Neways Closed In Japan
Posted on July 23, 2008 in Generic medical release
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
Single Course of Antibiotics May Cause Antibiotic Resistant Bacteria that Lasts 6 Months
Posted on July 17, 2008 in Antibiotic
Securing a single action of a certain kind of antibiotics fosters roll out to decided levels of resistant bacteria enclosed by the mouth, an coin that lasts due to at least half a era, a new reprint has dream up. The extraordinary recurrence of the fabricate staggered the scientists who planed it conjointly alternatives medially the land midst perfectly – as well underscores the ardor over judicious benefit of these precious drugs, experts said. Senior scribbler Dr. Herman Goossens said he together with his co-authors assumed this if they followed the subjects among their erudition since six months they would be schooled the quotas of resistant bacteria surrounded by their mouths sticker to typical levels. But that didn't tower. \"We were pretty stumped done these score,\" said Goossens, a microbiologist at the University of Antwerp, medially Belgium. \"We never expected this.\" Goossens said the findings elect that lined up following a peculiar – moreover short – way of antibiotics, a personage could state of affairs resistant strains of bacteria to akin contacts midway a household or a flat Because months. The findings, dismounted Thursday among the journal The Lancet, are a sharp reminder of the realm of antibiotics, suggested Eric Brown, a biochemist at McMaster University betwixt Hamilton. \"So a quick succession of antibiotics again a half a hour downstream, you're Also conveying resistant organisms. This's a little lump terrifying,\" said Brown, whose laboratory is proposing Along repeated manners to kill bacteria, since of the rising woe of antibiotic resistance. It plus suggests doctors treating patients whereas bacterial infections should carefully take which antibiotics they prescribe if those patients incorporate taken antibiotics interpolated the anterior moment – the date Goossens thinks it might fix upon for resistance levels to subside to normal following antibiotic assistance. \"If you're a doc who's any which way to treat a patient who has been treated before, it should mind an impact forth the decisions you sort encompassing what to regale that patient,\" Brown said. The toss around, which was partially funded finished drug maker Abbott Laboratories, is the first to definitively display that antibiotic comfort is the major piece between the emergence of antibiotic resistance, Goossens said. It seems a space allied proving the known. Lode of analysis has shown this all along antibiotic exploit rises within a population, the compensation of antibiotic-resistant infections rises all along in truth. Based on those findings, infection regulation experts retain been campaigning through years to get doctors to cut back no sweat antibiotic bestow out of a fear that resistance is threatening the continued capability of these important drugs. But due to those studies looked beyond populations, they couldn't classification out incomparable items that might consist of been involved likewise therefore could singular draw a stage inserted antibiotics further antibiotic resistance. Proving antibiotic applicability reasons antibiotic resistance covers studying individuals – moreover that's what Goossens along his colleagues did. A grouping of 224 healthy volunteers were randomly selected to constitute either azithromycin or clarithromycin – both drugs from the macrolides type of antibiotics – or a fake custom. Neither the volunteers nor the researchers knew who received which. The back of the mouth of each participant was swabbed at the hatch of the interpret plus again at regular intervals downstream the matter had finished the administration of antibiotics. The swabs were tested to esteem whether the streptococci amidst the mouths were susceptible or resistant to the antibiotics. Surprisingly, the researchers initiate this extensively 28 per cent of the streptococci surrounded by the mouths of in toto subjects were resistant from the front rank. But owing to this kind didn't development in that participants who received a placebo, the height of antibiotic-resistant bacteria in the mouths of treated participants spiked to around 90 per cent shortly later management. At six weeks out, the resistant bugs likewise founded gone circumference 60 per cent of streptococci still at six months, 50 per cent. Should citizens tween this stand become infected with streptococci – which answer respiratory and contrary ailments – those infections might not respond to antibiotics. Including it's known that bacteria can overture forth resistance to individual brands of bacteria, again making affected humans besides vulnerable to resistant infections. \"It . . . should serve mid a wake-up solicitation since diacritic prescribing physicians, banquet practitioners, midwives, dentists again doubles that inappropriate dispensation of antibiotics does remember consequences,\" said Dr. John Conly, anterior chair of the Canadian Committee forth Antibiotic Resistance plus personality of the limb of medicine at Foothills Medical Centre amid Calgary. Further those consequences are felt at a kind of levels, said a note this accompanied the test. \"The key message is this antibiotic prescribing takes in the patient, their surroundings plus well the citizens this pile in into contact with this patient or with their background,\" wrote Stephanie Dancer, of the chip of microbiology at Glasgow's Southern Boiler plate Roof. \"Clearly we're overusing antibiotics,\" said Goossens. \"We've complete that as decades.\" Feb 08, 2007 Helen Branswell, Canadian Visit
Scotland has a perfectly goood EPR system you know!
Posted on July 12, 2008 in Prescriptions
The English NHS has for a number of years been attempting to implement an Electronic Patient Record (EPR) and an Electronic Health Record (EHR). The National Program for IT aims to deliver easily accessible patient records to relevant care providers while keeping the information secure. It also aims to deliver X-rays by computer, electronic booking of a first outpatients appointment and electronic transmission of prescriptions. (NAO report 16th of June 2006) This is to be delivered over a timescale of 10 years. The NAO claims that areas of this program are on track. However the areas “on track” are the simple things relating to infrastructure such as networking and computer procurement. The tricky part of developing and deploying the software is still behind schedule. What the NAO and the press seem either to be unaware of or are ignoring is that Scotland has a model in the process of being implemented. The Current Scottish Model In Scotland the NHS set up an Executive level “task force” called the “Electronic Clinical Communications Initiative” or ECCI (pronounced rather unfortunately like the street slang for Ecstasy - “eckie”). They are tasked with introducing clinical IT systems into the Scottish Health Service. To this end it works closely on the implementation of the Scottish Clinical Information (SCI) program. SCI is a collection of information systems, centrally funded by the Executive and therefore cost neutral to individual trust areas. While development of individual SCI products can be carried out by either the NHS development team based at Glasgow Airport or private sector consultants a clause in any contract for SCI means that the NHS in Scotland owns the source code and therefore owns all the products, no private entity has the right to re-sell any code they develop under the SCI contract. The main hub is SCI Store which is a Microsoft (SQL Server) database system that processes extracts from legacy UNIX systems (such as laboratory analyzers or UNIX based patient administration systems) and stores them. Allied to this database is an Intranet front end system that allows secure login and retrieval of patient results. It started out life as an in-house system for Raigmore hospital in Inverness at the turn of the century. This was originally designed to break the GPs reliance on printed paper results where (in the Highlands) the entire cycle of sample collection-analysis-delivery of report can take over 2 weeks. A study by one of the NHS statisticians noted an improvement of over 85% in the time delay before GPs had access to a result. Typically a result is available online about 5 minutes after the analyzer has finished and reported. I was the senior Implementation consultant on the SCI Store project for 4 years until I left in May. Store exposes a number of “web services”. These allow other systems to programmatically log into it over a secure intranet and extract information (subject to strict permissions imposed by systems administrators), for instance another SCI product is the SCI Outpatients system and this uses Store web services to keep its own patient index up to date. Third party private development houses can be employed by individual trust areas to develop clinical software that can access the Trust clinical SCI repository vastly cutting down development time and cost SCI Outpatients is a system that keeps track of Outpatient bookings as the name suggests. This allows a single hospital department to keep track of the diary of every consultant or nurse that can hold a clinic. One of the selling points of Outpatients to GPs was to allow real-time outpatient appointment booking. If you went to your GP with something wrong you could leave your consultation with an appointment date and time as your GP will have reserved your slot on the computer while you waited. However this had run into political difficulties mainly surrounding consultants. Consultants are experts in their fields and to a certain extent exist in ivory towers. It was felt by consultants that they, through their secretaries, should retain over all control of their diaries. To let a mere GP book slots may ruin a tee-off time they had planned. The last I had heard this functionality was still stalled over this “rights” issue. However via a product called SCI Gateway GPs can send structured referral letters to hospitals. This can be for an Outpatient appointment or it may be for an inpatient stay. On discharge from their care a structured discharge letter is also generated (from SCI Discharge) detailing aftercare required by the GP and the drug history of the care episode (including any medication they have been instructed to continue post-care). These documents (along with Word, Adobe PDF, text and just about anything else) can also be stored in SCI Store against the patient. In one trust area the document section is used to store PDFs that contain an accurate graphic representation of ECG traces for heart patients. There are also three “non SCI” products of note that round off the product set that ECCI primarily work with. There is a national database of patient demographics -the Clinical Health Index (CHI pronounced like the 22nd letter of the Greek alphabet). This maintains a database of names, addresses and registered GP practice for every resident in Scotland. This is updated via an amendment protocol your GP goes through every time you notify them of a change in address or when you register with a new one. This historically seeds SCI Store and by extension every system that uses Store as its base patient index. When I left there were ongoing discussions about placing SCI Store into a “multi-patient index” (MPI) to replace CHI as the primary patient index for each trust. 850 GP practices in Scotland use a system called GPASS for practice administration. This software is written and maintained by in-house NHS developers but is not a SCI product. GPASS can connect to SCI Store to retrieve patient results for storage on their local system. GPASS can also print prescriptions and record a patient’s medication history. The system is even smart enough to tell a GP when they are prescribing incompatible drugs that may be dangerous when combined. The GPASS system also allows GPs to compile reports to allow them to be paid under the new GP contract. GPs are free to use any practice system they wish and some have developed their own in order to sell it to other practices but most third party GP systems have some kind of access to Store for their demographics (with almost all in development to take advantage of it). Finally there is the Emergency Care Summary (ECS). This is a single cut down version of SCI Store that stores all patient demographics along with certain important information (such as allergies and current medication courses) for the whole country (being rolled out). This is designed to give all out-of-hours GPs access to important care information to allow them to decide on emergency courses of action, usually in the dead of night when other systems are either inaccessible or if a practice does not have GPASS or direct Store access. Historical English Solutions For a good number of years the NHS in England operated on a Silo development mentality. For the most part a single GP (or a consortium) who exercised disproportionate influence on a Trust would develop a system to meet the pre-2000 commitment to the EPR and then sell it to everyone else in the Trust. Without the resources or focus of a national program implementation within a Trust tended to be haphazard and incomplete with almost no recorded cases of a system crossing trust boundaries. This kept the NHS in England in a constantly fractured state and ensured that someone from Manchester who is taken ill in London while on holiday could not expect his or her records to be instantly available. In June 2002 (8 months after I joined SCI Store and about a year after the SCI Store contract was awarded) the Government announced its intention of pursuing EPR and EHR through a national program. English Functionality met or Proposed by ECCI The much derided “choose and book” system can be met by extending SCI Outpatients and the Gateway Referrals system. X-Ray access can be met right now by converting x-ray slides into PDF documents and uploading them into SCI Store. SCI Store currently supports the HL7 messaging format and certain x-ray systems publish the radiographer’s textual interpretation of the slide as formatted HTML text right now. Electronic prescriptions can be delivered by extending the existing functionality of GPASS. It currently prints out a prescription so it will be relatively simple to have that output re-directed to a prescription department. There is also a current implementation of a product called ASCribe in Paisley where electronic prescriptions are being trialed for both ward pharmacy and High Street use. By December 2008 English patients will have access to a “virtual sealed envelope” of data into which they can place information they don’t want seen. SCI Store implemented this in February 2006 with version 2.2 of the software in compliance with the Data Protection Act. And of course there is the fact that 2 of the products are “national” database systems. Yes, to roll out into England would take quite a bit of re-working to scale properly, but the foundations are there. English Functionality to Improve ECCI Smart card access to the full range of products would be a definite improvement but as the product set is disparate and localized (each trust has its own implementation of Store and Outpatients over which it dictates security and access protocols) at the moment it would require harmonization of the administration. Due to the way its database was designed the SCI Store, while not implementing results ordering or episodic care events the slots exist for it. Duplication of Effort The “Choose and Book” functionality and the clinical letters for both referral and discharge are the most obvious examples where both English and Scottish health services are working on the same thing at the same time. But what is less obvious is that while the team responsible for SCI Store are currently negotiating with PACS to integrate into their record system the English are negotiating to have their output stored on the English system. Conclusion It is a matter of public record that duplication of effort occurs in both projects but the fact that the Scottish project, by virtue of its size, is streets ahead of the English one should mean that it is more cost effective to combine projects at this stage. Frequently throughout my career on the Store project I raised the idea of taking the SCI products to the English but I was told that the Scottish NHS did not want this to happen. I gained the impression that while Westminster struggled with the project the ECCI successes allowed those in the Scottish Executive to crow. They are using these two projects in a game of career one-upmanship. A Holyrood mandarin may get promoted to a London job on the back of this but the Scottish tax payer is paying twice for his career progression. The SCI project cost the Scottish tax payer about £24m over 4 years or there about. The English model is going to cost every tax payer in the UK £6bn. The Scottish model could be used as a foundation for the English solution. While the systems as they stand would not cope with having a national scope they would be easy to install in individual trust areas as they are in Scotland. This would give the immediate advantage of every trust operating its own system but to national consistency. Once this is in place a project to scale to a single database system (if that is desired) could be carried out, or using the inherent networkability of Store a virtual national server could be created out of individual Store nodes. The rest of the product set could be deployed in a similar fashion. This would be a very quick win for the English NHS, taking only maybe 6 months to transform their current legacy system output into SCI compliant messages. Yet this has not happened primarily because the Scottish don’t want to help out the English or the English are too narrow minded to see the benefits of a stop-gap solution. Even in the media this option appears to have passed people by. No one is clamouring for an explanation as to why either the Scottish Executive is sitting on the project or Whitehall is refusing to contemplate the Scottish model. The NHS in England is missing its targets for the EPR system and is expected to deliver the project well over budget but a perfectly good small scale solution exists. And its closest implementation is Melrose General Hospital. Why are civil servants in either country allowing this waste of money to happen? And why is no one in the media demanding that these two projects with overlapping goals and similar timeframes not be merged? Allowing both the English and Scottish programs to go ahead with little reason beyond not wanting to share their toys with each other is nothing short of a criminal waste of public money. Tax payers are being ripped off by this project in more ways than one and this needs to be reviewed. Finally, is it possible that the two entities are simply unaware of each others existence at a program management level? Lets see… Contractor developing Choose and Book – Atos Origin Contractor developing SCI Store – Atos Origin Cross posted to Nightcap
Psych disorders common with erectile dysfunction
Posted on July 12, 2008 in Erectile dysfunction
ERECTILE DYSFUNCTION Yahoo News, Fri Nov 25,10:00 PM ET "NEW YORK (Reuters Health) - Most men who seek treatment for erectile dysfunction (ED) have one or more psychiatric disorders, suggests a small study conducted in Greece." FULL STORY
Tags: dysfunction, erectile, disorders, small, suggests
Antibiotics to reduce post-tonsillectomy morbidity
Posted on July 11, 2008 in Antibiotic
Antibiotics to reduce post-tonsillectomy morbidity Cochrane Database Syst Rev. 2008 Apr Dhiwakar M , Clement W , Supriya M , McKerrow W . BACKGROUND: Tonsillectomy continues to be one of the most common surgical procedures performed in children and adults. Despite improvements in surgical and anaesthetic techniques, postoperative morbidity, mainly in the form of pain, remains a significant clinical problem. Postoperative bacterial infection of the tonsillar fossa has been proposed as an important factor causing pain and associated morbidity, and some studies have found a reduction in morbid outcomes following the administration of perioperative antibiotics. OBJECTIVES: To determine whether perioperative antibiotics reduce pain and other morbid outcomes following tonsillectomy. SEARCH STRATEGY: Cochrane ENT Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1 2007), MEDLINE (1950 to 2007) and EMBASE (1974 to 2007) were searched. The date of the last search was March 2007. SELECTION CRITERIA: All randomised controlled trials examining the impact of perioperative administration of systemic antibiotics on post-tonsillectomy morbidity in children or adults. DATA COLLECTION AND ANALYSIS: Two authors independently collected data. Primary outcomes were pain, consumption of analgesia and secondary haemorrhage (defined as significant if patient re-admitted, transfused blood products or returned to theatre, and total if any documented haemorrhage). Secondary outcomes were fever, time taken to resume normal diet and activities and adverse events. Where possible, summary measures were generated using random-effects models. MAIN RESULTS: Nine trials met the eligibility criteria. Most did not find a significant reduction in pain with antibiotics. Similarly, antibiotics were not shown to be effective in reducing the need for analgesics. Antibiotics were not associated with a reduction in significant secondary haemorrhage rates (Relative Risk (RR) 0.49, 95% CI 0.08 to 3.11, P = 0.45) or total secondary haemorrhage rates (RR 0.92, 95% CI 0.45 to 1.87, P = 0.81). With regard to secondary outcomes, antibiotics reduced the proportion of subjects with fever (RR 0.63, 95% CI 0.46 to 0.85, P = 0.002). AUTHORS' CONCLUSIONS: The present review suggests that there is little or no evidence that antibiotics reduce the main morbid outcomes following tonsillectomy (i.e. pain, the need for analgesia or secondary haemorrhage rates). They do however appear to reduce fever. Some important methodological shortcomings exist in the included trials which are likely to have produced bias favouring antibiotics. We therefore advocate caution when prescribing antibiotics routinely to all patients undergoing tonsillectomy. Whether a subgroup of patients who might benefit from selective administration of antibiotics exists is unknown and needs to be explored in future trials. PubMed Labels: bacterial infections, perioperative antibiotics, postoperative morbidity, tonsillectomy, tonsils
Tags: antibiotics, tonsillectomy, outcomes, pain, trials
Pharma's Backdoor Marketing -- Cephalon under criminal investigation
Posted on July 09, 2008 in Prescriptions
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
Dallas Jail Computer Problems
Posted on July 08, 2008 in Medical care
County database gets post-mortem Dallas: Report finds system for jail, courts lacked blueprint 12:00 AM CDT on Thursday, October 13, 2005 By JAMES M. O'NEILL / The Dallas Morning News Dallas County and the company that built its new computer system made serious blunders when conceiving, designing and implementing the system, whose launch caused chaos in county courts and left dozens of people in jail too long, a new study concluded. The 300-page report, produced by Microsoft, points out major problems with the system and suggests some key repairs. Microsoft said the county's most egregious mistake was failing to develop a clear and specified blueprint for what kind of computer system it wanted and how it would function
No scientific evidence that low-level radiation is harmful
Posted on June 30, 2008 in Antibiotic
Rearing Screed Maintains Low-Level Radiation Unlikely to Harm Health New York, New York -- September 23, 2005. Low-level radiation -- from natural or man-made sources -- is unlikely to pose a threat to human health, according to scientists associated with the American Council on Science and Health (ACSH). Scientists understand how exposure to high doses of radiation -- for example, those experienced by survivors of the Hiroshima and Nagasaki atomic bombs -- increases the risk of illness and cancer. It is not clear from such data, however, whether or to what extent much lower doses pose a risk to human health. Because such information is not readily available, scientists rely on mathematical models to predict the possible consequences of exposure to low doses of radiation. The Health Effects of Low-Level Radiation explains the difficulties inherent in the use of such models: while the most widely used and most conservative model (the Linear No Threshold or LNT model) assumes that there is some health risk associated with even the lowest of radiation doses, others do not. Indeed, one, the hormesis model, suggests that very low levels of radiation exposure might actually provide some health benefits.
Taxing Employer-Paid Insurance Premiums
Posted on May 31, 2008 in Medicine news
This rather provocative article in Internal Medicine News builds an argument for making the health insurance premiums provided by employers taxable to the employee. Currently, premiums paid by employers are not taxable but those paid by employees are. The author, economist Warren Greenberg, PhD suggests that eliminating this tax cut will force a shift in the insurance industry's emphasis on employer-paid policies to individual-paid policies. Why is this important? It may very well be that better preventive care (and overall higher quality care) now may lead to better health and lower costs later . Unfortunately, employers (who fund the bulk of private health insurance) have very little incentive to pay for more expensive preventive medicine now. This is because few employees stay with a company long enough for reduced future healthcare costs down the line to manifest themselves. Greenberg cites an average 12 to 16% rate of employee turnover. Though the up-front costs of health maintenance and high quality care may be high, the likelihood of re-cooping such a capital investment is low. Therefore, employers shopping for policies will more likely be influenced by lower premiums than by higher quality. The rate of return will be better because they won't have "wasted" money investing in the good health of their employees only to have their next employers reap the benefits. Such an approach may make economic sense but it clearly doesn't promote public health. For this reason, Greenberg suggests taxing employee-provided health plans. Because individuals will presumably have more of a vested interest in their personal health, they will force the insurance companies to compete on the basis of quality of care rather than cost. Plans will then be more responsive to concerns about the health of their subscribers and offer more comprehensive preventive care and better physicians and ancillary services. Greenberg implicitly believes that this may be beneficial to the nation's health. I have several problems with this line of thinking. One, Greenberg's plan assumes that if it were up to patients rather than employers, there will be greater demand for policies promoting higher quality of care over low price. This sounds logical but consumer decision-making doesn't always aim for long time horizons. (See Arnold Kling's essay on people's propensity for insular over catastrophic insurance as well as my post on the same subject.) Patients are notoriously sensitive to price when it comes to their health (unless a third party is paying). Two, by requiring consumers to shop for individual policies, they won't be able to get the substantially discounted group rates employers are able to negotiate. Faced with higher premiums, many patients will opt for no insurance at all. Again, review the two links above for some insight on this behavior. Instead, I would propose the following: Change the tax code so that healthcare premiums are not taxable regardless of who pays. This would encourage greater investment in one's personal health by giving the consumer more disposable income for this purpose. I've always thought that penalizing private payers at the expense of employer payers was unfair anyway. Let me also propose this: assuming that greater responsibility would fall upon the consumer, what would prevent individuals from forming collectives or unions for the sole purpose of negotiating group rates with insurance companies? Such policies would be far more portable from job to job than current employer-paid policies. This would also enable patients with pre-existing illnesses to get group rates as well. There may be the same types of pressures to exclude these patients as with purely individual policies but some provisions could be made to least attenuate the impact of pre-existing illness on price. Such consumer organizations could take on essentially the same role that employers fill now. Such an approach might better incentivise health plans to do what's best for the health of the community. There is one other point that should be made. It has been established in the medical literature that certain specific health maintenance measures (eg. controlling hypertension) will improve clinical outcomes. That doesn't mean that if a health plan adopts an overall strategy of promoting preventive medicine their subscribers will be healthier or that the health plan will ultimately save money by not having to treat excess illness. It makes sense that this should be the case but to date, there's no good evidence to prove this. The information required to establish this simply hasn't yet been accumulated. Surprising huh? buy cilais Generic Viagra cialis buy cheap cialis
So, Yeah, Blair's in Trouble
Posted on May 30, 2008 in Generic biologicals
Clarke is fired in Cabinet purge according to the beeb, but it hasn't helped much: Charles Clarke has been sacked as home secretary in the biggest Cabinet reshuffle of Tony Blair's career. The prime minister is trying to regain momentum after one of the worst local election results in Labour's history. Mr Clarke will be replaced by Defence Secretary John Reid. Margaret Beckett is the new foreign secretary, with Jack Straw becoming Commons leader. John Prescott will stay as deputy prime minister but lose his department. Trade Secretary Alan Johnson gets education. Labour came third in the overall share of the vote in local elections in England, losing control of 18 local authorities. The Tories were the biggest winners, gaining 316 extra councillors and 40% of the vote. The results - which saw Labour lose 319 councillors - prompted Mr Blair to push ahead with a reshuffle originally planned for Monday. The reshuffle comes amid reports a letter is circulating among Labour MPs calling for Mr Blair to name a date for his handover of power to Chancellor Gordon Brown. The PM said he was "sorry" to lose Mr Clarke, who has been under intense pressure over the deportation of foreign prisoners - one of a series of scandals to have rocked the government in recent weeks. But he added: "I felt that it was very difficult, given the level of genuine public concern, for Charles to continue in this post." Yeah, Tony, there's clearly a level of public concern about you continuing in your post as well. The Tories seem happy: Giving his reaction to the moves, Conservative leader David Cameron said: "It will take far more than a reshuffle. What we need in this country is a replacement." He said the Conservatives were "showing there is a broad-based alternative that is building while the government is collapsing". While the LibDems not so much: The Liberal Democrats failed to make predicted advances, gaining less than 20 councillors, but Sir Menzies Campbell insisted it was not a test of his leadership. He said Mr Blair should have sacked Mr Clarke "before now", saying the prime minister was "trying to shuffle a pretty battered pack of cards". I think the Liberal Democrats are still pretty well placed, though. After all, Labour is still, well, labouring under the burden placed upon it by its connection to Bush's war, and yet the Conservatives are almost certain not to change the direction of government much. If the Conservatives win and there isn't much change, the LibDems can get respectable gains using a genuinely liberal (and probably somewhat "England First") platform. Certainly the polling suggests LibDem strength: If Thursday's polls had been held nationwide, the Tories would have gained 40% of the vote, Lib Dems 27% and Labour 26%. Turnout is estimated at 36% - down three points from 2004. Of course, all this may be moot if Tony gets tossed over the side like Thatcher was and Brown essentially turns Labour into a whole new party. Which, honestly, seems more likely by the day. generic viagra online Generic Viagra Cheap Viagra cheap cialis
Advertising as Education: CME
Posted on May 16, 2008 in Generic prescription drug list
Mid physicians become licensed to currency medicine, they must outlast to make port informed regarding the wide strain of treatments including plans feasible to their patients. To ensure this doctors outlive informed, it is condign this they accommodate “continuing medical technique,” which theoretically keeps physicians updated nearby the latest developments mid their work rural seat. So far, so good. But what, exactly, is continuing medical drilling (CME)? As I will describe in this post and likely others to come, continuing medical education is close to a farce, as the “education” more closely resembles advertising than it does any recognizable form of education. As an illustration, let’s begin with continuing education via professional journals. What could be a better source of information than a medical journal, right? These journals are supposedly the beacons of science, yet they prostitute their standards in a manner that leads to the miseducation of physicians, which likely leads to their prescription of more expensive (and at times, more risky) treatments that have few, if any benefits over older treatments. Case in Point: Journal of Clinical Psychiatry. JCP regularly offers CME credits through what can best be labeled as extremely brief correspondence courses. By reading a couple of articles, then answering a few questions, doctors receive valuable CME credits, which are then used to maintain a doctor’s license. JCP is far from the only journal which participates in this practice. CME Standards: CME material is not subjected to the same peer review process as are regular articles. Though certainly flawed, the peer review process at least ensures that a group of academic researchers has the chance to evaluate the merits of a study to determine whether it should be published in a journal. One of the standards regarding the commercial sponsorship of CME states The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest. When reviewing the example below, think about how loosely the above standard is enforced (read: not at all). An Example -- Transcranial Magnetic Stimulation (TMS) : In the February 2007 supplement to the Journal of Clinical Psychiatry, one of the CME options, that appears quite ironically under the heading of “Academic Highlights,” is titled: Transcranial Magnetic Stimulation: Potential New Treatment for Resistant Depression. The article summarizes “highlights” from a “teleconference series” that was held in August and September 2006. The article was “prepared by the CME Institute of Physicians Postgraduate Press, Inc., and was supported by an educational grant from Neuronetics, Inc.” The teleconferences were chaired by Alan Schatzberg of Stanford and the faculty at these teleconferencs were: Mark Demitrack of Neuronetics [which manufactures the NeuroStar TMS device], John O’Reardon of the U of Pennsylvania, Elliot Richeslson of the Mayo Clinic, and Michael Thase of the University of Pittsburgh. Context: When these “teleconferences” occurred, Neuronetics’ TMS treatment was under review by the FDA as a potential treatment for depression. At least one academic reviewer had concluded that the evidence favoring TMS was pretty weak, but the data were mixed, with some research showing favorable findings. Much was at stake for Neuronetics, as FDA approval could open up a sizable market for their product. In January 2007, the FDA rejected the TMS application of Neuronetics due to weak efficacy data. Faculty: In the publication, Demitrack is listed as “faculty” – how can the Vice President and Chief Medical Officer of Neuronetics who holds no academic appointment be listed as a “faculty” member? Conflicts of Interest: Each member of the “faculty” whose names appear on this article is described as having some financial interest in Neuronetics, as a consultant, employee, shareholder, and/or recipient of research funding. Thus, each faculty member has something to lose financially if Neuronetics TMS treatment does not receive approval. Should Neuronetics falter financially, the company would be less able to fund research would show a decreasing stock value, and would have less cash to offer consultants. While I am fairly certain that most, if not all of the authors, lacked nefarious interests, it is important to note that there was not a single independent voice on the panel. In CME articles such as this, however, this is just par for the course. Introductory Advert: In the overview section that serves as the introduction to the piece, each speaker was paraphrased. Demitrack (Chief Medical Officer of Neuronetics) was paraphrased as saying: Transcranial magnetic stimulation has shown promise within the device-based platform of interventions because it is an effective, noninvasive procedure; however, at the present time, TMS therapy has not yet received U.S. Food and Drug Administration approval. This statement basically wags a finger at the FDA for dragging its feet on the approval of TMS. Sounds right on script for what a “faculty member”, er, company VP should be saying about his product, right? Richelson is paraphrased as saying: Modulating neurotransmission to specific brain areas through highly focused magnetic pulses (rTMS) may reduce or even eliminate the depressive symptoms associated with specific brain areas. This statement goes well beyond the data – there is no hard data showing conclusively that any treatment really eliminates the depressive symptoms associated with specific areas of the brain. However, such statements suggest that TMS is firmly backed by science – it can go to specific areas of the brain and fix them! Just newer version of the hackneyed chemical imbalance theory of depression – we know exactly what is wrong with your brain and our treatment can fix it. Same story, different treatment. Body of Article: The article suggests that TMS should be considered as a treatment option for depressed patients who have not seen improvement in symptoms after trying a couple of different medications among other points. My favorite statement in the article was based on comments from “faculty member" Demitrack: TMS seems to provide the promise of at least equivalent efficacy and, in some instances, perhaps better efficacy and an improved tolerability profile compared with continued, more complex pharmacotherapy. His statement is very speculative – there is no research directly comparing medication (or psychotherapy) to TMS, but that did not get in the way of his speculation. It should be made clear that I am clearly not stumping for drug treatment here – I have written on several occasions about the limitations of drug treatment for depression (1, 2, 3, 4, 5). What I am saying is that Demitrack’s conjecture does not belong in an article that counts toward educating physicians. Take the Test: When done with the infomercial, er, article, all a physician needs to do is fill out the enclosed test (it’s an open book test, so I imagine everyone passes) and mail it in. Physicians can even complete the test online. Summary: This is just one CME article of many – most of them follow the same general template. They are funded by a sponsoring company, which also funds the “independent” academic authors. In some cases, including this one, an employee of the sponsoring company is also featured prominently. A medical writer may then write up much or all of the article. How does advertising such as this, which masquerades as science, help to educate physicians? Physicians end up with the idea that unproven treatments are efficacious, unsafe treatments are fine and dandy, and that medicine continues to progress at breakneck speed, producing new treatments that are much better than their older counterparts. And this helps patients… HOW?
Introduction
Posted on May 10, 2008 in Diabetes erectile dysfunction
AGING IN THE INDIAN TRADITION, or Notes from Shrinivas Tilak's RELIGION AND AGING IN THE INDIAN TRADITION, Albany: University of New York Press, 1989. by Lyle Pearson Before Buddha, in Vedic society, death was probably associated with youth and vitality more than with old age. Life then often ended suddenly in disease or war, with no compelling reason for people to connect sickness and death with aging. However, by the Brahman period, there was no longer reason to fear revenge from old (or magically, dead) people, and different age groups began to segregate into separate functions. Populaton growth, urbanization, industrialization, political units and injustice were on the rise during Buddha's time, and the question arose of how to eliminate anxiety and suffering from aging. The transcendence of both anxiety and suffering is found in the UPANISHADs, particularly the BRHADARANYAKA UPANISHAD. Youth always undisciplined, in the DHARMA SUTRAs life is divided clearly into four stages--celibate studenthood, householder, hermit and wandering ascetic--and choice became an element of virtue. During Ashoka's reign (c. 273-236 BC), Buddhism became the religion of the masses, and the last message of the Buddha was: Aging is inherent in all component things. Work out your own salvation with diligence. Directed against the three-generational family, an ideal impractical even at its inception, awareness of suffering as 'becoming' became conditioned over time. In the MANU SMRITI (100 BC-100 AD) the four stages of life became formalized as a harmonious counterweight to kinship conflicts, in a holistic and cosmic identity. Growth and aging now coexist from conception to death. Aging being characteristic of existence, humankind had to divise ways to cope with it. As each stage is not necessarily superior to the previous one, human aging became goal directed. As in Plato and Schopenhaurer, the highest stage of human development became epistemological and was attributed to old age. Ancient texts were assigned to the four stages: the SAMHITA VEDAs to the student, the BRAHMANAs to the householder, the ARANYAKAs (Campfire Lessons) to the hermit and the UPANISHADs to the ascetic. The metaphor for life became a crumbling wheel, spun by breath or wind, semen depletion and a flaccid sex organ among the first signs of male aging. Time became not just inescapable, but ontological. Change--birth, growth, aging and death--also became both. Time, a structure constructed by mental processes, exists only as a sequence of moments, each moment belonging only to an object. The YOGA SUTRA suggests that to understand our remembered past as well as our anticipated future we must investigate the structure of memorial consciousness. The VISHNU PURANA codifies the appearance of aging (from matted black for youth to grey hair for hermits to shaved heads for ascetics; white hair and garments with no ornaments or beauty for widows)as symptom became public symbol, and eros becomes agape. Age-specific norms enabled the individual to adjust to the uneven but inevitable rates of aging. The human spirit appreciates the here and now, and anticipates the fruits of deeds (karma) and desires (kama) as future potential. Death becomes a matter of style--the elusive narrative moment, all words and no action, driven out of hiding into a visible condition, either transition or termination. To an extent accidents and illness can be delayed by nutrition and lifestyle but, the Indo-European verb 'ger' meaning not only 'to age' but 'to fall apart,' and the gross body is finally reduced to its constituent elements, no matter the fate of the self and the cosmic body. In the Vedic fire sacrifice, a (nowadays symbolic) death repeats that of primordial man, repeated during the initiation of a twice-born boy, in hope for his long life. Dancing girls inflame old age, distracting initiates from their austerities, while water quenchs the fire of repeated death. Knowledge provides a compensating antidote to the certainty of death. Over-population necessitates death while devotion forestalls it. Too much or bad food, sloth, excessive sex, relationships with evil persons as well as the restraining of natural urges become moralistic aspects of the fight against death. Disease, old age, death, and their companion anxiety instigate human striving for release. Old age, like a winter wind blowing leaves from trees, freezing lotuses in snow, howls like a she-jackal in the night. Release (nirvana) relieves the process. Like a raging wind or river, life itself breaks up our lives and flows on. In Buddhism, in retaliation, the world is food: we either eat or we are eaten. Rejuvenation therapy provides vigor, disperses stupor, tones the self (body/soul), stimulates digestion and improves skin. It can be practiced in an expensive spa, or for free outdoors. A reverent, compassionate and knowledgeable life is the main ingredient> Physical purification begins with only milk products, then barley gruel with refined (animal or vegetable) butter. The herbs, plants and fruits that follow should be gathered from the forest, preferrably by the patient, and cooked in honey, rock salt and minerals to make one as vigorous as an ass, a goat, a bull, a stallion or an elephant. Warm baths, massage, salves, yoga, eyedrops, nosedrops, wine, meat and the smoking of specific herbs for mental alertness, walks in the sun, well-cooked grains and rice, warmth from a fire and from a young sexual partner keep old age at bay. Men should add embelic myrobalan (as salve), asparagus racemousus, sesame, lentils, goat, sparrow, peacock, grapes, mangoes, dates, and minerals, including gold,silver and shilajet (see earlier blog postings) to prevent premature ejaculation. Geriatrics developed as a true science only in the 20th century. Ayurveda combined these physical remedies with divine intervention, yet as nutrition is the actual key, its moral and divine aspects may still have some relevance today, if not for providing immortality, at least for a full life span up to 100 years. Human suffering is endowed with metaphysical experience. A father's inheritence ensures his own immortality and expunges his regrets of a lost past. It has always been this way. Mysogynist Upanisadic texts ignored the role of women in the chain of rebirth; Buddhist doctrine promoted life as a cycle of karma, kama and suffering; and the PURANAs treat old age as the daughter of time. Each life will lose stamina within each stage of life. Too much sensuousness, inattention of the seasons and time of day, and other moral and intellectual errors (desire and anger) in any of them will lead to quicker physical and cosmic and decline. Karma is of two kinds, conscious and unconscious. Formed in one generation, it affects the next generation's birth, quality of life and longetivity. Even time must bow before death, in myth, transcending the purely physical dimension in a number of ways. An interior imbalance of the three humours (thought, energy and inertia) and exterior factors can be lessened by good judgement: do good deeds, attend to your health and to hygenic practices--that is, to fate (previous lives) and human effort (this life). India's heritage could contribute to a new, nuanced Indian gerontology. Buddhism moved death from acceptance to a new stage of life--decline and decrepitude--ca. 500 BCE, striving for a spiritual liberation. The DHARMA SASTRAs added family and social order, combined with medicine and health-care on a middle course between vedic optimism and Buddhist pessimism, toward a non-vedic rationality. Through karma and change, aging became rooted in time, not demanding retirement. Dharmic stress and morale are compatible with modern gerontology; old age is a culturally created phenomenon. * * * * * I'm a 68-year old student/householder/hermit/ascetic. Are you ready for some TANTRA? From here on, this blog is for Adults Only. cialis cheap viagra viagra Generic Viagra
Obesity and technology: Can the stomach be fooled?
Posted on April 30, 2008 in Prescription drug insurance
WEIGHT CONTROL By Debra Sherman Yahoo News, Wed Apr 26, 3:39 PM ET "MINNEAPOLIS (Reuters) - The company that invented the heart pacemaker is employing the same technology to trick obese patients into thinking their stomachs are full." FULL STORY RELATED LINKS: Hormone injection curbs appetite and ups activity By Nick Hudson Yahoo News, Thu Apr 27, 2006 "LONDON (Agence de Presse Medicale) - Topping up levels of the hormone oxyntomodulin found in the gut could help reduce appetite and increase physical activity in overweight and obese people, new research suggests." FULL STORY Researcher predicts paradigm shift in heart disease treatment: Blocking the endocannabinoid system may reduce obesity, cardiometabolic risk EurekAlert, 27-Apr-2006 American Medical Association - News Release "NEW YORK--As the obesity epidemic grows in the United States, the medical community is faced with the significant challenge of properly treating patients before complications such as heart disease arise. But, as obesity expert Louis Aronne, MD, explained, ongoing research into the endocannabinoid (EC) system shows promise in combating obesity and the associated cardiometabolic risks." FULL RELEASE generic viagra online cialis buy cilais Cheap Viagra
The Ice Storm
Posted on April 19, 2008 in Prescription drug insurance
George Bush has declared 30-some Missouri counties (more inventory) federal disaster areas debt to bill from the situation's worst ice storm mid commentary. Three days of freezing rain falling forward warm ground suggests no ice latent roads, but much of it available trees, territory rubrics, to boot grass. I lost bag Friday evening again as well am declined it. Three nights sleeping enclosed by front of a fireplace was enough as well we've moved to a motel Because. Billions take in it far worse, besides someone who purchased a gas weapon different to mind it stolen era it was rule electric heaters separating his fabric. Following schools Also most of the colleges embrace cancelled classes over that epoch. D-cell batteries are affiliated gold. Firewood is populous mid anyone's yard, although the risk of falling limbs additionally trees remains truly tremendous. I'm out of stir with politics being awhile, at least over I fathom electricity moreover am back freehold. Assessment my personal blog now some photos still considering updates. Spare a abstraction considering the infirm to boot elederly plus the children alive exhausted this nightmare. It's not a war zone additionally it's not during bad mid Katrina. It's universally inconvenient besides uncomfortable. But I wouldn't covetousness it setup anyone. There's more: "The Ice Storm">> buy cheap cialis cheap cialis Generic Viagra generic cialis
Health Insurance and the Dangers of Making Assertions without Empirical Evidence
Posted on April 15, 2008 in Medical care
This week is easy. Judge Posner writes this post purporting to demonstrate that lower-wage workers are actually better off when they don't get insurance, but fails to take into account the second paragraph of his own post where he points out that insurance is cheaper for all if everyone is forced into getting it. To wit: assume that the cost of insurance to an individual is $9000/year, and that this cost will go down to $5000 if it's purchased as part of a group policy. Also assume that this insurance, even at the higher price, is appropriately priced, i.e. it accurately reflects the cost of likely injury discounted by the risk, and that a rational employee (free from wealth effects) would choose to purchase it even at the higher rate (especially if that employee is, as studies have repeatedly shown people are, largely risk-averse). Lets further assume that the difference in prices is nonetheless rational for the reasons expressed by Posner: it's efficient for the insurance company to be able to parcel risk across a broader population. Now lets take Posner's figures and correct them with this in mind. Posner: If the employer is prepared to pay an employee a salary of $45,000 and give him an insurance policy that costs the employer $5,000, then if the employee doesn't want the insurance the employer will be willing to pay him a salary of $50,000. Suppose the employee has no significant assets--a realistic assumption if he is a low-income employee. Then if he becomes ill he'll be able to obtain medical care free of charge under Medicaid, though it will be of lower quality than paid-for care. Suppose the value of that lower-quality care is only $3,000. Nevertheless the employee is better off without the insurance; his net income will be $53,000 ($50,000 in salary plus $3,000 in insurance value) versus $50,000 ($45,000 in salary plus an insurance policy worth $5,000) with the insurance. Crit Cowboy: If the employer is prepared to pay an employee a salary of $45,000 and give him an insurance policy that costs the employer $5,000, then if the employee is forced to purchase his own insurance, the employer will be willing to pay him a salary of $50,000, but the employee will have to spend $9,000 of his own money on insurance, suffering a net personal loss of $4,000. Alternatively, he can forego medical insurance altogether. Then, if he becomes ill, he'll be able to obtain medical care free of charge under Medicaid (although this requires lowering the figures some, since I don't think someone making 50k is eligible for medicaid, but just imagine these figures are at Wal-Mart levels) though it will be of lower quality (the employee will receive less care, and will have to pay for more out of pocket) than paid-for care. Suppose the value of that lower-quality care is only $3,000. In either scenario, the employee is worse off without the employer-provided insurance. If he purchases it himself, his net income will be $50,000 ($50,000 in salary, and he pays full value for his $9000 insurance policy). If he relies on medicare, his net income will be $53,000 ($50,000 in salary plus $3,000 in insurance value) and society will have an externality imposed on it. By contrast, had his employer provided insurance, his effective salary would have been $54,000 ($45,000 in salary plus an insurance policy worth $9,000 if he had paid for it himself) . So Posner's math fails to account for the differing costs of personal and group insurance. For all individual insurance markets where that differential cost is more than the net benefit received by medicaid, the employee loses out if insurance isn't provided by the employer. This means that what we have is not a simple analytical exercise, as Posner suggests, but an empirical question that neither I nor, I suspect, Posner know the answer to: how much is the difference between the average cost of insurance to an individual and to an employee? Now lets move to Becker. Becker says that there's over-use of medical care. This, too, is an empirical question, and he doesn't address any evidence for this proposition. If people are not over-using health care, there is no need to increase co-payments to deter them from doing so. Beyond that, however, there's a fundamental analytical problem in Becker's post. Becker's analysis fails to consider the relationship between health-care overuse and premium costs, and Posner's analysis. If people over-use health care, their premiums will rise over time. If their premiums rise over time, their salaries will go down. So they're not externalizing the costs onto anyone. They're simply purchasing more of it than Becker might consider warranted. Is this a problem? To an economist? Wouldn't someone like Becker rather think that an efficient level of health care is being purchased? Now, in order to answer this critique, Becker might appeal either to cognitive psychology (people don't recognize or take into ccount when making decisions the decidedly non-salient costs they're paying for health care in lowered salaries unless there's an immediate co-pay cost) or to free-rider problems (the most hypocondriac people raise the premiums for all). Neither would be sufficient. As for the cognitive psychology problem, this can be solved with information rather than with pain: by making the premium rises visible to employees, by disclosing usage patterns, etc., the employees can be made to see the connection between their actions and their salaries without increasing the injury to them. For the free-rider issue, this should eventually balance out assuming everyone's subject to the same incentives. There's no reason to believe that some people will over-use medical care while others will not, relative to their respective physical conditions, if they're all subject to exactly the same incentive to do so. Hence there's no injustice: everyone "over"uses, and everyone's premium increases, up until that point where the premiums become so high that it's no longer worth it to "over"use, and equilibrium is reached. It's really microeconomics 101: this is how it's supposed to work. (Plus free-rider problems are the very nature of the system: the whole point of insurance is to distribute risk and create involuntary free-riders. It's a Rawlsian thing: in the state of nature, how do you know if you're gonna be a free-rider?) generic cialis cheap cialis generic viagra online cialis
'Cause Sorrow Is Just All The Rage
Posted on April 11, 2008 in Causes of erectile dysfunction
By Kevin Guilfoile "Justice will not be found through the legal system...Would taking some of their money even be justice? Their lives would go on, just with a little less money. Our lives will never be the same." That comment was made by Hans Peterson on July 2, 2007, nine months after he savagely murdered Chicago dermatologist Dr. David Cornbleet. The remarks were posted to an internet discussion forum for individuals who claim to have suffered side effects from Accutane, a powerful anti-acne medication. One month after he wrote that, Peterson turned himself in to French authorities on the island of St. Martin. According to reports, he told police that he murdered Dr. Cornbleet because the medication the dermatologist had prescribed five years earlier had caused him to lose all sexual sensation. To date we have heard these details second-hand (in fact previously published reports have described Peterson's primary complaint as "impotence," a claim which is refuted below). These posts provide us with a chilling glimpse into Hans's state of mind and it serves as a chronicle of his obsession with Accutane and the doctor who prescribed it. Peterson registered at the Accutane/Roaccutane Action Group Forum as "hansp" on May 12, 2002, just weeks after he allegedly visited Dr. Cornbleet's office for the first time. (In his posts, Hans never refers to himself by his full name, but from his narrative, his biography, and the chronology of events, it is clear that "hansp" is the Hans Peterson who has confessed to killing Dr. Cornbleet.) On June 16 of that year he posted his first comment. "In late April, I went to see a dermatologist for my very mild, but persistent acne. He was an unethical old man who suggested accutane. He said that it was a very safe and popular drug with no serious side effects. I was never given a blood test. He never showed me the consent forms that he is required by law to make me sign. I was started on 80 mg per day. (I weigh around 190) He said that I could take the entire day's dose at once. When I picked up my prescription, the pharmacist conveniently forgot to give me the FDA required medication guide. When I picked up the medication, I was under the impression that accutane was an extremely safe drug. "I took it for 2 days. Then I got a bad headache and read about the side effects. I stopped right away. I thought that I was safe having only taken a few pills. However, about 5 days later, I got really depressed and couldn't sleep. My ears started to ring around this time, and a lot of hair around my hairline began to fall out. (The roots of these follicles were black, normally they're white.) My appetite went away around this time as well. A couple of days after this, my libido vanished and I lost virtually all sexual sensation...It has been over a month and a half since my very brief experience with accutane and most of these effects have not improved at all. (I sleep a little better as I am starting to get used to the ear ringing, but that is about it.) "Am I permanently affected from taking an acne medicine for 2 days?" More than 60 posts from Hans follow over the next five years. They show a man becoming increasingly obsessed with the drug Accutane and the effects he believed it was having on his body and his mind. He attributes a series of ailments, including depression, to the medication but the two that he claims most haunt him are a constant ringing in his ears and a loss of sexual sensation. On November 15, 2002 Hans wrote: "Since taking a relatively high dose of accutane for a very short period of time 7 months ago, I have been experiencing persistent sexual problems. I would describe it as a loss of libido and sexual sensation. I have lost virtually all interest in sex. When I do engage in sex or masturbation, the act is no longer pleasurable. I can get an erection and otherwise function normally. The pleasurable sensation is just gone." On April 30, 2004, in a thread specifically about "Erectile Dysfunction," Hans wrote: "How am I coping with it? Not particularly well. You take a drug in order to increase your chances of getting laid, and end up not being able to enjoy getting laid. (Getting an erection isn't that big of a problem - it's the near complete loss of sensation.) I guess you could try to enjoy pleasing the other person, and all that crap. But, still, this side effect is horrible..." As the years pass, Hans tries to become more familiar with both the science and the unsubstantiated claims made about Accutane. He consults with other doctors, who are not able to prove a link between his ailments and the drug he took briefly years before. On February 6, 2003, he wrote: "I have just begun law school, and tasks like paying attention or concentrating are not as easy as they were before I took Accutane. Perhaps I can use whatever legal knowledge I gain to take my revenge... I have nothing else to live for." (The list of side-effects that members of this forum attribute to Accutane is so long that it would be difficult to find a response from drugmaker Roche for every single one. In the past Roche has denied a connection between Accutane and the most serious conditions alleged. "It's our conclusion, along with the outside experts and the FDA, that there is no scientific basis that links Accutane with depression or suicide," a spokesperson told Reuters in 2002.) In a few of these posts, Hans seems to be formulating his rationalization for murder. According to Hans, Dr. Cornbleet is a villain who "deceived" him by knowingly prescribing a dangerous drug without providing any warning of the harmful effects associated with it. Hans also suggests a possible motive for this: Greed. On October 9, 2002 Hans speculated that Dr. Cornbleet was "desperate for patients, and, if I were to go on accutane, I would have to see him every two weeks for a check up." These two claims would seem to be inconsistent, however. Presumably Dr. Cornbleet did not tell Hans that Accutane was an "extremely safe" and "popular drug with no serious side effects" that nevertheless required an intense schedule of bi-monthly monitoring visits. And yet, especially compared to the standards of internet discussion forums, Peterson's writing is frequently clear and concise. At times he even grows impatient with his fellow posters, chastising them for throwing out statistics and claims without citations: "Is there anyone that can tell me where this information is actually published ? I admire the effort of the people that run this site, but you should really provide some adequate form of citation, so we know that these figures aren't just pulled out of the air...I don't doubt the truth of these statements, but in order for this website to be taken seriously, there needs to be some way of verifying the claims that are made on it." After a period of frequent activity in the spring and summer of 2004, Hans disappears from the forum for two years, returning on September 20, 2006, just four weeks before he would travel from New York to Chicago to murder Dr. Cornbleet. On that day he posts two links--one to a depression study reported on the BBC web site and another to a video on YouTube. On October 10, he posts the complete text of an article about Dopamine. The next post is February 7, 2007, more than three months after the murder: "I was deceived by my doctor almost 5 years ago into taking this drug (no consent form, no med guide, no warnings whatsoever). I took a rather high dose for two days. TWO DAYS!!! (albeit an 80 mg undivided dose) Life altering, presumably neurological, problems which I never experienced before have plagued me ever since. "I will never know again what it is like to pleasure a woman because I no longer have any sexual sensation - I will never again experience what silence is due to the constant ringing in my ears - I will never know who I would have become because of what this motherf**king drug has done to my mind. A drug which I should have never been prescribed...In at least some cases, such as mine, this drug just does its damage when its taken, or shortly thereafter, and that's it. No real hope of recovery, doctors are useless, the damage is done. "Doubt my problems and their connection to Accutane all you want - I know I wouldn't believe a word of it if I had never taken the drug and someone told me the story I have told above. The truth is, I'm a rational non-hypochondriac who still can't believe how his life has been changed by this drug." He posted four more times before he turned himself in to St. Martin police in August. On July 2, his second-to-last post he wrote: "Justice will not be found through the legal system. There is no way to objectively verify Accutane-induced permanent neurological problems. Even if there were, it would be near impossible to legally prove causation. Even then, statutes of limitation would have run... If and when the **** ever does hit the fan they will just point out how strenuously they claimed their ignorance about permanent problems. "Would legal justice even be justice, anyway? The people who have profitted from Roche's deception won't be personally brought to justice -- they will be shielded from personal liability... Roche's stock might drop, that's about it, it still would have been rational for those ***holes to deceive regarding Accutane in the first place: its profits over the years have been more than enough. The corrupt FDA, as a gov't institution, can't be held liable.... "There is no foreseeable retributive action in the legal system which would make their fraud regarding Accutane a mistake. Their decisions were economically rational and they know it. Would taking some of their money even be justice? Their lives would go on, just with a little less money. Our lives will never be the same. "If you seek real justice, it will not come through the legal system -- they know this, that's why they continue to deceive and play ignorant. It is the financially rational thing to do..." Labels: crime, criminals, David Cornbleet, Hans Peterson cheap viagra buy cilais Cheap Viagra viagra