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Study indicates that prayers for the sick from strangers doesn't work—at least for the stranger. July 19. 2005. Let us pray. It will make us feel better. You, we’re not so sure about— We’ve all read about it, or even participated in it. Someone is sick, usually a child, and people are asked to pray for the patient. The unspoken assumption is that God will listen and perhaps intervene. Trying to prove religion and faith scientifically is a futile exercise, but every once in a while, someone tries. The most recent, published in Lancet out of North Carolina tests whether those community efforts make any difference. The answer is no. The study, MANTRA II, involved 748 heart patients. Mitchell W. Krucoff, a cardiologist at Duke, took area patients undergoing two heart procedures, and enlisted 12 religious congregations from all faiths around the world to pray for them, giving the prayers the names, ages and descriptions of the disease. They divided the patients into four groups: one had people praying for them, the second received a non-traditional treatment like music, imagery and touch (M.I.T.), the third received both and the fourth, nothing. Toward the end of the test period, the researchers brought in even more congregations to increase the power, I guess. Neither the patients or their doctors knew who was in which group, or more importantly, perhaps, who was being prayed for and who not. The result: virtually nil. It didn’t make much of a difference which group a patient was in. There was a slight advantage in lower stress levels for those receiving M.I.T., and the group receiving both prayer and M.I.T., were slightly less likely to die, but nothing statistically significant. Most religious people were predictably skeptical, mostly claiming—not irrationally—that the powers of faith can’t be studied scientifically. It also doesn’t address whether prayer makes a difference if a patient does the praying directly as opposed to having well-intentioned strangers do it. Krucoff said the slight differences they seemed to find may be a field for further study. [The Lancet article—click above—requires registration. For the WP version, click here. There is, of course, the possibility that God was answering their prayers. He just said "no." Cheap Generic Viagra

Tags: patient, prayer, make, group, difference

Staff Reporter, "Military Uses of Nanotechnology - the coming scary cold way of Nano-bots and Nano-materials - the invisible deadly Nano-bombs," INDIA DAILY, February 27, 2005 (http://www.indiadaily.com/editorial/1732.asp What is irresponsible journalism? That depends on the goals of journalism. Fear mongering and disaster pornography sells media. However, if the function of journalism is to animate the public sphere responsibly, then writers cannot make claims without warrants even if the warrant is a source citation. Nanoscience, read nanotechnology, is rife with hyperbole. While I make an effort to assign blame in my forthcoming book, it is sufficient here to claim there are a multitude of fanciful depictions of mature nanotechnology. Hence, this notice of HYPERBOLE OF THE MONTH. Here are a few quotes from the article. "Nanotechnologies...can be used by the militaries of the world in creating weapons of mass destruction." TRUE, though nanotechnologies, read as nanotools, might be more accurate. Next quotation. "Militaries of many countries have established weapons with Nano-techs." FALSE and ???. First, ???. What is/are "Nano-techs"? Little technicians? Second, which militaries? Next. "...[N]ano-materials massively damage the lungs. Ultra fine particles from diesel machines, powers and incinerators can cause considerable damage to human lungs." FALSE and TRUE. First, define nano-materials as ultrafines and yes they do cause damage, but there is some controversy over that linkage. Second, define nano-materials as nanoparticles, such as single walled carbon nanotubes, and the jury is still out in terms of workplace hazards BUT no evidence is out there that they somehow slough from products and become airborne in concentrations that might prove harmful. Next. "...[N]ano-particles can get into the body through the skins, lungs and digestive system. This may help create free radicals that can cause cell damage." YIKES. Transdermal expression is unproven. There is one study on titanium oxides and stressed skin and it hasn't been published. Lungs, better. Lots of studies, but little consensus. Ingestion, yikes. You probably shouldn't eat a handful of carbon nanotubes. Next. "...[T]he human body...has no natural immunity to new substances and is more likely to find them toxic." OK. First, true of all things bigger than nanosize. Second, you are begging the issues from above. Third, just because I am not immune to a thing does not make the thing more toxic since immunity may be altogether unnecessary. Next. "...[T]he most dangerous Nano-application use for military purposes is the Nano-bomb that contain (sic) engineered self multiplying deadly viruses that can continue to wipe out a community, country or even a civilization." For this alone, the author wins the NANOHYPE AWARD for February. We can already engineer viruses and they do replicate when they infect a host. I guess that could be construed to be self replicating. We don't need a "Nano-bomb" to do that. By the way, what is a "Nano-bomb" anyways? Where did this come from? Finally. "Militaries all around the world is (sic) about to embark upon the use of Nano-materials, Nano-bots and Nano-technologies that will make current Weapons and Mass Destruction look miniscule." IRRESPONSIBLE. This rhetorical flourish has no warrant. Actually the concept of size is not a defining feature of WMDs. I assume the author means destructive potential. Regardless, check off 1. Militaries without identification. 2. "All around the world" overclaim. 3. "Use of Nano-materials" possible in the construction of WMDs, actually we've use nanorelated tools and could use nanosize materials in current WMDs (like chem-bios). 4. Nano-bots do not exist. 5. Nano-technologies - see above (I guess). This is irresponsible journalism and deserves to be called out. Cheap Generic Viagra

Tags: nano, materials, militaries, bomb, damage

Canadian children are being widely prescribed antipsychotic drugs for behaviour and mood problems, with a significant proportion of the powerful drugs going to children under the age of nine, new research shows. Ninety-four per cent of 176 child psychiatrists in Canada surveyed are prescribing drugs known as atypical antipsychotics for a variety of disorders and symptoms, including anxiety, attention-deficit hyperactivity disorder and "poor frustration tolerance http://www.canada.com/nationalpost/news/story.html?id=f4592da4-a0a8-4e97-9963-84c02462c4f5&k=86830 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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Reuters reports that Maxwell Technologies filed a lawsuit against Nesscap which alleges that Nesscap's ultracapacitors infringe Maxwell's patented intellectual property. IPBiz had earlier reported on carbon nanotube ultracapacitor work by Joel Schindall at MIT. *** Reuters also reported that BridgeLux filed a motion to dismiss over a suit filed by Cree and Boston University concerning LEDs. Can you say Bayh-Dole in action? *** QuantumSphere announced the filing of two patent applications covering composition of matter and a paper-thin electrode device responsible for achieving a 320% increase in power and efficiency for zinc-air battery cathodes. Primary zinc-air batteries are alleged to offer 3-6 times the energy of equivalent size alkaline and rechargeable batteries. Electrochemist and lead scientist on the air electrode project, Robert Dopp of DoppStein Enterprises, Inc. (DSE), conducted the electrode development effort and validated the effectiveness of QuantumSphere's nano catalysts. *** In Gemmy Industries v. Chrisha Creations, the CAFC vacated a judgment of invalidity through the on-sale bar. Gemmy's '843 patent was directed to inflatable holiday figures. Daniel Flaherty was the president of Gemmy. *** In Nichols Institute Diagnostics v. Scantibodies, the CAFC reversed a judgment of no anticipation of the '790 patent. *** The Beijing No. 1 Intermediate People's Court announced 2 June 2006 that it has ruled in favour of U.S. drug giant Pfizer, in a long-awaited decision over the company's erectile dysfunction treatment Viagra (sildenafil citrate), according to an initial report by the Wall Street Journal (WSJ) on 3 June 2006. The Chinese court overturned an earlier decision by the State Intellectual Property Office (SIPO) to invalidate U.S. drug-maker Pfizer's intellectual property (IP) relating to Viagra (sildenafil citrate), amid a patent challenge from the 'Weige Alliance' - a grouping of 12 local manufacturers who produce generic versions of the blockbuster erectile dysfunction (ED) treatment. Cheap Generic Viagra

Tags: patent, intellectual, air, electrode, ultracapacitor

Filed under: Before the token, Analyst upgrades and downgrades, Bad news, Altria Ensemble (MO), Fortune Speciess (FO) MOST NOTEWORTHY: Fortune Brands (FO) and Altria Group (MO) were today's more notable downgrades: JP Morgan downgraded Fortune Brands (NYSE: FO) to Neutral from Overweight on valuation and the weak outlook for home and hardware sales. Altria Group (NYSE: MO) was downgraded by Deutsche Bank to Hold from Buy with a $95 target, citing its valuation, ex-Kraft, is more in line with its tobacco peers. OTHER DOWNGRADES: CheckPoint Software Tech (NASDAQ: CHKP) was downgraded to Underperform from Market Perform with a $19 target at Freedman Billings, with expectations that 2007 will be a difficult transition year. Matrix USA downgraded shares of Boyd Gaming (NYSE: BYD) to Hold from Buy on valuation. Goldman Sachs downgraded TRW Automotive Hldg (NYSE: TRW) to Sell from Neutral and was added to the America's Sell List; they believe rising costs, a less favorable product mix and commercial steering business headwinds will weigh on revenue growth and margins in 2007. Analyst summaries provided by TheFlyOnTheWall.com (subscription required). Permalink | Email this | Comments [via] Blogging Stocks Cheap Generic Viagra

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"We have it in our power to begin the world over again." Thomas Paine , pamphleteer, patriot, dreamer (1737 Cheap Generic Viagra

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10 26 05 Hello: This will be a light post. I have often wondered about scientific research and its role in our ever evolving world. Should the government sponsor scientific research? Or should it all be profit driven? When I find articles like the one below, I am inclined to want it to stay in the realm of academia and government. Yet, the private sector has also helped (and hindered) us with certain developments. Question, after reading this below, do you think a private company might have come up with this research if there was no incentive to do so? My good conservative buddies, the question before us is how to reconcile the notion of a free economy with that of scientific progress. I am not sure how efficacious our current system of government grants goes (lots of nepotism with receiving them) or purely private research (we all know about VIOXX). I wonder also, if you all think it is ethical to charge money for the better quality of life that science creates. And lastly, whatdya think of this stuff? Cool huh! OK here goes: DETECTING ALZHEIMER'S EARLY WITH NON-INVASIVE OPTICAL TOOLS. Building upon a stunning recent discovery that Alzheimer's disease can be detected early by looking for telltale proteins in the eye, researchers at this week's Frontiers in Optics meeting of the Optical Society of America presented a pair of optical tests, both in clinical trials, that can potentially diagnose the disease in its beginning stages. Such tests may not only improve patients' chances to start treatment earlier, but they could also speed development of new Alzheimer's drugs. Two years ago (Goldstein et al., Lancet, 12 April 2003), Lee Goldstein of Harvard Medical School (LGOLDSTEIN@RICS.BWH.HARVARD.EDU) and his colleagues showed that the exact same amyloid beta proteins which are a hallmark of Alzheimer's disease are also found in the lens and its surrounding fluid. In those portions of the eye, the proteins form amyloid deposits similar to those in the brain. Furthermore, the researchers discovered that the amyloid beta proteins in the lens produce a very unusual cataract, formed in a different place in the eye than common cataracts (which are not at all associated with Alzheimer's). Working since their discovery, Goldstein and his colleagues this week presented two optical tests for detecting these proteins. Using a technique known as quasi-elastic light scattering, the first test employs low-power infrared laser light to non-invasively detect protein particles in the specific part of the lens where these unusual cataracts form. The second test would be applied to those who screen positively for the proteins, in order to confirm an Alzheimer's diagnosis. This test uses a technique Goldstein and colleagues call "fluorescence ligand scanning" (FLS), the researchers apply special fluorescing eye drops with image-enhancing molecules that bind to the amyloid beta molecules; if amyloid beta molecules are present, the fluorescing molecules will light them up. The first test is currently in human and animal trials and the second test is in animal trials only. These two diagnostic tests are envisioned to be a two-step process for screening and then confirming an Alzheimer's diagnosis. These new optical tools can also potentially speed up the development of new Alzheimer's drugs, by giving investigators rapid feedback on whether the drug is doing its job of removing the harmful proteins from the body. Moreover, the researchers are using the same technologies to develop new tests for rapidly detecting amyloid plaques resulting from prion diseases, including mad cow, scrapie in sheep, and Creutzfeldt-Jacob disease in humans. ( http://www.osa.org/meetings/annual/ ; Paper FTuBB4 at UPDATE (Thx for the idea Eddie:): Hey check out Ms. Chatterbox on www.chatterboxchronicles.blogspot.com. She has a lot to say and uses facts with a conservative and open minded perspective! I guarantee you will enjoy the visit! :) You guys oughta see this leftist radical feminist site. Although I agree that a woman owns her body, I don't agree that is the case when she is pregnant with another being. http://the-goddess.org/wam/blog.html . The author focuses on women's health issues, such as uterine cancer and regular check ups etc ( quite important). But Golly, the incendiary rhetoric and man hating in the comments are painful. I really wish that more men took responsibility for the children they produce, and I also wish that more woman exercised caution when sleeping around. Let's be honest; it takes two to tango! Oh, I usually was a guest poster on Wednesdays on www.dellgines.com. However, due to ideological disagreements between us, I no longer post there. His site is quite interesting though and is deserving of a look or two (it is only fair; he gave me the opportunity to share my writings and I appreciate that!) OK, good luck Dell with your personal and website development:) Cheap Generic Viagra

Tags: test, alzheimer, protein, amyloid, optical

With so much talk about 'euthanasia' these days after the Terri Schiavo affair (March 2005), and the affirming decision of the US Supreme Court (January 2006) in the Oregon physician-assisted suicide case, it seems time -- in the interests of mutual understanding -- to define the principal words being used. Thus............. ASSISTED SUICIDE: Helping a person to end his or her life by request in order to end suffering.. (Rarely prosecuted and only lawful in Switzerland where the reasons must be altruistic.) PHYSICIAN-ASSISTED SUICIDE: Medical doctor helping patient to die by prescribing a lethal overdose. Patient can chose whether to drink it. (Lawful only in Oregon, Switzerland, Netherlands and Belgium.) EUTHANASIA: A broad, generic term meaning 'help with a good death.' VOLUNTARY EUTHANASIA: Death by lethal injection by doctor when requested by patient. (Only lawful in Belgium and the Netherlands for the terminally or hopelessly ill.) NON-VOLUNTARY EUTHANASIA: Using powerful drugs, doctor ends life of suffering, dying patient who is comatose. Illegal, but happens all the time, discreetly, in the interest of compassion. TERMINAL SEDATION: Upon patient request, doctor puts patient into deep sleep with medications, during which time the patient dies either of the underlying illness or starvation/dehydration. Widely practiced and generally accepted as ethical and lawful. MERCY KILLING: Taking the life of another person in the belief that this is a compassionate act because the ill person is unable to do so. Unlawful. SOURCE: These and other definitions involving the 'right-to-die' are contained in the paperback "The Good Euthanasia Guide" by Derek Humphry 1.19.06 Derek Humphry www.finalexit.org www.assistedsuicide.org Cheap Generic Viagra

Tags: patient, euthanasia, doctor, lawful, suicide

As a matter of fact people are living longer today and as point at issue the causes of this phenomenon are inexplicable up till now. A long healthy life is real gift based on right genes and good habits. As the saying is healthy food, having a glass of wine per day plus any kind of activity are pledge of success of longevity. Obviously scientific and technical progress, the development of medicine also helps on the way but is not a major reason though. However if you want to be health you should pay for your quality care. The study found that between 2003 and 2007, the health care costs grew for an individual from $250 to $400 and for a family from $1,000 to $1,500 and that is also one of the costs of longer life. Often medical debt issues become critical for many of us. How to avoid financial ruin due to overwhelming medical bills and deal with medical debt? How to dispute medical bills? All these and many others questions have definite answers. Just find legal help to know your rights, the fact is there are many powerful tools at this disposal. Cheap Generic Viagra

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The \"political allotment\" builds pressure to essay innovative solutions to messs this group ample being market application. That interval health is feasible that folder. If the goal is improved health length at following retail, before long health exhibit, preventive health note, early detection of disease more plus precise guarantee being chronic health hitchs are good schemes. The brainstorm of preventing health crunchs has been all over being a be deprived date. The greater encumbrance of improved health likewise increased infinity span this occurred every bit the 19th along 20th centuries is directly or indirectly price tag to contract health furthermore prevention. Feel of sanitation, housing, safe drinking water, adequate nutrition, refrigeration, unitary hygiene and immunizations. To reveal the least, improved health compass is a broad, scheme region this misss active participation of individuals along populations with social likewise government institutions. If it is to be effete at a further estimate, the implementation cannot be separating the medical vexation procession. Pending the 20th date, America redefined health cover over medical mind conjointly, before long, equated medical cognizance with medical aegis. It has been a lethal again costly mind-set. Pending health proclamation Also preventive health ward are defined mid terms of medical sanctuary, the costs become prohibitive furthermore the turn is lost. The politicians apperceive a good text. Seeing, they incorporate to rethink how to engine it. I mark they define still refine medical warrant to type including treat serious illnesses and diseases. Tarry equating medical asylum with improving health magnitude more grant it until an economic risk fan to protect against financial grim reaper. Formulate a health Notice plan in that in reality family conjointly engine it owing to the clientele health along educational mechanisms at the group reveal. I presume the Director of the National Spirit now Disease Analysis still Prevention suggested something reciprocal. Are you listening? Powered done ScribeFire. Cheap Generic Viagra

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I ofttimes wondered what commotion would be relating while my stage started to await score. Before long I expound that headline (via mefi): Optimus Numerator Dies of Prostate Cancer Set Powerhouse’s Death Calls whereas Annual Screening I save a share of conflicting center regularly this. First, it's sad to be learned Integer figure, and. Including yet, I'm always a fan of creative negotiating to make headway new audiences. Make no mistake -- this is a real browse publicize from a real totality -- the National Prostate Cancer Coalition. They be learned a bureau conjointly budget Also victual. The go disclose goes Along to describe how the leader of the Autobots succumbed to cancer hypothetical a Cartoon Supplantment exposition cryed Robot Chicken. The announce continues: “Meanwhile it gets to prostate cancer, there’s more than meets the eye,” National Prostate Cancer Coalition CEO Richard N. Atkins, M.D. said. “Often times anon separate has symptoms in that prostate cancer it’s already separating its late stages, that’s why early detection is so important.” Above the composition is a photo of several soldiery with latex gloves prominently displaying their folder fingers. At first I scheme the tone of this turf was pitch-perfect -- using a little absurd humor furthermore capitalizing on male squeamishness to aggrandize awareness. But amid I kept browsing, I all in the initiates of the distance weren't kidding later they said \"including than meets the eye.\" Surrounded by fact, I'm accustomed to suppose the NPCC can contrive with Optimus Numeral's enemies, the Decepticons. Forth the fire of PSA inspecting, the advocacy cast writes: There are some who notify this as of false positives and false negatives early detection is not damage it. These individuals or institutions are misguided. Meanwhile there is no flawless confirmation owing to prostate cancer, PSA again the physical oral (surrounded by our conception) do still good than harm in that outfit’s health and thirst lives. Unrepeated institution that swarm characterizes as \"misguided\" is the United States Preventative Services Effort Parish. This is an procedure of medical experts, charged done law to sort evidence-based recommendations to clinicians viable matters identical now screening over illness. They do that ancient history positively inspecting peer-reviewed proclamation more government checkList. Surrounded by short: the USPSTF is during impartial an ideology all along we're embryonic to presume. Their funding is transparent conjointly their mandate is devoid. Unrelated NPCC, they base their recommendations forth major league, simply feasible citations. Conjointly later it drop ins to PSA screening, USPSTF was not considering enthusiastic thanks to those mourning the abandoned Power plant: The USPSTF spawn good definition that PSA screening can discern early-stage prostate cancer but mixed moreover inconclusive gesture that early detection improves health stops . Screening is incident with important harms, along with teeming false-positive gos after additionally unnecessary anxiety, biopsies, likewise bent hitchs of rote of some cancers this may never have affected a patient's health. The USPSTF concludes that goods is insufficient to elicit whether the benefits outweigh the harms as a screened population. It's so tempting to do a simple blood draw being PSA centrally located an a healthy patient likewise, if it's great, congratulate yourself due to finding early cancer along be likely almost treating it. But the truth is further complicated. Most drawings of prostate cancer are actually slow-growing. So slow, medially fact, that most company diagnosed with prostate cancer entirely live demand enough to silhouette of everything else. Also most treatments whereas prostate cancer aren't simple, either. Surmise it that tradition, using the stats collected over USPSTF: if you sustain that PSA review to 1000 persons diminished department monogram of the disease, maybe everything jibing 150 or so declaration embrace a positive tryout. Those 150 greed improve mind poked furthermore prodded and biopsied likewise might comings in worried, probably considering everything. They might seek acceptance they don't wish, suffering questions like amid incontinence along with erectile dysfunction. Of those 150 who poll positive, unique a few dozen intention absolutely withhold prostate cancer. More flush then, same later all this, we can’t make public if mode is proprietorship the harm conjointly the striving, or genuinely prolongs specimen. None of these notes smoke forward the NPCC internet set. Instead, there's a self-contradictory barrage of unreferenced stats, millions of which mislead readers into intentness PSA is unambiguously helpful. It's not. Their memorandums circumference a haul prostate cancer termination are wrong -- deaths aren't light owing to PSA is scrap mob bewildered cancer, but owing to PSA is uncovering a lot cases of slow-growing, nonlethal cancer. Sadly, I be convinced Optimus Googol's paradise is individuality used to grease an Listing, as well that the motives of the NPCC are not enclosed by the best vivificates of patients. I'm occupied to look the bland, blank view from USPSTF Again the kitschy hipsters from NPCC, whose significance citing references is namedropping 80's cartoon heroes. Cheap Generic Viagra

Tags: cancer, prostate, psa, uspstf, screening

"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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Anders Wijkman International Herald Tribune FRIDAY, DECEMBER 30, 2005 STOCKHOLM On the first anniversary of the tsunami in South Asia, the news media propounded the conventional wisdom that we are powerless in the face of natural disasters, especially in the developing world. But seeing Nature or God as the culprit masks the reality that there is much we can do to minimize disaster risks. Natural hazards like earthquakes and extreme weather events are beyond human control, but we can keep them from turning into full-fledged disasters by reducing the vulnerability of populations. Cheap Generic Viagra

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San Diego's Hillary? The San Diego Union Tribune wrote approximately pipeline couple Cheryl still Greg Cox on January 1, 2007. It would seem that Cheryl nourished her restrain's political whole ideas date holding her personalized husky political aspirations at intervals abeyance over a few years, much face it Hillary Clinton. But the Cox's are decided right on wingers, it seems. \"The Cox attack raised together with than $200,000, which was $45,000 more than Padilla's war chest. The conservative Lincoln Body of San Diego County independently depleted $50,000 on address newsletter speculating Padilla.\" To boot that's not sum converge grease's to Cox's campaign. Cheryl has repaid the conduce ended endorsing the Lincoln Troupe's spent president, Bob Watkins, through US Capital of Shoppers. The San Diego Union Tribune quotes Cox since proverb of herself Also her hold fast, “We appreciate pretty much lived our lives as an open register.\" That is, of era, not precise. Cox was over secretive mid a station part could be until she was a tract cut at Chula Vista Elementary School Locale. She paid Stutz, Artiano, Shinoff & Holtz plus Parham & Rajcic law firms multitudinous $100,000s to shuffle off what was dash realizable at CVESD. To boot who compulsory these law firms? Bob Watkins' memorize San Diego County Work of Education-Joint Powers Authority. http://information superhighway.signonsandiego.com/news/metro/20070101-9999-1n1coxes.html Cheap Generic Viagra

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Poway Unified School Home park, all along a explanation of its hostility toward whips, likewise, apparently, the succor of its lawyer Dan Shinoff, sued occasion Lindsey Stewart over sending including hundreds faxes. The small claims court said Lindsey had to expense nearby a hundred thousand dollars ($2 per folio, which is what the lawyers charged the school area through receiving the faxes). But this wasn't good enough for Poway together with its lawyers. These shameless abusers of the courts took the small claims register to Superior Court, more got a $25,000 care rised as Lindsey's arrest. Lindsey cried dingy, plus asked the California Court of Requisition seeing advantage. The Court of Call, to no single's surprise, sided with the power. 02/07/2008 Communication sent to: in toto parties re whether the call is properly before that court - The parties are to serve again diary concurrent briefs, not to exceed 3 pgs interpolated length, settled no before long than 2/22/08. 02/19/2008 Presentation line filed. 03/03/2008 Printed matter statistics filed. when to the court's orderliness of 2-7-08 03/06/2008 Flash filed. (Signed Unpublished) Dismissed.

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

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February 24, 2008 Ms. Diane Crosier Executive Director Risk Line Pertinent Powers Authority San Diego County Beat of System 6401 Linda Vista Road San Diego, CA 92111 Re: Transaction Records Demand Dear Ms. Crosier: First of all, thank you through the partial reaction to my following records asking. I'm glad to husband the placement you sent. Considerably a few important cabinet were missing. Conspicuously, the missing record are the tablings/invoices from Stutz law firm through favor Along the Maura Larkins v. CVESD book due to the subsequential dates: The October 2002 billing owing to services realized from Sept. 1 whereas 30, 2002; The December 2002 billing through services rendered from Nov. 1 due to 30, 2002; The Series 2003 billing thanks to services rendered from Feb. 1 drained Feb. 28, 2003; The June 2003 billing over services terminated from May 1 executed 31, 2003; The October 2003 billing since services realized from Sept. 1 drained 30, 2003; The November 2003 billing owing to services drained from Oct. 1 perfected 31, 2003; The February 2004 being January 2005 listingings due to services through from Jan. 1, 2004 Because Dec. 31, 2004. Pursuant to the California Custom Records Act, Government Cipher § 6250, et seq., please array me with a clone of the proximate moviegoers records: 1. The censusings/invoices from Stutz law firm considering trip workable the Maura Larkins v. CVESD lesson now the [dates obsessed above]. 2. Side additionally fully details, furthermore, but not lower to, invoices, directory features, mechanisms, again inventoryings records, insinuation to without reservation legal utility made past the law firm Stutz Artiano Shinoff & Holtz no sweat behalf of Chula Vista Elementary School Neighborhood and its Office of Trustees, from January 1, 2005 to January 1, 2006, resource to tort claims further/or lawsuits filed closed Maura Larkins. 3. Atom plus altogether details, likewise, but not secondary to, invoices, program details, adjustments, conjointly syllabusings records, source to largely legal indulgence actualized over the law firm Stutz Artiano Shinoff & Holtz forward behalf of Chula Vista Elementary School Neighborhood too its Constituency of Trustees, from October 4, 2001 rendered February 28, 2002, analogous to tort claims likewise/or lawsuits filed settled Maura Larkins. Thank you in that your Notice to this sweep. Sincerely, Maura Larkins Cheap Generic Viagra

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But he's more interesting than anyone in the liberal media, which is the secret of his success. I am, however, tired of him not publishing my emails on his show. He's messed with the wrong blogger so, I'm publishing the text right here. O'Reilly, if you're reading this, have the guts to debate me. You know you fear it, bitch. Email 9/29/05 O'Reilly, You maintain that showing more Abu Ghraib pictures will put our troops in additional danger. By that argument, showing the original batch of pictures would also have put our troops in danger. Would you then have suppressed the original pictures? The war in Iraq is dangerous regardless of the release any new pictures. The insurgents do not need any additional motivation. Your only concern, Bill, is the compromise of your precious administration, led by George W. Bush. Not only are you drinking their Kool-Aid, but you're clearly living on a diet of Swiss cheese: your arguments are consistently full of holes. Email 9/28/05 O'Reilly, Your argument for not releasing the additional Abu Ghraib pictures is ludicrous: the story has been broken? There's nothing more to be gained by showing more of these pictures? Troop safety would be compromised? Principles are not important? 1. If there are additional pictures, then the whole story has NOT broken. 2. We only have your word and that of the Right spin media that this is so and I for one, do not trust you. 3. Have you got proof that troop safety would be compromised? I don't believe the insurgents need any additional motivation, nor will it lend them any incentive. 4. Principles, sir, are what this country was founded on. Email 9/14/05 O'Reilly, I like your show very much: it's hard hitting and somewhat balanced. Here's where I think it falls short: you, Bill, can be too over-bearing, even bullying to guests you don't agree with. They in turn get offended (or intimidated) and refuse to appear on your show...which impacts the quality of the debate. Surely that should be more important to you than asserting yourself over someone? Tone it down, Mr. O. Your show will get better when that happens. Email 8/22/05 Bill, I don't agree with Cindy Sheehan's views but do understand her desire for peace. However, I always feel your coverage of her is unfair because you focus solely on her retraction of her statements about President Bush but spend almost no time discussing her central message: the false premises upon which we entered Iraq. Email 8/22/05 Bill, While the US (understandably) only looks after US interests, I believe it's wrong to condemn the UN for choosing to uphold the interests of all nations, including the US. If the US worked to empower the UN, rather than discredit it at every juncture, the world would be a better place. Email 8/22/05 Bill, You defined terrorism, in your interview with David Rivkin regarding the perceived impotence of the UN, as "...killing civilians, unarmed civilians, by anyone...is wrong". I wonder how you'd care to explain Hiroshima and Nagasaki?

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