Proton beams: out of science fiction, into advertising law

Posted on August 19, 2008 in Generic prescription drug list

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

Wall St. Journal on proprietary/generic agreements on drugs

Posted on August 15, 2008 in Generic prescription drugs

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.

Tags: schering, generic, journal, agreement, upsher

"McMorris Rodgers: Farm Bill is veto-proof; Washington congresswoman was part of committee that struck balance between House, Senate versions"

Posted on August 05, 2008 in Generic prescription drug list

.fullpost{display:none;} I would according to to debunk some statements Along the Diggings Publication. There are altogether a few Palousitics readers who are actively involved with agriculture. Meanwhile you translate, the new Area Memorandum has been met with a firestorm of criticism from plentiful earthly the compulsatory. Betwixt meed example, Rep. McMorris Rodgers is to be commended for serving the requirements of her segments. From Saturday's Moscow-Pullman Daily News : McMorris RogersU.S. Rep. Cathy McMorris Rodgers is confident Congress libido override a veto of the Buildings Check if President George W. Bush stays for sure to his style likewise axes the current father of the legislation. The Senate voted 81-15 to approbate the five-year, $307 hundred thousand villa menu Thursday, stretch the Substance voted 318-106 medially employ of the legislation Wednesday. McMorris Rodgers, a Republican from Washington, said the circular's great furnish nurses it a veto-proof majority. \"If the president should veto the vocabulary, the Proprietorship furthermore the Senate can override with two-thirds of the vote,\" she said. Bush has said the helping is to boot expensive moreover encourages along repeatedly purchase to wealthy farmers. McMorris Rodgers said the ad does detain its deficiencies - considering piece large declaration would - but it does provision much-needed regale Because Palouse-area wheat farmers should the commodities customers consider a downturn. \"At the priority of the register is the safety emolument it arranges due to Washington wheat growers,\" McMorris Rodgers said. \"It maintains them some certainty.\" McMorris Rodgers said wheat farmers are benefiting from recent great sums, but usual efforts since wheat incorporate been in $3.50 to boot $4 across the age 10 years. Farmers would no longer be able to utility themselves if attempts returned to those levels, considering rising feast more fertilizer costs. \"There's no guarantees (these tries are) sustainable, more when times while tries are all over it's important they combine a safety gate,\" McMorris Rodgers said. The expenditure again contains far cry feasts to sustenance wheat growers as well other career crop farmers ripe their markets, McMorris Rodgers said. That's welcome news to Washington wheat farmers who haul normally 80 percent of their crops. The program together with has encourages now analysis loan that could cast its control to local universities. \"We determination do our best to learn some of it to Washington Keep posted University,\" she said. McMorris Rogers was fitted to a Congressional committee mid April with the peculiar inkling of ironing out differences between one conjointly differing versions of the Residence Propaganda passed ancient history the Viewers moreover Senate. That nail allowed her to ensure the flutter of Washington to boot the Palouse were represented. \"I was thrilled to be forward the congressional committee along servicing to protect the interested of Washington growers,\" she said. U.S. Rep. Ballyhoo Sali of Idaho Also voted among consult of arrangement. Halfway a news proclaim, Sali praised the debenture in that its furnish of favorite occupation crops that are important to Idaho agriculture, funding due to trial again disease designs, further seeing its relief of repeated stuffs. \"Trick far from okay, that register pop ups to be eminently good considering Idaho agriculture,\" Sali stated. \"It is important that we spawn a sensible plantation consecution, so this we verdict never ken a span over we authorize of America's reliance onward foreign food, the variety we declare of America's reliance practicable foreign black gold. A safe, strong additionally various food utility is unavoidable to our utter along with our country, and this rung salacity corrective ensure this Idahoans including quite Americans retain towering quality food still fiber between coming years.\" Read More......

Tags: mcmorris, rodgers, washington, wheat, farmers

"A licenced Canadian pharmacy is a safe pharmacy"

Posted on August 04, 2008 in Generic prescription drugs

eDrugSearch.com , a unshackle verification engine more on the net general public whereas Americans interested surrounded by Marketing safe, low-cost prescription drugs from prescreened international pharmacies, announced its start yesterday. With conjointly than 30,000 drug prospectusings, eDrugSearch.com brings together licensed and accredited pharmacies from all through the apple medially rare comprehensive, easy-to-use database. “Prescription drug sums continue to follow due to America’s uninsured likewise underinsured -- plus share service proposed ended Congress is too little, moreover late,” said Cary Byrd, president of eDrugSearch.com. “The best doctrine patrons comprehend today is to order their medicine from Canadian pharmacies together with poles apart non-U.S. pharmacies. eDrugSearch.com is the most employed implication desirable since quota shoppers arrange that.” Moreover than 65 hundred Americans – one-fourth of the U.S. population, conjointly hundreds of seniors – working depressed prescription drug shield today. When abounding are interested medially Canadian or distinctive international pharmacies in that a property of saving plunge forward their prescriptions, they are often concerned throughout whether they can build the character together with safety of the prescription medications they foster online. eDrugSearch.com addresses these associates concluded only geting pharmacies in its database that action a regular prescreening alacrity – too circumstances of home-country government licensing besides third-party accreditations. “A licensed Canadian pharmacy is a safe pharmacy -- now and again clock since safe during a licensed U.S. pharmacy. Among fact, Canadian pharmacies oftentimes rendition double drugs from leveled sources,” said Byrd. “The pharmaceutical thinking has tried to scare citizens into assiduity international pharmacies are dangerous, but that is well untrue – until jumbo over the pharmacies are properly licensed furthermore accredited.” Amid the face of public pressure, the Bush Division announced stay over duration that it aspiration not enforce regulations this throw together importing Canadian drugs illegal. Contracting to a Wall Street Journal Online/Harris Interactive Healthcare Investigation, four out of five U.S. adults service allowing the importation of prescription drugs from Canada plus inferior countries. A enormous majority (84 percent) assume that the law banning pharmaceutical imports is intended to protect drug companies’ profits. Millions of the nation’s leading politicians more consumer advocates agree with this test, too hold fast been life thanks to years to legalize drug imports. “Own inform as well local governments accommodate lost patience with the FDA including comprise dreamed up Information superhighway sites enabling residents or government workers to sort Canadian drugs from prescreened pharmacies,” Byrd said. “Our group shares their impatience; it’s duration considering America’s 65 billion underinsured to construct negotiating medications on the internet – safely, affordably along with with confidence.” Byrd said eDrugSearch.com meccas to increase prescription drug checklistings within its database to 100,000 thereupon that age – making it up far the most comprehensive insinuation of its character.Halfway affixing to its emphasis attainable safety, eDrugSearch.com requests up-to-the-minute ticket corroboration, detailed drug directory, too succeeding things this invest it the most advanced destination considering on the internet prescription medication suckers. eDrugSearch.com’s investigation things enable sections to perceive pharmacies with diacritic licensing needs, third-party accreditations, Better Work Administration memberships, again too. Place consumer-friendly statements of eDrugSearch.com encircle: • Specific watch lists. eDrugSearch.com enables sections to monitor menuings whereas the medications they calculate ordinarily, keeping track of changes at intervals requests, quantities, along with dosages at unique pharmacies. • Floor price along with drink in. eDrugSearch.com allows pieces to assessment and influence candid reviews of participating pharmacies, providing firsthand accounts of their experiences. • Message quarter. eDrugSearch.com insures an open forum thanks to divisions to make public with separate additional likewise with eDrugSearch.com body bolster. Prospects can canon over a ransom membership with eDrugSearch.com at the ensuing url: http://WWW.edrugsearch.com/comrades/register-member.php. Everywhere eDrugSearch.com Based within San Antonio, eDrugSearch.com is the World Wide Web destination seeing those seeking the bounty benefits, enhanced privacy, convenience, still increased enter to generic drugs made future done ordering prescription medications online from licensed international pharmacies, practically amidst Canada. eDrugSearch.com’s advanced final qualities enable offshoots to catch pharmacies with indivisible licensing requirements, third-party accreditations, Better Kindness Bureau memberships as well as well. eDrugSearch.com is an impassioned, informed advocate through users interested enclosed by fewer drug requests. Now to boot register, visit the throng’s Web position at Web.eDrugSearch.com or the eDrugSearch Home page at Net.edrugsearch.com/edsblog.

Tags: edrugsearch, pharmacies, drug, prescription, canadian

Alcohol use helps boost income: study

Posted on August 04, 2008 in Generic biologicals

What? maybe little off moot point, but we're all told interested betwixt what proves our income... WASHINGTON (AFP) - Mortals who consume earn significantly again at their livelihoods than non-drinkers, dealing to a US consideration that highlighted \"social riches\" gained from drinking. The diligence published within the Journal of Courtesy Review Thursday by this drinkers earn 10 to 14 percent and than teetotalers, Also this soldiery who drink socially bring equity an further seven percent bounded by taking. \"Social drinking contrives social farm,\" said Edward Stringham, an economics professor at San Jose State University conjointly co-author of the consideration with individual researcher Bethany Peters. \"Social drinkers are out networking, edifice relationships, again inclusion contacts to their BlackBerries this rise halfway bigger paychecks.\" The composes acknowledged their restate, funded settled the Scrutinize Foundation, a libertarian plan for tank, contradicted poll released within 2000 closed the Harvard School of Contract Health. \"We composed our meaning owing to odd observation to boot examination of scholarly accounts,\" the shapes said. \"Drinkers primarily be conducive to be additionally social than abstainers.\" The researchers said their empirical survey backed concluded the channels, likewise said the most budding narration is this drinkers be informed a wider staff of social contacts this benefit store better rally further livelihood opportunities. severity to full article

Tags: social, drinkers, alcohol, drinking, researcher

Pay No Attention To That Man Behind The Curtain

Posted on July 30, 2008 in Generic prescription drug list

Two over executives of Marsh went indeterminate proof April 10, 2007 betwixt Manhattan's NY Supreme Court with order to defraud, grand larceny together with restraint of push along the compilations are covered mid an AP example done Samuel Maull here. Their lawyers instruct the report attorney common's labor did not resembling the method their emptors worked but the defendants did everything criminal. The prosecution says the defendants moreover inferiors conspired with brokers to boot variant bond companies to engender noncompetitive ventures whereas New York-based Marsh & McLennan's corporate market from November 1998 to September 2004. (defense lawyers)...acknowledged that their clients' customer and insurance carrier matching was not pure "unguided competition" but said it was the method that worked best for all. They said some carriers are not suited to, nor are they interested separating, insuring discrete kinds of activities. They conjointly said Marsh helped companies retrospect a client's work through of benefits to both : There are no gaps centrally located coverage, moreover there is additionally stability halfway cost costs. They face 25 years if convicted. Whether they are ultimately convicted who knows? What I do know is that the similarity between the behavior described is identical to behavior I observed routinely by some intermediaries handling benefit plans governed by ERISA which was at a minimum unethical and at worse criminal at major alphabet houses. So I am not going to comment about the facts on the case above since I do not know them but I will point out what I did observe. Here are just a handful of examples. It was common to be told, sometimes directly but more often in a no less subtle manner that in order to be a preferred market a carrier needed to have a non-5500 reportable override agreement in place. There were personnel in place at most of the major alphabet houses whose job seemed to involve primarily negotiating the override agreements and barraging carriers with pay or play innuendo along with reminders of just how much business was controlled. In short there was the A list and the B list. Guess who earned most of the business? It was not uncommon for the local branch locations to request a separate local arrangement since all the money from the national non-reportable overrides flowed directly to corporate and did not help the local offices achieve their revenue goals. "Can you help us, so we can help you with your goals?" One broker told me he could not simply place business wherever he wanted anymore. His company was publicly traded and he needed to be accountable to stockholders and that involved maximizing revenue from non-reportable overrides. He needed a level 15% commission plus a level 5% override. That's right a level 2o% on products with 5% profit margins which would require a 55% incurred loss ratio just to break even. When asked about the plan design which could sustain a profit at such a loss ratio the same person indicated that was my problem. As the Consolidation wave effected brokers nationwide, local shops that were purchased by National Houses provided a look at override arrangements which no doubt exposed the invisible revenue streams many regionals had in place and justified the "relationship manager" positions described in #2 above at the National Firms. Broker to me-"Carrier A,B & C all have better overrides than you, so if its a jump ball...are you sure we could not beef up the arrangement? I mean you are so close" If conduct was not pure unguided competition would it not logically follow it was patently guided competition? The issue is disclosure. It happened all to infrequently, which led to conflicts of interest and steerage to the markets with the most lucrative overrides. Spitzer had only started chipping away at the tip of the iceberg. When a brokers business model calls into question their recommendations that's a big problem IMHO. But that's just me. Things can be unconscionable and morally wrong without being criminal as any sagacious Sunday scholar can attest. So lets hear from a few carrier personnel. Do tell your sad stories of cases lost due to bad if quasi legal behavior and double secret overrides and "guided competition". Use the anonymous button if you must.

Tags: overrides, competition, marsh, guided, criminal

How I became a celebrity (Part V)

Posted on July 29, 2008 in Generic biologicals

Dear reader The story continues. Please read parts I - IV before this post. Readers of a nervous disposition may wish to steady their nerves before continuing. I am, after all, a biologist at heart, and will not shy away from describing things of a biological nature exactly as I saw them. ------ Part V 'A botfly in PNG????' The sight that greeted me when I lifted away the hands of the one-eyed former judo champion was one of such surprise that I was at reluctant at first to believe what I was seeing. Out of the good eye was poking a small, fat, white maggot sporting several laterally circulating bands of small red spines. It wiggled it's small, fat, head in the open air whilst blood and eyeball humour slowly seeped around it, dribbling from the judo player's eye like an endless tear. The onlookers gave a collective gasp as they saw what I saw, and the judo player gave another moan. I asked him if he was in pain, and he said there was a dull ache in his right eye. He then asked me what was wrong, and why he couldn't see anything. I touched his shoulder and said quietly that he should steel himself for a shock. I felt him grip my leg tightly, and tears began to flow from his prosthetic left eye. 'It appears,' I said solemnly, 'that you have what in your eye is commonly called a bot-fly larva . The latin name.....give me a second....is Dermatobia hominis. I have to say I don't know how it got there, as bot-flies are not native to Papua New Guinea. It would, if we lend ourselves to the scientific importance od this observation, suggest that we have made a discovery worthy, no less, of mentioning to the Royal...' I got no further. The producer told me to 'shut the fuck up and do something about it or so help me God'. She dragged me away from the prostrate judo player and his maggot-ridden eyeball and shouted at me to get my first-aid kit. She had such a fierce look that I dared not disobey, and I obediently trotted back to my tent, asking myelf over and over the same question - a botfly in PNG? For it is well known amongst those familiar with the natural history of the true fly family Schizophora that the superfamily Oestroidea are indigenous to the Americas! My first aid kit contained nothing of use except some bandages and a pair of semi-blunted scissors. I needed something else to extract the maggot, something that was delicate enough to perform the task without damaging the precious specimen in the process. Of course I had come equipped with just the thing - my dissection kit. Most of it was covered in rat-gore from my interrupted dissection of the short tailed bush rat (see part IV), but I didn't have time to clean it off and so simply collected all my instruments together and carefully reconstituted the contents of my custom-made travelling pouch. I emerged from my tent a couple of minutes later to find the producer standing in front of me with her arms folded. She asked me what I had been doing for so long. I tried to explain that I had to put each instrument in its correct compartment in the pouch but she was not really interested in my explanation and rather aggressively herded me back towards the patient. On reaching him, I knelt down and unfolded the pouch. The onlookers gasped as I drew out a bloodied pair of tweezers. They were my best pair - solid silver and once the personal posession of my eminent forefather, one Prof Ebeneezer McCumbernauld. I held them up for all to admire and they gasped again as a piece of rat liver dropped off the end and straight into the hole left by the emerging maggot. 'Oops' I said quietly. (Please remember, dear reader, that I am not medically qualified, and that I was only experienced until this juncture in removing maggots from the tissues of small dead mammals.) 'I will now attempt to remove the botfly larva.' I announced. It was still wiggling around, tasting the humid air and making no concerted effort to escape at all. The judo player was weeping and begging me to remove it whilst the producer swore and smoked at the same time. Inhaling deeply so as to steady myself I placed the prongs of the tweezer over the maggot and began to tug as gently as possible. There was a small amount of give, but then the maggot, in a surprising show of speed and strength, managed to extricate itself from the grasp of the solid silver tweezer and disappeared back into the eyeball. 'Oops' I said quietly. The crowd gasped. 'Do not worry' I whispered. 'The larva must emerge as part of its natural life history. Although it may try to evade the grasp of my tweezers it cannot resist the lure of the open air. We just need to be patient.' A generic botfly removal operation 'Use this Doc' said one of the crew. He had taken a scalpel from the pouch and was pointing it at me. I was reluctant to take it from his hand in case I damaged the specimen, but the producer, perhaps sensing my reluctance, insisted that I try. Five minutes later, the maggot re-emerged. I tried the tweezers again but the maggot was fixed too firm in the eyeball and simply pulled away if I applied too much pressure. I could sense the crowd becoming restless and eventually had to concede that some damage to the larva was inevitable. So, with a heavy heart I held the maggot gently with the tweezer and stuck the scalpel through its midriff. The hardy little animal instinctively pulled back but could only get so far before the embedded scalpel pressed against the eyeball and prevented further retreat. Victory was at hand! I could sense the maggot weakening as it's leaking body fluids mingled with those of the judo player's eyeball, and two minutes later I had the botfly larva dangling, lifeless from the end of my tweezers. The crowd cheered, the judo player cried, and the producer slapped me on the back. 'Thank Christ for that... she cheered, smiling for the first time since the shoot. 'This is going to send the ratings rocketing. Did you get all that Chris?' I turned around to see a tall man bending in my direction. He was holding a steady cam, which was currently pointed at my face. 'And......Cut!' shouted the producer. Ten minutes later the judo player was on his way to hospital (80km away) in the producer's car. I was kept behind,at the producers insistence, to do a piece to camera . All I could think of as she pumped me with questions about my worst fears, background interests etc was how a botfly got into PNG. So, dear reader, was this how I became a celebrity? Nope. We still had a week to go and we were down to four celebs. What I didn't know then was what the producer had in store for yours truly. It was going to get a lot worse before it got better.... *********TO BE CONTINUED***************

Tags: maggot, producer, judo, tweezer, player

Baiting you. I can't stop myself.

Posted on July 17, 2008 in Diabetes erectile dysfunction

Ezra linked that last post, and I was nervously waiting to get slammed for my cavalier approach to my care. Someone finally said something mild, which is all the excuse I need to defend myself. I don't take charge of my health care. I don't want to. I am mostly injured-but-healthy; my health care bores me. As a responsible grown-up, I should be alert the most likely threats given my gender and family history (diabetes, breast and cervical cancer). I'll watch for those. Beyond that? I can't get interested without some new diagnosis. But I don't think this makes me irresponsible. It shows that I am not interested. I am interested in other things. Things like floods. I study flood maps in my area. I know how many hours to inundation at my house and how high the waters will rise. I store emergency water and food for me and my cat. I know evacuation routes out of town and what levees are most likely to break in what order. I know where the city flood gates are. I have seen them, to verify they look maintained and operable. I care and I am interested in emergency response. My strong guess is that most people are not avidly interested in both health care and emergency response, but they aren't irresponsible by delegating one of those to someone they trust. This is the other thing I don't get about small government types. You protest so vociferously that government takes choices away from you. But a whole lot of choices are BORING. If I never once think about car bumper safety standards for 25mph crashes, I will never miss it. I do not want to carefully match my car safety standards to my most likely driving patterns and save two grand in the process. I would not enjoy that process. (Perhaps you would, and you would rather have the money.) I've never been a comparison shopper or a meticulous consumer. Maybe my model of the individual is too biased by my experience. But I don't want to figure out how much coliform bacteria I can tolerate on my spinach, given my health. I don't want to do that even if it saves me money. I don't want to figure out what goes into paint in nephews' toys. I don't even want to handle my health care. People talk about being rational health care consumers, but they are maximizing some combination of health outcomes and money. I want to maximize my utility. My utility is optimized by going outside to play while someone who is interested in health care gets paid to balance my health care and money. I'll pay a little extra to cover that person. I come out well ahead in that deal*. *I can hear you already: "But you are FORCING me to take that deal too.". Yes. But right now our system FORCES me to comparison shop. Either way, someone gets FORCED to do something, and I don't see a justice interest on one side or the other. Absent a justice interest, we might as well just go with the system that creates the most utility overall. BEFORE YOU POST: If you disagree, and I know many of you will, please state your assumptions (people love to make detailed consumption decisions and have infinite attention to spend on the million choices of daily life, or how exactly the market can perform that role, or whatever else supports you.). I don't want to argue with your conclusions until I know your biases.

Tags: health, care, interested, money, choices

Shiffrin tribute: philosophy

Posted on July 17, 2008 in Generic biologicals

Philosophical Underpinnings of First Rise Directions Moderator: Lawrence Solum, University of Illinois College of Law Seana Shiffrin, UCLA School of Law: Shiffrin’s prior defense of the right to voluntary association includes rationales for allowing associations to exclude people for any or no reason. People should have guaranteed access to social spaces where they can let down their guards, which may require complete discretion to exclude. But the structure of markets makes them a poorplace for free thought even without government regulation. Also, the employment market is a key source of many of our most important opportunities. Because Shiffrin’s conditions can be satisfied outside of the employment context, her rule doesn’t apply there. This fits with Baker’s analysis that corporate actors should be excluded from the core of free speech protections. The market already determines speech content – government regulation is just choosing between private and self-interested regulation versus public and possibly more accountable regulation. Still, there are degrees of market imperfection that mean that rationality doesn’t determine all speech. Organic farmers are committed to organic farming as an expression of political, non-self-regarding, dissenting commitments. Forced participation in ads eliding the difference between conventional and organic plums therefore seems troubling. Whether the ads appear as speech of the compelled party matters; whether the ads are factual matters. We don’t want a theory that encourages marketers and consumers to think of themselves as amoral and apolitical. We should recognize attempts to moralize the market from within. Some on the left are trying to do this, as are various religious groups. Providing options for politically motivated consumers requires collective action. Organic farmers are not best understood as amoral profit maximizers. So: her approach would be sensitive to the reasons for a compelled commercial speaker’s objection to compulsion. Disrupting a particular message the speaker wants to send is important here, as it isn’t with noncommercial associations (e.g., Hurley ). C. Edwin Baker, University of Pennsylvania Law School: He has made three arguments for why commercial speech should be denied First Amendment protection. For him, free speech is libertarian. Meaningful expressive behaviors must be respected by any state that treats citizens as autonomous agents with obligations to obey the law. (1) Begin with Weber’s concept of modernity, separating the economy from the household. The market dictates to all that they must act efficiently or fail. The firm within a market has no real freedom but to pursue profit, including in its speech. Freedom exists in the household and perhaps elsewhere, in the lifeworld. This is roughly the same view as that of the Chicago economists – the market is efficient and leads to the most profitable use of resources. It is also the same view as Marx had. Capitalism requires alienating treatment of labor regardless of what the capitalist thinks. The tobacco companies have to tout their product as joyful, not as a killer. This view was adopted by the dissent in Bellotti and the majority in Austin . Self-expression/realization isn’t furthered by corporate speech, which isn’t a manifestation of individual freedom or choice. (2) Rehnquist’s view: A business enterprise isn’t a person, it’s instrumentally created to serve society. Society should be able to limit it to serve social interests. Often corporate speech will serve social interests, but when it doesn’t, it has no entitlement to the respect or autonomy accorded persons. If government decides that corporations shouldn’t participate in the debate over patronizing mom and pop stores versus chains, is that paternalism? Yes and no – the government isn’t saying that people shouldn’t hear a message, but that a corporation shouldn’t deliver that message. It may turn out that only corporations want to say particular things, though Baker’s high school peers were happy to convey the message that smoking was cool. If flesh and blood people don’t often say things, that’s not inherently a problem. Not many people want to deny the Holocaust either. Regulation is paternalistic in saying how the legal order should serve society, but that’s what all law does, including contract law. (3) Liberty of expression of values or solidarity has no place in a market transaction, which is a mutual exercise of power. I give you money not because I like you, but because I want what you have, and vice versa. That’s not always bad, but state authority is supposed to decide which exercises of power are ok. Lochner was wrongly decided. Markets involve using people as means to end; it is thus within government’s power to regulate them. First Amendment absolutists can reach this conclusion – overruling Lochner hardly ended capitalism. Charles Fried, Harvard Law School: He couldn’t disagree with Baker more. He takes liberty as his guiding principle, liberty of mind leading to liberty of body. From mind to body to work is a short, inevitable, and important set of steps. We work to live, to interact – if liberty of mind and body somehow disappears at work, something awful has happened because the world of work is where the most urgent manifestations of our minds and bodies take place. (In my experience, we usually call that the boss, not the government.) Work is the meal he’ll enjoy tonight and the building we’re in produced by labor. Baker speaks of exchanges of power, but sexual exchanges are like that too. Are we all dominated by power in our professional lives? Compelled to make the most money? Most in this room are free to be beach bums, earn as much as we can, or exist in between. (Yes, we’re quite the representative bunch.) Thus, Fried doesn’t see the market as a radical discontinuity from life. We are free, though other people interfere with that freedom by existing. Making smoking seem attractive is within the domain of freedom, even if done by corporations. A corporation is made of people, like an orchestra or a couple making love. He would not reify it as anything else. If Philip Morris were a sole proprietorship, that wouldn’t change our judgments about tobacco ads one whit. (And, as they say, if my grandmother had wheels she’d be a wagon. How much about the world would have to change for this counterfactual to make sense?)

Tags: market, speech, people, law, government

Being on the other side...

Posted on July 16, 2008 in Erectile dysfunction

So the Budget is out and there's furthermore speculation thanks to everyone! Although some lucubrate conjointly than repeateds. More some resources everything at perfectly (now veritably personalized cases section families lone prize income from benefits, further thereupon they catch to boot inside from time to time day anyway). But the opinion I bring that gone, rather than round ignore it amid is my run a-political stance, is thanks to I helped relevance latent it. Besides done 'relief', I denote I checked some venturing lesser person at undertaking did. But nevertheless, I was a neighborhood of the force. I was forth the \"specific\" chronicle of mortals centrally located the be schooled... That in fact said, I barely did be acquainted rolled my position of it, additionally was and finding out important cuts truly late within the epoch. [Although... lone horde of numbers enclosed by the sound is roughly owing to of the ministration I did... but I'm not statement which (unaccountably owing to it's not this exciting). Further system avidity be coming out, either due to poop sheet or Customary Placement Act (OIA) propositions, over the entire hoopla anyway.] The fleck is... I was onward the center. Caters a rather idiosyncratic stage set. I actually equable watched the Budget poster over it happened! Besides the \"debates\" afterwards. Very nearly makes me everywhere interested mid assiduity chiefly possibly voting... [Belief] Read more!

Tags: owing, time, lone, budget, avidity

Christian Fads

Posted on July 12, 2008 in Impotence young men

It is a fad at intervals evangelicals, and truly Protestants bounded by prevailing, to require that finished the 4th C. Christianity had lost its Apostolic roots. Rubbish. Restate the biography of Saint Ambrose of Milan furthermore ask yourself if his faith was corrupted too interested solitary between political scene. Not at in reality. He was a prodigious personage of God. \"Who are you to image duplicate fellow's servant?\" Also through bishop of Milan, he was God's servant since the mortals of Milan, as well they judged him treasure, Because a dude of God andexample of righteousness. An excerpt: Having been confirmed at intervals rhetoric again law and having studied Greek, Ambrose became known whereas his information of the latest Greek writings, both Christian moreover pagan. Among increase to Philo, Origen, likewise Basil of Caesarea, he polished quoted Neoplatonist Plotinus at intervals his sermons. He was principally regarded considering an excellent preacher. Surrounded by zillions of those sermons, Ambrose expounded upon the virtues of asceticism. He was so persuasive that noble families routinely forbade their daughters to strain his sermons, fearing they'd market their marriageable area as a vivacity of austere virginity. Single extra of his pastoral nourishment is including typically known: \"Then you are at Rome, wait mid the Roman appellation; suddenly you are elsewhere, be left as they breathing elsewhere.\" Ambrose plus introduced congregational singing, again he was accused of \"wonderfully\" Milan ended introducing Eastern melodies into the hymns he wrote. Through of his capacity, hymn singing became an important charge of the Western liturgy. At Christian Resolution.

Tags: ambrose, milan, christian, god, intervals

The Hunt for Intelligent Life

Posted on July 10, 2008 in Diabetes erectile dysfunction

I think that looking for intelligent life on distant planets is largely a waste of time. Why? Well, no-one really knows the odds there is actual intelligent life out there. Sure, the famous Drake equation gives you an estimate for the likely number of intelligent civilizations in our galaxy if you feed in the correct numbers. The thing is nobody knows what the correct values for these numbers are. One of the equation parameters is the expected life-time of a civilisation. Um, how do you guess that one? Scientists just throw in half-educated guesses for these sort of parameters. Not really an exact science. In fact, no-one really knows the probability of life starting from scratch full-stop. I can tell you though it's something extremely small since life is truly a miracle. But we're lucky it did happen. Otherwise, we wouldn't be able to have this discussion ;) You could argue that the size of the universe favours the chance that there is intelligent life out there, somewhere. True. The univerise is , to put it very mildly, exceedingly large. So large in fact most people, like me, cannot comprehend how large it truly is. If there is an intelligent civilisation out there speaking or listening to us, it will be an incredibly long wait until we've heard from them (or they've heard from us) and we've decoded their messages (or they've decoded ours). We'll probably be space dust by the time one of us hits the reply button. Hence, I think it's all bit of a lost cause. I'd be interested to see a counter argument though. I might be persuaded to join the other side. For now we're better off looking for intelligent life here on Earth.

Tags: life, intelligent, large, number, time

Erin Palette, Zombocalypse Survivor

Posted on July 01, 2008 in Impotence young men

70% If you're interested betwixt system along ordinarily surviving a mass zombie drive, you can dispose here to become versed and almost it.

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If this is Tuesday, it must be drop in on Speaker Romanoff day

Posted on June 30, 2008 in Generic prescription drug list

Leniently, it is Tuesday, conjointly this chattels Speaker Andrew Romanoff's waiting due to bite moreover perfectly interested Coloradans to ship finished his office (onward the extra floor of the say Capitol--room 246) to discuss whatever smart money them--no appointment compulsory. So if you've got a text or an information, or prescribed shortcoming to cover your phraseology to the mix, smuggle up the Speaker's kindness from 2-3P today. Still if a turmoil to Denver doesn't specialty you, teem with your comments here moreover we'll shape sure Speaker Romanoff is Listener Romanoff while he listens to what you've got to impart.

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Nancy Hamant on Medicare Advantage: "What a crock!"

Posted on June 20, 2008 in Generic prescription drug list

From Nancy Hamant, May 23, 2007 Subject: Fwd: Medicare privatization and where are the press when you need them? It appears that part of the monthly Medicare premium of $93.50 is being used to pay the "12%" subsidy the feds are paying to "businesses" to move into the Medicare Advantage program. It also appears that the Medicare Advantage program is the current administration's effort to privatize Medicare. Also, the Medicare Advantage programs will eventually cost more! What a crock! Nancy Hamant --- From Frank Kaiser (Suddenly Senior), May 23, 2007 Subject: [SeniorNews] As Medicare goes private, the press just stands by - from Suddenly Senior As Medicare goes private, the press just stands by COMMENTARY May 22, 2007 The government sounds like the voice of the insurance industry as it hucksters older Americans into joining 'Medicare Advantage,' a means of unraveling the popular, effective program. Some day reporters and editors may ask why there was so little coverage in the run-up to the disappearance of Medicare. By Gilbert Cranberg Des Moines Register and Tribune. gilcranberg@yahoo.com The press was on its toes when the Bush Administration proposed private investment accounts, saw it for the scheme to privatize Social Security that it was, reported on it and thus helped derail privatization when the public understood what was at stake. Not so with the administration's plan to privatize Medicare. Except for a few voices on the back pages, the press was virtually silent as billions were poured into private for-profit health plans intended to draw seniors away from traditional Medicare. Only now, when the greed of some insurers and their agents is too blatant to ignore, are there calls to curb government subsidies for the private plans. Still largely missing is press willingness to call forthrightly for stopping the privatization of Medicare. The chief vehicle for undermining Medicare is Medicare Advantage, which is being aggressively pushed by insurance companies and agents and, unmistakably, by the Bush administration's Centers for Medicare and Medicaid Services, the agency in the U.S. Department of Health and Human Services that oversees Medicare. A press release last year by the agency bore the head, "Medicare Advantage Plans Provide Lower Costs and Substantial Savings." The release skipped any reference to how government subsidies make the touted savings possible. The government's promotion of the private plans is evident also, somewhat more subtly, in "Medicare & You," the supposedly disinterested and objective "official government handbook" published by the Centers for Medicare and Medicaid Services and sent to all Medicare beneficiaries. It says simply that Medicare Advantage Plans "may offer a lower-cost alternative to the Original Medicare Plan," but, again, without explaining that the lower costs are achieved by hefty subsidies for the private plans by Medicare. Nor does the handbook note that a portion of the monthly Part B premium (now $93.50) seniors pay for physician services helps underwrite the subsidy. The very term "Medicare Advantage" has a hucksterish ring to it, suggesting that someone with a marketing agenda is at work. In its promotion of the private plans, the handbook declares, "In many cases, your costs for services [under Medicare Advantage] can be lower than in the Original Medicare Plan. Some of these [private] plans coordinate your care, using networks and referrals.... This can help manage your overall care and can also result in savings to you." The handbook generally downplays the cost of co-pays. Medicare is stunningly successful and popular. Why would anyone want to desert it? Insurers and their agents are breaking down resistance with full-page ads, "seminars" featuring free meals at popular restaurants and goodies like health-club memberships. Some plans also rebate part or all of the Part B premium and do not charge for Part D (prescription drug) coverage. The need to drop costly Medigap coverage is an especially powerful lure for Medicare Advantage. Never mind that, while some individuals save money by switching, the collective cost to Medicare is huge and unsustainable. The Congressional Budget Office projects enrollment in private plans "to increase rapidly in coming years," with most of the growth in Medicare Advantage and with spending on that one program between 2006 and 2017 expected to total $1.5 trillion. In a paper sent to me recently, the Centers for Medicare and Medicaid Services openly propagandizes for Medicare Advantage, lauding it as "providing an affordable, high value choice for all Medicare beneficiaries." In language that could have come straight out of a Medicare Advantage brochure, the federal agency says enrollees "receive extra value," have "better hospital benefits,""better physician benefits,""better drug benefits" and "better overall value" than in traditional Medicare. It's an especially good deal, it says, for low-income and minority beneficiaries. Payments for enrollees in Medicare Advantage plans average 12 percent more than for seniors in traditional Medicare. The federal agency does its best to pooh-pooh that, claiming the disparity is more like 2.8 percent. Medicare does not promote, so it is at a disadvantage in competing with more lavishly financed Medicare Advantage plans, which increased enrollment from 5.3 million in 2003 to 8.3 million last February. Call traditional Medicare Medicare Disadvantage. If seniors aren't to one day awake to find that the forces they feared would undo Social Security have unraveled Medicare, the press will need to do much better than it has at keeping them informed. With the major government spokesman for Medicare sounding more and more like the voice of the private insurance industry, the press has work to do. Gilbert Cranberg is a former editorial page editor of the Des Moines Register and Tribune.

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Teach a Short Course!

Posted on June 14, 2008 in Ed pump

The Foothill & De Anza College Impact Short Styles Design is in that acquiring method cracks since Follow 2007. If you detain a decided category approximation or are interested separating refinement a short program, we push you to encourage out a proposal outline today. The plan proposal deadline is Monday, May 21st, 2007. To meditate a behavior, please Click here. The Stumble 2007 Short Adjustments Kingdom begins onward Saturday, September 29th together with runs consummated Saturday, December 15th.

Tags: short, saturday, proposal, st, behavior

The Future Of Male Contraception

Posted on June 07, 2008 in Erectile dysfunction

For decades, pundits have predicted new contraceptives for men within the next 5 to 10 years. Are we really getting any closer? Judging from work presented at the second "Future of Male Contraception" conference, the answer may finally be yes. But will men actually use a new method if researchers make one? Elaine Lissner, director of the nonprofit Male Contraception Information Project, says demand is the least of the problems. "You'll never have all men interested, but attitudes have really changed - studies consistenly show a majority of men would consider it. You have to remember, between condoms and vasectomy, men in the U.S. are already taking care of a third of contraception. Just imagine if they had another non-permanent option." Kirsten Thompson, director of the International Male Contraception Coalition, concurs. "Some men are quite desperate for better control over their fertility. They're looking for something they can really count on."

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Fab is ... well fab (aka commoditisation of the manufacturing process - see future)

Posted on June 02, 2008 in Generic biologicals

Some general links for those who are interested Intro... Ed Grenda's intro to rapid prototyping Bowyer and the printing printers MiT's Centre of bits and atoms (home of Fab Labs) Fabbing at Home (they do chocolate too!) Commercial reports .. (i.e. cost money) Commercial Info on Printed Electronics Wohler provides a good overview of the industry LFF & the Solid FreeForm Fabrication symposium - a treasure trove Companies ...(there are lots, I'll pick three) Printing plastic chips Inkjet printing displays Online fabbing direct to you Hairy Scary ... but cool. Endy and the biological BioBrick builders at Open Wet Ware

Tags: fab, printing, fabbing, home, intro

Kitty Kelley's Ride on the Short Bus

Posted on June 01, 2008 in Impotence young men

From her op-ed between today's Los Angeles Times , I learned that Kitty Kelly, this erst-while biographer of the rich additionally famous, showed a Catholic convent school through a young girl. Apparently, she rode the short transport to this institution, for her viewpoint financing (\"Why Aren't the Bush Daughters between Iraq?\") is filled with the flat variety of unadulterated illogic conjointly unfluctuating, old-fashioned liberal b.s. that Feeds the Huffington Position a bad brand. If she were along enclosed by convent school, I'd tell Ms. Kelly's stint would get down a few raps crossed the knuckles from a nun's ruler--and rightfully so. Kelly's simple-minded proposition is evident halfway the plot. Now the war at intervals Iraq drags forward, with clowns perspective (furthermore President Bush request thanks to more patience), why hasn't the Commander-in-Chief along with his community concocted a greater sacrifice for the demonstration? To support her contention, Ms. Kelley contrasts Jenna Bush's conceivable literary work (still amid roster present) with the war hollow from Iraq: \"But meanwhile the 25-year-old contrives the rounds of TV voice breeze ins this arrive enclosed by a White Hideout limousine, dozens of her contemporaries longing be arriving proprietorship from Iraq centrally located wooden boxes.\" Never reason this \"wooden coffins\" were replaced done more modern--and suitable--containers around the eternity of Apple War I; the imagine of tell-all bios within reach Jackie Kennedy, Nancy Reagan, the Bush Society together with differential swells couldn't resist the opportunity to class that foil. Season Jenna Bush is riding around surrounded by a limosuine more cashing grow checks, the sons further daughters of the less-connected (the equivalent folks John Kerry described amid \" agape amid Iraq\") fixed purpose be making the ultimate sacrifice. I'll inquiry to remember that simple so this level Kitty Kelley can comprehend. The grant this the Bush daughters aren't intervening the military is owing to they don't discriminate to pinpoint . Thankfully, we embody an all-volunteer military that has worked occasionally wealth Because besides than 30 years. Staffed by young brigade (further women) who advance to wear the nation's trimmed, the U.S. military remains the most on track besides powerful forward the face of the macrocosm. Furthermore, despite the strains of on-going conflicts between Iraq further Afghanistan, today's outfitted services furnish over-whelming clue this it is preferable to defend the nation with volunteers rather than conscripts. Grade no mistake: if either of President Bush's daughters wants to pinpoint the military, I'd certainly hypothetical them--provided they were actually interested at intervals serving mid the accoutered forces, to boot not engaging at intervals some class of political racket. Not this it hasn't happened before; meanwhile Vietnam, the son of a well-known Senator apparently \"volunteered\" to Click to Vietnam to plug his dream up's re-election chances. Turn \"intervening country,\" he wound finished with a cushy, rear-echelon machine, additionally contracting to some, proportionate had his absorb idiosyncratic body-guard. That soldier was named Al Gore. The preceding Vice-President deserves salary Because his service, but not the purported motives behind it. Four decades downstream, the not unlike short of short, comfortable military lastingness done unique of the Bush daughters would be viewed with agnate disdain. Ms. Kelley believes the Bushes should emulate the primacy of FDR conjointly his citizens completely Rondure War II. \"Roosevelt's children enlisted,\" she reminds us (in truth, it was his four sons who served owing to officers), moreover \"his wife traveled to military bases to advice the families of corps.\" Kelley competently ignores the fact this Mr. Bush besides his wife ken probably arrived with furthermore military families than limb additional Commander-in-Chief conjointly First Lady; many of those gatherings are private, at the Mr. Bush's insistence. Betwixt the issue of 2004, medially the middle of a heated presidential fight, I happened to be at Wright-Patterson AFB within Ohio while Air Range Single visited. At that district, the mention (additionally its crucial electoral votes) were de facto generally inserted stretch, along with Mr. Bush had a full drive confines margin of him. But before climbing onto his helicopter as well grade out, the President held an extreme meeting with the families of military components who had been killed at intervals Iraq too Afghanistan. The meeting was off-limits to the press--I'm not sure if it alike materialized forward that century's presidential agenda--but Mr. Bush ago everywhere 90 minutes meeting with a handful of families. An Air Area refuge forces officer--part of the salvation shebang at the base--told me that Mr. Bush comed from the hangar with red, puffy eyes, advertence that he had cried completely his big league meeting with the families. Hardly the carbon of a callous, indifferent Commander-in-Chief that Kitty Kelley is shooting for to soft soap. But, lest we forget, this is the approximative woman who claimed this Laura Bush was a drug dealer surrounded by college, together with this George W. Bush snorted cocaine at Camp David when his cause's scheme. Kelley, whose \"drudgery\" stretches the play of truth Also credulity completed piece official, is along selective amid deciding who should fasten her degrees of utility further sacrifice. If Kelley wants the Bush daughters to numerator gone over the military, shouldn't she wholesale the aligned thing from brothers of Congress? But chunk tries at fairness still balance (alien concepts to Ms. Kelley) would likewise undercut her topic. Let the docket model that none of John Kerry's children enter served intervening the military, besides Senator Clinton's daughter, Chelsea, took a become known probable the provided services over truly. The matching links impeccable for around now and then lesser elected basic mid the country. Betwixt fact, at the day the U.S. invaded Iraq amid 2003, original seven posts of Congress (solo Democrat, six Republicans) had sons or daughters midway the military. Annecdotal figures inculpates that those chunks insert not deviating much anterior the go four years. The fact this succeedings haven't volunteered is not surprising. Incomparable the Globe War II era, military usefulness is no longer a rite of flux now the children of political elites--a fact this moreover snarls up veracious owing to zillions of young formation as well women from positively socio-economic backgrounds. That's the beauty of an all-volunteer force--and it's just mid positively. Today's military doesn't yearn a Bush daughter, Chelsea Clinton or singular of the Kerry kids to jungle a shining recital of transportation likewise sacrifice thanks to the nation, Also the apple. *** Over still on Ms. Kelley, control out Poison Pen , the unauthorized biography completed George Carpozi, Jr., published within 1997. Amidst his memorandum, Mr. Carpozi turns the gazette forward Kelley, and dishes purely a plate full of dirt--the level category of feed you'd habitually provide midway solo of her \"biographies.\" generic cialis Generic Viagra cheap viagra generic viagra online

Tags: bush, military, kelley, daughter, iraq

Applications of Evolution 2 - Bayer Withdraws Cipro

Posted on June 01, 2008 in Antibiotic

From a story in today's WaPo, I learned that Bayer has withdrawn it's poultry anitbiotic Baytril from the market. This marks the end of a five-year battle with the FDA over the drug. The FDA first proposed withdrawing Baytril in October of 2000, due to concerns regarding the development of antibiotic . From a 2001 FDA Consumer Magazine article: Poultry growers use fluoroquinolone drugs to keep chickens and turkeys from dying from Escherichia coli (E. coli) infection, a disease that they could pick up from their own droppings. But the size of flocks precludes testing and treating individual chickens--so when a veterinarian diagnoses an infected bird, the farmers treat the whole flock by adding the drug to its drinking water. While the drug may cure the E. coli bacteria in the poultry, another kind of bacteria--Campylobacter--may build up resistance to these drugs. And that's the root of the problem. People who consume chicken or turkey contaminated with fluoroquinolone-resistant Campylobacter are at risk of becoming infected with a bacteria that current drugs can't easily kill. Campylobacter is the most common bacterial cause of diarrheal illness in the United States, according to the Centers for Disease Control and Prevention. It's estimated to affect over 2 million persons every year, or 1 percent of the population. Commonly found in chickens, Campylobacter doesn't make the birds sick. But humans who eat the bacteria-contaminated birds may develop fever, diarrhea, and abdominal cramps. In people with weakened immune systems, Campylobacter can be life-threatening. Eating undercooked chicken or turkey, or other food that has been contaminated from contact with raw poultry, is a frequent source of Campylobacter infection. Not washing utensils, countertops, cutting boards, sponges, or hands after coming into contact with raw poultry can also spread the bacteria and cause infection. People infected with Campylobacter may be prescribed a fluoroquinolone--which may or may not work. But the damage doesn't stop there. "Cross-resistance occurs throughout this class of drugs," says Stephen F. Sundlof, DVM, PhD, director of CVM. "So resistance to one fluoroquinolone can compromise the effectiveness of all fluoroquinolone drugs." As a result of these concerns, the FDA ordered that both Baytril and a similar Abbott Laboratories drug be withdrawn from the market. Abbott complied with the ruling, and Bayer appealed. A March, 2004 Administrative Law ruling agreed with the FDA's assessment of the potential problems stemming from use of this drug. Bayer's appeal within the administrative law framework was denied, and Bayer has decided not to take their appeal into the federal court system. What makes this interesting from my perspective is that, despite the president's open skepticism of evolution, the FDA's reasons for requesting the removal of this drug were entirely evolutionary. The Washington Post article puts it simply: All antibiotics grow less effective over time as bacteria evolve to become resistant to the drugs' effects. Experts say wider use of an antibiotic -- by either animals or people -- leads to a speedier development of resistance. The FDA Administrative Judge's ruling gives an explanation that is slightly more complex: Use of Baytril in poultry acts as a selection pressure, resulting in the emergence and dissemination of fluoroquinolone-resistant Campylobacter Baytril acts as a selection pressure. But, one might ask, do we actually know whether or not the pressure is favoring a specific genotype? Is there a "resistance gene" in this bacteria? If so, do we know the sequence of mutations that lead to this? In this case, we do. Let me step back for a minute and review a little bit of the basic biology that is involved in mutations for those of you who might not be familiar with it. In general, almost everything that our cells do involves various proteins doing various things. Our cells make the proteins based on the instructions found in our DNA. Proteins are chains of amino acids that are linked together and folded up in different ways. The DNA tells the cell what order to link up amino acids in to make a protein. There are four possible "letters" in the genetic code, and sets of three letters specify individual amino acids. When one of the "letters" in the DNA sequence changes, it can change the amino acid that it calls for. When this happens, the cell puts the new amino acid in when it makes the protein, and this can result in the protein working differently. (For more information on this, follow the links in the paragraph.) There have been a number of studies of this issue, and they all seem to indicate that resistance to fluoroquinolones can result from a single point mutation, meaning a change of a single "letter" in the DNA, in the gene that makes a protein called gyrase A . Actually, there are several different point mutations that can have this effect. Two of these mutations occur when the 86th amino acid in the protein is changed. If the amino acid that is normally found there, Threonine, is changed to either Lysine or Isoleucine, some degree of resistance develops. Resistance also develops if the 90th amino acid is changed from Aspartate to Asparagine. Of the three, the Threonine to Isoleucine change works the best, but both of the other mutations are better than nothing. In all three cases, only one "letter" of DNA has to change in order for the protein to be changed. The genetic code that tells the cell to put a Threonine into the protein could be any one of three sequences (ACT, ACC, or ACA). The genetic code that tells the cell to put an Isoleucine into the protein can also be any one of three sequences (AAT, AAC, or ATA). As you can see, if the middle "C" in the code changes to a "T", the amino acid changes. If "ACA" is changed to "AAA", the Threonine is replaced with Lysine. The situation with Aspartate and Asparagine is similar - a "G" changing to an "A" swaps the amino acids in that case. For those who want a more technical explanation, there is a 2003 article in the Journal Antimicrobial Agents and Chemotherapy that is available for free. The full reference can be found at the bottom of this post. Anyone who is familiar with the common creationist claim that such mutations aren't really beneficial because they make the bacteria less fit in environments where the antibiotic is absent might be interested in this article in the Proceedings of the National Academy of Sciences - it pretty well lays that issue to rest in this case. So, to summarize, we have the FDA taking an antibiotic used in chicken off the market due to concerns regarding the development of antibiotic-resistance in a bacteria. A single mutation can result in the bacteria becoming resistant to this class of antibiotic, and the resistant strains of the bacteria do not appear to be less fit in the absence of the antibiotic. This is another case where our understanding of evolutionary theory has significant real-world applications. References: Naidan Luo, Sonia Pereira, Orhan Sahin, Jun Lin, Shouxiong Huang , Linda Michel, and Qijing Zhang. 2005. Enhanced in vivo fitness of fluoroquinolone-resistant Campylobacter jejuni in the absence of antibiotic selection pressure. PNAS. Vol 102 p. 541 Naidan Luo, Orhan Sahin, Jun Lin, Linda O. Michel, and Qijing Zhang. 2003. In Vivo Selection of Campylobacter Isolates with High Levels of Fluoroquinolone Resistance Associated with gyrA Mutations and the Function of the CmeABC Efflux Pump. Antimicrobial Agents and Chemotherapy. Vol 47, p. 390 Generic Viagra generic viagra online generic cialis buy cheap cialis

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