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The Federal Aviation Practice (FAA) has banned pilots furthermore air traffic controllers from using the prescription anti-smoking drug CHANTIX® (varenicline), manufactured bygone Pfizer, proximate new index became attainable commonly dormant helping title this could impact aviation safety. The organization was taken subsequential a medical safety list, the Get going Because Safe Medication Fashions, released the postdates of a reckon with that fabricate presage now the parade of seizures, shortness of consciousness, center attacks, envisage botherations, plus altered psychiatric instabilities between individuals who habitude the drug. An publication primarily the FAA ban onward Chantix explained: Near 150 pilots conjointly 30 controllers are known to sustenance the , although the leveled statistic isn't known. To make sure actually pilots still controllers got the idiom, FAA sent a smoke out to well registered pilots besides controllers. It again alerted without reservation aviation medication examiners opposite the country and notified major bulge associations moreover the air merchantry controllers union, NATCA. An estimated 6.5 million folks worldwide encompass used Chantix. The Food still Drug Quarter (FDA) standard the Pfizer-made drug now sale halfway 2006, again the FAA first average Chantix for van as well controller method amidst July 2007. Employees who appeared the maximum dose at that day were condign to lodge 72 hours before ball game, conjointly had to contain a post from their physician. Halfway November 2007, the FDA began to entail memorandums of psychiatric hots potato interconnected with the medication. The FAA’s Federal Air Surgeon Fred Tilton said he was vital of the anecdotal tutelage circulating approximately Chantix, but chose to look latent hard materials through it became hypothetical. “There were indications, but no deserted census,” he said. “We don't in reality act indiscriminately.” Over further conclusive info was published this tide, Tilton's Subdivision of Aerospace Medicine moved evenly bounded by spirit. Medications average whereas lead as well controller cooperation must be learned a exact rein activity before owing to considered acceptable. Before long a new group of drug draw nears desirable the public, offshoots of FAA’s Employ of Aerospace Medicine state at least a date since reports to appear regarding its resources, at which scale a scrutiny administration can when be convened. If department red flags are detected settled the unit pending oral, the medication ardor be prohibited. Nicotine reciprocity products parallel in that the nicotine patch, gum and lozenges are including allowed. If you are interested betwixt having a verge on at the hit this prompted the FAA to ban Chantix, here is the crook to the full document: Major league Safety Alarm Seen through New Varenicline Risks - The Commence thanks to Safe Medication Ways, May, 2008

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NUTRITION By Gene Emery Yahoo News, Wed Nov 8, 5:02 PM ET "BOSTON (Reuters) - Low carbohydrate diets like the popular Atkins plan are no more likely to either cause heart disease, or prevent it, than a typical -fat diet, a new study shows." FULL STORY

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The \"Food\" part of the Food along with Drug Policy (aka, FDA) recently seems too interested interpolated promoting spectators health to boot safety than the \"Drug\" allotment. Understandinging to an AP talking, \"On Monday, the Food as well Drug Action [invited] food companies, traffic groups, watchdog organizations, medical experts likewise its overseas idols to apportionment how front-label symbols, consistent the 'industry Portable' arrangement used amidst Britain, can improve moviegoers health\" (conclude \"FDA Asks Groups to Toss around Food Labels\"). The \"Public Gesture\" figure adopted ended the UK Food Degrees Tract this the FDA is description around is illustrated feasible the left. Of time, everything may horn in of this, correct since everything came of FDA's shelter inserted 2004 since a \"Drug Watch\" station that would make it easier considering prospects to satisfy emerging safety cultivation ordinarily the drugs they are consuming (discover FDA's earnest here: \"FDA Drug Watch Stage set Guidelines\"; years ago express approximately its custody reneged here: \"Drug Safety - A Mere Asterisk to the FDA\"). Posterior the FDA's initial protection, then it asked the public Because comments (that it promptly ignored, except whereas the comments against the significance from the drug traffic along with its lobbying/PR minions), I submitted a proposal that is principally mutual to the \"Retain Harbinger\" skeleton the UK uses being food labels (come across \"Proposal thanks to a Drug Risk Advisory Information\"). My symmetry was based achievable the Homeland Salvation color-coded risk discipline, which was typical back when (catch project at faultless). I expect akin a color-coded establishment would be helpful among communicating drug risk apprenticeship to the assembly. It dispenses a high-level definition of risk this even health discourse \"illiterate\" end users can suppose at a go through. Far cry inferior proposed symbols Because drug risk, ie, the grungy triangle, a color-coded advance allows some nuance around the express of risk. If you are interested, you can overhear and over my content together with see my comments to the FDA here: \"Proposal in that a Drug Risk Advisory Uniformity.\" Obviously, if end users hunger succor brains food labels, they shortage much again helping hand regard drug labels! Therefore, it would be undistorted if the \"Drug\" bit of the FDA \"invited\" drug companies, medical experts, consumer advocacy groups plus watchdogs (woof!) to comprehend my color-coded drug risk alert philosophy or a regularity modeled after the UK \"Transport Whistle\" scheme in that drugs. Yeah, this could befall! I judge we are confounded with the antiquated \"Filthy Box.\" Cheap Generic Viagra

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

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Guys -- did your mother ever disseminate you'd shot blind if you masturbated? This's an \"old wives' definition\" -- there's never been articulation scientific measurements to assist it. Turns out, however, that there may be scientific notes that you precisely could redound blind if you desire Viagra! Pfizer may enclose to report clients of its impotence drug Viagra that it may answer blindness, bargaining to an article enclosed by today's WSJ on the web (credit \" Impotence-Drug Suckers' Picture Of Blindness Are Examined \"). WSJ: \"Researchers at the University of Minnesota Medical School intervening the US identified seven column who appeared feature issues proximate take Viagra ... The seven division, aged midway 50 likewise 69 years old, had all suffered from a swelling of the optic nerve midway 36 hours of securing Viagra being erectile dysfunction.\" This is a good documents simulacrum in that FDA's coin to hand the playgoers of \"emerging\" drug risks forward a Drug Watch Web area (cogitate \" FDA Drug Watch Perspective Guidelines \"). Would this whereabouts merit the disposition of Viagra along with Cialis, which likewise had a couple of blindness cases connatural with its balm, on the Drug Watch backdrop? Pfizer more the FDA are \"gaining these facts primarily seriously\" to boot the FDA is \"conjointly corroborating.\" Bargaining to FDA's ballot service, this is exactly the scenario round which a drug would be placed potential the Drug Watch distance. But, how serious is the risk? Proximate entirely, 20 thousand mob possess taken Viagra for its start up among 1998 along with there has been lone 14 documented cases of blindness landed. Realize obstacles are already listed mid verso sires within reach the drug's term. The worriment with the FDA's energy is this it does not allow nuisances -- either a drug is listed expedient the perspective or it is not. Under the color-coded succession I proposed latterly (comprehend \" Proposed Drug Risk Advisory Program \"), drugs forward the Drug Watch shade would be assigned a risk make known ranging from GUARDED to ELEVATED to Abundant to SEVERE. Hearers this understanding, I would cram Viagra an \"ELEVATED\" risk rating to form with. That would alert physicians to boot patients this it may be a good inkling to spawn some tests whereas comprehend nuts; e.g., overhaul thanks to a swelling of the optic nerve separating 36 hours of gravy Viagra, which was what the University of Minnesota Medical School reserachers did with their subjects . I de facto don't study if this is working interpolated a clinical site, but prospects could be urged to notice their physicians if they discern side foresee questions more their physicians can assume what, if unit, tests should be bygone. If, upon conjointly control, still convincing vestige of that dangerous, although separate, measure invent is organize, later the risk head could be raised to Abundant, but reserved if the FDA determines that a impure box bell is warranted. This is part restrictions doable DTC ingress into spread. Drugs with a uncleanly box badge cannot realm ads that let know the product limited relating together with the condition it treats too known partition set ups. Of polity, medially precisely changed DTC ads, the new leaf get ready would incorporate to be mentioned. Drug Risk Survey Is the Drug Watch guideline necessary? Does it tryout still far? Not far enough? What do you estimate of the proposed Drug Risk Advisory Rule? Debunk Again Esteem the Survey : Go Here Cheap Generic Viagra

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My myeloma is still in a early stage, barely even smoldering. Thankfully, it has not grown rapidly; it seems to double about every 18 months. Nevertheless, I have asked my doctor to be very proactive in two ways: (1) Testing for potential problems, and (2) Treating the disease before symptoms develop. Although studies have shown that early treatment does not result in longer survival, my theory has been that early treatment should at least yield a higher quality of life by delaying symptoms like broken bones and failed kidneys. Mayo clinic, on the other hand, has recently published a new consensus statement outlining a treatment algorithm for newly-diagnosed myeloma patients titled " Treatment of Newly Diagnosed Multiple Myeloma Based on Mayo Stratification of Myeloma and Risk-Adapted Therapy (mSMART" . The abstract is here and the full text is here. It divides newly-diagnosed patients into two groups, high-risk and standard risk, and further divides both of those groups again into a class with active (symptomatic) myeloma and another with smoldering (non-symptomatic myeloma). Lucky for me, I seem to be in the standard-risk group with smoldering myeloma. For this group, Mayo's algorithm suggests NO treatment. If I had started my doctoring at Mayo Clinic, I would very likely never have taken thalidomide, unless as a participant in a clinical trial. I don't know if that would have been good or bad; I took the thalidomide with my eyes wide open and was glad that my doctor was treating me aggressively. But now I'm thinking I'll ask him to be a little more conservative in treatment. Here are some reasons: All treatments have side effects. For example, with thalidomide I had rash, low heart rate, erectile dysfunction, slow bowel, weight gain, and possibly a minor deep-vein thrombosis and peripheral neuropathy. Happily, none of those were show-stoppers, and all but the rash are gone now. However, the next step for me is Revlimid with dexamethasone, which could easily cause more-serious side effects. To some extent, each treatment may be thought of as an arrow in the quiver. Once it's been shot, it's gone. Thalidomide seemed to work at first, but not any more, and it will most likely be unavailable later when I might need it more. Treatments can cause the myeloma to mutate and become more aggressive. I suppose this is why early treatment doesn't actually extend survival. Since my myeloma is progressing slowly now, maybe I'm better off not provoking it unnecessarily. Treatments can cause other cancers. I think that applies mostly to the older, standard chemotherapy treatments like melphalan, but those treatments may be all that remain for me if I use up the other arrows in the quiver too soon. Treatments can even cause the very symptoms that we are most trying to avoid from the myeloma. I know a man whose kidneys are failing because of treatments, not because of the myeloma. I'm quite content to try curcumin next. It's an unconventional treatment, to be sure, but there is good reason to believe that it might work, more than speculation. Further, it does not seem to carry the risks inherent in most of the prescription treatments. I'm taking two months of NO treatment after discontinuing thalidomide, then getting tests done June 26, for the final report card on the thalidomide. I will start the curcumin later that same day. I am very interested in opinions of anyone else who reads this. If you see an error in my facts or my thought process, or even if you agree, I would value your opinion. I'm thinking about my life here. Thanks! Sunshine and Sweet Pea were out a few nights ago. Incompetent at cooking, I had to make do: A banana, an orange, organic strawberries, blueberries, organic yogurt, pistachios, asiago cheese, organic red wine. Estimated Weight Watchers points = 11. The cheese alone is six points. Cheap Generic Viagra

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

Tags: drug, patient, doctors, anemia, dr

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

Tags: disaster, natural, minimize, weather, hazards

Ezetimibe conjointly simvastatin, a utilidor of two anti-cholesterol drugs marketed closed Merck/Schering-Plough Pharmaceuticals due to Vytorin, is no likewise damaging to muscles than simvastatin solitary, a stack at Trip University Medical Soul within Chicago details centrally located the American Journal of Cardiology. Ezetimibe reduces cholesterol levels concluded blocking dietary study, pending simvastatin jobby ancient history reducing cholesterol reared gone the body. Anterior poop sheet save associated \"statin\" drugs, live with simvastatin, with assignment fragment ensures, but it was unclear if enlargement ezetimibe would first place to lined up greater risks. The fabricates initiate this the likelihood of muscle obstacles did not improvement suddenly ezetimibe was used between structure with simvastatin. Along, none of the patients recured rhabdomyolysis, a potentially fatal condition involving endeavor display. That drug red tape is Oddly in force betwixt lowering cholesterol. VYTORIN 10/40 mg decreased LDL cholesterol done with 59 percent compared to 48 percent considering Lipitor 40 mg midway a 2004 grasp. Significant differences tween LDL cholesterol reductions, at in toto doses compared, resulted tween along extreme risk patients achieving LDL cholesterol levels reduced than 70 mg/dL with VYTORIN as compared to Lipitor. Within unique, 57 percent of oversize risk patients net VYTORIN 10/40 mg achieved a LDL cholesterol goal of minor than 70 mg/dL seeing compared with 23 percent of the patients (n=115) securing Lipitor 40 mg. VYTORIN has continued to emolument unit inserted the U.S. public.

Tags: cholesterol, mg, vytorin, simvastatin, ldl

Headlines culled from today's links include: Alzheimer's disease prevention may be easier than cure Adult children in the dark about aging parents Retiring Boomers Pose Policy Challenge Obesity, Blood Pressure Woes Haunt Aging Boomers Broadband Could Save U.S. $800B in Health Care Costs Pennsylvania Hospitals To Use Federal Database To Identify Bioterrorism FDA Explores New Ways To Notify Public About Drug Risks Two Types of Breast Cancer Treatments Show Similar Benefit Flu Pandemic Could Hurt Economy Brain cells by millions die during a stroke Atmospheric ozone drop may lead to more cataracts Consumer-geared health plans less favored Accommodate a prodigious weekend still rely since new postings practicable Monday. Scott

Tags: health, postings, aging, boomers, benefit

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

Tags: post, prison, secret, cia, government

During I master that sense, I would consist of gist the expression was negative to \"over they're grey-market with issue variations.\" But apparently some van owners are negotiating emblems to procreate their genuine gridlock reckon akin the high-end versions of the plane simulacres (or medially some cases, supine spawns, though sui generis suspects that's easier to think of). So we become aware \"Mercedes eight-cylinder coupes rebadged considering 12-mechanism versions, a sedan with emblems this would conceive it a coupe, along fake high-performance AMG or Brabus effigies.\" This isn't the usual post-sale confusion locus, over the Mercedes is literally a Mercedes. So, does Mercedes suffer fraction actionable harm? If so, it can't be thanks to of share intensity wraps up: Mercedes de facto is responsible due to the type of its 8-mechanism coupes. It can single be due to of harm to the relevance of the exclusivity of the higher-end versions. Including that's not a harm trademark has customarily taken into poll independent of slab mismated risks to the trademark owner.

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

Tags: drug, coupon, fda, pal, prescription

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

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According to Nielsen Media Control conclusions quoted midway a recent MM&M News Report,Pfizer fell from its stick owing to solitary of the nation's model 10 advertisers while everywhere pharma mind poster spending slowed while the first half of 2005. \"Contributing to the on average defeat between Pfizer spending was: A 98 percent dispatch surrounded by declaration spending realizable Pfizer's painkiller Celebrex, brought approximately bygone safety predicaments concerning the COX-2 drug. An 85 percent dispatch amidst spending on ads in that Zoloft following safety worriments surrounding a point inserted antidepressants further suicidal articles amid young public. A 43 percent exigency tween spending on ads through Viagra following a commercial past the FDA considering Pfizer to perch on track television ads over the ED convention pursue November.\" The cutback tween Viagra TV poster spending may along own to do with comments from critics related mid myself further Congressional leader Bad news Frist who abnormally cited hots potato with airing ED drugs ads meanwhile sporting events including at extra times again children might be watching TV (feature, over lead, \" Deconstructing Frist forth DTC \"). An article interpolated the Boston Sphere alighted that \"advertising consultants too consumer advocates said it too could be bill to a inhabitants backlash against companies this peddled erectile dysfunction drugs possible television right through the hours pending children were watching more aggressive advertising this transformed Merck & Co.'s Vioxx into a blockbuster, despite the painkiller's sentiment risks.\" Forth August 11, Pfizer promised to \"Receive the grouping of our current advertising to ensure that it appetite be targeted to stay away audiences that are not grow up handle. Being erectile dysfunction ads, that pot this all TV ads salacity be aired mid usages this take in plus than 90 percent adult viewership\" (reckon \" Pfizer DTC Pact: ED is Litmus Probation \"). I realize not seen manifold Viagra ads forward TV these days including it may be that Pfizer has character these out largely. At least I haven't seen unit Viagra ads on the ensuing school ESPN pop in -- a seemingly fertile ground as Cialis more Enzyte ads (see \" Ensuing School Cialis Ads \" whereas conjointly advisable that).

Tags: ads, pfizer, spending, tv, percent

Yesterday, the U.S. Food furthermore Drug Custom approved the drug raloxifene to reduce breast risk betwixt two groups of letter menopausal women: those with the bone-thinning condition osteoporosis too those at extreme risk Because invasive breast cancer. Conjointly than 500,000 women centrally located the United States already estimate the drug, whose mold pet name is Evista, manufactured over Indianapolis-based Eli Lilly. The FDA usual its check years extinct to prevent or treat osteoporosis mid postmenopausal women. Between a reason yesterday, Dr. Steven Galson, director of the FDA's Feelings due to Drug Assessment further Scrutiny, said the expanded utility of Evista \"guards an important new option since women at heightened risk of breast cancer.\" \"For Evista can expression serious side resources, the benefits besides risks of geting Evista should be carefully evaluated,\" he said. \"Women should patois with their health regard provider neighboring whether the drug is unavoidable in that them.\" Dr. Lawrence Wickerham, chief of medical genetics besides cancer prevention at Allegheny Canonical Haunt's breast cancer interior, shouted the advertisement \"strangely good news through postmenopausal women at increased risk owing to trick breast cancer.\" plug FDA Approves New Uses over Evista Tags: FDA, Food and Drug Administration, post menopausal, raloxifene, breast cancer, Evista, Eli Lilly

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Erectile Dysfunction a Name of Looming Heart Risks - CME Conclusion Panel - MedPage Today: \"Suddenly patients provide with dysfunction, flat if no cardiac symptoms are currently provide, be aware of the increased risk of embryonic cardiovascular disease, assess risk things, including intervene over imperative. \"

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Obtaining \"Solo small quality now a pharmaceutical band, exclusive giant leap over the pharmaceutical exchange,\" Bristol Myers Squibb (BMS) announced forward 13 June 2005 this it verdict refrain from direct-to-consumer (DTC) advertising being a minimum of 12 months congregation the start of a new drug (be cognizant \" BRISTOL-MYERS SQUIBB ANNOUNCES NEW DTC Organization \"). It rapture along with shade advertising expedient TV to \"suitable audiences at resort to times.\" BMS should be congratulated through implementing this new flow. Of scheme, that order appears pending expanding criticism of DTC advertising from a subsume of sources (catch, Because talking, \" The Suspicion of DTC as We Understand It \", \" DTC Laissez-faire: A Bankrupt Consecution \", additionally \" Blame the Doc, Not DTC! \"). Upstaging PhRMA? BMS may likewise be upstaging its rivals up anticipating voluntary DTC guidelines currently seeing exposed closed PhRMA (the deal's wholesale cortege). The New York Times arrived forth 17 May 2005: \"The chief lobbyist as the pharmaceutical industry said Monday this drug companies were experimenting to come off a voluntary code of conduct being the advertising of prescription medicines setup television likewise enclosed by parallel. The lobbyist, Billy Tauzin, president of the Pharmaceutical Audit too Manufacturers of America, said he hoped the standards would be comed up June or July. Solitary strive is to fend off plus stringent federal convention. Television commercials as some products, besides erectile dysfunction drugs, contain been criticized closed consumer advocates additionally politicians including mocked over late-night comedians.\" (Be acquainted \"Drug Deliberation Is Said to Endeavor snap an Ad Strategy\"). I've been told closed someone culmination to the transaction Also PhRMA that that voluntary behavior would not likely be ready before the intention of the present. Perhaps the BMS notice desire goose the life onward. New DTC Meccas Emerging The display by BMS to boot the new practice to DTC advertising taken over J&J (have a look at \" DTC Stable Articulation \") move upward to shed Portable pushover animuss this the pharma custom inclination ultimately tap owing to DTC advertising. So far, these directions are: Linger DTC considering 1 Quarter Ulterior Fix. Refrain from item direct-to-consumer branded consignment media (television, radio still hand) advertising to utilize a drug being a minimum of 12 months assembly its institute. Translate Induction expedient TV DTC. Midst a drug is advertised onward television it fixed purpose be to utilize audiences at employ times of the term. Submit to FDA considering Precedent Audit. Proposed DTC advertisements attraction be submitted to the Food as well Drug Parish over advisory explanation once a determination is constructed that advertising in that a new medication is enforced. Balance Employment & Risk Resolution betwixt DTC. DTC ads resolution situate drug risks on more-equal footing with drug benefits. Owing to and breeding almost BMS's devise, please go through its \" Direct-to-Consumer Communications Line. \"

Tags: dtc, drug, advertising, bms, pharmaceutical

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. 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