the plasma concentration will be lowered. Dosage and price As with all prescription drugs, proper dosage is at the discretion of a licensed medical doctor. The dose of sildenafil is 25 mg to 100 mg taken once per day between 30 minutes and 4 hours prior to sexual intercourse. It is usually recommended to start with a dosage of 50 mg and then lower or raise the dosage as appropriate. The drug is sold in three dosages (25, 50, and 100 mg), all three costing about US$10 per pill. Name-brand Viagra sildenafil is not scored and a fairly hard coating makes it more difficult to accurately cut the pills in half, even with a pill cutter. Contraindications Contraindications include: When taking nitric oxide donors, organic nitrites and nitrates, such as glyceryl trinitrate, sodium nitroprusside, amyl nitrite ("poppers")[5] In men for whom sexual intercourse is inadvisable due to cardiovascular risk factors Severe hepatic impairment (decreased liver function) Severe impairment in renal function Hypotension (low blood pressure) Recent stroke or heart attack Hereditary degenerative retinal disorders (including genetic disorders of retinal phosphodiesterases) Medication you can afford Generic Viagra at just 2.50 USD Get the medication you need. Buy Generic Viagra online for just 2.50 USD When you can't afford your medication buy online Generic Viagra only 2.50 USD Cheap Generic Viagra

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ONE: They've shipped American jobs overseas to boost the economies of foreign nations while our workers go on forced, unpaid vacations. It's the same old GOP payoffs: Longtime Layoffs. TWO: They've shifted to the backs of the middle class increased taxes once shared by the rich and famous. The chosen few get their breaks in inflated rebates. The poor get a pittance and good riddance from the GOP. THREE: The "decider" decided all on his own to set the stage to defeat a raise in the minimum wage. Big business doesn't want that. They want to grow big and fat while the rest of us stay stringbean lean. That's the way in the Republican USA. FOUR: Medicare's become an I Don't Care for those who need it most---the poor, the needy, the unemployed and, you bet, our GIs and our Vets. The bulk of those who once enjoyed fair price care now have no cash to spare. Costs are rising and it's not surprising and so are prices for operations and for already expensive medications. FIVE: No matter what they say, inflation's rising everyday. At the grocery. Yessiree! Did prices jump at the pump? You bet! Get your tank filled and your wallet's flat. Go tell that to George, the Chief gauger for the oil industry. They raised the price of a gal two bucks, then lowered it a dime or two. Who can say they didn't do that to you with a big OK from Bush and Cheney. Ain't it a zany thing to do? SIX: Medicare's become an I Don't Care way to guard your health and deplete your wealth. The cost is rising and so are medications and that's a chronic cause of inflation. This is the last for now. We'll have more posts about Bush Boasts. Maybe you can add a few. Let's hear from you! Cheap Generic Viagra

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Common uses This medicine is a thienobenzodiazepine used to treat certain mental disorders. Before using Some medicines or medical conditions may interact with this medicine. Inform your doctor or pharmacist of all prescription and over-the-counter medicine that you are taking. Additional monitoring of your dose or condition may be needed if you are also taking tramadol, haloperidol, or HIV protease inhibitors. Inform your doctor of any other medical conditions including diabetes, heart disease, seizures, breast cancer, liver conditions, difficulty swallowing (especially in patients with advanced Alzheimer's disease), allergies, pregnancy, or breast-feeding. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine. Directions Follow the directions for using this medicine provided by your doctor. This medicine may be taken on an empty stomach or with food. If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Store this medicine at room temperature in a tightly-closed container, away from heat and light. Cautions Do not take this medicine if you have had an allergic reaction to it or are allergic to any ingredient in this product. Do not stop using this medicine without first checking with your doctor. Do not exceed the recommended dose without checking with your doctor. Keep all doctor and laboratory appointments while you are taking this medicine. Laboratory and/or medical tests, such as fasting blood sugar levels, may be done to monitor your progress or to check for side effects. This medicine may cause dizziness. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Ask your doctor or pharmacist if you have questions about which medicines cause dizziness. Alcohol, hot weather, exercise, and fever can increase dizziness. To prevent dizziness or fainting, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness or weakness. Do not become overheated in hot weather or during exercise or other activities since risk of heatstroke may be increased. This medicine may increase your risk of developing diabetes, or increase blood sugar levels. High blood sugar levels can cause serious problems if left untreated. Contact your doctor for more information. Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. For women: if you plan on becoming pregnant, discuss with your doctor the benefits and risks of using this medicine during pregnancy. It is unknown if this medicine is excreted in breast milk. Do not breast-feed while taking this medicine. Diabetics: this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine. Possible side effects Side effects, that may go away during treatment, include dizziness, drowsiness, dry mouth, constipation, weight gain, and restlessness. If they continue or are bothersome, check with your doctor. Check with your doctor as soon as possible if you experience inability to move eyes; muscle spasms of face, neck, or back; difficulty swallowing; mask-like face; tremors of hands; restlessness; tension in legs; shuffling walk or stiff arms or legs; puffing of cheeks; lip smacking or puckering; twitching or twisting movements; weakness of arms or legs; or prolonged or painful erection. Contact your doctor immediately if you develop symptoms of high blood sugar such as increased thirst, increased urination, or vision changes. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. If you take too much If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include fast/irregular heartbeat, agitation, severe drowsiness, difficulty speaking or slurred speech, muscle stiffness, and unconsciousness. Additional information Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children. If using this medicine for an extended period of time, obtain refills before your supply runs out. Drug interactions Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Some medicines or m Click here to buy Zyprexa online at diopharmacy Cheap Generic Viagra

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Nicotine use is highly addictive in primates, say researchers who conducted an unusual study of squirrel monkeys. The study by researchers from the Centre for Addiction and Mental Health in Toronto and the U.S. National Institutes of Health examined the reinforcing effects of nicotine. It found that squirrel monkeys who could give themselves nicotine by pressing a lever initially used it very little - but over time developed a "high motivation" for using it. "The number of the lever presses that the monkey had to perform to get a single injection of nicotine progressively increased," said Dr. Bernard Le Foll, a CAMH scientist and associate professor at the University of Toronto. "We were able to measure the motivation to take nicotine ... This revealed a high motivation to take nicotine, with monkeys pressing up to 600 times to get a single injection of nicotine." A catheter was implanted into a vein of the animals. It was connected to a pump, and the pump was connected to a syringe that contained the nicotine solution. Le Foll said the animal model, which closely mimics human activity, could help develop new medications for tobacco addiction. "I was surprised to get such high level of responding by the monkeys, because previous investigators had lots of difficulties to obtain significant self-administration behaviour with nicotine in primates," he said in an interview Tuesday. "That is an indication that nicotine is a critical component of tobacco smoke and that it is the desire to obtain nicotine that is an important drive of smoking behaviour." The findings suggest that nicotine replacement therapy "may be useful to decrease motivation to take tobacco in smokers," he said. Story here . monkeys Labels: monkey, nicotine, study 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

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Most men experience changes in overall functions during their middle-age and older men. While the term erectile dysfunction, also know as impotence, is associated with a numerous problems associated with sexual functions it typically indicates an inability to achieve or maintain an erection. Erectile dysfunction can occur at any stage in life. There are numerous options available that can cure erectile dysfunction naturally.The natural approach has been proven effective.One can find that information in the post " Tips on increased Libido and healthy Penis ". Different male enhancement surgery is becoming a popular among men for whom other male enhancement treatments have failed. Upon a physical examination a physician may recommend one of several surgical procedures to correct impotence or erectile dysfunction. Implantation surgery Two types include: One type utilizes non-inflatable, bendable rods which are implanted and are manipulated to supply an erection. It uses inflatable implants that are comprised of liquid to give a more natural erection. An erection is achieved with the fluid movement within the cylinders. Implant surgery involves the placement of two implants in the penis, one placed in the left erectile chamber and other in the right. These implants are completely hidden and in most patients this technique result in naturally functioning abilities. Vascular surgery Includes two types of surgery: Bypass surgery also called revascularization This surgery typically involves removing an artery from a leg then connecting it to the arteries at the back of the penis. This bypasses any blockages and restores blood flow. Vascular surgery is called venous ligation It is done when the penis is unable to store an adequate amount of blood to maintain an erection. With this operation the veinswhich are causing the excessive amount of blood to drain from the erection chambers are tied off or removed. Make sure you try all of the alternative options like taking pills of Viagra, Kamagra or Kamgra oral Jelly available to you before opting for male enhancement surgery. Cheap Generic Viagra

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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

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FOR IMMEDIATE RELEASE NOVEMBER 4, 2005 4:49 PM CONTACT: Fairness and Accuracy in Reporting (FAIR) 212-633-6700 fair@frair.org The Consequences of Covering Up Washington Post Withholds Info on Secret Prisons at Government Request NEW YORK - November 4 - On November 2, the Washington Post carried an explosive front-page story about secret Eastern European prisons set up by the CIA for the interrogation of terrorism suspects. While the Post article, by reporter Dana Priest, gave readers plenty of details, it also withheld the most crucial information--the location of these secret prisons--at the request of government officials. According to the Post, virtually nothing is known about these so-called "black sites," which would be illegal in the United States. Given the abuses at Abu Ghraib and Guantanamo Bay, news that the U.S. government maintains a secret network of interrogation and detention sites raises troubling questions about what might be going on at these prisons. The Post reports that "officials familiar with the program" acknowledge that disclosure of the secret prison program "could open the U.S. government to legal challenges, particularly in foreign courts, and increase the risk of political condemnation at home and abroad." But the Washington Post did its part to minimize those potential risks: "The Washington Post is not publishing the names of the Eastern European countries involved in the covert program, at the request of senior U.S. officials. They argued that the disclosure might disrupt counterterrorism efforts in those countries and elsewhere and could make them targets of possible terrorist retaliation." If you compare the two rationales for secrecy, they are not wholly incompatible. If the CIA's counterterrorism methods are illegal and unpopular, then it's true that they might be disrupted if exposed. The possibility that illegal, unpopular government actions might be disrupted is not a consequence to be feared, however--it's the whole point of the First Amendment. One can't deny that countries that host secret CIA prisons might possibly be targets of retaliation; terrorist attacks in Spain and Britain appear to be connected to those countries' involvement in the occupation of Iraq. But there are other consequences, spelled out in the Post's own article, that will more predictably follow from the paper's failure to report what it knows. Without the basic fact of where these prisons are, it's difficult if not impossible for "legal challenges" or "political condemnation" to force them to close. As the Post notes, there has been "widespread prisoner abuse" in U.S. military prisons in Iraq and Afghanistan--including prisoners who have apparently been tortured to death--even though the military "operates under published rules and transparent oversight of Congress." Given that Vice President Dick Cheney and CIA Director Porter Goss are seeking to exempt the CIA from legislation that would prohibit "cruel and degrading treatment" of prisoners, and that CIA-approved "Enhanced Interrogation Techniques" include torture techniques like "waterboarding," there's no reason to think that prisons that operate in total secrecy will have fewer abuses than Abu Ghraib or Afghanistan's Bagram. Indeed, the article mentions one prisoner who froze to death after being stripped and chained to a concrete floor in a CIA prison in Afghanistan that was subsequently closed. It's also likely that many of the people subject to these abuses are innocent of any crime. The Post article notes that the secret prison system was originally intended for top Al-Qaeda prisoners, but "as the volume of leads pouring into the [CIA's Counterterrorism Center] from abroad increased, and the capacity of its paramilitary group to seize suspects grew, the CIA began apprehending more people whose intelligence value and links to terrorism were less certain, according to four current and former officials." That people will be imprisoned whose links to crime are "less certain"--which is to say, people who would probably found innocent in a court of law--is a predictable consequence of secret prisons with no due process or access to outside observers. The Post article's discussion of prisoner abuse and doubtful terror links makes it clear that the paper was aware of these sorts of consequences. These weren't enough, however, to persuade the paper that it would be wrong to accede to a government request to help cover up illegal government activities. (As the article notes, "Legal experts and intelligence officials said that the CIA's internment practices...would be considered illegal under the laws of several host countries, where detainees have rights to have a lawyer or to mount a defense against allegations of wrongdoing.") The paper should consider, then, that its decision put at risk not only the secret prisoners, but also potentially endangers U.S. soldiers and civilians. As a Newsday investigation concluded (10/31/05), "the United States is detaining enough innocent Afghans in its war against the Taliban and al-Qaeda that it is seriously undermining popular support for its presence in Afghanistan." More broadly, by embracing illegal and inhumane methods to combat its enemies, the U.S. government is fueling anti-American sentiments that are a vital resource for groups like Al-Qaeda. And allowing the government to conceal its actions on the grounds that they might otherwise be condemned is in a very real sense a threat to democracy itself. The Post's decision has struck some experts as enormously significant. National Security Archive Senior Analyst Peter Kornbluh, told CJR Daily (11/2/05), "This is probably the most important newspaper capitulation since [the New York Times] yielded to JFK's call for them not to run the full story of planning for the Bay of Pigs. By withholding the country names, the Post is directly enabling the rendition, secret detention, and torture of prisoners at these locations to continue. That is a ghastly responsibility." But the Post is not the only U.S. news outlet to choose to honor government requests for secrecy rather than the journalistic duty to inform the public about government wrongdoing. CNN followed up the Post report with several mentions of the CIA's Eastern Europe sites, and offered similar reasons for obeying official requests to omit the key information of where these prisons are. CNN reporter David Ensor said (11/2/05), "U.S. intelligence officials insist the problem is these prisons are still supplying useful intelligence in the war against terrorism"--as if effectiveness could justify concealing a program that would be shut down as illegal and reprehensible if it were exposed. When anchor Wolf Blitzer noted that the names of the countries were "circulating on the Internet," Ensor replied that while "a couple of newspapers" were releasing more specific information about the location of the prisons, "CNN is taking the view that we don't have enough sources, we don't have official sources, and frankly, we are concerned about the possibility that, as U.S. officials have said to us, lives could be as stake." Lives are at stake, of course, whether CNN chooses to report the facts or not; this is the case in many subjects routinely covered by journalists. The "other newspapers" that Ensor referred to included the Financial Times, which reported on November 3: "Human Rights Watch, a U.S. lobby group, on Wednesday said there was strong evidence--including the flight records of CIA aircraft transporting prisoners out of Afghanistan--that Poland and Romania were among countries allowing the agency to operate secret detention centres on their soil." Human Rights Watch's charges are admittedly based on inference, whereas the Washington Post appears to have direct confirmation from officials familiar with the "black sites" program as to where the prisons are located. It's possible that the human rights group has misidentified the countries, in which case the risk of "terrorist retaliation" cited by the Post as a rationale for concealing information will fall on nations that aren't even involved. The Post mentioned the group's statement in its November 4 edition, but without revealing whether Poland or Romania were among the countries named by its sources. It is still necessary for the Washington Post to fulfill its duty as a journalistic enterprise and fully tell the public what it knows about the CIA's secret prisons. ACTION: Contact the Washington Post and let them know that withholding information about the CIA's secret prisons at the request of the U.S. government was the wrong journalistic decision. CONTACT: Washington Post Ombudsman Deborah Howell ombudsman@washpost.com Phone: 202-334-7582

Tags: post, prison, secret, cia, government