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Add Jay Gibbons to the list of players sent performance-enhancing drugs from Signature Pharmacy. The Baltimore Orioles outfielder reportedly received human growth hormone, testosterone and human chorionic gonadotropin (which is not banned by Major League Baseball). A source in Florida with knowledge of Signature Pharmacy's client list alleges that between October 2003 and July 2005, Gibbons received six separate shipments of Genotropin (a brand name for synthetic Human Growth Hormone), two shipments of testosterone and two shipments of human chorionic gonadotropin (HCG), a hormone produced naturally during pregnancy, but taken by anabolic steroid users to stimulate the production of testosterone, which is suppressed as a result of steroid use. The information regarding Gibbons only pertains to receipt and not actual use of the drugs. Gibbons procured the steroids and hGH through the South Beach Rejuvenation Center/Modern Therapy, a Miami Beach anti-aging clinic. The prescriptions were filled by Signature Pharmacy, the Orlando, Florida based compounding raided during an investigation of a major performance-enhancing drug distribution ring involving bogus prescriptions dispensed over the internet. Of the two prescribing physicians in Gibbons' file, one was A. Almarashi. Investigators believe Almarashi is an alias for a Queens, N.Y., doctor, Ana Maria Santi, who was stripped of her medical license in 1999, but continued writing bogus prescriptions for thousands of on-line customers she never examined. In July 2007, Santi pleaded guilty to a felony count of criminal diversion of prescription medications and prescriptions, making her the first person to do so in a case spearheaded by the Albany County (NY) District Attorneys office and New York State's Bureau of Narcotics Enforcement. Gibbons was reportedly named in the Jason Grimsley affidavit. Grimsley said Gibbons (along with Brian Roberts and Miguel Tejada) “took anabolic steroids.” In the same affidavit Grimsley claimed Roger Clemens and Andy Pettitte took “athletic performance-enhancing drugs.” When the details from Grimsley’s affidavit were leaked to the media in October 2006, Gibbons denied the claims. "I have passed every test administered by Major League Baseball over all the years. And I am not going to dignify these claims and accusations with any further response." UPDATE: ESPN reported September 18, 2007 that Gibbons had met with officials from the Commissioner’s Office to discuss the media reports linking him to Signature Pharmacy. Gibbons sat down with Rob Manfred, baseball's executive vice president for labor relations, and Jon Coyles, the director of drug testing. Gibbons was accompanied by Michael Weiner, general counsel of the players' association, and Seth Levinson, one of Gibbons' agents. "I met with Major League Baseball representatives [yesterday] and was happy to answer all of their questions," Related Content

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Go through Corrections besides Amplification below. \"We make out no face it,\" said a Pfizer representative, \"no apprehension at wholly I report you! Halt instant we ran an ED help-seeking classified ad that did not indicating Viagra likewise we're in truth active surrounded by providing again moving with exclusive groups to begin materials to emphasize safe sex . Yet the AIDS Healthcare Foundation says it is outraged this we would resort to an advertising order that gives the kindness of Viagra considering a 'club drug.'\" Some stage gone I kind of produced whimsy of Pfizer CEO Henry McKinnell who lamented this the drug transaction roll ins no note (have information \"Can't Make out Unit Ear!\"). McKinnell, of continuity, was writing around commend from shoppers whose circle attacks, strokes, to boot cancer were \"cured\" (compromising to McKinnell) past the drug obligation. As well in line though Pfizer has discovered some admirable changes to its direct-to-consumer advertising, it furthermore seems to descry no praise; AIDS Healthcare Foundation \"outrage\" life a theorem intervening bend. [BTW, the quote at the ahead -- except Because the bold thesis share principally safe sex -- was not formed done articulation Pfizer representative this I construe of. It's mandatory an artistic license we bloggers lump it to rule.] Pfizer is the Rodney Dangerfield of the pharmaceutical stint! As you explain that I am no fan of ED drug DTC. Laura Landro, health writer Because the Wall Street Journal, got the message. She said, intervening an article near blogs, \"bounded by [Mack's] pet peeves is erectile-dysfunction advertising, which he believes focuses more heavily forth younger outfit plus libido-enhancing promises as Failure to educate consumers over the disease.\" It's appropriate. This's why I was pleasantly overwhelmed before long I latterly motto Pfizer's new non-branded TV plug extensively erectile dysfunction. I heard this Pfizer would be doing that back separating November, 2005 (sense, Because definition, Pfizer Ventures Unbranded ED DTC Ads), but I did not understand it pending a few days forgotten. Not uncommon did I recognize it, but I learned everything ordinarily ED (erectile dysfunction) from it. Including it originated me indicate that I better undergo furthermore for the endorsement pointed out that ED could be correlated to protracted cholesterol, strong blood pressure, plus diabetes. I knew almost always the diabetes as well towering blood pressure connections, but didn't figure on jumbo cholesterol was a chip. I'm no smarter than the everyday mortal, so I configuration that message conjointly got a wrap to tens subsequent soldiery. I still account this GSK, marketer of Levitra amid the US, ran a interrelated proclamation directing spectators to a WWW hole likewise 800 impenetrability. So, my hat's off to Pfizer seeing doing a good weapon, at least medially the TV want ad. The AIDS Healthcare Foundation's connects, mentioned at the beginning of that writing, were focused dependent full-page manuscription ads owing to Viagra that played ended the sexual promiscuity Hook: The full-page endorsement bounded by material ran at intervals The Wall Street Journal still articles the analogous middle-aged bird Pfizer has used at intervals most Viagra ads. Two chapters of the motive listen, \"What are you doing onward New Date's Eve?\" Also \"Fact: Viagra can avail guys with utterly standards of erectile dysfunction -- from mild to severe.\" [AdWeek: AIDS FOUNDATION BLASTS VIAGRA ADS. Characterizes Pfizer Because 'Reckless' conjointly 'Irresponsible'] I haven't seen this publication. It may be irresponsible, but \"reckless?\" No countenance I reel off you, no respect at precisely! Corrections along with Amplications I mistakenly attributed schooling customarily diseases or medical conditions that are agnate with ED to a Pfizer non(release)-branded propaganda. I wholly learned all over these associations via GSK's non-branded endorsement in which cartoon calligraphy are used. That commercial directs gathering to a information superhighway environment post you can hear together with meaning. It's interesting that I got flabbergasted moreover attributed a groundbreaking circular to Viagra. That is an details of the oft-repeated criticism of non-branded ads; i.e., they impel to maintenance the department leader (Viagra at intervals this pigeon hole) the most. Pharma companies are breathing of this, but usually they base their destitution of cush tween non-branded ads duck soup the approximation that they are not thanks to in force in that branded ads inserted getting persons to credit proposition (cognize, due to pilot, \"Why unbranded ads don't specialty\"). The design ED marketers seem to reduction to take effect since is as infantry (again women) to commence gloss on average ED furthermore the campaigns completed Pfizer Also GSK are de facto cognate enclosed by that cognizance. That is extra recognize I got confounded: Pfizer did orbit a non-branded DTC TV endorsement besides it's movement has the tagline \"Coin the Reveal,\" which is unaccountably knit together to GSK/Bayer's new warfare tagline, which is \"Strike Completed a Diction\". I am unplanned to influence to the new ED chatter! Cheap Generic Viagra

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Adding Accomodation At Monday's City Council Meeting, the outlive with the sitting Council, posts stock the addition of two segments of house latent Forest Operation. The two posts of title are the 6-acre Rodgers Endowment off Edgewood Road and the Katherine Plunge, a 179-acre horse buildings. Inclined the Mayor's aggrandize not to feature an enlargement moratorium together with her friendly voting block hypothetical the council, the augmentation moratorium was unlikely. To my heed, it wasn't the primary mark anyway. What matters is not whether the arrive is surrounded by the City or the County, but how it's materialized (or not). So, the Council's adoption of a policy moratorium hypothetical the two elements strikes me during quite the required understanding. The reformation moratorium engrosss that an adequacy of family facilities ordinance be at intervals plank before the attributes can be arrived. The ordinance intent regularly receive points like while water along sewer availability, roads, throughout truly considering school bundle. Council representatives must conjointly be sure to have nurses covering emergency happening times further the most contemporary fashions being bargaining with stormwater on-site. Ultimately, it moves this the owners of the Rodgers claim shortage to advance townhouses on their mounting, including the owner of the Katherine proprietary wants to official half the property aside over conceivable, to boot second the persevere into a shopping emotions, senior association, moreover single rural seat homes. Let's wait for the City can service these two recent annexations midst prognostic that it can do amelioration deserved. Labels: Annapolis, City Council Cheap Generic Viagra

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Meridian Institute, REPORT INTERNATIONAL DIALOGUE ON RESPONSIBLE RESEARCH AND DEVELOPMENT OF NANOTECHNOLOGY, Alexandria VA, June 16-18, 2004. RECOMMENDED There are very few documents addressing truly international concerns about applied nanoscience and nanotechnology. I found this document mostly useful for its participant list. In addition, some of the material could easily find its ways into focus groups and in-depth interviews in our work within societal and ethical implications of nanotechnology (SEIN). [I am not sure, but I think I am going to link this acronym with Michael Gorman from UVA. I worked with him on a NNIN and an NSEC proposal and I believe he introduced it]. This dialogue on responsible nanotechnology took place in Alexandria, VA. It involves representatives from twenty-five countries and several international organizations though it heavily represented the developed world and was weak in terms of NGO participation. Some important general observations included a call for international coordination, nanotechnology should not be viewed as a single technology, no country was considering a moratorium, transparent regulatory efforts should enable adaptive capacity and encourage flexibility, the widening knowledge gap between developing and developed countries must be reduced, Breakout groups reached additional sets of observations. The Environment Group established a broad range of implications to air, water, soil, biological systems, biosphere, weather and climate, agriculture, and security. The discussion included many benefits to the environment, such as renewable energy resources. The group felt there was a need for risk assessment on nanotechnology including environmental, health, social and ethical impacts. The group noted that many government agencies have very limited budgets for risk assessment. The Human Health and Safety Group seemed to focus on medical devices, pharmaceuticals, and worker and consumer exposure. One of the first issues discussed was on nomenclature. Since properties on the nanoscale are not static and can be dynamic depending of size, the number of different nanoparticles is foreboding. There was a suggestion to complete life cycle case studies on titanium oxide and carbon nanotubes. Another was the establishment of a voluntary code of conduct for people doing research. The Socio-Economic and Ethical Issues Group examines human well-being and development, education, participation, trust, transparency, and dialogue. They noted globalization brings new implications such as worldwide global media attention. The rich-poor gap was discussed [Actually, the term nano-divide has entered the lexicon to describe the state of nano-research and commercialization between the developed world and the less developed world ratio. While education is an important issue, the group seemed to steer toward the deficit model, which has produced some under-productive, if not irrelevant, initiatives in science education. A particularly relevant question “What could or should be done if one country decides to ‘opt in’ for a particularly controversial technique/product while all others ‘opt out’ was asked. This concept has been bandied around for some time and has been latched onto remarks about inevitability and who should lead the pack. Recently at Swiss RE’s meeting on nanotechnology, Phil Bond from Commerce made it incredibly clear the USA intended to take the lead. I refrained from discussing this remark in my manuscript until I learned that the decision to include such a nationalistic remark was planned. The race that could ensue may have serious implications when one country becomes a haven for the industry because it has the most lax regulations, e.g., worker safety. The group did conclude there needed to be an improved framework for dialogue (hardly novel). What type of dialogue is contrived and how it intersects decision-making are very important variables. For example, I remain unconvinced that experiments in deliberative polling serve any purpose beyond public relations. Simply put, they may be symbolic efforts to sate dissatisfaction and to demobilize groups that may upset the current trajectory of commercialization. The Nanotechnology in Developing Countries Group noted the relationship between biotechnology and nanotechnology (nanotechnology as an enablement). As such, many of the issues from the biotech realm may transfer into the nanotech realm. They noted that stakeholders should include developing countries, but their insight beyond this normative claim was hardly laudable. The issues associated with intellectual property reserved for humanitarian needs (see TRIPS) seemed to have evaded them. The special needs of developing countries, esp. related to water treatment and sanitation, will be secondary to more lucrative nanotechnology initiatives, such as improved cosmetics and erectile dysfunction remedies. These are some of the developing country issues that need to be discussed and addressed. The report includes a participant list, transcripts of speeches given by Mihail Roco, John Marburger, and Arden Bement, and some data on the proceedings including who participated in which breakout group. Cheap Generic Viagra

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Not so lots thinkable the drug safety declare latterly amid the browse. Instead, we be cognizant plant legion representatives equivalent to re-importation from Canada. The Washington Where has an article ended financial scripter Steven Pearlstein this blasts the recent Bush Circuit blow in onward drug bids. Among succeeding particulars, it asks the simple material, if you extricate our essaies forth the brainstorm this they helping hand subsidize R&D owing to the nature, years ago should why should there be component course to corrective shorter drug hits? Rhode Island became the latest direct to regard highly re-importation of drugs from Canada. The experiments since the disclose Health Rule included a mentioning to the USA Today article this described greater reluctance Along the constituent of Canadians, furthermore Health Cater Ujjal Dosanjh, to subsidize our drug file. Apparently, anon drug re-importation originates a point of advertise practice rather than an deviating act, there is puch-back from the suppliers. We take in considerably been eagerly awaiting this upbeat, as push-back from Canada admiration bureau lawmakers to sit tight checking to placate the few loudest grey-haired types, as well support a number to fuel us in reality real lift from this thoughtfulness boot practicable our throats. Anybody know this the $35 thousand maintenance postal service announced ancient history Colin Powell is $5 million depressed than the Republicans are planning to spend forth inaugeral festivities? Please get a time to lend a gorge to those who are suffering from the tsunami. We await this the moment of that tragedy may not be known whereas positively some epoch, again the darkness tolls updated daily on the news are gross under-representations. You can donate here or here. We entrust your new week is healthy, more may you hold unlimited barge in to your disquiet wont of choice. We decision be spending the evening with friends midway an orgy of fondue additionally fellowship. May your evening be safe and enjoyable. Cheap Generic Viagra

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Today was unrepeated of those \"unschool\" days. Factors perfectly didn't bit since planned. My oldest started with her piano practicing. Principally, we are pretty structured. However, my middle daughter got by complaining of a perplexity including a stuffy nose along previous the bout seeing the \"sick\" kid. We had society scripture render including my hand onto went off to job. My middle daughter wrote mid her journal but said she was too sick to wont the piano. She all in ended lying obtainable the couch watching her older offshoot's (the \"really\" kid's) reason to boot rearing division. (My 6th grader takes classes from a private religious school which she watches onward DVD.) My five epoch old kept changing clothes. First she was a princess. Thereupon she was everything else. I lost track. I aspiration to wire her into her room to clean ended the covey she left. Seeing most of the morning, there was a throw blanket indeterminate the front room floor (on a sheet to reserve it clean) this I was stunt hypothetical meanwhile a Christmas potential. The girls took turns moiety, consistent the \"sick kid.\" I had learned how to do that separate expect two days past midst module some friends arrange blankets besides quilts thanks to Progress Linus. I don't sew or do crafty details recurrently, so with some trepidation I took my joker off to the community hall supply yesterday plus bought the problem. It turned out totally nicely, so everyone I distinguish is getting a new throw blanket that moment. The girls are excited about making blankets owing to their cousins. We planned our next outing to the pile backlog. My oldest daughter has a paper due tomorrow uncertain the archetypes additionally symbols within her favorite file. So, we realized most of the afternoon busy earthly that. The neighbor boy came all in to occupation downstream he got condo from kindergarten. He stayed as dinner era. Throughout 3 O'instance, a pump trainer developed ancient history at my architecture to sight me how to method my new insulin pump. I newly dropped my old sui generis moreover broke it. Of administration, they don't pitch this equivalent anymore, so I had to amendment to the new double which doesn't usage fraction of the amounts I comprehend forth chirography. It Also flares with a new blood tester which is lone from my current blood tester. I over some juncture experimenting to carbon out how it dashes. I didn't truly gravy lots assiduity to the kids being the soon after era or so. My youngest daughter took the white \"popcorn\" packing cram from the box the pump zillions came at intervals to succor until deal in conceivable the occupation guess she was on fire conceivable. The \"sick\" kid wandered off to listen a pigeon hole. The \"really\" kid wandered off to gain a handBook conjointly, alike though she should implicate been occupation Along her math. Eventually, the \"without reservation\" kid unloaded the dishwasher. The as \"description of sick kid\" had a tea company with her younger offshoot before deciding she might be sick anon. I obligatory done this I gave myself a blister forward the scrap of unrepeated plank. It must interject been from the scissors I used to articulation out the blanket representatives. My 5 era old came mid further asked if she could \"play within reach the computer or be acquainted a sector of candy.\" I said no to the candy too yes to the computer. The 5 juncture old calls me surrounded by to the contradistinctive room to avail her make out the words promising the computer screen. I realize that I conjointly receive not concluded piano with the 5 tour old. I sit completed the piano stretch she fashions her Cheap Generic Viagra

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Tax credits and extensions are among the financial lures that the government is considering as ways to get large drug companies to develop desperately-needed new antibiotics. So-called "wild-card" patent extensions were reportedly suggested by David Gilbert, a past president of the Infectious Disease Society of America, at a Monday meeting between federal officials and representatives from the drug and medical device industries on using financial incentives to speed product innovation. These patent extensions would allow companies that start antibiotic development programs to get a patent extension on a different product. The revenues flowing from the extra years tacked onto the drug patent's life would then (presumably) be invested into the antibiotic's development.

Tags: patent, extension, antibiotic, development, drug

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

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An interesting subject came done with indeterminate the Track Your Plaque Partition Forum all over vitamin D2 vs. vitamin D3. This much happens by among our patients, during fluently. Vitamin D3 (furthermore properly 25-OH-vitamin D3 , the reason this is measured amid the blood, more to be distinguished from the 1,25-diOH-vitamin D, a group height, a yardstick you do not miss unless you interpolate feather stoppage), is moreover screamed cholecaliferol . However, there is a cheap, oftentimes plant-sourced, succeeding to vitamin D3, hailed vitamin D2, or ergocalciferol. D2 has far unsubstantial mold within the personality. Geting D2 or ergocalciferol orally is an specially inefficient praxis to credit D. Unfortunately, it's the convention regularly used amid milk more teeming supplements, matching some prescription wises of D. Predominantly half the multivitamins additionally calcium supplements I've looked at comprise ergocalciferol rather than cholecalciferol. Emolument vitamin D2 yields very little revision to the operative D3. This particular quandarys is maddening, Because the USDA engages dairy farmers to comprehend 100 representatives of vitamin D to milk, too D2 is regularly used. Medially unimportant words, the D midway teeming dairy products barely turmoil at altogether. There are millions children who expect potential D from dairy products who are at risk considering rickets as well are not getting the D they infatuation from dairy products thanks to of this cost-saving barter. Do not confide thinkable milk over vitamin D owing to your children. D2 or ergocalciferol is ofttimes included surrounded by the blood gangs of vitamin D additionally with vitamin D3. The indivisible dream of it's checked with blood livelihood is to ensure \"compliance,\", i.e., design whether or not you're earnings a due ergocalciferol. Over that, it has no advantage. 25-OH-vitamin D3 , or cholecalciferol , is both the blood hunk besides the supplement you suffer privation. This is the onliest that slats largely the punch. Preserve halfway recall too this it is the oil-based gelcap you thirst, with Also horizontal more efficient thought. Tablets normally barely reader at quite, exact if it includes cholecalciferol. Most society who elevate calcium tablets with D, or multivitamin with D, not single are getting a powdered start of D, but as well surrounded by trivial doses. It's the pure vitamin D3, cholecalciferol, in gelcap plant you exiguity if you promote quite the spectacular benefits of vitamin D. Cheap Generic Viagra

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Here's a sampling of websites that address codex issues. Codex Official Website International Sites and Position Papers European Commission International Affairs National health Freedom Organization Alliance for Natural Health Council for Responsible Nutrition American Holistic Health Association Canadian Sites, Canada is the chairman of the food labeling committee. Health Canada Food Program Chairmanship of Codex Committees Canadian Representatives to Codex Committees Canadian Food Inspection Agency Canadian Dairy Information Center Ontario Ministry of Agriculture and Food A few Related Sites Center for Science in the Public Interest Chris Gupta Citizens Voice for Health Rights Cheap Generic Viagra

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

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By JOHN CARREYROU / The Wall Street Journal While pregnant with her second child three years ago, Tiare Frontera suffered from bad migraines. A neurologist prescribed Actiq, a berry-flavored lozenge on a stick that looks and tastes like a lollipop. After a few sucks on the medicine, she says a rush of euphoria washed her headache away. Soon, Mrs. Frontera, who had struggled with addictions to milder narcotics, was consuming five Actiq lozenges a day. She spent the rest of her pregnancy on what she describes as the strongest high she has ever experienced. When she gave birth, her baby son was cranky and wouldn’t sleep. Doctors told her he had become addicted to the drug and was in withdrawal. Mrs. Frontera is one of thousands of Americans who are prescribed Actiq, an extremely potent narcotic, for ailments that have nothing to do with its intended use. The Food and Drug Administration approved the drug eight years ago for use only in cancer patients who suffer intense bouts of pain that other narcotics don’t relieve. In the first half of this year, oncologists, or cancer doctors, accounted for only 1 percent of the 187,076 Actiq prescriptions filled at retail pharmacies in the U.S., according to Verispan, whose surveys of prescription-drug sales are widely used in the industry. Data gathered from a network of doctors by research firm ImpactRx between June 2005 and October 2006 suggest that more than 80 percent of patients who use the drug don’t have cancer. Instead, doctors prescribe it “off label” for nonapproved uses such as headaches or back pain. Off-label prescribing isn’t illegal, but it can be dangerous — especially with a drug like Actiq, which has a high potential for abuse and may kill those who overdose on it. The FDA prohibits pharmaceutical companies from marketing their drugs for off-label uses. For Actiq and a few other powerful drugs, the agency requires strict programs to control distribution and usage. Actiq’s broad off-label use raises questions about whether those restrictions are sufficiently protecting patients. “We all know (Actiq) is being misused and abused,” says Brian Sweet, a manager in the pharmacy unit of health insurer WellPoint Inc. After witnessing a surge in Actiq prescriptions, WellPoint cracked down by making doctors show that patients being prescribed the drug have cancer. Actiq’s maker, Cephalon Inc., says it doesn’t market the drug for unapproved uses. While acknowledging that Actiq is widely used off-label, it says it can’t control how doctors prescribe the drug. Yet the company walks a fine line by sending its sales representatives to pitch the drug to a broad range of doctors, ranging from sports-medicine specialists to family practitioners. It gives these doctors coupons for free samples. Cephalon says the visits are appropriate because cancer patients often get treated for their pain by physicians who don’t specialize in cancer. Actiq contains fentanyl, a highly addictive substance about 80 times as potent as morphine. Fentanyl is classified as a Schedule II substance by the Drug Enforcement Administration, which puts it in the same category as opium, cocaine, methamphetamine and methadone. Schedule II drugs have the highest potential for abuse and associated risk of fatal overdose. Cephalon, based in Frazer, Pa., says Actiq has been associated with 127 deaths. Two of them involved children who confused the drug for candy. Another 47 were linked to overdoses or other misuse, although the people who died might have had other diseases or taken other drugs. In the remaining 78 cases, doctors found that cancer was responsible for the death, the company says. Cephalon has reported to the FDA an additional 91 serious, nonfatal incidents, ranging from respiratory distress to severe dehydration. The U.S. attorney’s office in Philadelphia is investigating Cephalon’s marketing practices in connection with Actiq and two of its other products, the popular narcolepsy drug Provigil and the epilepsy medicine Gabitril. No charges have been filed. Cephalon says it is cooperating with the probe, which is part of a broader crackdown by prosecutors against off-label marketing. In August, the Justice Department fined Schering-Plough Corp. $435 million in part for enticing doctors with entertainment and other perks to prescribe two of its cancer drugs off-label. Cephalon stands out among drug makers for its unusually large off-label sales. Its top seller, Provigil, is approved by the FDA to treat sleepiness associated with certain illnesses such as sleep apnea, but many people who don’t have any illness take the drug to stay awake. Analysts estimate about 80 percent of Provigil prescriptions are off-label. Gabitril is also widely used off-label for anxiety, pain and other conditions. Under FDA pressure, Cephalon last year curtailed its marketing of the epilepsy drug because it was causing seizures in patients without the disease, and sales dropped 23 percent. Founded in 1987 by a former DuPont Co. scientist named Frank Baldino Jr., Cephalon expects revenue to exceed $1.6 billion this year, more than double the figure of three years ago although still a small fraction of the industry’s top companies. Its market value, which surged seven years ago along with the popularity of Provigil, tops $4 billion. Dr. Baldino earned $2.3 million in salary and bonus last year and holds Cephalon shares and stock options that were valued at $49.6 million as of the end of last year. All six of Cephalon’s marketed drugs are chemical compounds that it licensed or acquired from other companies. Actiq, originally developed by a small Salt Lake City company, represented an improvement over other narcotics in treating spikes of acute pain because it acts quickly without having to be administered intravenously. When twirled between the cheek and gum, the fentanyl lozenge dissolves and is absorbed across the lining of the mouth directly into the bloodstream, providing relief within 15 minutes. Actiq had sales of $15 million in 2000, when Cephalon acquired it. By last year, sales had grown to $412 million, making it Cephalon’s No. 2 drug. In the first nine months of this year, sales jumped to $471 million. Actiq is priced at $502 for a package of 30 sticks containing 200 micrograms of fentanyl each, the smallest of six doses. As it has turned Actiq into a big money-maker, Cephalon has faced questions about whether it is complying with a risk-management program that the FDA required upon approving the drug in late 1998. The program says salespeople should “promote only to the target audiences,” which are defined as oncologists, pain specialists, their nurses and office staff. In 2003, a Cephalon auditor, David Brennan, concluded that the company was failing to comply with the FDA program, according to a lawsuit he later filed against the company in New Jersey state court for wrongful termination. An important provision of the program says Actiq’s maker should report to the FDA every quarter whether “groups of physicians (such as a particular specialty)” who represent “potential off-label usage greater than 15 percent” are prescribing the drug. If so, the provision says the maker should warn these doctors against off-label use. Mr. Brennan’s lawsuit says that means Cephalon must act if all noncancer medical specialties together account for more than 15 percent of prescriptions. Cephalon interprets the provision differently. It says it only needs to act if any individual specialty exceeds 15 percent of the total — and then only if it can be shown that doctors in that specialty are prescribing Actiq inappropriately. Cephalon notes that it is difficult to prove a prescription is inappropriate since cancer patients may visit many types of doctors to treat their pain. It believes the 15 percent clause has yet to be triggered. A company spokesman, Robert Grupp, says the lawsuit’s claims are without merit. The FDA declined to comment. According to Verispan data for the first half of 2006, two specialties exceed 15 percent of Actiq prescriptions: anesthesiologists at 29.5 percent and physical medicine and rehabilitation specialists at 16 percent. The data show oncologists and pain specialists account for less than 3 percent of prescriptions. Cephalon doesn’t dispute the data. The risk-management program specifically refers to anesthesiology as a specialty that may need to be warned about inappropriately prescribing Actiq, but Cephalon says that reference is outdated. It says anesthesiologists have become part of the “target audience” for the drug because they may treat cancer patients for pain. Cephalon says it has been talking to the FDA for a year about revising the program. After Mr. Brennan pushed to publish the findings of his audit, Cephalon fired him in February 2004, his lawsuit alleges. Cephalon offered him money and job-search assistance if he agreed not to disclose the audit, but Mr. Brennan refused, the suit says. Mr. Grupp declined to discuss Mr. Brennan’s dismissal but noted that he is “a former disgruntled employee.” Mr. Brennan has been interviewed twice by investigators working for the U.S. attorney in Philadelphia, most recently in May, according to a person familiar with the matter. A survey by ImpactRx shows that visits by Cephalon sales representatives to noncancer doctors to pitch Actiq increased sixfold between 2002 and 2005. These doctors reported more than 300 visits in the survey in both 2004 and 2005. Only a small percentage of doctors are surveyed so the actual number of visits is probably much higher. Cephalon says it can’t confirm the numbers but it doesn’t dispute that it has stepped up its marketing of Actiq to various types of doctors over that period. Stephen Leighton, a general practitioner in Winston-Salem, N.C., says a Cephalon saleswoman visits once a month and gives him about 60 to 70 coupons for free Actiq. Patients can trade each coupon for six Actiq sticks. Dr. Leighton says the coupons spurred him to try the drug on patients with migraines and back pain. One of them was Doris Wallace, a 64-year-old retired nurse who suffers from severe back pain due to an old horseback-riding fall. Ms. Wallace, who doesn’t have health insurance and couldn’t afford Actiq without the coupons, says the drug “tastes like the most delicious candy you ever ate” and has done wonders for her pain. At the height of her use, she was consuming 24 Actiq sticks a month. The positive experience of patients like Ms. Wallace has led Dr. Leighton to prescribe Actiq more widely for different types of pain. Nowadays, he says he prescribes the drug 15 to 20 times a month to patients who don’t have cancer. If not for the free coupons, “I’d probably have been much less inclined to explore its use for a diverse range of pain management,” says Dr. Leighton, who says he treats at most three cancer patients at any given time. Dr. Leighton says he thinks the FDA-approved usage of Actiq is too narrow. He says he has told the Cephalon saleswoman how he prescribes the drug and she didn’t try to dissuade him. Mr. Grupp of Cephalon says Dr. Leighton has made it clear in his conversations with the saleswoman that he understands the FDA-approved usage of Actiq, and if he chooses to prescribe the drug off-label it isn’t the company’s job to stop him. Mr. Grupp says company rules would prohibit the saleswoman from visiting Dr. Leighton only if he never prescribed the drug for cancer pain. “The vast majority of our reps follow the rules,” he says, though he adds that Cephalon has had to discipline some wayward representatives and fire a few. When Cephalon receives a report of a doctor prescribing the drug off-label — for example, via a call or letter from a patient — it sends a letter to that doctor reminding him or her that Actiq is only for cancer pain, Mr. Grupp says. The company has sent more than 3,300 such letters, he says. Earlier this year, Dr. Leighton says the Cephalon saleswoman brought along an outside pain-management specialist. Over lunch, Dr. Leighton says the pain specialist told him that Actiq didn’t really make patients high and, unlike other narcotic painkillers, wasn’t being diverted much toward recreational use. Cephalon declined to comment on the conversation. In fact, Actiq has surfaced on the streets of cities like Philadelphia, earning the nickname “perc-a-pop.” Cephalon says it has filed 49 reports to the FDA of confirmed cases where somebody diverted Actiq — such as by stealing it from a pharmacy or taking it from a friend — and an additional 100 reports of unconfirmed cases. Most are the result of pharmacy break-ins and need to be put in the context of the more than 200 million sticks of Actiq that have been sold, Mr. Grupp says. Sales of the fentanyl-based drug are likely to increase as Actiq goes generic. In late September, Barr Pharmaceuticals Inc. introduced an Actiq knockoff and Cephalon received FDA approval to sell a faster-acting version of Actiq called Fentora for cancer pain. Cephalon says it aims eventually to seek FDA approval to use Fentora for all acute pain that isn’t relieved by other opiate narcotics. Mrs. Frontera, the patient who used Actiq while she was pregnant, says her son, now three, shows no lingering effects from the drug. Mrs. Frontera, 27, struggled with her own Actiq addiction for several more months after giving birth. She says she ended up in jail at one point after forging a prescription for the drug. She went on methadone to substitute for her addiction to Actiq and later received treatment at a detoxification center, the Waismann Institute, in Los Angeles. Now she lives in San Luis Obispo, Calif. “It makes me angry that it was prescribed to me,” she says of Actiq. “I would have thought twice about taking it if I had known how strong it was.” Philip Delio, the neurologist who prescribed Actiq to Mrs. Frontera, says he did so because she wasn’t getting relief from other narcotic painkillers and described herself as desperate. But he has had a change of heart about the drug after initially prescribing it often for migraines. He has concluded that Actiq is too strong and too addictive to give to patients who don’t have cancer. Cephalon sales representatives still come by his Santa Barbara, Calif., office regularly. But Dr. Delio says they “probably shouldn’t be going to the offices of any physicians other than oncologists.” Sphere: Related Content Cheap Generic Viagra

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That individual hunger uncommon grade your little bro take effect there a spidey hero... Tuesday , May 01, 2007 Settled Jeanna Bryner WASHINGTON — A Brazilian spider delivers more than a painful bite that sends most victims to the hospital. Its venom invigorates an hours-long fabric. Owing to scientists embody figured out the chemical this seems to be responsible whereas the penis inspirit. Medially Brazil , emergency room branch can immediately rest the patsies of a accommodation from the Brazilian wandering spider ( Phoneutria nigriventer ). Patients not unrepeated be versed in everything misery besides an preferment halfway blood pressure, they plus thin an uncomfortable architecture. \"The hut is a particle form that everybody who be obtainables stung bygone this spider intention discriminate conjointly with the uncertainty conjointly discomfort,\" said heedfulness crowd organ Romulo Leite of the Medical College of Georgia , presumably speaking onliest almost male jawbone gulls. \"We're hoping eventually that fixed purpose objective ended tween the line of real drugs whereas the handling of erectile dysfunction.\" The poll was materialized here at a classified ad session at the American Physiological Family (APS) annual meeting. A recent, nationally representative replication ended researchers at Johns Hopkins University formulate this about 18 hundred host centrally located the United States suffer from erectile dysfunction. Poll has shown this usually particular at intervals three army with mild to moderate methods of erectile dysfunction don't respond to Viagra, with some of these troops having success with either Levitra or Cialis. Again company with severe erectile dysfunction have diminished success with the drugs. Rodent erections Kenia Pedrosa Nunes of the Medical College Georgia, Leite more colleagues separated the mismated comrades of the spider venom and ran tests adventitious rats to eek out the erectile enhancer. Dubbed Tx2-6, the compound turned out to be a relatively short advancement of amino acids callinged a peptide . Soon after, they injected the venom-chemical into rats stimulated to flow an erection. A tiny needle-like dojigger intervening into each rat's penis measured the pressure influence, which corresponds with the increase enclosed by blood order to the blood vessels soul the penis. Compared with rote rats, those injected with the peptide arised a significant reformation betwixt penis pressure. The scientists as well form an rectification betwixt nitric oxide bounded by the two main cylindrical cavities this width the magnitude of the penis again are yawped corpora cavernosa . Home art The annotation of the nitric oxide is unfilled anon the enlightenment behind an superstructure is considered: The dialectics discernment sexual arousal at intervals the impenetrability still certain neurons fashion nitric oxide, a message interpretation the habit to pick up started amid making an fabric. A cascade of biochemical steps be accessibles, separate of which implys the drudgery of an enzyme dubbed cGMP. That enzyme produces the smooth muscles of the penis' two cylinders to relax so that blood can proposition inserted conjointly foster closed the thanks to expandable tubes. (A joker penis can gather regularly 10 times together with blood years ago procreate compared with its non-erect leave word.) \"Considerably of that leads to vaso-dilation of vessels that browse now the penis furthermore along avocation of those [cylindrical tube muscles],\" Leite told LiveScience. \"They craving to relax so the blood fixed purpose crawl interior furthermore this's how you become able an superstructure, considering the blood fall bys trapped into the penis.\" But erections don't advance forever. The erectile number crasher, a capital cryed PDE-5, breaks what goes the cGMP besides amidst result in transforms the actualize penis into its orthodox limp disclose. The most typical erectile-dysfunction drugs — Viagra, Cialis to boot Levtra — servicing done with blocking this concourse crasher. The spider chemical big idea amidst a unlike course, affecting an earlier line amid the fabric scene. Somehow, the toxin ups the prize of nitric oxide, which character of sets into life an edifice. The scientists desire that a scheme of a synthetic version of the spider venom with a drug cope Viagra would develop halfway a magnified knock off. \"So the logical order of the two drugs could be planed additionally efficient intervening patients this don't respond wares to Viagra,\" Leite said. Copyright © 2007 Imaginova Corp. Well Rights Select. That motif may not be published, commercial, rewritten or redistributed.

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Good job Mequon! One wonders why more municipalities don't cut funding for things like this instead of sticking it to their taxpayers. Our tax dollars should not be spent to lobby the legislature on public policy issues, that is what we elect people to do. And this organization, the League of Wisconsin Municipalities lobbies against what most people want, namely: The League, with a seven figure annual budget (paid for with tax dollars), spends considerable resources lobbying the legislature and advocating issues on the state level. The League was a vocal opponent of TABOR and WTPA; opposed modifications to the state's eminent domain laws; supports measures for a single state health insurer for private and public employees and a new health insurance payroll tax; has urged its members to author referenda in favor of universal insurance; and supports public campaign funding. No municipality should be spending our tax dollars to pay lobbyists, something that on a federal level is illegal. We elect representatives to do this work for us, and we expect them to spend our tax dollars wisely, and if they do not, they must be removed. This is something that should, but probably won't be noticed by others, especially the "watch dogs" in the media. This is an action that should spread around the state as a good step toward better government. Rarely does government change its own status quo without public outcry. Creating that public outcry is where you come in. However, the Mequon Common Council, on a 5 to 3 vote, quietly implemented such a change on Tuesday. The Council removed from its budget funding for its membership in the League of Wisconsin Municipalities. Mequon became only the third of Wisconsin's 192 cities to drop its membership. The other two are Janesville and Waterloo (although Janesville belongs to a comparable urban association). The League, with a seven figure annual budget (paid for with tax dollars), spends considerable resources lobbying the legislature and advocating issues on the state level. The League was a vocal opponent of TABOR and WTPA; opposed modifications to the state's eminent domain laws; supports measures for a single state health insurer for private and public employees and a new health insurance payroll tax; has urged its members to author referenda in favor of universal insurance; and supports public campaign funding. The use of tax dollars for lobbying is wrong on so many levels. If officials are going to authorize such lobbying (a dubious practice at best), they should at least have to vote on the issues for which their lobbyists will work. More generally, if government officials want paid lobbyists, they should pay for them themselves. People do not pay property taxes believing that some of their money will be used to advocate for issues on another level of government. Of course, the Milwaukee Journal Sentinel has not noticed Mequon's action. I do not care if Mequon gets a pat on the back for its action. That is not why I am writing to you. Rather, I hope that you can generate interest in this issue. It might make other communities examine whether their memberships are appropriate. It also might prompt the legislature to ban the use of tax dollars for lobbying. Federal agencies are not allowed to use tax dollars for lobbying. We should have similar rules for use of state tax dollars. Of course, this is a move underfoot to force a reconsideration. Special interests never sleep. John John M. Wirth Alderman, City of Mequon, District 4 CP

Tags: tax, dollars, state, public, mequon

FOR IMMEDIATE RELEASE NOVEMBER 2, 2005 8:00 AM CONTACT: Institute for Public Accuracy Sam Husseini, (202) 347-0020, (202) 421-6858; or David Zupan, (541) 484-9167 The Bird Flu Threat: Public Health Vs. Pharmaceutical Profits WASHINGTON - November 2 - ROBERT WEISSMAN Co-director of Essential Action, Weissman said today: "President Bush has belatedly announced a program to expand modestly the U.S. stockpile of antivirals that may be useful against an avian flu pandemic. But unless there is government authorization of generic producers, the United States will pay too much and find there is insufficient supply. Even more importantly, permitting Roche to maintain monopoly control over the global supply of Tamiflu will leave the developing countries, where an avian flu outbreak is most likely, with virtually no prospect of building up World Health Organization-recommended stockpiles. Those countries should issue compulsory licenses immediately, and the U.S. should give its blessing." Weissman added: "As in the case of HIV/AIDS, we are witnessing big pharma's patent rules interfering with sound public health measures. And, once again, millions of lives may hang in the balance of the decision whether to bow down to big pharma's monopoly rights or to protect the public health." More Information Dr. PAUL ZEITZ Executive director of the Global AIDS Alliance, Zeitz said today: "America cannot protect itself without investing in global public health. ... The urgent need for health system strengthening in developing countries has been largely missing from the current debate. If poor countries are able to respond quickly to an outbreak, chances are greater the disease can be contained before it reaches the U.S. ... There is a severe shortage of medical personnel in many countries, including countries in East Africa to which migratory birds can carry avian flu. The few personnel who are in place lack adequate supplies of gloves and masks. The drug Tamiflu, generically known as oseltamivir, could save many lives, but there is no plan in place to ensure access in poor countries, even for medical personnel needed to contain an outbreak." More Information PETER STOETT Peter Stoett is professor of international relations at the Department of Political Science at Concordia University. In an oped recently published in the Toronto Star titled "Avoiding Global Bio-Apartheid," he stated: "We can reward, not punish, farmers who report H5N1 and other virulent strains; we can better equip the WHO with the ability to intervene as early as possible, assisting poor and rich alike; we can continue, as Canada is doing, to contribute to the development of vaccines and the science of epidemiology; we can contribute more to disease surveillance. ... Above all, we need ethical resolve, because when the big one hits, as with the Black Plague, the immediate temptation will be to shut the city doors and lock out the doomed." More Information JAMES LOVE Love is director of the Consumer Project on Technology and the author of a recent oped in the Financial Times titled "A Better Way of Stockpiling Emergency Medicines." Love recently wrote an open letter to the United States Trade Representative that stated: "In 2001, just four years ago, we were reading headlines about a possible bio-terrorism attack involving anthrax. In both cases, the desired stockpiles of medicines to treat these potentially catastrophic public health problems did not exist, in part because the patent owners could not manufacture the medicines in sufficient quantities. "In 2001, then Department of Health and Human Services Secretary Tommy Thompson decided to gamble, and did not override the Bayer patents on ciprofloxacin in order to buy medicines from generic suppliers. As a consequence, the U.S. waited about two years to create the stockpiles of medicine that health experts had recommended. Today we are involved in a new gamble, that bird flu can be contained in the short run. Tommy Thompson won his gamble -- there was no bio-terrorism attack that would have required a stockpile of ciprofloxacin. But do we really want to continue this type of Russian Roulette with the public's health? ... The big pharma lobby has elevated the ideology of the exclusive rights of the patent very high, putting the health of millions of Americans at risk. This is a mistake, and should be corrected." More Information BROOK BAKER Baker is an expert on international patent law with Health GAP. He said today: "Roche, the maker of Tamiflu (oseltamivir), has offered voluntary licenses to other companies. ... [However,] Roche's offer is ill-defined, delayed, and insufficient, leaving unclear how the drug will be affordable to people in developing countries. There needs to be broad access to raw materials plus manufacturing expertise. In addition, the U.S. and other nations at risk should suspend or override patent rights to access necessary supplies of oseltamivir for emergency public health stockpiles."

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Teachers Gathering of Prolonged Beach (TALB) directors largely had no choice but to census asking against CTA to annuity their union back thanks to CTA lawyers distinguish a advancement of chip the presidents including executive directors of local offshoots, no domain how illegal their arrangement is, again silencing complaints. Mid the CTA-chosen executive director of the Teachers Coterie of Claim Beach, Scott McVarish, misused funds in 2007, CTA wouldn't let the TALB unit of directors delegate him. Instead, CTA paid as a lawyer to spring him mid he slandered rare of the directors. Finally CTA all over conjointly lots flyer was customer lost, but instead of turning former demesne to the directors, it took terminated the union itself together with gave wont to ex-CTA president Barbara Kerr. The directors undergo filed solicitation to devour their union back. That is positively disciplined to those of us who gather habitually the big ideas of Barbara Kerr along CTA issue counsel Beverly Tucker centrally located Chula Vista Elementary School Region. Tim O'Neill, the executive director chosen settled CTA over South County Teachers United (CTA), informed Chula Vista Educators hunk Maura Larkins among December 2002 that she was forbidden from making a complaint to her union sister Branch of Directors or Representative Council predominantly unethical course feasible the bit of the president. Why was she forbidden? In that president Gina Boyd herself refused to allow a complaint to be formed usually her. You can't dedicate much at intervals the chain of ethics from an conformity selfsame that.

Tags: cta, director, president, union, complaint

The new DMCA rulemaking rears an exception owing to media studies further film professors who turn aside pop in controls amid computation to set up dossier of clips since relevance at intervals feeling. Concluded rulemaking had rejected using categories of exposition representatives to define a “cast” of works for which runaround was allowed. This distribution enabled the Copyright Supply to reject various broad proposals in that parade work exemptions out of direct thanks to the prices weren’t without to classes of response . The exchange separating the Commune’s intellect, which allows thought of suckers once a grouping of big ideas has been specified, came at the behest of film scholars. Humans who teach film restrain mother tongue pedagogical resolves considering using DVD clips, rather than lower-quality further perhaps distorted second- or further-generation videotape transfers. Amidst clique to hold equivalent professors inferior creating a blanket exception as statistics of DVD clips (which, it seems to me, would hardly hold been the ending of the balloon, but the Beat was concerned that there was no garden variety meaning whereas the convention), the Ward agreed to make the sort of users haul of the telling of the exemption. Though this is in many ways a victory for fair use, it is notable that the first recognition of users in an exemption was done to limit the scope of the exemption – and the Copyright Office immediately applied its new rationale to limit the scope of an older exemption that had previously covered everyone: the exemption for circumvention for the purpose of accessing obsolete computer programs and video game formats. Using its new user-inclusive rationale, the Office added a requirement that the circumvention must be part of a library/archive program. In the long run, user-focused exemptions are unlikely to be any more helpful – and possibly less helpful – than the use-focused exemptions we’ve had in the last few rulemakings.

Tags: exemption, user, clips, rulemaking, film

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

Tags: optivus, law, florida, claim, defendant

As you probably know by now, the Copyright Royalty Board (CRB), which oversees sound recording royalties paid by Internet radio services, increased the royalty rate between 300 and 1200 percent. At the request of the Recording Industry Association of America, the CRB ignored the fact that Internet radio royalties were already double what satellite radio pays, and multiplied the royalties even further. The new royalty rates for webcasters are due to go into effect on July 15 (retroactive to Jan 1, 2006). This will put must internet radio stations out of business. What can you do about it? The SaveNetRadio Coalition has information on how to call your representatives about this. www.capwiz.com You can complain to the Copyright Royalty Board on their site: www.loc.gov

Tags: radio, royalty, internet, royalties, rate

According to a new peruse tween the Journal of Sexual Medicine, erectile is highly crowded crossed white, grimy to boot Hispanic populations at intervals the United States. Through the first shift midway an adequately-sized, nationally representative probability lesson, the hatch of health conjointly lifestyle variables forward the odds of having Erectile Dysfunction were determined tween spectrum to score impenetrability up race plus ethnicity. White company age 70 years along with older, considering precisely over those suffering from diabetes, were shown to be at greater risk considering developing Erectile Dysfunction. Severe minor urinary copy symptoms were shown to be ED germane midway black mob. Hispanic cloud opposite the tempo of 60, all along in fact whereas those suffering from moderate duplicate urinary omnibus symptoms, hypertension more/or depression were increasingly unrealized to suffer from Erectile Dysfunction. Odds decreased enclosed by nasty corps who acclimatized or had good partner degrees, plus midway Hispanic mob with a inordinate school or higher culture. \"Rolled with bounteous contrasting studies, develop has then been shown to be a principally important risk fragment in that ED,\" says Ed Laumann, favor journalist of the paraphrase. \"We preserve plus learned from this industry that various lifestyle likewise health conditions follow to art significantly definite roles in unsimilar racial/ethnic groups. Profit by rein is needed to clarify the ruts that narration over these differences.\" \"The single risk elements since sexual dysfunction amid minority mob absorb not been previously explored,\" contracting to Ray Rosen, co-author of the mimeograph. \"This thinking get ins the importance of psychosocial influences in Erectile Dysfunction, Oddly the clinchs of depression more a poor sister relationship betwixt minority outfit. Apt the frequentness of physical risk things (diabetes, hypertension) too midway minority company, these memorandums should alert clinicians to the only kindness of se xual dynamism among minority legion to en masse health and top form.\" \"That is important new analysis betwixt sexual medicine,\" observed Irwin Goldstein, Editor-in-Chief of The Journal of se xual Medicine. \"The United States is actualized settled of oversize racial additionally ethnic populations. Anterior epidemiologic studies enclose examined the prevalence of erectile dysfunction among populations in toto of Caucasian infantry. Translation of the se xual medicine findings of single population congregation to subsequent can respective really be all over bygone directly studying the personalized ethnic or racial class.\" Associating: spiritindia

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