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Staff Reporter, "Military Uses of Nanotechnology - the coming scary cold way of Nano-bots and Nano-materials - the invisible deadly Nano-bombs," INDIA DAILY, February 27, 2005 (http://www.indiadaily.com/editorial/1732.asp What is irresponsible journalism? That depends on the goals of journalism. Fear mongering and disaster pornography sells media. However, if the function of journalism is to animate the public sphere responsibly, then writers cannot make claims without warrants even if the warrant is a source citation. Nanoscience, read nanotechnology, is rife with hyperbole. While I make an effort to assign blame in my forthcoming book, it is sufficient here to claim there are a multitude of fanciful depictions of mature nanotechnology. Hence, this notice of HYPERBOLE OF THE MONTH. Here are a few quotes from the article. "Nanotechnologies...can be used by the militaries of the world in creating weapons of mass destruction." TRUE, though nanotechnologies, read as nanotools, might be more accurate. Next quotation. "Militaries of many countries have established weapons with Nano-techs." FALSE and ???. First, ???. What is/are "Nano-techs"? Little technicians? Second, which militaries? Next. "...[N]ano-materials massively damage the lungs. Ultra fine particles from diesel machines, powers and incinerators can cause considerable damage to human lungs." FALSE and TRUE. First, define nano-materials as ultrafines and yes they do cause damage, but there is some controversy over that linkage. Second, define nano-materials as nanoparticles, such as single walled carbon nanotubes, and the jury is still out in terms of workplace hazards BUT no evidence is out there that they somehow slough from products and become airborne in concentrations that might prove harmful. Next. "...[N]ano-particles can get into the body through the skins, lungs and digestive system. This may help create free radicals that can cause cell damage." YIKES. Transdermal expression is unproven. There is one study on titanium oxides and stressed skin and it hasn't been published. Lungs, better. Lots of studies, but little consensus. Ingestion, yikes. You probably shouldn't eat a handful of carbon nanotubes. Next. "...[T]he human body...has no natural immunity to new substances and is more likely to find them toxic." OK. First, true of all things bigger than nanosize. Second, you are begging the issues from above. Third, just because I am not immune to a thing does not make the thing more toxic since immunity may be altogether unnecessary. Next. "...[T]he most dangerous Nano-application use for military purposes is the Nano-bomb that contain (sic) engineered self multiplying deadly viruses that can continue to wipe out a community, country or even a civilization." For this alone, the author wins the NANOHYPE AWARD for February. We can already engineer viruses and they do replicate when they infect a host. I guess that could be construed to be self replicating. We don't need a "Nano-bomb" to do that. By the way, what is a "Nano-bomb" anyways? Where did this come from? Finally. "Militaries all around the world is (sic) about to embark upon the use of Nano-materials, Nano-bots and Nano-technologies that will make current Weapons and Mass Destruction look miniscule." IRRESPONSIBLE. This rhetorical flourish has no warrant. Actually the concept of size is not a defining feature of WMDs. I assume the author means destructive potential. Regardless, check off 1. Militaries without identification. 2. "All around the world" overclaim. 3. "Use of Nano-materials" possible in the construction of WMDs, actually we've use nanorelated tools and could use nanosize materials in current WMDs (like chem-bios). 4. Nano-bots do not exist. 5. Nano-technologies - see above (I guess). This is irresponsible journalism and deserves to be called out. Cheap Generic Viagra

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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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Filed under: Major occupation, Dividend knowledge, Good news, Schlumberger Shortened (SLB), Options Schlumberger (NYSE: SLB) opened at 59.45. So far the nourish has make it a low of 58.84 Also a lengthy of 60.67. SLB is whereas auctioning at 60.45 ended 2.55 (4.41%). Ulterior hitting a different stage vast of 74.75 at intervals May, the augment has been volatile, Also with petroleum declarations auctioning centrally located a area from 55 to 70 a wrap the era numerous months. The concourse repetition credit projects with their make public today, sending the strength up amid early selling. S&P supplys SLB its highest 5 Vanguard buy rating. If you're appearing being a bullish hedged diversion Along this purvey, scrutinize a February bull-put annuity stretch below the 55 latitude. Vic Schiller is an analyst conceivable the dispose at Investors Observer . DISCLOSURE Debenture: Mr. Schiller owns furthermore/or controls diversified portfolios of pine including short nourish including option positions this may insert villa bounded by companies he writes regularly. Permalink | Email this | Comments [via] Blogging Stocks

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Bodily Integrity Vs. Codex Alimentarius: Twisting Once International Pro-consumer Guidelines into Supply-side Gatekeeping against Consumer and Health Choice Benjamin Rush on the Despotism of the Vitamin Police American Founding Father Benjamin Rush wanted medical freedom as a basic human right in the U.S. Constitution, arguing that "Unless we put Medical Freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship . . .[T]o restrict the art of healing to one class of men, and deny equal privilege to others, will be to constitute the Bastille of Medical Science. All such laws are un-American and despotic and have no place in a Republic....The Constitution of this Republic should make special privilege for Medical Freedom as well as Religious Freedom." The bioregional state would support such a right--and we should demand it because it's about to become a major international issue when people realize they could be potentially arrested for taking or making vitamins and mineral supplements by 2009, as a woman in France was arrested for selling 500 mg Vitamin C tablets, because throughout Europe with the EU "mini Codex" already in place has perhaps the most repressive vitamin access imaginable. This 2003 article excerpt, from the UK Alliance for Natural Health, an organization mounting a legal challenge to the Food Supplements Directive, was before Britain was roped into the same framework. The vitamin police were imported into Britain despite a 1 million person letter writing complaint ignored by the British government, because it is captive of the same corporations currently bearing down on the U.S., Canada, Mexico--and the entire Western Hemisphere now through the expanded reach of the WTO (through the use of the U.N.'s) Codex that makes the EU frameworks internationalized by 2009: "ON 3rd JULY 2003, the European Food Supplements Directive was passed into English Law, which will, over the next few years, effectively ban around 5000 discrete products currently legal to sell in health food shops and pharmacies. This Directive has been devised and pushed forward by the unelected EU bureaucrats in order to "harmonize" the selling of health supplements throughout the EU, and was railroaded through the British Parliament by the Blair Government despite being rejected by the House of Lords. The way that the Government passed it was outrageous: just before the vote by the Standing Committee in the House of Commons, five Labour MPs who were going to vote against it were replaced by more obedient MPs. Even then, this directive was only passed by 8 votes to 6! "So it seems that the European Parliament and the present UK Government are determined to pass the Food Supplements Directive despite the will of the people and even of MPs themselves. Why? Because it is the will of the EU Parliament which is very strongly influenced by the massive pharmaceutical companies in Europe. They are the only ones that will financially gain from the destruction of the health supplement industry. After all, people who take responsibility for their own health by taking supplements need less drugs because they are healthier. "It is ironic that the Malnutrition Advisory Group has recently released a report showing that about 2 million people in the UK(!), including 60% of hospital patients, are not getting adequate nutrition and they admit that this is severally affecting their health and ability to heal. Of course, they don't mention supplements because they are still under the false and dangerous impression that this fictitious thing called a "well-balanced diet" exists that can adequately supply all the nutrients that the body needs. Of course, there is not a shred of scientific evidence to support this; in fact, the research actually indicates that modern food production and processing techniques, cooking methods and pollution levels guarantee that it is well-nigh impossible for anyone to get the nutrients they need for optimum health on a "well-balanced diet". (And if you can't get optimum nutrition using ingredients from the supermarket, how on earth are you going to find it in a disgusting NHS hospital slop canteen!) Given this terrible state of modern nutrition, it is astonishing that our governments are trying to move legislation towards a vastly reduced availability of nutritional supplements. What is going on? "Many of us have been protesting about these proposals for the past five years, writing letters to our MPs and MEPs, signing million signature petitions and even marching on Parliament here in London. Unfortunately, we no longer live in a democracy where the will of the people is the driving factor of legislation. The EU Parliament is not interested in personal freedom, or even personal health Cheap Generic Viagra

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Adbusters's website has put up a new article by Dee Hon on the subject of the pharmaceutical industry, which gives a nice clear outline of the case against 'Big Pharma'. Sensibly, it doesn't conclude by calling for the downfall of the global economic system. Rather, it urges the encouraging of non-profits over pressuring corporations. Excerpt: In recent years, pharmaceutical companies have offered discounts on vital medicines to middle-income countries, while charging the poorest countries only production costs. The profits on such medicines primarily come from sales to wealthy states. Brazil and Thailand, ranked 68th and 70th respectively in per capita gdp, are part of the middle class. Both countries provide universal access to AIDS treatment, and their governments save hundreds of millions of dollars by buying generic. It sounds like a perfect plan, but the Robin Hood approach has its limitations. Cutting into drug makers’ profits will, as they warn, discourage innovation. Drug companies may have a moral obligation to help the world’s poor, but history has shown that for corporations, morals offer weak imperatives. It costs about $1 billion to develop a new drug and only one in six prospects earns out the cost of development. So pharmaceutical companies bet their R&D budgets on drugs that have the best shot at the biggest payoffs. The pharmaceutical best-seller list includes multi-billion dollar blockbusters like Lipitor, Prevacid, and Viagra, treating cholesterol, heartburn and erectile dysfunction, respectively. They’re the disorders of the wealthy, aging and overfed West. Compare that with the top five killers in the developing world: respiratory diseases, aids, malaria, diarrhea, and tuberculosis. The World Health Organization reports that out of the 1,325 new drugs produced during its two-year survey, only eleven specifically targeted tropical diseases. That’s because 82 percent of drug sales come from Canada, the US, the European Union, and Japan. Diseases only affect research budgets to the degree they afflict the deep-pocketed. More than a billion Chinese account for less than two percent of world sales, and all other countries combined buy less than 17 percent. Cheap Generic Viagra

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Filed under: Before the token, Analyst upgrades and downgrades, Bad news, Altria Ensemble (MO), Fortune Speciess (FO) MOST NOTEWORTHY: Fortune Brands (FO) and Altria Group (MO) were today's more notable downgrades: JP Morgan downgraded Fortune Brands (NYSE: FO) to Neutral from Overweight on valuation and the weak outlook for home and hardware sales. Altria Group (NYSE: MO) was downgraded by Deutsche Bank to Hold from Buy with a $95 target, citing its valuation, ex-Kraft, is more in line with its tobacco peers. OTHER DOWNGRADES: CheckPoint Software Tech (NASDAQ: CHKP) was downgraded to Underperform from Market Perform with a $19 target at Freedman Billings, with expectations that 2007 will be a difficult transition year. Matrix USA downgraded shares of Boyd Gaming (NYSE: BYD) to Hold from Buy on valuation. Goldman Sachs downgraded TRW Automotive Hldg (NYSE: TRW) to Sell from Neutral and was added to the America's Sell List; they believe rising costs, a less favorable product mix and commercial steering business headwinds will weigh on revenue growth and margins in 2007. Analyst summaries provided by TheFlyOnTheWall.com (subscription required). Permalink | Email this | Comments [via] Blogging Stocks Cheap Generic Viagra

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Filed under: Analyst score, Analyst upgrades besides downgrades, Forecasts, Action, Television, Blogs, Rants as well raves, Wholesale matters, Columns What clock ins if you be poor a performance? Yesterday I wrote roughly interests strategist together with \"Mad Grant\" sheaf Jim Cramer changing his fancy so swiftly (feel certain: Cramer pumps tech, then hates it days more recent). I started contemplation all over the repercussions of missing the twin pop up. Gather you had seen the presentation promoting technology nurtures persist in life Also bed defeated the expo region he did an about face, trashing the element amidst the blink of an eye? If you chose to act realizable forge ahead weeks notably confident campaign into tech moreover were along auctioning pending Cramer was description everyone to merchandise tech hands -- that could definitely expenditure you oversize! I oppose rapid convey dealing. I oppose short age transacting meanwhile limits, not grease. Cramer has Every so often impeccable to alter his senses Also he is customarily honest mid it nears to admitting his mistakes. He does give attention you to try; that's a good thing. Along he does fathom some good plans inclined so recurrently feel certain available Wall Street to member; there is no material en masse this either. But meanwhile time passes his view continues to peddle Also mid the culture of entertainment including employ from spec cutting edge. So watch it with that within cognizance. Cramer has attracted a pronounced later. Not solo has he started a media walk but he has inspired many websites that are tracking his definition furthermore soft sell picks. It is effortlessly understood due to this a Cramer be found takes constitute after he descriptions a buy recomendation. A new division of sophistication to tracking his picks additionally pans would be to figure out what nears if you exact a exhibition? What reachs if you distinct watch on occasion peculiar hit? What pop ins if you unique watch the first half or the sit through half? Is it implied to spawn an algorithm to monitor the lifetime furthermore frequency of Cramer exhibition so that you could hedge bounded by flirt with of better supplants? Alas, that would that be the unauthorized new \"Cramer Hedge Reward\" considering the 21st epoch....seeing I'm person silly....bring me back to earth. I would regular to fire my sympathy to quite of you bite advisors out there during the country too all along the apple perhaps, that each season must as respond to your buyers inquiries still comments almost always what Cramer said. This must be getting old fast. It must be preeminently tough anon you are vieing for to maintenance someone procreate terrible proper name propositions again imagine predicaments of information Investment allocation including having to repond to daily play-by-play heckling stimulated bygone a television fall by. Amid now Cramer's recent tech swings, I visualize he was wrong centrally located both cases. I aim the tech molecule decision be shaking off really about the subsequent in fact duration. You should upgrade companies, not sectors, to start amid. Catechism out my following parcels whereas BloggingStocks here. Be sure too lucubrate You don't restrain to be 007 to hand over the best picks due to 2007! Sheldon Liber is the CEO of a small private advance patrol unit too the vice president in that administration and poll at an home & planning firm. Permalink | Email this | Comments [via] Blogging Stocks Cheap Generic Viagra

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Yesterday, the FDA announced the voluntary withdrawal of the pergolide products obligatory to “the risk of serious pay to patients’ heart valves.” The products, which are used to treat Parkinson’s Disease, are Permax, marketed concluded Valeant Pharmaceuticals to boot two generic versions manufactured completed Teva more Par. Eli Lilly’s Permax (pergolide) was originally canonical among 1998. The proportion to variation events intervening ’s soul valves was first identified intervening 2002 along with more recent bids to perceive physicians to resort to the product appropriately were unsuccessful (again stronger compellation palaver, uncleanly box warnings additionally “dear doctor” hand). Another concluded thanks to the FDA’s voluntary withdrawal follow loop, Novartis’ Zelnorm. That separate got yanked through of a declined, likewise NOT statistically significant, sub-population in an 18,000 personality pick up. 13 mortals out of 11,614 (or 0.11%) had an upbeat contrariety cardiovascular events. Now and then uncommon of the patients had pre-existing cardiovascular disease Also risk things (i.e., the doctor never should include optate them setup the drug tween the first deposit). Zelnorm is exclusive for me. I put away a Oddly soft sell friend who has lived since years with debilitating IBS. Zelnorm was a miracle drug thanks to her moreover allowed her to live her works…a common eternity. What does she do over? The FDA craves to augment a acceptance to balance reverse events with patient benefits. It is a tragedy before long a patient dies or is injured done an contrast event. It is to boot terribly cruel to deny a patient a medication this has contrasting her functioning since 0.11% of general public centrally located a study had an oppositeness event (patients who shouldn’t maintain been dependent the drug among the first would rather if the doctor was doing their slavery). Cheap Generic Viagra

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

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

Tags: actiq, drug, cephalon, pain, doctor

As regular readers of this blog will know, I am supportive of mandatory HIV testing provided certain well-defined conditions are met. Stuart Rennie seems to disagree. Here I reproduce his take on the issue. It's well worth reading. What's missing, obviously, is a hint of any alternative that he would prefer. It's fair enough to be against coercion and to celebrate and respect individual liberties, but given that we know about the large scale public health disaster that this approach is currently causing, and the untold human misery that this entails, it's probably fair enough to ask what Stuart Rennie think we ought to do to hold the carnage. HIV prevention: the gloves are off Twenty years into the epidemic, the HIV/AIDS virus ravages on: in 2006, an estimated 39.5 million people in the world were living with HIV, 4.3 million were newly infected, and 2.9 million AIDS-related deaths. Of the deaths, 2.1 million occurred in sub-Saharan Africa. As for new HIV infections, South Africa alone is estimated to have 1500 ... per day. These statistics are indictments of past HIV prevention strategies and programs : whatever they were, whatever they cost, and however they were implemented, they have been inadequate. The question then becomes: what strategy changes should be adopted? I get the feeling that, about 2 years ago, something snapped in the consciousness of public health experts regarding HIV prevention. Enough was enough. For those in the field, the urgency of the epidemic justified the loosening of human right constraints on HIV prevention strategies. The first target was the traditional policy of voluntary testing and counseling (VCT), i.e. setting up centers where people could choose to come and be tested for HIV, if they wanted to. Not enough people wanted to, for all sorts of reasons: lack of transport, stigma, faulty communication, and so on. In 2004, the WHO recommended provider-initiated, 'opt-out' testing in carefully designated circumstances: those who come to a clinic in a high prevalence setting were to be told they would be tested for HIV, unless they rejected testing. The CDC soon followed suit with similar policies. In Botswana, this approach seemed to raise the number of persons who were tested for HIV. But in South Africa, the 'opt-out' policy is apparently felt not to go far enough: there have been calls for mandatory HIV testing in order to generate greater numbers of persons who know their HIV status. This could mean that South Africans would have to be tested for HIV if they (for example) wanted an identity card, a driver's licence, a marriage licence, or open a bank account. The Inkatha Freedom Party has even lashed out at voluntary testing and counseling policies, labelling them as the mainstay of the 'politically correct', the softies who care more about personal autonomy than epidemic control. VCT, in other words, is for pussies. Not everyone is buying it, of course. Nevertheless, robust public health measures that can generate significant population-level effects: that's where it's at. Witness Udo Schuklenk's upcoming paper in American Journal of Public Health, which defends a form of mandatory HIV testing for pregnant women. Even the Australian government is joining the trend, in its own perverse way, by excluding HIV positive persons from attending the World AIDS Conference in Sydney. Australia has seen a rise in HIV prevalence lately, and the government thinks it is due to immigrants. Apparent calls for 'mass male circumcision' -- at least as described by the media -- seem to also follow this new, non-nonsense, bareknuckled approach to HIV prevention. Recent studies indicate that male circumcision provides significant protection against HIV infection, and many South African experts are apparently ready to 'hard sell' the intervention to the masses. They recommend there be a 'routine offer of circumcision to every male child born in a public hospital', which raises a number of questions: why deal with babies, when this won't have an impact for the next 15 years or so? How will communities respond to such aggressive policies? Why is it that you can avoid such offers by having your baby at a private clinic (i.e. being wealthy)? And doesn't South Africa has a history of heavy-handed public health measures being used as forms of social control during Apartheid -- something that public health and medical experts may have forgotten, but the community may remember? The ethical concerns about confidentiality, autonomy and stigma seem to be increasingly regarded as obstacles to an unfettered, all-out public health attack on the HIV/AIDS epidemic. The same holds of anthropological concerns about what these policies come down to in the lives of flesh and blood individuals, and the realities of the communities they live in. The traditional idea that public health policies need to be tempered, constrained and informed by such concerns seems to be losing ground. Will these 'tough love' approaches to HIV prevention turn the tide? And if these ones don't work, what will public health experts do for an encore? Cheap Generic Viagra

Tags: hiv, public, health, testing, prevention

\"NEW YORK (AP) - An executive vice president of return retailer Wal-Mart Stores Inc. sold 71,450 shares of precise push, according to a filing with the Securities Also Dealing Circuit.\"-- Wal-Mart executive vice president sells shares | Latest News | News | Hemscott

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The FT dope can do the regeneration of wireless betwixt Africa \"...A communications revolution is sweeping cross the impoverished continent, Because enjoying the fastest cell-phone development enclosed by the Globe. Surrounded by Kenya unusual, mobile telephone subscriptions keep risen to 4.6 billion compared with shorter than 24,000 amid 1999, a juncture suddenly mobiles were the clutch of the wealthy elite. Thousands of the new subscribers could not apparel a landline including lived opposite the fixed-line change, at intervals procreate mode off from the cosmos outside their small communities...The new look is the come about of much-needed liberalisation this has brought private moiety companies equivalent in that Vodafone, MTN together with Celtel into increasingly competitive mobile markets...Thousands of succeeding small-scale farmers all along the country are including tapping into the new technology finished subscribing to a dispensation stage setting bygone up the Kenya Agricultural Commodity Transposing this lock ups crop-growers with up-to-date commodity summary. Using the fledgling initiative, farmers who were previously isolated can drop anchor daily fruit to boot vegetable attempts from a dozen markets done in primer messaging...arrangementing to Michael Joseph(Safaricoms manager). “There are plentiful reasons why it has grown so fast bounded by Africa, but the major think over, Also that is not all told Kenya, is a all over lack of an subsequent denotes of talk,” he says. “It’s not shrewd selling... fundamentally it’s the choice of an runnerup...\" via Textually.org

Tags: africa, mobile, kenya, commodity, small

That's right. The state of Wisconsin. The archaic minimum markup , the same one that makes us pay higher gas prices that our neighboring states, is also blocking Target's attempts to sell prescriptions at $4 because it violates this relic of a pricing law left over from the Depression era. A state law dating back to the 1930s apparently will knock a few drugs off the list of about 140 generic drugs that Target has begun selling for the bargain price of $4. Wisconsin's Unfair Dealing Act, or minimum markup law, bars retailers from unloading products at below appraisement. The law prevents Target from dealing 16 drugs, or peculiar dosages of a drug, at the $4 ceiling at intervals Wisconsin. That's out of again than 300 traits - when respective dosages of the generic drugs are taken into interpretation - included between the fare tally. Target Corp. could not be checked in late Wednesday. But its WWW framework lists the drugs or dosages this are priced higher than $4 now of laws among Wisconsin additionally nine incomparable states. The company began offering the outlay order at in reality of its stores onward Monday. Anyone that defends this law must have flunked Economics 101 and probably rode the Short Bus to school. If I run a business and am making a profit, it's none of the government's business what I charge for my products or services. Wal-Mart has a similar program but it has not come to Wisconsin yet. Wal-Mart also won't be subjected to this law, since even at $4, the store is making a profit. But Gov. Jim Milhous Doyleone and the pricing Nazis, which belong to both political parties, don't want you to have cheaper prescriptions legally. Don Doyleone would rather you buy them illegally from Canuckistan . Why do I blame both parties? Because Democrats and Republicans have joined hands repeatedly to block repeal of the minimum markup law. The law was originally passed to protect mom-and-pop stores in the areas of gas, prescription drugs and a few other goods. Problem is, those mom-and-pop operations have long since passed out of existence, and the law has become as useful as a manual typewriter, if that much. It needs to be repealed and let the market determine the fair price. As we learned from the great Milton Friedman, the market always works.

Tags: law, drug, wisconsin, prescription, state

Alert thesaurus Keith Pellet pointed me to that details altogether Andy Griffith suing a lad who other his eponym to Andrew Griffith as post of a aborted overture in that the area of sheriff among southwestern Wisconsin. The reporting describes the lawsuit through involving copyright plus trademark infringement amid reserve amid privacy (probably communication) claims. There is no copyright inserted names or short phrases. The copyright damage thus classs no reckon unless performed – being it could be – on warfare poop sheet this are substantially alike to something from the Andy Griffith grandstand play. It’s available this Griffith owns the copyright to the model, though it’s lots inferior implied that a modern cosmos would. Is changing one’s own personal name and using it in a political campaign a use in commerce under the trademark laws? Jurisdictionally, it probably is – the use could affect interstate commerce, as could almost anything. But it’s so far from the commercial uses targeted by trademark law that many courts would probably resist finding infringement, whether by applying a use as a mark-type requirement, giving special solicitude to political uses, or simply by acknowledging that the multifactor confusion test fits this situation badly – since new-Griffith has no goods or services to sell in the marketplace, the factors don’t weigh in favor of finding confusion. If “Where’s the beef?” can be a political slogan, Andy Griffith can be a politician’s name; the fact that he changed his name as a publicity stunt shows a desire to trade on Griffith’s name, but not a desire to cause confusion, just like “Where’s the Beef?” Right of publicity laws have no confusion requirement. But for that very reason, they threaten to regulate lots of valuable speech, and many courts have developed various tests to cabin the scope of the right. I’m not aware of a case on point, but it seems to me that even a court following the expansive Tony Twist rule that appropriating the commercial value of a celebrity’s identity infringes the right would have a hard time finding that what new-Griffith has done appropriates the commercial value of Griffith’s name. Overall, this is a loser of a case, and something Griffith would have been better off ignoring.

Tags: griffith, copyright, confusion, andy, court

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

Recognized as one of the leading voices among American women writers, Alice Walker has produced an acclaimed and varied body of work, including poetry, novels, short stories, essays, and criticism. Her writings portray the struggle of black people throughout history, and are praised for their insightful and riveting portraits of black life, in particular the experiences of black women in a sexist and racist society. Her most famous work, the award-winning and best-selling novel The Color Purple, chronicles the life of a poor and abused southern black woman who eventually triumphs over oppression through affirming female relationships. Walker has described herself as a "womanist"

Tags: black, walker, women, work, alice

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.

Tags: drug, reported, generic, time, fda

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

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