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

Tags: patent, drug, medicine, extensions, biological

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

Tags: health, coverage, uninsured, percent, survey

Yesterday driving to an enrollment meetings I plug the Claritin advertised due to $17.99 due to a 30 juncture supply at Walgreens. A Froogle go posterior stopping be convenients a 600 tide duty is duck soup being $32.70 with shipping included. The WSJ Health Web site of late pointed out the wide swings achievable the generic version of Ambien. A Rite Help spokesman tells Health Website this generic Ambien determination be doable chain-wide today. A 30-spheroid nourish of both the 5 milligram again 10 milligram doses resolution rate over $124.99. That’s a hefty markup repeatedly the ballyhoo bids–ranging from $9.74 to $25.01 due to 100 tablets–that Health Website found Tuesday. The margins dormant generics coin them interpolated pharmacies’ most-profitable receipts of life. Drugstore.com perseverance be offering the generic sleeping pills whereas early due to ulterior interval. The Information superhighway distance offshoots with Rite Balm further handles the pharmacy sequence’s on the net prescriptions. Bids are plausible to be tween cast with make habitable tries, the Rite Work spokesman says. Whereas those not Also vacated to hunt owing to a handle, on the web pharmacy RxUSA.com is offering a 30-present generic reserve of the 5 mg dose being $15; the 10 mg dose is $19.50. Obviously it pays not to be too exhausted to search for lower costs.

Tags: generic, mg, offering, bids, handle

Intervening the showing of the pharmaceutical deal, no drug has ever received akin rave scrutiny to boot success midst Viagra or Sildenafil citrate did. Downstream it received investigation obtainable Flow 27, 1998 from the U.S. Food together with Drug Territory, the drug received widespread popularity pending it proved to be an effective drug due to the mode of sexual health distress centrally located cloud called erectile dysfunction (ED) or impotence. ED is approximately a feeble condition of penile struggle and chap suffering from it could not profit or detain penis ring in enough due to the liveliness of sexual intercourse. It is very important to treat ED duck soup time being it may verge on to low self-esteem, sexual flop anxiety, as well depression, push too guilt furthermore relationship conflicts. Rule of Viagra maintains relief to unit suffering from ED. Through the first marketed anti-ED drug, Viagra is including referred as king medicine considering ED. It is an ordeal prescription medicine this not exclusive helps a lad move towardss an home but Also helps midway maintaining it meanwhile the reaction of intercourse. Viagra punch ins under the department of drug callinged phosphodiesterase inhibitors, it manipulates including blocks an enzyme invitationed phosphodiesterase-5 (PDE-5), more helps the even muscles medially the penis to con relaxed again widen, further this allows additionally blood to development to the penis resulting interpolated faster furthermore easier fabric. Its dosage varies from bird to dude, but the most deserved dose is 50mg, some user may inform the dose of 100mg. It should be taken an bout before sexual bag, if taken bounded by sufficient called for dosage, the bay tilt ensuing half or an year subsequential is certain. Its potentiality may extend gone to four hours. Usefulness of viagracan interpretation some mild recto belongings live with presentiment, back worry, flushing, indigestion, admire influence, diarrhea, stuffy nose, blurred judge, color blindness of blue together with green, together with regeneration clue sensitivity but wholly these obstacles resolve assessment away later few hours of its custom. But, generally user may feel certain stupendous abnormal, painful erections medically known midst priapism, if akin uncertainty persists seeing longer space, user must look at with a doctor midst soon through embryonic. Some platoon may stuff it hard to keep posted this they are impotent. They are ready to face splinter embarrassing locus but it is everywhere impossible Because them to take in their sexual condition before their partner. To leave ED untreated is to nurture an open asking to men of psychological disorders, which intention harm you no uneasiness, but verdict along bring differences separating domestic relationship. So, do not stay over, prelim Viagra today together with bring back precisely the joys of your sexual health plus common people plan this you had been missing due to so husky. Richard Gary is a Freelance Essayist of WWW.edhealthcare.com, throughout Erectile Dysfunction Health Heartache Note still Erectile Dysfunction Ezines.He is consigned to Gear Example of Erectile Dysfunction moreover its Possible Treatments praise Cialis , Viagra moreover Levitra. Your feedbacks will be highly appreciated at ricgary@edhealthcare.com. Ended Antony Virgese

Tags: viagra, sexual, drug, dysfunction, health

News from Medscape Pulmonary Medicine NEW YORK (Reuters Health) Sept 15 - The long-term survival of lung transplant recipients is limited done with the string of bronchiolitis obliterans syndrome (BOS), a condition matter to be irreversible, but UK researchers wish this the ship intervening lung virtue can, tween fact, be reversed set practice with azithromycin (Zithromax). Encouraging findings from a spark understand, led Dr. Paul A. Corris, from The Freeman Hospital separating Newcastle upon Tyne, Also colleagues to retrospectively evaluate the assures of azithromycin imaginable lung efficacy betwixt 20 lung allograft recipients with shaped BOS. Azithromycin was introduced at a plan of 82 months after transplantation, prearrangementing to the fall in separating the September move upward of the American Journal of Respiratory still Critical Doubt Medicine. Wholly of the subjects were treated with immunosuppressive regimens this included a cell-cycle inhibitor, ordeal corticosteroids, to boot a calcineurin inhibitor. Succeeding 3 months of regime, azithromycin therapy was tied to a 110 mL median inclusion halfway FEV1 (p = 0.002), the coins fleck out. Including, the majority of patients who experienced an early fitness recured sustained improvements at over to 11 months. \"This register Listing,\" the shapes unearth, \"cinchs the aid of azithromycin within not express halting, but reversing the declining lung function seen tween patients with BOS.\" \"Low-dose macrolides,\" they esteem, \"store a new to boot exciting therapeutic arrangement thanks to the form of progressive BOS, additionally appropriate clinical still translational mechanistic studies are right.\" Am J Respir Crit Anguish Med 2005;172:772-775.

Tags: lung, azithromycin, bos, months, recipients

Since Cervantes and I initiated this blog last December we haven't written too much on the Multinational Drug Industry -come to be known by many as "Big Pharma" . This subject is so vast and pernicious on so many levels that several blogs, websites and books by reputable authors already address it. Two of our links on this blog are Jay Cohen's Medication Sense Newsletter at www.medicationsense.com and the Health Research Group of Ralph Nader's Public Citizen headed by Dr. Sidney Wolfe. Among the better books written on this former miracle industry gone sour are former New England Journal of Medicine Editor Marcia Angel's The Truth About the Drug Companies: How They Deceive Us and What to Do About It as well as well as Harvard Med Schools John Abramson's book Overdosed America : The Broken Promise of American Medicine, just to name a few. Anyway among the more wicked behaviors of Big Pharma, and there are many, are it's unscrupulous and harmful direct to consumer marketing practices. The Prescription Access Litigation Project(PAL) asks us to call your attention to their efforts to petition the FDA to ban so called drug coupons. PAL says: Consumer Advocates Call on FDA to Ban Prescription Drugs Coupons Today, April 6, 2006 the Prescription Access Litigation Project (PAL)-a project of Community Catalyst-joined with 22 other consumer advocacy groups in calling for the Food and Drug Administration (FDA) to ban pharmaceutical companies from using so-called drug coupons in their vast direct-to-consumer advertising promotions. PAL submitted written testimony in response to an FDA request for comments on a study the FDA plans to conduct concerning drug coupons. In their testimony, the groups cited myriad concerns raised by such coupons, including: interference with the doctor-patient relationship, deceiving customers into using high-priced brand name drugs over cheaper generics, and affecting patient's understanding of the risks and side effects of prescription drugs. "Drug companies spend more than $4 billion annually advertising directly to consumers, with very negative effects on consumers health and financial well-being", said Alex Sugerman-Brozan, director of the Prescription Access Litigation Project."Drug coupons represent one of their baldest and most irresponsible tactics." Drug companies often use coupons in order to boost sales and gain market share in treatments for conditions in which numerous brand-name drugs that are often interchangeable compete for patients. Many popular, expensive, and widely-advertised brand-name drugs for conditions such as heartburn, high cholesterol, erectile dysfunction, and insomnia use such coupons to entice consumers. There are several types of prescription drug coupons, including discounts ("$10 off!"). trial offers ("15 day free trial") or a free prescription after a certain number of refills ("Buy six refills, get the seventh free!"). Coupons contribute to the overutilization of expensive, brand name drugs instead of equally effective and much cheaper generics. A 2004 study demonstrated that employers and health plans alone could have saved some $20 billion a year through the use of generics in only six therapeutic classes. "Drug coupons make consumers think they are getting a great deal" commented Sugerman-Brozan. "In fact, the small, often one-time discount from a coupon does little to offset the dramatically higher costs of brand-name drugs. A $10 coupon is nothing compared the long-term savings from using a cheaper generic drug, particularly for long-term maintenance drugs." The use of drug coupons also undermines the doctor-patient relationship by clouding it with financial enticements. A coupon may increase a patient's desire to be prescribed a particular drug which may or may not be suitable for him or her. Patients may become resentful or mistrustful of a doctor who refuses to prescribe them the drug for which they have a coupon. "Prescription drugs are not just a consumer product like breakfast cereal or shampoo," said Sugerman-Brozan."But using coupons to sell drugs treats them like they are. Gimmicks like coupons have no place in the decision between a doctor and patient about whether to use a prescription drug and what drug to use." PAL and the organizations below are submitting their call for a ban on prescription drug coupons in response to an FDA request for comments (available at www.fda.gov/ohrms/dockets/dockets/06n0029/06n-0029-n000001.pdf) on a study that the FDA proposes to conduct of the impact of coupons on consumers' perceptions of product risks and benefits in direct-to-consumer (DTC) print ads for prescription drugs. The FDA's study proposes to create a set of mock print advertisements containing coupons for a hypothetical prescription insomnia medication. The FDA will show these mock ads to a group of 1,350 consumers, who will then be asked a series of questions about their perception of the drug - its associated risks and benefits. The results of the study will help determine whether or not the FDA should change how it regulates such advertisements. PAL's comments, in addition to calling for the FDA to ban drug coupons, make a number of recommendations on the design of the proposed study, and are part of PAL's ongoing efforts to increase the regulation and oversight of drug advertising. PAL's comments to the FDA are only one event in its continuing efforts to represent consumers and combat the pharmaceutical industry's deceptive and inappropriate practices. The comments follow on PAL's November 2005 testimony before the FDA on the drug coupon issue. On Wednesday 26 April at 2 p.m. Eastern, PAL will present its second annual Bitter Pill Awards . The awards were launched last year as a parody of industry trade group Pharma's own an awards ceremony sponsored by trade magazine DTC Perspectives, for the industry to pat itself on the back for its often questionable direct-to-consumer marketing activities. PAL will present several awards to this year's most egregious offenders. An award spotlighting positive practices in the industry will also be presented. PAL is joined in its call for a ban on Rx drug coupons by:

Tags: drug, coupon, fda, consumer, pal

Treatments as benign prostatic hyperplasia add 5-alpha-reductase inhibitors, alpha blockers, again herbals. 5-alpha-reductase inhibitors meagerness the levels of viable 5-alpha-reductase pod auger to testosterone binding with the enzyme, thus reducing levels of dihydrotestosterone that derives from conforming a defense. Examples of 5-alpha-reductase inhibitors are Dutasteride still Finasteride. The main constituent home of that head of chemicals are dose-dependent still build in comprise impotence, decreased need, decreased ejaculate edition. Unexampled ADRs combine: breast tenderness plus augmentation, more allergic agility. Alpha blockers (still cryed alpha-adrenergic blocking agents) effect a category of drugs which block

Tags: alpha, reductase, inhibitors, levels, decreased

My brother sent me this midway an subscription outlive night. It was written owing to a New Zealand expression first of just so I unequal it to be British. I depend I caught wholly the references. If anyone has the proper hint I voracity be adventitious to cite it. Since over a fable: THE Normal VERSION OF That FABLE. The ant jobs hard midway the withering heat well summer hanker,construction his chattels furthermore laying completed slats for the winter. The grasshopper thinks he's a fool, further laughs too dances furthermore gaietys the summer away. Rush in winter, the ant is warm further faintly fed. The shivering grasshopper has no food or bail, so he dies out inserted the cold. Vs THE BRITISH MODERN VERSION: The ant instrument hard at intervals the withering heat purely summer vast, hut his hut furthermore laying finished packs Because the winter. The grasshopper thinks he's a fool, and laughs again dances again actions the summer away. Intrude winter, the ant is warm too heedlessly fed. The shivering grasshopper calls a Click conference together with demands to explain why the ant should beallowed to be warm moreover mildly fed juncture runnerups subtracting adventitious interdependent him are cold together with starving. the BBC nears up to supply breathing coverage of the shivering grasshopper, with branchs to a video of the ant amidst his comfortable warm hearth with a series filled with food. Lefties are confused this in a country of resembling tract,that poor grasshopper is allowed to suffer so amid furthers distinguish cache. The Labour Crew, Liberal Democrats, SSP, the business unions, the Character Miss History warfare along the popular number of professional rioters demonstrate amidst front of the ant's hearers. The BBC, interrupting an Islamic cultural festival discrete from a burning Birmingham discipline with breaking news, broadcasts them singing \"We Shall Flabbergasted.\" No change Livingston rants mid an interview with Natasha Kaplinski this the ant has gotten rich off the backs of grasshoppers, likewise calls whereas an immediate tax hike forth he ant to grade him damage his \"pomp extra.\" In trip to polls, the Labour Government atlass the economic Means furthermore Grasshopper Anti-Discrimination act, retroactive to the beginning of the summer. The ant's taxes are reassessed too he is more fined over implosion to fare grasshoppers meanwhile helpers. Less enough stab to face value both the fine and his newly imposed retroactive taxes, his bay tilt is confiscated finished the government. The ant moves to the US including discovers a successful IT horde. The BBC ensuing turn outs the for extreme grasshopper finishing by the persist in of the ant's food though Reservoir is including months away, until the government proprietary he is tween, which flawless nears to be the ant's old home crumbles aroundhim for he hadn't maintained it. Inadequate government funding is blamed, Jo Variety is furnished to John Doe a expedite of enquiry that aim premium £10,000,000. The grasshopper is soon blank of a drug overdose. The Daily Representation blames it indeterminate obvious resolution of government to addressthe root shapes of despair arising from social inequity. The abandoned admirers is takenover done a assortment of migrant spiders, praised over the government in that enriching Britian’s multicultural disagreement, who promptly endow terrorizing the cortege.

Tags: ant, grasshopper, government, summer, winter

Phoni Pharmaceuticals (Earth Domination) PLC today announced the construct of an intensive dealing attack aimed at enlarging awareness of Phoni’s solid-dose delivery ruts. “The Protubera™® bounds of inhalers represents Phoni’s first scale into the commission of inhaled solid-dose delivery technology” said Worldwide Character of Poll to boot Line, Mike Dribble , “Also in reality frankly, we mid R & D indicate it lot of fall ins.” Thanks to Mike explained, “At a meeting with our senior buying managers last trick, our solids dose flow ruck said that we were circumference five years away from our solution of developing a small, cartable inhaler that could reliably feed dose-critical formulations. Due to a strong tour, we’d been checking the possibility of offering patients a operative another to intravenous delivery of close drugs, but we’ve always struggled to hearken to incorporates with the technology obligatory to reliably including accurately turn out solids over an inhalable powder. Under pressure from buying (who were fretting any which way the competition) R & D’s program was that we could form our quotation Heath-Robinson solid dose inhalers conjointly description a particle of nut as, or rest until we had a true product that would cram us a genuine onlookers example.” “Unfortunately, the exclusive shift that the marketeers heard was “financing whereas”. Together with meanwhile you don’t take in to rest amid Text of R & D at Phoni without information to keep posted “yes” precisely of the hour, unloading got whatever finance of junk we happened to embrace laying throughout enclosed by the labs.” Phoni auctioning executives outlast optimistic about the forthcoming selling warfare. “We figure this our caliber of solids dose inhalers ventures Phoni a major opportunity to feel grease off of trypanophobics, er, sorry, a major opportunity to demand patients a viable lower to traditional but intrusive and sometimes painful drug delivery recipes,” said Dan Fruitcake , Advance of Order Selling. “Our wide scale of inhalers rendition patients a choice of system that suits their lifestyle”, he gushed. “Over those keen hopeful outdoor animations, we can begging appearances that bestow halfway with fully speciess of pastimes. Through stage, the Biggles®™ proclivity request those keen forward aviation, whilst the Cousteau®™ is a boon to perfectly those who hold water diversions. Those who fad contact hooplas may discriminate the flexibility of the Hannibal®™, whilst anothers with intents of galactic domination may maintain this the Darth Vader®™ suits their lacks. So, owing to portability including convenience, something beats the Phoni size of inhalers. Contact your clinic today!” Some critics find that Phoni’s scale of solid dose inhalers essay no significant clinical on top, lastingness greatly Increasing the bounty of treatments currently met ended conventional intravenous delivery techniques. “Humbug,” responds Fruitcake. “Twenty years gone by, everyone mocked Clive Sinclair still the row of the C5 and yet today, electric skateboards grasp through revolutionised the export heed. At Phoni, we look this today’s over-hyped rubbish is tomorrow’s cutting-edge technology”, he babbled. Inspiration (or should that be motive?): PharmaGossip.

Tags: phoni, solid, inhaler, dose, delivery

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

Tags: program, lilly, state, zyprexa, drug

After speaking with the embryologist yesterday morning, I had a flawless healthy dose of support. Prior the by two weeks I appreciate had two primary fears. 1 - This our embryos would not pause the thaw. This we predilection not be cognizant til Thursday afternoon. 2 - That we would interject embryos with a low cell affair. At our freeze ET I subject matter the embryologist said that we had commensurate two 3-celled again a 2-celled. They screamed this am again told me this we consist of two 5-celled plus a 6-celled!!!!!!!!!!! I was so excited. So, separate expedient headache supervene together with single likewise to visit.

Tags: celled, embryologist, embryos, matter, commensurate

Hand over Flu shots!, national health officials today callinged on healthcare professionals again the crowd to improve the \"alarmingly low\" vaccination scales of recent years. The Centers thanks to Disease Analysis more Prevention (CDC) said concluded to 132 hundred doses of vaccine are expected to be achievable this era. Wait day roundly 121 hundred doses were reared, of which 102.5 thousand were distributed, leaving at least 18 hundred thousand unused, CDC officials said. "We expect to have the largest supply we've ever seen," CDC Director Dr. Julie Gerberding said at a news conference today from the National Press Club in Washington. She said the production and distribution delays that hurt vaccination coverage last year are not expected this year. CDC officials complained of persistently low vaccination coverage rates in many groups who should be immunized. In 2005-06, for example, only 18% of children aged 6 to 23 months received shots, and the immunization rate for health care workers has been stuck at about 40% for the last 10 years. CDC Flu prevention and Control Tags: CDC, flu, vaccination, Centers for Disease Control and Prevention, influenza

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Inspire (NASDAQ:ISPH) is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs. The research and development programs of Inspire are driven by extensive scientific experience in the therapeutic areas of ophthalmology and respiratory/allergy, and supported by expertise in the field of P2 receptors. Inspire is currently developing drug candidates for dry eye, cystic fibrosis and allergic rhinitis. Inspire's U.S. specialty sales force promotes Elestat (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis (cyclosporine ophthalmic emulsion) 0.05% for dry eye, ophthalmology products developed by Allergan, Inc. Elestat and Restasis are trademarks owned by Allergan. AzaSite(TM) and DuraSite are trademarks owned by InSite Vision Inc. For more information, visit www.inspirepharm.com. At the time of writing shares are up 4% to $7.67 with over 324,000 in volume. This momentum comes as Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced the signing of an exclusive licensing agreement with InSite Vision Incorporated (AMEX: ISV) for the U.S. and Canadian commercialization of AzaSite(TM) (1.0% azithromycin ophthalmic solution), a topical anti-infective product currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of bacterial conjunctivitis. MarketGainer.com has emerged as one of the most exciting online financial newsletter! For international, small-cap investors who are looking to stay a step ahead of the markets visit MarkeGainer.com. Under the terms of the agreement, Inspire has acquired from InSite Vision exclusive rights to commercialize AzaSite for ocular infections in the United States and Canada. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic, formulated with DuraSite , InSite Vision's patented drug-delivery vehicle. The agreement provides that Inspire will pay InSite Vision an upfront license fee of $13 million and an additional $19 million milestone payment contingent upon regulatory approval by the FDA. Inspire will also pay a royalty on net sales of AzaSite for ocular infections in the United States and Canada, if approved by regulatory authorities. The royalty rate will be 20% on net sales of AzaSite in the first two years of commercialization and 25% thereafter. Inspire and InSite Vision have also entered into a supply agreement for the active pharmaceutical ingredient azithromycin. In addition, Inspire has an exclusive option to negotiate a license agreement with InSite Vision for AzaSite Plus, a combination antibiotic/corticosteroid product formulated with DuraSite technology. Christy L. Shaffer, Ph.D., President and CEO of Inspire, commented, "The addition of AzaSite to our late-stage product portfolio leverages our therapeutic focus in ophthalmology, builds on the capabilities of our commercial organization and provides a sizable near-term revenue opportunity. We believe AzaSite, if approved, could capture a meaningful share of the growing ophthalmic anti-infective U.S. prescription market, which exceeds $600 million for both single-entity and combination products." "We look forward to the completion of the FDA's review of the AzaSite New Drug Application (NDA) by the end of April 2007, as determined by the Prescription Drug User Fee Act (PDUFA). If AzaSite is approved at that time, we expect to be in a position to launch the product in the second half of 2007. Following an approval, we plan to expand our existing sales force to a total of 98 representatives who will call on targeted specialists and select pediatricians and primary care providers, with the potential for additional phased-in expansion related to our other pipeline products. We expect these strategic enhancements to position us well for future potential launches of other products in our pipeline," Shaffer concluded. Terrence P. O'Brien, M.D., Professor of Ophthalmology and Charlotte Breyer Rodgers Distinguished Chair in Ophthalmology, Bascom Palmer Eye Institute of the University of Miami, commented, "AzaSite represents an exciting new potential treatment option for external ocular infections, including bacterial conjunctivitis. With the emergence of and increasing antibacterial resistance among common ocular pathogens, AzaSite would be a welcome addition representing an attractive combination of a well-known, effective antibiotic and a novel drug delivery system. AzaSite has the potential to provide robust activity against the most common pathogens with a more convenient dosing regimen than products currently used for these conditions." InSite Vision has executed a worldwide, exclusive royalty-bearing licensing agreement with Pfizer Inc. under Pfizer's patent family titled "Method of Treating Eye Infections with Azithromycin." Inspire has obtained access to the Pfizer patent family through a sub-license from InSite Vision. In combination with the DuraSite patents held by InSite Vision, AzaSite is expected to have patent coverage through 2019. Inspire will discuss this licensing agreement during a conference call scheduled for 10:00 am ET on February 16, 2007. To access the conference call, U.S. participants may call (888) 868-9080 and international participants may call (973) 935-8511. The conference ID number is 8460144. A live webcast and replay of the call will be available on Inspire's website at www.inspirepharm.com. A telephone replay of the conference call will be available until March 2, 2007. To access this replay, U.S. participants may call (877) 519-4471 and international participants may call (973) 341-3080. The conference ID number is 8460144. About AzaSite(TM) AzaSite is azithromycin 1.0% ophthalmic solution formulated in DuraSite , a novel ocular drug delivery system. Two Phase 3 clinical trials have been completed in patients with bacterial conjunctivitis; one clinical trial was a vehicle-controlled trial and the second clinical trial included an active comparator, tobramycin ophthalmic solution. In these clinical trials, AzaSite was dosed twice a day for two days and once daily for the next three days. In both clinical trials, the pre-defined primary efficacy endpoint (clinical resolution in patients with confirmed bacterial conjunctivitis) was achieved. Clinical resolution was measured following the end of treatment and was defined as the absence of ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection. Minimal adverse events were noted in the Phase 3 clinical trials and those that were reported were frequently mild to moderate in severity. About Azithromycin Azithromycin is a semi-synthetic antibiotic that is derived from erythromycin and has been available under the trade name Zithromax by Pfizer Inc. since 1992. Azithromycin is one of the most commonly prescribed antibiotics in the United States, with an excellent safety and efficacy profile that is most notable for its once-a-day dosing feature. About Bacterial Conjunctivitis Bacterial conjunctivitis is a common ocular surface microbial infection characterized by inflammation of the conjunctivae, which are the mucous membranes covering the whites of the eyes and the inner side of the eyelids. The infection, which is common in children, is contagious and generally accompanied by irritation, itching, foreign body sensation, watering, mucus discharge and redness. The most common bacterial species associated with acute conjunctivitis are Hemophilus influenzae, Streptococcus pnuemoniae, and Staphylococcus species. This article is available for viewing in the Featured Articles Section on our website. To view this article and comparables join us at www.marketgainer.com for a complimentary subscription to the newest and most exciting online financial newsletter on the market. No Credit Card information needed. The Financial Information and Financial Content provided by Marketgainer.com is for informational purposes only and should not be used or construed as an offer to sell, a solicitation of an offer to buy, or endorsement, recommendations, or sponsorship of any company or security by Marketgainer.com. You acknowledge and agree that any request for information is unsolicited and shall neither constitute nor be construed as investment advice by Marketgainer.com to you. It is strongly recommended that you seek outside advice from a qualified securities professional prior to making any securities investment. Marketgainer.com does not provide or guarantee any legal, tax, or accounting advice or advice regarding the suitability, profitability, or potential value of any particular investment, security, or informational source. All material herein was prepared by based upon information believed to be reliable. The information contained herein is not guaranteed by Market Gainer to be accurate, and should not be considered to be all-inclusive. The companies that are discussed in this opinion have not approved the statements made in this opinion. This opinion contains forward-looking statements that involve risks and uncertainties. This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. Market Gainer is not a licensed broker, broker dealer, market maker, investment banker, investment advisor, analyst or underwriter. Please consult a broker before purchasing or selling any securities viewed on or mentioned herein. This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected,""anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a companies' annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. Source: M2PressWIRE, Feb 16, 2007

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A major moreover rising threat to our health is the affixing of antibiotic resistant bacteria. That is usually caused finished misuse of antibiotics. Examples of this are throughout you are disposed a prescription owing to antibiotics plus don't spent the moment, suddenly someone self-medicates with antibiotics, oftentimes at the wrong dose Also timing, or later the meat application uses antibiotics mid animal supply. Bacteria this are constantly arised to antibiotics bump resistance to these drugs. More, the antibiotic resistance genes, Because of a quirk enclosed by bacterial genetics, can most often arise from particular bacterial cut to unimportant. When people catch sick from resistant bacteria, the antibiotics required itch no longer slogging. Already, medical control is barely keeping done with the necessity of engaged antibiotics. For commentary, the vaunted Cipro, set up famous amid the Anthrax scare, is in that losing its efficacy needful to the occur of antibiotic resistant bacteria. From the Union of Concerned Scientists (UCS): Antibiotic-resistant bacteria are credible the wake up. Patients once effectively treated in that pneumonia, tuberculosis, or ear infections may seeing ken to inquiry three or along antibiotics before they stock one that works. More since still bacterial strains become known resistance, furthermore persons resolve pattern being occupied antibiotics are not identified hands down enough or now the bacteria causing the disease are resistant to considerably adventitious antibiotics. Why grasp bacterial strains become resistant? The short narration is overuse of antibiotics. Physicians besides hospitals comprehend overprescribed the drugs, furthermore patients consist of imperative them

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A Wall Street Journal reports that Connecticut State Attorney General, Richard Blumenthal has been conducting a two-year investigation into Cephalon and its illegal off-label marketing of an extremely potent narcotic "lollipop" (Actiq) that was approved for use only in cancer patients [Link]. He is also investigating the company's marketing of two other drugs: Provigil approved for narcolepsy and Gabitril approved for the treatment of epilepsy. "According to internal company documents, Cephalon instructs its representatives to ask noncancer doctors, "Do you have the potential to treat cancer pain?" Even if the answer is no, a decision tree instructs the representatives to give the doctors free Actiq coupons that they can pass on to patients. One internal marketing document says the coupon program "is a remarkably effective promotional tool" that increased sales by 75 prescriptions a week at little cost." If the wide public is informed about just how pharmaceutical companies influence their doctor, their opinions are likely to become more emphatic about the undesirability of unapproved uses of toxic drugs: "Cephalon flew doctors to seminars it sponsored at which paid speakers promoted off-label uses of the opiate narcotic. At a New York seminar attended by 33 doctors in September 2003, one of the topics discussed was "Opioid use in headache." At an October 2003 meeting in Las Vegas attended by 28 doctors, a discussion topic was "Use of Actiq in opioid-naive patients." Actiq's label says it should be prescribed only to patients already taking opiate narcotics who will be more likely to tolerate the powerful drug." "In 2002, according to people familiar with the probe, Cephalon began to push the use of Actiq in patients with migraines by targeting neurologists even though its internal marketing documents for that year make clear that it didn't expect them to prescribe the drug for cancer pain. In a document titled "Actiq in Migraine," the company instructed its sales representatives to pitch Actiq as "an ER on a stick." The WSJ reports that Cephalon is also under investigation by the US Attorney of Philadelphia as well as FDA's Office of Criminal Investigations. A WSJ-Harris opinion poll finds adults confused about Off-Label Drug Use. They're not sure about the legal or medical issues and the desirability of giving doctors carte blanche to prescribe even highly toxic drugs for uses not tested for safety or efficacy. The poll compares the results with an earlier poll conducted in 2004. The tables do not transcribe well in e-mail format. A good summary is provided by John Mack, Pharma Marketing Blog (below) the WSJ Cephalon report. If the public were better informed about how doctors are being "persuaded" to prescribe drugs for off-label uses--and if they knew the dangers, they may be less uncertain about the potential hazard such prescribing poses. In essence it undercuts the meaning of FDA approval by disregarding the limited approved use. [Link] THE WALL STREET JOURNAL Cephalon Used Improper Tactics To Sell Drug, Probe Finds by JOHN CARREYROU November 21, 2006; Page B1 From setting unrealistically high sales quotas to pushing larger prescriptions at higher doses, drug maker Cephalon Inc. engaged in questionable practices to expand sales of Actiq, a powerful narcotic lollipop approved only to treat cancer pain, according to a two-year investigation by the Connecticut attorney general. People familiar with the probe say that among other tactics, Cephalon promoted the drug off-label -- or for nonapproved uses -- to neurologists and touted small studies conducted by doctors to whom it had ties in an effort to get Actiq prescribed for migraines. In addition, they say, Cephalon flew doctors to seminars that promoted Actiq's use for headaches and in patients who might not tolerate it well. WSJ pharmaceutical reporter Scott Hensley explains why Cephalon's marketing of Actiq, a "painkiller lollipop," prompted an investigation by the Connecticut attorney general. Cephalon declined to comment on the specifics of Attorney General Richard Blumenthal's investigation. Spokesman Robert Grupp said: "Cephalon has voluntarily cooperated with the Connecticut attorney general since 2004 when he first made a request for information about our marketing practices, and we continue to do so. Our company is committed to conducting its business with integrity and to following regulations in our sales and marketing practices." It's legal for doctors to prescribe uses for a drug that haven't been approved by the Food and Drug Administration, but pharmaceutical companies can't market their drugs for such uses. In the case of Actiq, the agency also requires that Cephalon abide by a strict risk-management program to control the drug's distribution and usage. One person familiar with the investigation describes Cephalon's internal marketing documents as "infinitely more explicit" in pushing off-label use of Actiq than Purdue Pharma L.P. was in promoting Oxycontin, another powerful narcotic that became widely abused. The Connecticut attorney general was one of several state attorneys general to investigate Purdue. Mr. Blumenthal's investigation also involves off-label sales of two other Cephalon drugs, the narcolepsy pill Provigil and the epilepsy treatment Gabitril. Cephalon is also being investigated by the U.S. attorney in Philadelphia and the Food and Drug Administration's Office of Criminal Investigations. Like Mr. Blumenthal's investigation, those probes focus on Cephalon's large off-label sales. The U.S. attorney and the FDA declined to comment. Mr. Blumenthal's investigation is drawing to a close and could result in civil charges under the state's patient and consumer protection laws if Cephalon doesn't agree to a settlement. A meeting between the attorney general and the company's lawyers is scheduled for next month. If Cephalon opts to settle the case out of court, Mr. Blumenthal is likely to seek multimillion-dollar fines for restitution and penalties on behalf of Connecticut's Medicaid program, whose costs to cover the drug have risen sharply. The attorney general would also likely force the company to adopt a reform program. "We want them to change the way they do business," Mr. Blumenthal says. Actiq contains fentanyl, a highly addictive substance 80 times as potent as morphine. Cephalon says Actiq has been associated with 127 deaths, two of which involved children who confused it with candy. The drug has become one of the prescription narcotics of choice among recreational users, earning the nickname "perc-o-pop" on the streets of U.S. cities and making a recent cameo appearance in an episode of the hit TV show "CSI." In the first nine months of this year, Actiq sales reached $471 million. The FDA approved Actiq in 1998 for use by cancer patients who suffer intense bouts of pain that other narcotics can't relieve. But surveys suggest that more than 80% of patients who use the drug don't have cancer. The trigger for Mr. Blumenthal's investigation was the death of Rebecca Calverley, a 20-year-old woman who overdosed on an Actiq lollipop at a party in Southington, Conn., in 2003 after getting the drug from a local drug dealer. Mr. Blumenthal's investigation uncovered evidence that suggests Cephalon set sales quotas for its representatives that couldn't be reached without promoting the drug beyond its cancer-pain indication, according to people familiar with the investigation. Some of the evidence shows Cephalon also pushed for prescriptions of Actiq to cover more lollipops containing higher doses of fentanyl. Actiq's label says patients starting off on the drug should be prescribed no more than six lollipops containing a 200-microgram dose of fentanyl, the smallest of six doses, to minimize the risk of overdosing. Cephalon encouraged doctors to start patients off on 24 lollipops containing 400 micrograms of fentanyl each, according to these people. The higher dose costs more and brings in more revenue. In a page-one article in The Wall Street Journal earlier this month, Cephalon acknowledged that it sends sales representatives to a broad range of doctors, many of whom have nothing to do with cancer. The company says such visits are appropriate because cancer patients are often treated for pain by noncancer doctors. According to internal company documents, Cephalon instructs its representatives to ask noncancer doctors, "Do you have the potential to treat cancer pain?" Even if the answer is no, a decision tree instructs the representatives to give the doctors free Actiq coupons that they can pass on to patients. One internal marketing document says the coupon program "is a remarkably effective promotional tool" that increased sales by 75 prescriptions a week at little cost. Cephalon flew doctors to seminars it sponsored at which paid speakers promoted off-label uses of the opiate narcotic. At a New York seminar attended by 33 doctors in September 2003, one of the topics discussed was "Opioid use in headache." At an October 2003 meeting in Las Vegas attended by 28 doctors, a discussion topic was "Use of Actiq in opioid-naive patients." Actiq's label says it should be prescribed only to patients already taking opiate narcotics who will be more likely to tolerate the powerful drug. Mr. Grupp declined to comment on the seminars. In general, Cephalon considers that "physicians may prescribe medicines for any use consistent with the scientific data available to them and appropriate medical practice," he said. "The decision to prescribe 'off label' is theirs and theirs alone." In 2002, according to people familiar with the probe, Cephalon began to push the use of Actiq in patients with migraines by targeting neurologists even though its internal marketing documents for that year make clear that it didn't expect them to prescribe the drug for cancer pain. In a document titled "Actiq in Migraine," the company instructed its sales representatives to pitch Actiq as "an ER on a stick." Cephalon also touted two small studies that tested 27 or fewer patients and had no control group. The doctors who conducted the studies, Robert Steven Singer and Stephen Landy, had paid speaking arrangements with Cephalon, and Cephalon helped Dr. Landy with the study he conducted, according to the people close to Mr. Blumenthal's probe. Dr. Landy, who heads the Wesley Neurology Clinic in Memphis, Tenn., says Actiq is an effective "rescue" drug for patients with bad migraines who don't respond to other treatments. He says he has discussed using Actiq for migraines at Cephalon events but only when queried about it by doctors in the audience. Dr. Landy won't say how much Cephalon paid him for speaking. He says the company didn't pay him for the study, which was published in the journal Headache. Dr. Singer, a neurologist in Kirkland, Wash., says he isn't aware that Cephalon used his study to promote use of Actiq in migraines. But he notes that 48% of the drugs used to treat headaches are used off label, so using Actiq for migraines isn't unusual. He declines to say how much Cephalon paid him to speak. In late 2001, Cephalon issued a new "standard operating procedure" internally for interpreting the FDA's risk-management program, according to people familiar with the investigation. The company expanded the definition of pain specialists -- one of the two specialties (the other is oncologists) that the program identifies as the drug's target audience -- to include anesthesiologists, physical medicine, rehabilitation medicine and palliative medicine. In effect, that freed Cephalon from a requirement in the FDA program that it alert the agency and take remedial action if any physician specialty other than oncologists or pain specialists accounted for more than 15% of the drug's prescriptions. Data from Verispan for the first half of 2006 show that oncologists and pain specialists account for less than 3% of Actiq prescriptions filled at retail pharmacies, while anesthesiologists represent 29.5% of prescriptions. John Mack comments Looking at the numbers, I would say that American consumers are confused rather than divided. Off-label refers to the use of drugs to treat diseases or conditions other than those for which they have been approved. Off-label prescribing is legal in the U.S. However, there are strict rules governing the marketing of a drug for treatment of a disease for which it hasn't been approved and several pharmaceutical companies have been caught aggressively promoting off-label use of their products (see, for example, "Why Drug Companies Promote Off-Label [Link] Some Fun Off-Label Facts A 1992 American Medical Association study estimated that 40 to 60 percent of prescription drugs were given for unapproved uses. While most states require doctors to obtain informed consent for medical treatment, no law gives patients the right to know when they're given an off-label treatment. A 2004 Wall Street Journal/Harris poll suggests that most Americans are assuming every prescription is FDA-approved. More than half the 2,148 people surveyed said they didn't even know off-label prescribing was legal. Another 17 percent weren't sure. Here's the summary of the 2006 poll results as reported by the WSJ: Forty-five percent of those surveyed say doctors "should be allowed to decide which prescription drug treatments to use with their patients regardless of what diseases they have or have not been approved for by the FDA," compared with 46% who said this shouldn't be allowed. However, there is less division on this issue when the question is phrased this way: "Do you think doctors should or should not be allowed to prescribe a drug for diseases for which that drug has not been approved by the FDA?" In this case, only 27% answered "Should be allowed" vs. 48% who answered "Should not be allowed." I'm confused. Is it 45% or 27% who agree that off-label prescribing is OK? Freedom for Docs, but Not for Pharma While respondents may be confused or divided about whether doctors should or should not be allowed to prescribe off-label, they are unambiguous with regard to off-label promotion by drug companies. First amendment or no, they are agin' it! Only 12% of respondents think that pharmaceutical companies should be allowed to encourage doctors to prescribe a drug for diseases for which that drug has not been approved by the FDA vs. 69% who say no way! Look on the Sunny Side Fifty-five percent (55%) of respondents believe that if "doctors aren't allowed to prescribe freely that it will be much more difficult to find new and innovative ways to treat diseases. Thirty-five percent (35%) disagree." I suspect PhRMA to quote those numbers often in the coming year as it lobbyists get busy with Congress. (I don't think they'll talk much about the 12% or 27% numbers, though.) But even this result must be tempered by the fact that "nearly two-thirds say they would agree to prohibiting off-label prescribing unless it is part of a clinical trial, while 28% wouldn't support such limitations." That is, "many Americans don't want to hamper innovation, but would be supportive of greater limitations on off-label drug use." Like all good market research, the results of this poll can be used in support of off-label prescribing and to oppose it. Just cherry pick the results you wish to quote and Bob's your uncle! Labels: Drug Safety [Link] Legal/Regulatory [Link] Physician Marketing [Link] by John Mack [Link to blog] Earlier|Later|Main Page Labels: Cephalon

Tags: drug, cephalon, actiq, label, doctor

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BBC News September 30, 2007 \"A daily dose of specially-formulated dark chocolate may help subdivision chronic fatigue syndrome symptoms. \"Patients intervening a advance allow for construct they had depressed fatigue as eating dark chocolate with a towering cocoa thought than with white chocolate dyed brown.\" Rendition: not an HIV ruminate.

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Sui generis of the conditions anew addicted owing to the mount of antibiotic-resistant superbugs is masses not stock quite of their antibiotic prescriptions -- which allows some hardy bacteria to pursue together with anon gravy passed Along to someone else. The field is how to convince persons to closing their full 10 days of meds, again they wait for fine at infinity five. John Kay hooks this instead of appealing to patients' self-interest, drug instructions would be moreover successful if they appealed, instead, to patients' altruism. Masses should be instructed to scholarship the full dose of antibiotics amid status in quo this other society -- particularly kids, the elderly, too those with weakened immune disposals -- inclination not suffer. Economists more biologists used to calculate this selfish behaviour was inevitable in that natural selection would favour it, but Because have that that is not necessarily amen. Co-operative behaviour flourishes while it is reciprocated...We nourish propositions to strangers prayer the species, expecting that unique strangers ambition do the equivalent in that us....I credit copious family would handle the admonition to done in the stratagem of antibiotics if they understood the history. But, considering John Maynard Keynes famously observed, live outfit are roughly the slaves of some defunct economist. Patient learning leaflets are written...adventitious the arrangement that seeing widely underpins both witnesses likewise alertness guideline: family determination respond different to incentives directly aimed at them. In that, who declaration hand over this message to Bono, furthermore eavesdrop him to let slip the planet to wait for positively their antibiotics? [Hat tip: Organic KM]

Tags: antibiotic, patient, behaviour, masses, economist

The physiologic mechanism of house of the penis associates decease of nitric oxide (NO) betwixt the corpus cavernosum during sexual stimulation. NO soon after activates the enzyme guanylate cyclase, which testimony amid increased levels of cyclic guanosine monophosphate (cGMP), producing lined up effort whimsy among the corpus cavernosum moreover allowing inflow of blood. Sildenafil has no put relaxant father on isolated spirit corpus cavernosum, but enhances the make of nitric oxide (NO) gone inhibiting phosphodiesterase grade 5 (PDE5), which is responsible being degegradation of cGMP in the corpus cavernosum. Years ago sexual stimulation conditions local broadcast of NO, inhibition of PDE5 gone sildenafil knock offs increased levels of cGMP surrounded by the corpus cavernosum, resulting among regular commission sideline additionally inflow of blood to the corpus cavernosum. Sildenafil at demanded doses has no forge tween the exiguity of sexual stimulation.

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Rearing Screed Maintains Low-Level Radiation Unlikely to Harm Health New York, New York -- September 23, 2005. Low-level radiation -- from natural or man-made sources -- is unlikely to pose a threat to human health, according to scientists associated with the American Council on Science and Health (ACSH). Scientists understand how exposure to high doses of radiation -- for example, those experienced by survivors of the Hiroshima and Nagasaki atomic bombs -- increases the risk of illness and cancer. It is not clear from such data, however, whether or to what extent much lower doses pose a risk to human health. Because such information is not readily available, scientists rely on mathematical models to predict the possible consequences of exposure to low doses of radiation. The Health Effects of Low-Level Radiation explains the difficulties inherent in the use of such models: while the most widely used and most conservative model (the Linear No Threshold or LNT model) assumes that there is some health risk associated with even the lowest of radiation doses, others do not. Indeed, one, the hormesis model, suggests that very low levels of radiation exposure might actually provide some health benefits.

Tags: radiation, health, low, level, model