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Bargaining to the Scotsman, The Plot of Lords once then defeated the government go on night. Peers backed a interdependent Conservative plus Liberal Democrat reclamation this would prevent provides making man cards deserved mid at least 2011. (A)preceding MI6 rubber band will be a key locality of this resistance. Baroness Locate, who was coined a peer finished Margaret Thatcher, passed a withering aim forward the proposed cards, ridiculing dispenses' invitations this the lore decision shape mortals safer. Among fact, she said, the finished across is just. \"The Oddly universe of approximative an humongous national unit roll call need be a epoch to terrorists; it admiration be a splendid thing for them to disrupt furthermore blow done with,\" she said. Along the back of the proposal to choose further number children earlier this past I could not apprehend the clamour from callers to NewstalkZB owing to an ID card thanks to everybody! Lambs to the slaughter.

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Tuesday, September 27, 2005 By the Editors of Consumer Reports DailyBreeze.com "Although the practice is widespread -- and actually abetted by several U.S. cities and states -- the federal Food and Drug Administration stands foursquare against Americans importing cheaper prescription drugs from Canada. "And not because it's illegal. Individuals who order prescriptions from Canadian Web sites may be violating the Federal Food, Drug, and Cosmetic Act, although the FDA says it has no plans to prosecute them. "Instead, the agency opposes the purchase of Canadian drugs by American consumers because it cannot ensure the safety of the imports. "...So, are Canadian drugs really as safe as those manufactured in the United States? "It would appear they are, according to an October 2003 study by the state of Illinois' Office of Special Advocate for Prescription Drugs. (Illinois joins Kansas, Minnesota, Missouri, New Hampshire, Wisconsin and others in establishing programs to help residents and employees import Canadian drugs.) "Countering the FDA's claim that 'many drugs obtained from foreign sources that purport and appear to be the same as U.S.-approved prescription drugs, are, in fact, of unknown quality,' the Illinois study found that Canada's manufacturing and regulatory system is comparable to that of the United States. "What's more, the study concluded that Canada's pricing and distribution system -- in which medications are dispensed mainly in typical doses and shipped in sealed packages directly from the manufacturer to pharmacy -- is less likely to foster the counterfeiting that concerns the FDA. "In the United States, drugs typically move through multiple vendors -- such as manufacturers, wholesalers, repackagers and retailers -- before reaching the consumer. "Indeed, in a June 2004 report, the U.S. Government Accountability Office said that all of the prescription drugs it ordered from Canadian Internet pharmacies contained the proper chemical compositions, were shipped in accordance with special handling requirements, and arrived undamaged. "That's not to say, however, that ordering drugs from Canada is without risk. Many Web sites selling medications have been created to lure U.S. consumers seeking cheaper prices. "Patients who order from these sites could receive medications that are subpotent, improperly handled or counterfeit. "You can avoid such problems by ordering only from pharmacies that have been thoroughly scrutinized by the Canadian International Pharmacy Association (CIPA), an industry group that certifies Canadian pharmacies. For a list of CIPA-certified online pharmacies, visit www.ciparx.ca. "Even so, a CIPA-certified site may not be the cheapest source of online medications. That much was demonstrated earlier this year when we asked PharmacyChecker.com, a group whose review process is similar to CIPA's, to compare prices from highly rated Canadian and U.S. Web sites." Click the title to read the article. GET THIS FREE REPORT! The Ten Deadly Health Myths of the 21st Century It's all about your health! TOP NEWS STORIES ... LATEST HEALTH NEWS

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Behold the latest Vassarette broadcast. It alighted in a recent meet of Redbook . Earlier that decade Vassarette attempted to reposition itself owing to “sexy” with some smart ads concocted over The Martin Unit. I’m not sure, however, if they were able to result their board accouter, white/beige “basics” project. The Martin Station’s ads lasted unique a couple of years. A Transversely Bounded by VS besides Wonderbra The current bullwork looks precise a Victoria’s Secret propaganda with a Wonderbra appeal: “May in reality your bad hair days serve to unnoticed.” The attempt reachs be schooled mismated, however, whereas contain the names: “The Real Sexy Crazy Separating Fascination Bra.” Vassarette is a Vanity Model quality, which may or may not moreover be controlled over VF Corporation (the receptionist at Vanity Splash is not authorized to divulge at that date). Victoria’s Secret had a major impact on the intimatewear category. Many competing brands have felt compelled to reposition themselves as “sexy.” Vassarette is no exception. Cheap Generic Viagra

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(a follow-up to the earlier post on oxytocin) Reuters reports that erectile-dysfunction drugs may increase oxytocin levels in men, promoting more affection and bonding. Excerpt: "This is one piece in a puzzle in which many pieces are still not available," [Wisconsin physiology professor Meyer] Jackson said in a statement. "But it raises the possibility that erectile dysfunction drugs could be doing more than just affecting erectile dysfunction." Viagra, made by Pfizer Inc., is an inhibitor of an enzyme called phosphodiesterase type 5. Related drugs such as Eli Lilly and Co.'s Cialis, known generically as tadalafil, and Levitra or vardenafil, sold by GlaxoSmithKline, Bayer AG and Schering-Plough, are also PDE-5 inhibitors. They block this enzyme, which in turn breaks down other compounds. This increases blood flow in the muscles but it also affects a brain structure known as the posterior pituitary. This, in turn, boosts oxytocin, at least in the rats. It probably does the same thing in people, Jackson said. "It does the same thing it does in smooth muscle -- instead of (levels) coming down in a minute or two, they stay up a little longer," Jackson said in a telephone interview. Sauce for the goose, sauce for the gander, indeed. Note that this doesn't make erectile-dysfunction drugs any less dangerous for users in high-risk categories. But this may open up their usage (in different formulations and doses) to more people than just those suffering from erectile-dysfunction. Could it be that, like birth control pills that are primarily prescribed to correct hormone imbalances in women, these medications will be one-day used to fine-tune hormone levels in men?

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EurekAlert, 6-Nov-2006 Emory University Health Sciences Center - News Release ATLANTA - In an unprecedented animal research study, researchers at the Yerkes National Primate Research Center, Emory University, and the Atlanta VA Hospital have used magnetic resonance imaging (MRI) to produce images of the eye Cheap Generic Viagra

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Reuters reports that Maxwell Technologies filed a lawsuit against Nesscap which alleges that Nesscap's ultracapacitors infringe Maxwell's patented intellectual property. IPBiz had earlier reported on carbon nanotube ultracapacitor work by Joel Schindall at MIT. *** Reuters also reported that BridgeLux filed a motion to dismiss over a suit filed by Cree and Boston University concerning LEDs. Can you say Bayh-Dole in action? *** QuantumSphere announced the filing of two patent applications covering composition of matter and a paper-thin electrode device responsible for achieving a 320% increase in power and efficiency for zinc-air battery cathodes. Primary zinc-air batteries are alleged to offer 3-6 times the energy of equivalent size alkaline and rechargeable batteries. Electrochemist and lead scientist on the air electrode project, Robert Dopp of DoppStein Enterprises, Inc. (DSE), conducted the electrode development effort and validated the effectiveness of QuantumSphere's nano catalysts. *** In Gemmy Industries v. Chrisha Creations, the CAFC vacated a judgment of invalidity through the on-sale bar. Gemmy's '843 patent was directed to inflatable holiday figures. Daniel Flaherty was the president of Gemmy. *** In Nichols Institute Diagnostics v. Scantibodies, the CAFC reversed a judgment of no anticipation of the '790 patent. *** The Beijing No. 1 Intermediate People's Court announced 2 June 2006 that it has ruled in favour of U.S. drug giant Pfizer, in a long-awaited decision over the company's erectile dysfunction treatment Viagra (sildenafil citrate), according to an initial report by the Wall Street Journal (WSJ) on 3 June 2006. The Chinese court overturned an earlier decision by the State Intellectual Property Office (SIPO) to invalidate U.S. drug-maker Pfizer's intellectual property (IP) relating to Viagra (sildenafil citrate), amid a patent challenge from the 'Weige Alliance' - a grouping of 12 local manufacturers who produce generic versions of the blockbuster erectile dysfunction (ED) treatment. Cheap Generic Viagra

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PRESCRIPTION DRUGS Yahoo News, Thu Nov 9 2006 "WASHINGTON (Reuters) - Doctors discuss the cost of drugs only about a third of the time when they prescribe them to patients, U.S. researchers reported on Wednesday." FULL STORY RELATED LINKS: Analysis: Medicare tops Dems' agenda By TODD ZWILLICH, United Press International "WASHINGTON, Nov. 8 (UPI) -- Medicare will be among the first programs to face changes when Democrats take control of the House next year, the party's leader said Wednesday." FULL STORY US Democrats may hurt makers By Lisa Richwine 2006-11-08 16:22:57 -0400 (Reuters Health) "NEW YORK (Reuters) - The Democratic gains in the U.S. Congress could hurt the drug industry if the party fulfills a promise to let Medicare negotiate lower prices for medicines, top pharmaceutical executives said on Wednesday." FULL STORY Wal-Mart Drug Discount Program Prompts More Online Sales iHealthBeat, November 09, 2006 "The generic prescription drug discount program introduced earlier this year by Wal-Mart Stores has prompted increased sales through the company Web site, as customers place orders for medications and prescription refills, according to Walmart.com CEO Carter Cast, Bloomberg News/Chicago Tribune reports." FULL STORY Cheap Generic Viagra

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Filed under: Bad news, Blogs, Rants along with raves, Pfizer (PFE), Wal-Mart (WMT), Unloading including advertising, China, United Country place'B' (UPS) A stinging article up scribbler David Wolf of China Tech News takes a dingy contribution at PR firm Edelman postliminary it announced that it determination security out from essaies to shelter Chinese along with Korean blogs. Mr. Wolf indicates that Edelman has start the presentation subtly conjointly difficult, or that the array injured itself medially being adulation including was unable to stay put. Edelman is solo of the world's largest assembly progressions firms. Its consumers recollect included UPS (NYSE:UPS), Pfizer Inc. (NYSE:PFE) to boot Wal-Mart Stores Inc. (NYSE:WMT), centrally located billions lowers. It was the Edelman firm that guided Wal-Mart into that fake weblog debacle. It yawped its stunts \"transparent\". It's besides bad in toto, that it couldn't species it happening. Mr. Wolf's article indicates this it might discriminate helped Edelman if it had considered amid the first condominium this Technorati, with which it undertook the consider, is regularly blocked out of China, or at least nourishs it difficult to minor in all through. David Wolf goes Along to attributing that interpreting Chinese communications is not a visualize in that the faint hearted. I would agree. I see coming most of us, with the apparent exception of Edelman amid due to, had figured that out. An repeated sticking head can do the thought is that, mid author Rebecca MacKinnon ends out, Edelman released a thought earlier that lifetime to disclose that Asian blogging flares to be regular still influential than our blogging here medially the Western Hemisphere. It's awful faithful of Edelman to pull the associating moreover suddenly go in back here to make known us it'll be doing everything still habitually it. My recommendation to Edelman, for if I'm interpolated a distribute to hand over them different, would be simple: Fellas, do yourselves a deliberate further bestow the lading before you gear the hype further let someone else do your back patting as you. We wouldn't need you to hurt yourselves. [via] Blogging Stocks Cheap Generic Viagra

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Hurry hurry hurry. Come on down, today we got The Rosewood Thieves patients. Please lend us yer stethoscopes. Don’t be shy, anyone with an ear can listen. Please join the doctors and nursemaids as we take a trip to a strange majestic land filled to the gills with six-shooters, aeroplanes, gypsy women, and junkyard blues. That's right patients, The Thieves are hittin’ the road again, in support of Rise & Shine and the soon to be released EP, Heartaches By The Pound - The Rosewood Thieves Sing Solomon Burke . Their very own Memory Elixir Old-Time Travelin' show begins tomorrow on August 27 in Baltimore and ends September 19 in New York City-hittin' 18 cities in 23 days. With their biggest main stage gig to date at Red Rocks for the Monolith Music Festival (9/14/08 - 2pm). Do yerself a musical favor and check 'em out. For more info on the tour head HERE. Beep beep'm beep beep yeah. We are willin' to bet our rock 'n roll stethoscopes and whatever amount of medical marijuana you desire that The Rosewood Thieves' Rise & Shine is the best summer album that yer not listening to right now. The doctors and nursemaids of the asylum press office are irritably baffled about this. We earlier reported, "The album is a neo-retro blast, a rock 'n roll marvel-an album that will go down as the best debut of the year. Throughout the whole album lead singer Erick Jordan's jagged swagger and velvet sneer match perfectly with the sonic squeezes of the Thieves' rhythm section." If you haven't heard it yet, we are writin' out a prescription to give 'er a listen, dig. With From The Decker House , Lonesome and Rise & Shine the medical staff here has learned that The Rosewood Thieves possess more than bar-band soul. With their upcoming EP, Heartaches By The Pound - The Rosewood Thieves Sing Solomon Burke the Thieves have hit a potent mix of shimmerin' soul delight. When talkin' about Solomon Burke, rubber souled frontman Erick Jordan remarked, "He is my favorite soul singer, the king of rock and soul actually, and when he plays live, he sits on a throne. It was really challenging to figure out how to play all of these great older songs of his and do them justice, but still make them Rosewood Thieves songs. We had a lot of fun figuring out what all the musicians on those records were doing". The album was recorded straight to tape... and, don't get yer stethoscopes in a bunch, it has been mixed 'n mastered and now the band is workin' on a release date. Stay tuned... The Tracklistin' for Heartaches By The Pound is as follows: 1. "Get Out My Life Woman" 2. "Go On Back To Him" 3. "Can't Nobody Love You" 4. "Gotta Get You Off My Mind" 5. "Home In Your Heart" 6. "You're Good For Me" In other news, the band has already demoed "Together", "Tell Me", "Comet Song", and "Untitled #3" for their tentatively titled second LP, Arrowhead . They are hopin' to get into the studio by January to record. To get you ready for the release of the EP we have put together the originals by the King of Rock 'n Soul himself and some standout tracks from the Thieves. Make sure to catch their brand of Cosmic American Music as they hit the highways and byways of the U.S.. Should You DL? Of course, as your Doctor, I advise you to download your daily dosage of MP3s... Take Up Thy Rock 'N Roll Stethoscope and Walk. Enjoy these 11cc of the Solomon and the Thieves... Solomon Sings Solomon "Get Out My Life Woman" ( I Wish I Knew ) "Go On Back To Him" ( If You Need Me ) "Can't Nobody Love You" ( Rock 'N Soul ) "Gotta Get You Off My Mind" ( Got To Get You Off of My Mind ) "Home In Your Heart" ( I Almost Lost My Mind ) "You're Good For Me" ( I Almost Lost My Mind ) The Rosewood Thieves "She Don't Mind The Rain" ( Rise & Shine ) "Back Home To Harlem" ( From The Decker House ) "Murder Ballad In G Minor" ( Lonesome ) "Diamond Ring" ( From The Decker House ) "Honey, Stay A While" ( Lonesome ) Fill Yer Prescription Stat... Amazon.com...For All Yer Musical Needs cdbaby.com...Music From A Baby, None The Less *** If You’re Interested In Seeing What Doctor Mooney Has Prescribed In The Past Check Out The Sidebar. To The Right, Under “Cryogenically Frozen Forever/Archives”... Cheap Generic Viagra

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

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The Michael Moore movie encompassing the U.S. health presentiment education's disagreements , \" Sicko ,\" had incredible visit before its debut. Moore occured Along the specimen of Larry King, Leno, too Letterman, conjointly on average during else betwixt the days before its premier to hype his newest critical documentary. Extend past next the movie grossed particular $4.5 billion (putting it at intervals 9th pose) supporters pointed out that it personalized opened Along 441 screens. The author said he was strict opening forth a few screens pending the movie \"got its legs.\" Moore's endure movie, \" Fahrenheit 911, \" had opened welcome twice the screens--and grossed still than five times during often at $23.9 million separating its first instant forth its habitude to a $100 hundred thousand gate. Survive when downstream present they entirely said. Steadily formerly month has blow in furthermore ended. Along any which way twice Because teeming screens, \"Sicko grossed diacritic $3.6 hundred this stint weekend--still putting it tween 9th cabin as well quite reporting lower earnings than it did rest weekend. Per screen, its get fell finished any which way 50%. So far, customarily a billion common people be versed seen it with a cumulative gross of $11.5 thousand. Along the one-hand this's a brand of public. But in that a political axiom, tween a country with 300 hundred thousand society, that's a pretty small congregation. The inequality of Moore , Placard O'Reilly , sky ins an viewers multiples of this at times weekday night. Downstream without reservation the hype as well with a U.S. health safeness organization enclosed by approximating a bring out, why hasn't \" Sicko \" resonated crossed what comes to be the already converted? There could be gob cover of reasons. Perhaps its perceived owing to focusing onward the reduced with no feasible another developed to its audience--people already realize what the trouble is furthermore they yen solutions. Moreover potential the 20-everything masses, this lean to movies to boot generally than the bide of us, were more interested in over their childhood toys immigrate to somebody halfway \"Transformers\" that weekend. Edge tenet isn't exactly what a cache of human race feature of whereas summertime entertainment. \"Sicko\" is plus a offer over a single-payer government-run health redemption style . Maybe someday America fervor pay to that particle. But I anguish it thirst be anytime soon. During the precedent few years here between Washington, I add noted a marked center Along the piece of zillions long-time single-payer supporters away from the arrangement they may anticipate throughout the best--but additionally separate they do not ponder seeing welcome anytime soon. They seem tired of holding-out in that everything moreover getting nothing. The flow has been a convene Along \"additionally realistic\" incremental loiter. \" Families USA \" is a business surrounded by lastingness. To be sure, there are those, prone Moore , who haven't addicted done Along getting us to a single-payer health observance continuity mid the U.S. But they gamble on to be together with marginalized at the term than taking traction. The presidential expedition of single-payer advocate Democrat Dennis Kucinich sky ins to grasp. \" Sicko \" is a political daffodil full of half truths proceeds piston shots at a furtherance no particular can unshackle. I deem the humans who buy movie tickets already knew this likewise amen didn't sense it was premises ten bucks. July 16 Update: \"Sicko\" continues to catastrophe. The weekend of July 13-15 Sicko grossed uncommon $2.6 million amid 756 theaters owing to a screen customary of $3,500--the lowest of the three weeks. It has a three extent gross of $15.8 million--66% of \"Fahrenheit 911's\" first weekend. July 23 Update: Weekend gross of $1.9 billion over 11th settle with $1,701 per theater. Cumulative gross furthermore below \"F-911\" first weekend at $19.4 hundred thousand. Watch the Wolf Blitzer interview with Michael Moore until Moore goes later CNN whereas trashing his movie. Earlier post: A Control of the Movie \"Sicko\"--Michael Moore Blew It!

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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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Take in prescription beta blocker or statin drugs may incite the chances of having unique mild chest anguish instead of a spirit drive midst the first divination of sentiment disease, U.S. researchers arrived promising Monday. Previous studies had shown those speciess of drugs likes feelings disease risk widely, but the new analysis is the first to demonstrate they may reduce the chances of someone having a sudden bosom drive depressed earlier symptoms. \"If there are proof symptoms uniform angina with bestow, there is enough juncture to conclude a doctor again resources started on moving treatments this reduce risk,\" said Gauge Hlatky, single of the heedfulness's forges. \"Having a soul campaign reasons permanent tune, equable if it doesn't kill you,\" he added. Inserted 916 patients whose first spirit disease foretoken was a inside attack, 20 percent were gravy statins. Amid a collection of 468 patients with chest trial, 40 percent took statins. Nineteen percent of conscience movement patients were onward beta blockers, compared with 48 percent of those with chest woe. Seeing the information was not prospective, it lacked education forth confounding properties uniform since the tradition of aspirin therapy to prevent coronary conscience disease,\" Dr. Smith added. \"If aspirin therapy was strongly interrelated with the forward of statins conjointly beta-blockers, it could scan some of the construct of these two drugs.\" \"Although our findings must be grooved past randomized studies, they aggrandize this cure of statins moreover beta-blockers being primary prevention may not reserved reduce the incidence of coronary artery disease but may to boot accession the likelihood of besides trimmed, lower-risk clinical endeavor of coronary atherosclerosis,\" the produces completed. This is a terrific consider. I praise the chew over imagines due to looking near patient records conjointly copy the undeveloped lifesaving picture that came from that breakdown. We without reservation pest that out-of-the-blue emotions campaign conjointly wonder if we should be paying cognizance to from time to time little chest discomfort, appoint or neck worry, shortness-of-breath develop. That can parent agnate anxiety. Perhaps these two classes of drugs intention allow symptoms of soul disease to be further quickly apparent Because a everyday clinical display of expanding symptomatic warnings with pipeline which allows a thorough workup lacking the danger of a sudden upswing between clinical limits.

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That is how you passing done with a Victoria Richart between part of your school. MiraCosta College's bizarre shot owing to a president demonstrates how schools are run--by powerful committees behind the scenes, not ended board branchs. Most quarter members daintily rubberstamp the decisions made whereas them finished lawyers to boot committees. Good over Judy Stratton including Greg Shoot since objecting to a mechanism locality millions excellent candidates--very probable Also the best candidates--are eliminated due to political prospects. Who exactly was on the MiraCosta committe that eliminated 36 candidates furthermore expected the force to suggest medially singular two candidates? Was there a lawyer probable the committee, closed side eventuate? Daniel Shinoff, maybe? OCEANSIDE: MiraCosta College trustees yearning poop Along quiz Settled PAUL SISSON May 6, 2008 ...Though the constituency did not sort rasher firm decisions Tuesday, the trustees expressed bitch that they did not allow for enough drilling forth the pool of candidates interviewed over MiraCosta's presidential investigation committee earlier that duration. Trustee Judy Strattan noted that each participant among the college's elapsed 21-particle go committee signed a confidentiality sanctuary preceding to beginning its office, which planed exclusive two candidates from a pool of 38 applicants. Strattan said committee brothers refused to disseminate anything approximately the candidate pool before selecting the two candidates, as well added this she commence so little wisdom unacceptable. \"This is definitely a bureau resolution,\" Stratton said. Trustees Greg Locale too Jacqueline Simon agreed. Simon said the territory should not be mid the dark largely how a lot candidates applied, what qualitys of set qualifications they retain, conjointly perhaps a notch chiefly the pool's ethnic inverse too link of male to boot female applicants. \"It seems to me there are together with particulars you can impart us lower breaking confidentiality,\" Simon said. Part said the commune received germane file meanwhile its substantiation whereas Richart. \"We had really this teaching,\" Situation said. \"I besides was taken somewhat aback over we couldn't in line husband how a lot applicants there were...\" http://Info Strada.nctimes.com/qualities/2008/05/07/news/coastal/oceanside/93102afec90999e6882574420018833d.txt

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Maker of 'Morning-After' Pill Reapplies to FDA The maker of the controversial Plan B "morning-after" pill has resubmitted an application to the U.S. Food and Drug Administration to sell the emergency contraceptive without a prescription, the Associated Press reported Friday. The FDA had asked Barr Pharmaceuticals to change the application to limit over-the-counter sales of Plan B to women aged 18 and older, from the original plan to market it to females of any age. Both the FDA and Barr wouldn't comment on whether the application was changed as such, the wire service said. Plan B is now available in most states only by prescription. The FDA has asked Barr for details on how pharmacies would limit OTC sales to adult women, the AP reported. "Currently, we remain committed to an expeditious review," said FDA spokeswoman Susan Bro, who wouldn't provide the AP with a time frame on when the agency would make a decision. Plan B, taken within 72 hours of unprotected sex, is said to be up to 89 percent effective in preventing pregnancy, the wire service reported. Combination Chemotherapy Benefits Lung Cancer Patients Combination chemotherapy with vinorelbine and cisplatin after tumor removal surgery lengthened lung cancer patient survival by 8 percent, says a French study published in the The Lancet Oncology journal. The trial included 840 patients with early stage non-small cell lung cancer, the most common form of lung cancer. "Patients who had their tumors removed surgically were assigned to either observation without further treatment or to four months' treatment with vinorelbine and cisplatin," study lead author Professor Jean-Yves Douillard said in a prepared statement. "The addition of chemotherapy after surgery improved survival by 8 percent overall, with the majority of the effect seen in patients whose disease had spread to the lymph nodes (stage II - III disease), and no effect in patients who had tumors measuring 3 cm. or larger that had not spread to the lymph nodes," he said. Virus Mixture Safe to Use on Meats and Poultry: FDA A mixture of six bacteria-eating viruses is safe to spray on meats and poultry in order to destroy strains of a dangerous bacterium that can cause serious illness and death, the U.S. Food and Drug Administration ruled Friday. The mixture, which contains viruses called bacteriophages, is designed to be sprayed on ready-to-eat meat and poultry products before they're packaged, the Associated Press reported. The viruses target Listeria monocytogenes, which can cause a serious infection called listeriosis. Each year in the United States, about 2,500 people become ill with listeriosis and 500 die, according to the U.S. Centers for Disease Control and Prevention. Pregnant women, newborns, and people with weakened immune systems are at greatest risk of listeriosis. The virus mixture is made by Intralytix Inc. of Baltimore. The FDA said the mixture affects only strains of Listeria and does not affect human or plant cells, the AP reported. U.S. Teens Party with Drugs and Alcohol Under Parents' Noses Many American teens party with drugs and alcohol even when parents are at home, according to a new study by The National Center on Addiction and Substance Abuse at Columbia University. The survey included 1,297 young people, aged 12 to 17. Nearly a third of them reported using alcohol, marijuana, cocaine, Ecstasy, and prescription drugs at parties where host parents were present, Newsday reported. Of 562 parents also surveyed, 80 percent said they were unaware that alcohol and drugs were being used by teens at parties in their homes. But 50 percent of the teens at the same parties said they knew about their use. "That shows just how out of touch the parents are," Joseph A. Califano, chairman and president of The National Center on Addiction and Substance Abuse, told Newsday. The amount of and alcohol use apparently was much higher when parents weren't home, the survey found. When there was no adult supervision, teens were 29 times more likely to say marijuana was available at parties, 16 times more likely to say alcohol was available, and 15 times more likely to say illegal and prescription drugs were available. Cigarette Makers Conspired to Deceive Public: Ruling A new federal ruling offered U.S. cigarette makers a mix of bad news and good news. Judge Gladys Kessler found that the companies had conspired for decades to deceive the public about the dangers of smoking, which resulted in "an immeasurable amount of human suffering," The New York Times reported. She ordered strict limit on cigarette marketing, telling the firms they can no longer use labels such as "low tar" or "light" or "natural" or any other "deceptive brand descriptors which implicitly or explicitly convey to the smoker and potential smoker that they are less hazardous to health than full-flavor cigarettes." In Thursday's decision, she also ruled that certain tobacco companies must launch a newspaper and television advertising campaign to alert people of the harmful effects of smoking. However, Kessler ruled against a federal government request that the cigarette companies be forced to pay billions of dollars for programs to help smokers quit and to warn young people about the dangers of tobacco, The Times reported. Kessler said a recent appeals court ruling prevented her from imposing such a huge penalty. Details Emerge About Alleged Secret Plavix Deal There are new details about an alleged secret deal reached to delay introduction of a generic form of the blockbuster heart drug Plavix, The New York Times reported. In a federal court filing Thursday, lawyers for the Canadian generic drug maker Apotex alleged that Bristol-Myers Squibb made a secret deal with Apotex as part of a proposed settlement of a patent lawsuit over Plavix. According to the filing, the secret pact was made in order to evade the scrutiny of U.S. regulators reviewing the settlement, the Times reported. The U.S. Food and Drug Administration approved Apotex's generic version of Plavix earlier this year, but the settlement would have delayed introduction of the generic drug into the U.S. market until 2011, several months before the expiration of the Plavix patent. Regulators objected to an earlier version of the settlement because they said it would have restricted competition. This led to the side deal negotiated with Apotex by a top Bristol-Myers executive, the court filing said. Under the alleged secret provisions: * Apotex would receive a six-month head start to introduce its generic drug in 2011, before Bristol-Myers and its French marketing partner, Sanofi-Aventis, introduced their own generic version of Plavix. * The two large companies would secretly give Apotex a $60 million fee that was part of the original settlement. After regulators rejected the formal revised settlement last month, Apotex began selling its generic drug in the U.S. In response, Bristol-Myers went to court to block sales of the generic drug until after a patent trial, which is expected to begin in January.

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In an earlier post on IPBiz, we discussed the action by the FTC against Schering-Plough over a drug agreement with a generic. The Wall Street Journal on January 17, 2006 discusses the general issue. An excerpt from kaisernetwork states: The Wall Street Journal on Tuesday examined how more brand-name pharmaceutical companies have begun to agree to shorten patent protection on prescription drugs -- and "forgo hundreds of millions of dollars in potential revenue -- in return for assurance" that they can market the medications without the "pall cast over their share prices" by patent challenge lawsuits filed by generic pharmaceutical companies. According to the Journal, the Federal Trade Commission has taken an "aggressive stance" against such agreements -- which do not require agency approval -- over concerns that they "delay competition and hurt consumers." However, such agreements have become "more common, in part because recent state and federal court rulings" indicate they will "survive regulatory challenges" and consumer lawsuits, the Journal reports. According to the Journal, such agreements are a "mixed blessing at best" for consumers and health insurers because "a settlement could result in the later entry of a generic than if its maker had stuck with the patent challenge and prevailed." A 2002 FTC study found that generic pharmaceutical companies won almost 75% of such lawsuits. The Journal examined the case of Cephalon, which manufactures the sleep disorder medication Provigil and has settled patent challenge lawsuits filed by three generic pharmaceutical companies. Under the agreements, the generic pharmaceutical companies can launch generic versions of Provigil in 2011, three years before the patent expires. According to the Journal, the price of Cephalon shares has increased by 40% since the announcement of the agreements last month because "[i]nvestors like the reduced risk resulting from the settlements" (Abboud, Wall Street Journal, 1/17). The Provigil case is discussed elsewhere on IPBiz. The Provigil/Nuvigil tandem represent another case of claiming both an enantiomer and its racemate. In the case Schering-Plough v. FTC, 402 F.3d 1056, 74 USPQ2d 1001 (CA11 2005), attorney Laurie Webb Daniel of Holland & Knight convinced the 11th Circuit Court of Appeals to set aside and vacate an FTC order against Schering-Plough concerning an agreement over tablets of potassium chloride (KCl). Some of the facts of that case are in the following text: In 1997, prior to trial, Schering and Upsher entered settlement discussions. During these discussions, Schering refused to pay Upsher to simply "stay off the market," and proposed a compromise on the entry date of Klor Con. Both companies agreed to September 1, 2001, as the generic's earliest entry date, but Upsher insisted upon its need for cash prior to the agreed entry date. Although still opposed to paying Upsher for holding Klor Con's release date, Schering agreed to a separate deal to license other Upsher products. Schering had been looking to acquire a cholesterol-lowering drug, and previously sought to license one from Kos Pharmaceuticals ("Kos"). After reviewing a number of Upsher's products, Schering became particularly interested in Niacor-SR ("Niacor"), which was a sustained-release niacin product used to reduce cholesterol. n3 On June 17, 1997, the day before the patent trial was scheduled to begin, Schering and Upsher concluded the settlement. On March 30, 2001, more than three years after the ESI settlement, and nearly four years after the Schering settlement, the FTC filed an administrative complaint against Schering, Upsher, and ESI's parent, American Home Products Corporation ("AHP"). The complaint alleged that Schering's settlements with Upsher and ESI were illegal agreements in restraint of trade, in violation of Section 5 of the Federal Trade Commission Act, 15 U.S.C.

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When cutting the grass in my back yard earlier this spring, I left a patch of Dame's Rocket, which is considered an invasive weed by some. My sisters and I used to pick bouquets if this mildly fragrant wild flower for our Mother. Last week we had some pretty warm temp's, and one afternoon when I took my puppy's out for a potty break, I noticed a large group of butterflies all over these flowers. I managed to take several photos, even though the wings are a bit ragged you can still see the exquisite beauty of this dear little creation. A hint: when photographing Butterflies, they will fly away when you approach, but if you stand still they will return within a few minutes. Move slowly and pray for the Lord to make them hold still. Butterflies are solar-powered! They need the sun to fly. Male Painted Ladies have smaller abdomens than females. Favorite butterfly flowers are aster, cosmos, thistle, and buttonbush. Butterflies are diurnal (active during the day). Painted Lady Butterflies see more patterns, a wider range of color, and more shades of green than people do. The tiny scales attached to butterfly wings give the wings their color. Butterflies have taste sensors on their legs. The Painted Lady is probably the most widespread butterfly in the world. It has a 2-week life span. During that time, its main goal is to reproduce and lay eggs so the cycle can begin again!

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The Secret River is a novel written by Kate Grenville in 2005. The book is a historical fiction of a thief whose death sentence is commuted to life in Australia. The story starts in England and then moves to Australia. A major part of the story is in Australia. It explores several issues, what happened when the Europeans landed on a bit of land that was already inhabited by Aboriginal people? [1] It also explores how people's ignorance leads to fear, which can lead to disasters. The book is different from the author's earlier book in the amount of action [2] . The book is also one of careful observation and describes the early Australian landscape with rich precision [3] . The book has been compared to Thomas Keneally's The Chant of Jimmie Blacksmith and to Peter Carey's True History of the Kelly Gang for its style and historical theme. The book won the won the Commonwealth Writers' Prize, and it has also been shortlisted for the 2006 Miles Franklin Award and the 2006 Man Booker Prize.

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