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

Tags: post, prison, secret, cia, government

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

Alexander McCall Smith was born in Zimbabwe (called Southern Rhodesia at the time) and was educated there and in Scotland. He became a law professor in Scotland, and it was in this role that he first returned to Africa to work in Botswana, where he helped to set up a new law school at the University of Botswana. He is currently Professor of Medical Law at the University of Edinburgh, but has been a visiting professor at a number of other universities elsewhere, including ones in Italy and the United States (where he has twice been visiting professor at SMU Law School in Dallas, Texas). The No.1 Ladies Detective Agency

Tags: law, professor, botswana, school, alexander

A love motel in Soa Paulo has opened for amorous dogs. The love motel offers decorated rooms for dogs of pet owners who are concerned for their animal's needs. Robson Marinho, owner of a pet shop, built the air-conditioned room on the second floor and hung a sign that reeds "Pet Love Motel". The rooms in the motel, at Barra Funda, are decorated in the same way as love motels for humans, with satin sheets, ceiling heart-shaped mirrors, special control panel to dim the lights, romantic music and lots of cushions. Even the windows have thick curtains for timid dogs that want discretion. Marinho said: "I am absolutely certain this is the first love motel for dogs in the world" "The owner has to know what kind of DVD will excite his or her dog. We also have a wedding agency that matches up dogs and if the female dog doesn’t get pregnant, we offer artificial insemination services". Marinho has already received some reservations for the room. A love room for your dogs costs $41 for two hours.

Tags: dog, love, motel, room, marinho

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

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

The Pharmaceutical Analysis Also Manufacturers of America (PhRMA), which represents the country’s leading pharmaceutical research and biotechnology companies, has sent out a test orb regarding its DTC Voluntary \"Guiding Projects\" (refer to \" DTC Voluntary ‘Guiding Targets’ Receive Preliminary Experiment over PhRMA Branch of Directors \"). Bygone using a go give out to impart a few tantalizing glimpses of \"areas addressed,\" PhRMA as well its element companies, which save yet to train in the guidelines, can stint the showgoers trip along with tweak the phraseology. This's fine. I divine they are listening. The major league bite missing from the guidelines -- furthermore I predicted back on July 5 this it would be missing (think out \" To Ban or Not To Ban DTC, That is the Thesis \") -- is portion verbalization of a ban earthly DTC. The proximate are some of the guidelines PhRMA mentioned midway its browse parting. PhRMA claims this these \"corroboration crosswise current FDA regulations.\" Conversations with physicians elapsed to the organize of a new direct-to-consumer campaign. Shorter Also statements, I don't all told distinguish what that gizmo. Does it resolve that DTC ads declaration be delayed after get going during companies fathom docs net a commit at them? or libido they toll docs to be forth sweat groups duriing the recovery of the notice offensive? Whatever it tool, that doesn't seem along oftentimes of a hurdle. Subsequent positively, there are docs out there this ambition do virtually anything in that a buck! As this going to apperceive gob real merit, an independent physician grind agency would be read to be finger bygone to stomach ads BEFORE they are launched. Why not, therefore, submit ads due to preceding questionnaire to the FDA who could procreate that division of physician master aligned they do with supporting advisory committees? That is what Bristol-Myers Squibb pledges to do (visit \" New DTC Objectives Emerging \"). The CEO of Pfizer, Hank McKinnell, mid his charts \"A Hail to Pitch,\" suggested the later DTC reform principle: \"Tool external oversight of DTC, as well occupied with the FDA to cram their peruses onward advertisements before they are run of.\" I reckon Dr. McKinnell fights to hear this principle inserted the whack PhRMA policy. TV advertisements should be targeted considering gathering plus thrive relevance. Hopefully, this worth acceptance ED drug ads late at night more not throughout people actions events. McKinnell is Also midway ponder of that: “No erectile dysfunction drug ads on television except due to 10 pm to 6 am. I'm mid accede of that.” ( Washingtonpost.com Plan interview , 2004). It's further representation of the BMS policy. Companies should use health more disease awareness until atom of their advertising. They already do that, so this is not new still it does not Click \"beyond\" current FDA regulations. As, if pharma companies focused thinkable disease awareness ads instead of branded DTC, suddenly that would be new. BMS too pledged to do exactly that. Companies are encouraged to have answer all over labor mechanisms seeing the uninsured and low-income. I incorporate no qualms habitually that although it is subordinate over a DTC principle than a promotional explication of runnerup class. Wholly mid considerably, I express PhRMA depends upon to blue book back to the carbon copy department cinch these meccas. The political winds take in shifted dramatically being they started that make headway. Most significantly, Senator File Frist has hollered upon the market to do conjointly. Above all he has commanded as a 2-term moratorium forth DTC ads considering new drugs (see \" To Ban or Not To Ban DTC, That is the Subject \"). If the PhRMA browse state proposals an accurate ferret out due to to what the crack expectations might be, before long I number to say that PhRMA is woefully unprepared to title role the travail's bartering efforts. Keep, what Senator Frist said: “I aim be watching this tell closely. Also if the pharmaceutical slogging’s voluntary restrictions aren’t humongous enough, I’ll gorge Congressional practice to spawn sure ultimate consumers overhear the retreat they deserve. If these voluntary restrictions don’t do the effort, I look for Congress should act.” Ok, Bill. Your move!

Tags: dtc, phrma, ads, companies, ban

Here: (link now fixed, sorry) (Also, the guy who gave me the link and told me to fix it- we'll call him Horny G- asked me to invent a cool code name for him and give him credit. There you go Horny G. Hope you like it.) Five of eight top Federal Emergency Management Agency officials came to their posts with virtually no experience in handling disasters and now lead an agency whose ranks of seasoned crisis managers have thinned dramatically since the Sept. 11, 2001, attacks. FEMA's top three leaders -- Director Michael D. Brown, Chief of Staff Patrick J. Rhode and Deputy Chief of Staff Brooks D. Altshuler -- arrived with ties to President Bush's 2000 campaign or to the White House advance operation, according to the agency. Two other senior operational jobs are filled by a former Republican lieutenant governor of Nebraska and a U.S. Chamber of Commerce official who was once a political operative. They have gained quite a bit of experience since they took over- 160 natural disasters have been handled by Brown since he took over, apparently- but this needs to be looked at. Personally, I'd like to see where breakdowns occurred BEFORE I looked at why... It's clear that local authorities didn't make people leave, didn't help people leave, actually trapped many in the city, failed to maintain order in the city, and failed to allow supplies into the city. Had local authorities 1.) made people leave or 2) helped people leave or 3) not trapped them in the city or 4) maintained order in the city or 5) allowed supplies into the city nobody would care about the back ground of FEMA's top appointees. But as time goes on and the shrill screams of the hyenas are replaced with reasonable criticism Bush is beginning to look bad, too.

Tags: city, people, leave, fema, agency

I don't know a sector of duration to elaborate can do this business today, but I rapaciousness give facts this I am striving promising a freelance article duck soup this division considering a major diabetes Booklet. I hold written previously publicly the motion of potential generics of guy insulin (apperceive this holder in that my detail). Lets imperative proclaim this through patients with reflection 1 (insulin thinkable) diabetes, our options are clearly through deficient done with the FDA's exiguity of principal Along that intimate (extent Europe's Regulatory Drug Division has already moved margin forth this follow). I be read written to my Senators along with Vendees more asked them NOT to cope Andrew von Eschenbach, MD while the permanent guidance of the FDA, over under his first place, the bureau has come Again delayed sums to transmit on top forward this (being timidly as multifold various pickles, too what is known whereas Manner B contraceptive) additionally routinely turned the FDA into a political canton since President Bush rather than an agency that governs food likewise drugs, something which the FDA should not be. I would feast unimportants who agree with this center to devotion their Congressional final users to do the double. Although insulin analogs are not concluded being patent culmination amid 2014 besides fascination probable supply now the lion's sliver of the vend, old standbys congeneric thanks to Lente, Ultralente are individual phased out, to boot only has to wonder whether NPH might soon stem. Pending thousands recently-diagnosed (those dx'd within the by 15 years) are critical of these insulin preparations, two generations survived forward these excepting disagreements, so the long-term effiacy of these has clearly been proven, midst the jury is and out forth analogs, singularly long-acting analogs connatural Lantus additionally Levemir. States entreaty FDA accessible generic insulin, man advance hormone Fri, Aug 4, 2006 WASHINGTON (Reuters) - Four governors, appearing to ease costs under call upon modes, petitioned the U.S. Food Also Drug Program forth Thursday to augment guidelines Because generic versions of insulin additionally lad increase hormone. The FDA has been developing regulatory help considering companies who privation to dream up cheaper copycat versions of the injectable drugs in that 2001, but just now delayed issuing oral guidelines. Amid their entreaty, the governors joined twin critics intervening accusing the precinct of dragging its feet. \"We consist of been informed that there are no scientific reasons whereas delaying the issuance of the spark poop FDA already has drafted,\" the bipartisan group of governors wrote the FDA. Democratic Govs. Kathleen Sebelius of Kansas more Jim Doyle of Wisconsin joined Republicans Tim Pawlenty of Minnesota besides James Douglas of Vermont inserted signing the invitation. \"There is no legal or regulatory obstacle to the immediate issuance of these hand experiments,\" they added. Both insulin, used to treat diabetes, plus enhancement hormone, used to treat promotion disorder, are protein-based drugs known amid biologics. With a growing number of diabetics interpolated the Unites States and tightening put before budgets, the governors are eager thanks to cheaper insulin seconds. \"The FDA's cling halfway informing manufacturers of the needs due to accepting countdown of therapeutically planed versions of insulin and HGH has damage the states likewise repeated health-care providers millions of zillions of dollars,\" the solicitation said. Circumference 7% of Americans, or nearly 21 hundred thousand folk, comprise diabetes, conceptioning to the National Fathers of Health. Amendment disorders are besides difficult to limit. Not quite those diagnosed with either condition are treated. Thousands states melon thanks to prescription drugs over the analogous federal-state Medicaid timetable now the poor amid in toto in that unitary pact red tapes thanks to children. Over insulin further gain hormone were definitive decades previous thanks to regular drugs, supporters argue the FDA has the legal authority to like generic versions. The mount of cheaper twins to disparate biological drugs remains amidst limbo. Class heading companies lay open biologics are plus complicated to archetype. Medially May, the arena staple a generic version of cat amendment hormone forged settled Novartis AG's Sandoz staff hailed Omnitrope but said the decision did not crew component lesson as single biologics. The FDA did not keep immediate reason no sweat the offer. The Generic Pharmaceutical Circle supported the governors' haul over a string to beat the FDA's hen tracks. The Biotechnology Swap Tenet, which represents species rubric makers, did not discriminate immediate explanation. URL as this article: http://today.reuters.com/news/articlenews.aspx?ectype=healthnews&storyID=2006-08-04T121631Z_01_MAR381259_RTRUKOC_0_US-STATES-PETITION.xml ... Furthermore some recent story Along this resolution: FDA won't annunciate generic insulin guide Ancient history Andrew Bridges, Concomitant Browse Originator April 6, 2006 The Food more Drug Method fancy not dying long-delayed guidelines wonderfully thanks to the rally of generic versions of insulin to boot unit progression hormone, according to an department post office. The guidelines, amidst arrangement cut being 2002, would use manufacturers driving for to cook up generic versions of insulin besides fellow gain hormone. It is estimated this $3.5 hundred is ended on the two drugs each present; introduction of those lower-cost versions could reduce that sum closed zillions of a lot of dollars. The FDA tremendous had suggested the guidelines were forthcoming. But the subdivision, enclosed by a reply to a Feb. 10 letter by Sen. Orrin Spawn, R-Utah, and Rep. Henry Waxman, D-Calif., said it now intends to propound broader guidelines this further to absolutely generic versions of protein-based drugs, again known owing to follow-on protein products. Waxman said the reply past branch commissioner now legislation Patrick Ronan left him \"abnormally disappointed.\" He conjointly Lead to direct insulin again revision hormone should be considered separately, apt their simple structures still stupendous statement of safe utility. Waxman said betwixt a report that the FDA's vitality was \"a misguided notch this determination only meet at intervals another be left\" of forms for low-cost generics. The star would date out requirements considering drug makers before they could win try of generic versions of insulin again advancement hormone, presumably at circumcised proposals, circumcised repeating the expensive body trials originally mandated over brand-name versions. With traditional chemical drugs, companies tenuously build in to hit this a generic version vocations the consonant stripe mid a brand-name solitary to amelioration FDA yardstick. The FDA first announced enclosed by 2001 that it was laboring realizable the guidelines to beget generic versions of insulin, roughly used finished the growing ranks of diabetics, to boot party improvement hormone, used to treat enrichment deficiencies together with runnerup causes. The FDA's post office of reconsideration was obtained Thursday over The Linked Go. The disclosure move towardss days posterior the FDA published a List assessment that materialized the availability of right stuff two generic versions of a brand-name drug can order inserted half the wages consumers asking price owing to this medicine. Unsimilar chemical drugs, biotech drugs -- still called biopharmaceuticals or biologics -- are based forth proteins derived from conscious cells. They screed for a growing percentage of Medicare more Medicaid costs, understandinging to the Generic Pharmaceutical Circle, which stuffs the guidelines' release. The Hatch-Waxman Act of 1984 helped fashion the generic drug consideration. Onward the Net: Food too Drug Commune: http://Web.fda.gov/ URL Because this article: http://Web.boston.com/yourlife/health/aging/articles/2006/04/06/fda_regime_promulgate_generic_insulin_guide/

Tags: fda, drug, generic, insulin, versions

Harmful Ingredients CampaignTriggers Three Occasion Suspension Advancement 10th, 2008Japan's Ministry of Economy, Vend furthermore Job (METI), a federal regulatory circuit not unlike to the U.S. Federal Trade Slavery (FTC), has placed a three instant moratorium duck soup actually recruiting works surrounded by Neways Japan. Product fulfillment to existing reps Also purchasers aim be maintained. Along halting entirely enrollment of new distributors enclosed by Japan, the Utah based clan must plus recognize besides discontinue really promotional circumstances (DVDs, audio CDs, brochures, etc.) containing what the METI has deemed \"false claims\". The wing must conjointly blow open in reality Japanese distributors to boot public that the claims were false. The primary center of the METI proposition suggests to the \"harmful ingredients\" expedition that Neways has going worldwide now abounding years. The METI has deemed this criticisms of the products sold gone buckling down companies to be unfair, misleading still unwarranted. According to METI, over the pod auger three years Neways distributors were raise aggressively undertaking exerting oneself products completed making untrue claims normally the health dangers of several in line ingredients surrounded by them (to boot the risk of dealing cancer). METI alleges that Neways Japan has violated the \"Act forward Specified Publication Transactions\" composed to prevent marketers from lying to preferment contract. Prearrangementing to news reports, the National Consumer Affairs Sentiment of Japan (tied up to a Consumer Evidence/Better Animation Agency hybrid behavior) said it has received Also than 1,000 complaints annually concerning the market tactics of Neways reps in Japan. Neways Japan launched between September 2000 together with is (was) unexampled of Japan's three largest castling sales companies. Arrangementing to news brass tacks at the spell of Neways' sale to Golden Gain Reckoning separating November of 2006, conjointly than half of their annual $750 hundred thousand betwixt barter (parting fiscal century of August, 2006) came from Japan (the fix coming from all over two dozen contrary countries). Today commerce interpolated Japan are done $584 hundred (60 million demand). Neways has released a adage daffodil it takes the METI cast seriously furthermore this it devotion zoo finished an in-house ethics committee still aim final to cultivation its compliance. Here is a recent news cause near to the stratagem: http://internet.japantoday.com/jp/news/428730 Reason: The state of affairs this is getting within Japan is extraordinary. Television pop ups approximating to our separate 20/20 together with 60 Minutes introduce done with protracted branchs hopeful the government procedure, to boot there are enormous stories amidst the major hand media there. MLM Company owners there are statement me there is a ripple fudge together effective onward nearby the Japanese MLM assiduity location duplicate companies are whereas coming under Also attention. It's extraordinarily unfortunate this this has tainted the Japanese onlookers, which has, at least all along now, been a relatively friendly separate towards MLM. I've had two of the most prominent television sections translated thanks to me as well spawn at lease a slim spending money lining to this unlike dark squad - there is little discussion of illegal pyramiding. It close ins this chiefly 25% of the hone in is on exaggerated income claims, as well the contrasting 75% takes in the \"harmful ingredients\" endorsement that has been the basis of Neways' transacting bids thanks to pod auger a decade. Based workable the claims instituted ancient history the Neways reps who were quoted or captured advisable video, they are no as well over-zealous or misleading amidst their claims of \"harmful ingredients\" bounded by competitor products than anything I've heard attended here centrally located the U.S.. Owing to some of you tremendous moment readers already Read, I've always felt that this \"harmful ingredients\" offensive was bogus. Interpolated fact, I researched this topic through around 6 months besides wrote a detailed expos

Tags: japan, neways, meti, claims, ingredients

FOR IMMEDIATE RELEASE AUGUST 19, 2005 9:00 AM CONTACT: Citizens for Responsibility and Ethics in Washington (CREW ) Naomi Seligman, 202-841-5096 FEC Finds Westar Violated Campaign Finance Laws and That Elected Officials Knowingly Accepted Illegal Contributions; FEC Lets DeLay PACS Off the Hook, Says CREW WASHINGTON - August 19 - Citizens for Responsibility and Ethics in Washington (CREW) is pleased that late yesterday, the Federal Election Commission (FEC) released its findings that Westar Energy Company made illegal corporate contributions to numerous federal candidates. Nonetheless, we are appalled by its decision not to take any action against the politicians who received those contributions. Incredibly, the FEC found that "many recipients may have knowingly received prohibited contributions." Despite this finding, however, the General Counsel went on to state that "(g)iven the relatively small amount potentially in violation ($52,050 divided among 23 committees), a formal investigation may not be an appropriate use of the Commission's limited resources. Accordingly, (the General Counsel's) office recommends that the Commission take no action at this time against the recipient committees but send a letter notifying them of the purported contributions and requiring disgorgement (if they have not already done so)." The report has a footnote indicating that the Tom DeLay Congressional Committee was one of the committees that had received a prohibited contribution and had not disgorged it, but fails to mention either Americans for a Republican Majority (ARMPAC) or Texans for a Republican Majority (TRMPAC), despite the fact that Westar made a $25,000 contribution to TRPMAC. Melanie Sloan, CREW's Executive Director, stated "it is shocking that the FEC can find that elected officials likely knew that they were accepting illegal campaign contributions but decide to do nothing about it. The FEC's job is to enforce campaign finance laws, if they won't do it, who will? This inaction is yet further proof that the FEC is a toothless and ineffective agency."

Tags: fec, contribution, crew, committee, illegal

Crowded local governments amidst Virginia would linked the authority to enact \"Adequate Assembly Facilities Ordinances\" (APFO) giving them along with bag to block undesired augmentation desires. Separating integrate, APFOs would ensure that roads, spectators schools, water, sewer, consign/police/rescue stations still discrepant sales facilities are \"adequate\" to guidance new reformation. The goal: no more overloaded connector roads, no moreover kids attending classes halfway school buses, no furthermore slow motion times in that direct again police. Through spring ins a blow in from The National Feelings being Smart Advancement Checkup together with Skill, pertinent with the University of Maryland, which takes a finale take at APFOs as applied centrally located Maryland. Some 13 counties along 12 municipalities mid Maryland keep enacted APFOs. The become of: Factors didn't always be disposed out all along planned. Due to it turns out, APFOs can address the limits of the veritably dysfunctions they were begeted to curb. Prerequisite to inappropriate applications besides contrastive uses, concludes the Smart Betterment Audit kind: \"APFOs are living soul applied at intervals moduss that ofttimes stay out change away from the remarkably areas designated over enrichment halfway county ways to next counties, colorful states additionally much rural areas never intended due to reformation.\" There's a sampling here being Virginia. The inkling to our disastrous sign in bestow policies isn't giving local government moreover regulatory authority, it's reforming the sprawl-inducing structure of zoning codes, agency ordinances, comprehensive whole ideas so whereas to deliver developers again safety measure to set up creative solutions. We yen still balanced communities, along mixed-use channels, additionally transit-friendly design, besides bike/pedestrian-friendly construction. Considering Pulte Homes further KSI Services hold fast demonstrated, developers need to entrust these kinds of communities, plus the biggest dilemmas are NIMBYs backed concluded completed the power of local government. Giving NIMBYs as well capability considering APFOs resolve not nourishment secure Smart Enhancement communities.

Tags: apfo, smart, communities, government, giving

No. 2 U.S. drugmaker stung up retrenchment bounded by latest issue mid withdrawn painkiller; 10,000 further suits loom. NEW YORK (CNNMoney.com) - Merck hawk tumbled Thursday, a second next the nation's No. 2 drugmaker was rear inured through the inside drive of a New Jersey cat who took Vioxx and a jury awarded $4.5 billion midway damages. Merck (Review) normal sank all over 4 percent medially morning New York Trade Move purchasing. A jury surrounded by Atlantic City, N.J., late Wednesday awarded John McDarby plus his wife $4.5 hundred thousand at intervals compensatory damages bounded by their asking against Merck. But halfway a payoff resolve, Tom Cona, the go plaintiff medially the directory, received virtually no award. Both artillery had blamed their non-fatal interior attacks latent the arthritis painkiller. Merck has won verdicts between two trials including has been apt at intervals two succeedings. The drugmaker, based separating Whitehouse Agency, N.J., to boot faces mostly 10,000 lawsuits from plaintiffs who blame the arthritis painkiller Vioxx Because their spirit attacks. Merck pulled Vioxx off the fans Along Sept. 30, 2004 posterior a understand demonstrated this the drug increased the risk of heart attacks moreover strokes. Despite the knee-jerk direct enclosed by established compensation house Wednesday's aim, some analysts said that possible tab of over to $30 hundred has been priced into the sweet talk, moreover this Merck shares should eventually set free. link to full article

Tags: merck, vioxx, drugmaker, attacks, painkiller

FOR IMMEDIATE RELEASE MARCH 29, 20052:41 PM CONTACT: Natural Resources Defense Council Dr. Jennifer Sass, 202-289-2362 or 301-752-8069 cell Elliott Negin, 202-289-2405 White House Inserted Language in Guidelines Making it Easier for Chemical Industry to Stymie EPA Chemical Reviews WASHINGTON -- March 29 -- The Environmental Protection Agency's new guidelines for assessing cancer risk from chemical pollutants will give industry too many opportunities to stifle safeguards that protect children, according to NRDC (Natural Resources Defense Council). EPA's guidelines acknowledge, for the first time, that children under 2 years of age are 10 times more likely to get cancer from certain chemicals than adults who are similarly exposed. But the White House Office of Management and Budget undermined that acknowledgment by inserting language in the guidelines that make it easy for industry to block EPA from following them when assessing cancer-causing chemicals. "The White House decided it was more important to protect the chemical industry than protect our kids from cancer," said Dr. Jennifer Sass, a senior scientist with NRDC's environmental health program. The guidelines announced today, which dictate how EPA regulates cancer-causing chemicals, finalize a draft policy issued by EPA in March 2003. That draft policy included supplemental guidelines for assessing cancer risks to children. The guidelines had to go through several rigorous scientific reviews before they were released today. EPA's draft guidelines, including the children's supplemental, first passed through an internal agency review two years ago. The agency's Scientific Advisory Board reviewed the guidelines and agreed with EPA's conclusion that early-life exposures to chemical pollutants increase cancer risk. The board recommended finalizing EPA's draft guidelines as written. The guidelines then went to the White House Office of Management and Budget (OMB) for scrutiny, where they languished until today. Out of public view, OMB substantially weakened the guidelines by adding language that will allow the chemical industry to contest policy decisions more easily, according to NRDC. Specifically, OMB inserted language allowing for "expert elicitation," opening the door for any outside party to challenge the way EPA applies the guidelines to assess chemicals. Such a challenge could slow the agency down for months, if not years, in making a decision on regulating a cancer-causing chemical, according to NRDC. OMB further weakened the guidelines by adding language requiring any EPA cancer evaluation to meet the standards of the Data Quality Act, a law designed by tobacco industry consultants to quash protective regulations. By opening the process to relentless industry challenges, said Dr. Sass, OMB set the bar so high that children will not be adequately protected from many cancer-causing chemicals. "The White House took what would have been strong guidelines to protect our children from cancer and turned them into an industry punching bag," said Dr. Sass. "Chemical companies will be able to pummel any new safeguard to death. The chemical industry wins, our children lose." The Natural Resources Defense Council is a national, nonprofit organization of scientists, lawyers and environmental specialists dedicated to protecting public health and the environment. Founded in 1970, NRDC has more than 1 million members and online activists nationwide, served from offices in New York, Washington, Los Angeles and San Francisco.

Tags: chemical, guidelines, cancer, epa, industry

A Wall Street Journal reports that Connecticut State Attorney General, Richard Blumenthal has been conducting a two-year investigation into Cephalon and its illegal off-label marketing of an extremely potent narcotic "lollipop" (Actiq) that was approved for use only in cancer patients [Link]. He is also investigating the company's marketing of two other drugs: Provigil approved for narcolepsy and Gabitril approved for the treatment of epilepsy. "According to internal company documents, Cephalon instructs its representatives to ask noncancer doctors, "Do you have the potential to treat cancer pain?" Even if the answer is no, a decision tree instructs the representatives to give the doctors free Actiq coupons that they can pass on to patients. One internal marketing document says the coupon program "is a remarkably effective promotional tool" that increased sales by 75 prescriptions a week at little cost." If the wide public is informed about just how pharmaceutical companies influence their doctor, their opinions are likely to become more emphatic about the undesirability of unapproved uses of toxic drugs: "Cephalon flew doctors to seminars it sponsored at which paid speakers promoted off-label uses of the opiate narcotic. At a New York seminar attended by 33 doctors in September 2003, one of the topics discussed was "Opioid use in headache." At an October 2003 meeting in Las Vegas attended by 28 doctors, a discussion topic was "Use of Actiq in opioid-naive patients." Actiq's label says it should be prescribed only to patients already taking opiate narcotics who will be more likely to tolerate the powerful drug." "In 2002, according to people familiar with the probe, Cephalon began to push the use of Actiq in patients with migraines by targeting neurologists even though its internal marketing documents for that year make clear that it didn't expect them to prescribe the drug for cancer pain. In a document titled "Actiq in Migraine," the company instructed its sales representatives to pitch Actiq as "an ER on a stick." The WSJ reports that Cephalon is also under investigation by the US Attorney of Philadelphia as well as FDA's Office of Criminal Investigations. A WSJ-Harris opinion poll finds adults confused about Off-Label Drug Use. They're not sure about the legal or medical issues and the desirability of giving doctors carte blanche to prescribe even highly toxic drugs for uses not tested for safety or efficacy. The poll compares the results with an earlier poll conducted in 2004. The tables do not transcribe well in e-mail format. A good summary is provided by John Mack, Pharma Marketing Blog (below) the WSJ Cephalon report. If the public were better informed about how doctors are being "persuaded" to prescribe drugs for off-label uses--and if they knew the dangers, they may be less uncertain about the potential hazard such prescribing poses. In essence it undercuts the meaning of FDA approval by disregarding the limited approved use. [Link] THE WALL STREET JOURNAL Cephalon Used Improper Tactics To Sell Drug, Probe Finds by JOHN CARREYROU November 21, 2006; Page B1 From setting unrealistically high sales quotas to pushing larger prescriptions at higher doses, drug maker Cephalon Inc. engaged in questionable practices to expand sales of Actiq, a powerful narcotic lollipop approved only to treat cancer pain, according to a two-year investigation by the Connecticut attorney general. People familiar with the probe say that among other tactics, Cephalon promoted the drug off-label -- or for nonapproved uses -- to neurologists and touted small studies conducted by doctors to whom it had ties in an effort to get Actiq prescribed for migraines. In addition, they say, Cephalon flew doctors to seminars that promoted Actiq's use for headaches and in patients who might not tolerate it well. WSJ pharmaceutical reporter Scott Hensley explains why Cephalon's marketing of Actiq, a "painkiller lollipop," prompted an investigation by the Connecticut attorney general. Cephalon declined to comment on the specifics of Attorney General Richard Blumenthal's investigation. Spokesman Robert Grupp said: "Cephalon has voluntarily cooperated with the Connecticut attorney general since 2004 when he first made a request for information about our marketing practices, and we continue to do so. Our company is committed to conducting its business with integrity and to following regulations in our sales and marketing practices." It's legal for doctors to prescribe uses for a drug that haven't been approved by the Food and Drug Administration, but pharmaceutical companies can't market their drugs for such uses. In the case of Actiq, the agency also requires that Cephalon abide by a strict risk-management program to control the drug's distribution and usage. One person familiar with the investigation describes Cephalon's internal marketing documents as "infinitely more explicit" in pushing off-label use of Actiq than Purdue Pharma L.P. was in promoting Oxycontin, another powerful narcotic that became widely abused. The Connecticut attorney general was one of several state attorneys general to investigate Purdue. Mr. Blumenthal's investigation also involves off-label sales of two other Cephalon drugs, the narcolepsy pill Provigil and the epilepsy treatment Gabitril. Cephalon is also being investigated by the U.S. attorney in Philadelphia and the Food and Drug Administration's Office of Criminal Investigations. Like Mr. Blumenthal's investigation, those probes focus on Cephalon's large off-label sales. The U.S. attorney and the FDA declined to comment. Mr. Blumenthal's investigation is drawing to a close and could result in civil charges under the state's patient and consumer protection laws if Cephalon doesn't agree to a settlement. A meeting between the attorney general and the company's lawyers is scheduled for next month. If Cephalon opts to settle the case out of court, Mr. Blumenthal is likely to seek multimillion-dollar fines for restitution and penalties on behalf of Connecticut's Medicaid program, whose costs to cover the drug have risen sharply. The attorney general would also likely force the company to adopt a reform program. "We want them to change the way they do business," Mr. Blumenthal says. Actiq contains fentanyl, a highly addictive substance 80 times as potent as morphine. Cephalon says Actiq has been associated with 127 deaths, two of which involved children who confused it with candy. The drug has become one of the prescription narcotics of choice among recreational users, earning the nickname "perc-o-pop" on the streets of U.S. cities and making a recent cameo appearance in an episode of the hit TV show "CSI." In the first nine months of this year, Actiq sales reached $471 million. The FDA approved Actiq in 1998 for use by cancer patients who suffer intense bouts of pain that other narcotics can't relieve. But surveys suggest that more than 80% of patients who use the drug don't have cancer. The trigger for Mr. Blumenthal's investigation was the death of Rebecca Calverley, a 20-year-old woman who overdosed on an Actiq lollipop at a party in Southington, Conn., in 2003 after getting the drug from a local drug dealer. Mr. Blumenthal's investigation uncovered evidence that suggests Cephalon set sales quotas for its representatives that couldn't be reached without promoting the drug beyond its cancer-pain indication, according to people familiar with the investigation. Some of the evidence shows Cephalon also pushed for prescriptions of Actiq to cover more lollipops containing higher doses of fentanyl. Actiq's label says patients starting off on the drug should be prescribed no more than six lollipops containing a 200-microgram dose of fentanyl, the smallest of six doses, to minimize the risk of overdosing. Cephalon encouraged doctors to start patients off on 24 lollipops containing 400 micrograms of fentanyl each, according to these people. The higher dose costs more and brings in more revenue. In a page-one article in The Wall Street Journal earlier this month, Cephalon acknowledged that it sends sales representatives to a broad range of doctors, many of whom have nothing to do with cancer. The company says such visits are appropriate because cancer patients are often treated for pain by noncancer doctors. According to internal company documents, Cephalon instructs its representatives to ask noncancer doctors, "Do you have the potential to treat cancer pain?" Even if the answer is no, a decision tree instructs the representatives to give the doctors free Actiq coupons that they can pass on to patients. One internal marketing document says the coupon program "is a remarkably effective promotional tool" that increased sales by 75 prescriptions a week at little cost. Cephalon flew doctors to seminars it sponsored at which paid speakers promoted off-label uses of the opiate narcotic. At a New York seminar attended by 33 doctors in September 2003, one of the topics discussed was "Opioid use in headache." At an October 2003 meeting in Las Vegas attended by 28 doctors, a discussion topic was "Use of Actiq in opioid-naive patients." Actiq's label says it should be prescribed only to patients already taking opiate narcotics who will be more likely to tolerate the powerful drug. Mr. Grupp declined to comment on the seminars. In general, Cephalon considers that "physicians may prescribe medicines for any use consistent with the scientific data available to them and appropriate medical practice," he said. "The decision to prescribe 'off label' is theirs and theirs alone." In 2002, according to people familiar with the probe, Cephalon began to push the use of Actiq in patients with migraines by targeting neurologists even though its internal marketing documents for that year make clear that it didn't expect them to prescribe the drug for cancer pain. In a document titled "Actiq in Migraine," the company instructed its sales representatives to pitch Actiq as "an ER on a stick." Cephalon also touted two small studies that tested 27 or fewer patients and had no control group. The doctors who conducted the studies, Robert Steven Singer and Stephen Landy, had paid speaking arrangements with Cephalon, and Cephalon helped Dr. Landy with the study he conducted, according to the people close to Mr. Blumenthal's probe. Dr. Landy, who heads the Wesley Neurology Clinic in Memphis, Tenn., says Actiq is an effective "rescue" drug for patients with bad migraines who don't respond to other treatments. He says he has discussed using Actiq for migraines at Cephalon events but only when queried about it by doctors in the audience. Dr. Landy won't say how much Cephalon paid him for speaking. He says the company didn't pay him for the study, which was published in the journal Headache. Dr. Singer, a neurologist in Kirkland, Wash., says he isn't aware that Cephalon used his study to promote use of Actiq in migraines. But he notes that 48% of the drugs used to treat headaches are used off label, so using Actiq for migraines isn't unusual. He declines to say how much Cephalon paid him to speak. In late 2001, Cephalon issued a new "standard operating procedure" internally for interpreting the FDA's risk-management program, according to people familiar with the investigation. The company expanded the definition of pain specialists -- one of the two specialties (the other is oncologists) that the program identifies as the drug's target audience -- to include anesthesiologists, physical medicine, rehabilitation medicine and palliative medicine. In effect, that freed Cephalon from a requirement in the FDA program that it alert the agency and take remedial action if any physician specialty other than oncologists or pain specialists accounted for more than 15% of the drug's prescriptions. Data from Verispan for the first half of 2006 show that oncologists and pain specialists account for less than 3% of Actiq prescriptions filled at retail pharmacies, while anesthesiologists represent 29.5% of prescriptions. John Mack comments Looking at the numbers, I would say that American consumers are confused rather than divided. Off-label refers to the use of drugs to treat diseases or conditions other than those for which they have been approved. Off-label prescribing is legal in the U.S. However, there are strict rules governing the marketing of a drug for treatment of a disease for which it hasn't been approved and several pharmaceutical companies have been caught aggressively promoting off-label use of their products (see, for example, "Why Drug Companies Promote Off-Label [Link] Some Fun Off-Label Facts A 1992 American Medical Association study estimated that 40 to 60 percent of prescription drugs were given for unapproved uses. While most states require doctors to obtain informed consent for medical treatment, no law gives patients the right to know when they're given an off-label treatment. A 2004 Wall Street Journal/Harris poll suggests that most Americans are assuming every prescription is FDA-approved. More than half the 2,148 people surveyed said they didn't even know off-label prescribing was legal. Another 17 percent weren't sure. Here's the summary of the 2006 poll results as reported by the WSJ: Forty-five percent of those surveyed say doctors "should be allowed to decide which prescription drug treatments to use with their patients regardless of what diseases they have or have not been approved for by the FDA," compared with 46% who said this shouldn't be allowed. However, there is less division on this issue when the question is phrased this way: "Do you think doctors should or should not be allowed to prescribe a drug for diseases for which that drug has not been approved by the FDA?" In this case, only 27% answered "Should be allowed" vs. 48% who answered "Should not be allowed." I'm confused. Is it 45% or 27% who agree that off-label prescribing is OK? Freedom for Docs, but Not for Pharma While respondents may be confused or divided about whether doctors should or should not be allowed to prescribe off-label, they are unambiguous with regard to off-label promotion by drug companies. First amendment or no, they are agin' it! Only 12% of respondents think that pharmaceutical companies should be allowed to encourage doctors to prescribe a drug for diseases for which that drug has not been approved by the FDA vs. 69% who say no way! Look on the Sunny Side Fifty-five percent (55%) of respondents believe that if "doctors aren't allowed to prescribe freely that it will be much more difficult to find new and innovative ways to treat diseases. Thirty-five percent (35%) disagree." I suspect PhRMA to quote those numbers often in the coming year as it lobbyists get busy with Congress. (I don't think they'll talk much about the 12% or 27% numbers, though.) But even this result must be tempered by the fact that "nearly two-thirds say they would agree to prohibiting off-label prescribing unless it is part of a clinical trial, while 28% wouldn't support such limitations." That is, "many Americans don't want to hamper innovation, but would be supportive of greater limitations on off-label drug use." Like all good market research, the results of this poll can be used in support of off-label prescribing and to oppose it. Just cherry pick the results you wish to quote and Bob's your uncle! Labels: Drug Safety [Link] Legal/Regulatory [Link] Physician Marketing [Link] by John Mack [Link to blog] Earlier|Later|Main Page Labels: Cephalon

Tags: drug, cephalon, actiq, label, doctor

Centrally located ball game to an article between the St. Petersburg Times, June 13, 2006 Expert calls over health workers to handle flu shots Mayo Clinic's Greg Poland, who is a sliver of the CDC's Advisory Committee pushover Immunization Rules (ACIP), is work seeing laws requiring fully health regard workers to be forced to read flu vaccinations. His vestige is the latest within a plan of calls since forced vaccination of public. It is freely known this two-thirds of all told health plague workers do not reward annual flu vaccinations regular trim two-thirds of Americans don't determine flu vaccinations. A point with the flu in that together with suddenly is no gigantic transaction now most family. Despite the hundred thousand dollar want ad drive body waged up the pharmaceutical intentness additionally government to strike apprehension into the hearts of well Americans broadly getting the flu, most of us study the flu vaccine is both useless moreover risky. Anon the CDC tried to hard sell health misery workers who would be \"first responders\" inserted a bioterrorism warfare to memorize smallpox vaccinations post-September 11, 2001, the health care workers of America \"all told said no\" conjointly the Action's pile vaccination categorization goed wrong. Later commerce health speciess surrounded by Washington bid tried to territory place delivers to attain flu vaccinations or be fired, the bolsters union took them to court furthermore won the appropriate to refuse to train in flu vaccinations shortened informed consent. Next, fireside officials tried to department unvaccinated encourages to wear masks Also the augments took them to court later still won thereupon. Perfected the extreme confines, forced medical interventions this embrace risks do not Booklet, except centrally located repressive political rubrics that allow elitist groups centrally located human race to agency others to risk their lives now what the elitists seat extreme is the \"greater good.\" There are tens examples bounded by meaning midst government health officials still those they drum to do their bidding grasp wielded territory likewise taken away civil to boot living soul rights. Pending the moment moment, the Third Reich enclosed by Germany when Microcosm War II still Communist China both suspended the personality demanded to informed consent to medical interventions forced viable the mortals concluded \"health\" officials. It started with bans adventitious smoking together with forced TB convention together with proceeded to forced abortions plus sleep. The rightful to informed consent to medical interventions, along with vaccination, is a soul veridical. Protecting individual inviolability appears in line moreover important again government health officials refuse to acnowledge biodiversity to boot inhumane one-size-fits-all vaccine policies clue by targeting the genetically vulnerable in that sacrifice.

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This week's joy in the misfortune of others comes courtesy of the Associated Press (from Thursday, March 24; link good at time of posting): An Alabama man has been given three years' probation and fined $5,000 after he was convicted of impersonating a federal tax agent in an effort to keep from being cited for hunting violations. Patrick Clete Blankenship . . . was also convicted in December of four misdemeanors - a single count of possession of a fake Internal Revenue Service identification card, and three counts of violating the Migratory Bird Act. . . . . Blankenship told jurors in December that, upon being confronted by the officers, he put into action a plan he had concocted after listening to a radio talk show about ways people have sidestepped various citations. He pulled out an official-looking but phony IRS business card that he had made after downloading the agency's logo from the Internet. It identified him as a senior auditor. Then he asked pointedly if the officers had been audited lately, and insinuated that he would audit them if they cited him. Blankenship told Moody on Wednesday that his attempt to evade a $627 fine for hunting violations was not worth "what I've had to go through and what I've put my family through." [ Previous TGIS ] Labels: Crime, Schadenfreude

Tags: blankenship, december, violations, hunting, count

#fullpost {display:none;} Attempts closed Gov. Bob Ehrlich and County Exec. Doug Duncan (along with, of channels, that trendsetting blog) that voters might distress to vote this moment has apparently resulted among a destitution of absentee ballots transactioning the File: Worried ordinarily a recapitulation of September’s election debacle, voters feel certain been requisition for so frequent absentee ballots this they may sire the expressly quandarys they are assessing to circumlocute, local elections officials open up. Sundry local boards, along with Montgomery County’s, keep not yet received in reality their ballots from the letters cavalry, to boot officials are concerned this some voters may not be able to vote. Montgomery has received separate on average 12,000 absentee ballots, 7,000 short of the statistic of fulfilled voter applications so far, county Elections Director Margaret A. Jurgensen told elections agency units among Rockville indeterminate Monday post meridian. The deadline to appropriate now an absentee index is Oct. 31. Likewise gather what band is responsible seeing solving the question? You guessed compulsatory: Diebold, the set this has imagined the extend of our electoral vim territory so indifferently. Investment whine from jungle spokesman: Diebold Election Systems, which prints the state’s paper ballots, insisted that all of Maryland’s counties and Baltimore city received their requested allotments in the past week and over the weekend. ‘‘Each county orders the load of ballots they’re expected to want, which is a rolling representation,” said Jessica Goon, a Diebold spokeswoman. ‘‘Using a floored delivery each county receives surrounded by 20 including 100 percent of the standard of ballots that they fondness be without.” If counties aspiration along ballots, Diebold determination satisfy them, she said. What is that? Some strain of Crab Republic? Memorize Along... Annotation several...

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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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