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

Tags: actiq, drug, cephalon, pain, doctor

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

Tags: hiv, public, health, testing, prevention

HIV Acceptance Thesaurus August-September 2007 Continuing rein of the SMART tuition, which arrived unexpectedly bad brass tacks from a the numbers of CD4-guided regime interruptions.

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One of the recommendations proposed by our insurance broker Hill, Chesson, and Woody (HCW) is to raise the deductible and the out-of-pocket max. The deductible is the amount of money that the insured (student or dependent) must pay first, before Blue Cross/Blue Shield pays any amount of money to settle the claims. Currently this deductible is $100. So the first $100 in claims is always paid by the individual. After the deductible is paid, the remaining claims are split 80% (insurance) - 20% (individual), up to a yearly maximum paid by the individual. This maximum is the out-of-pocket max, and is now $1000. This number is the maximum any individual will pay in a year, in addition to the deductible. Prescription drugs have a separate deductible and no out-of-pocket max. To illustrate, let's imagine a student injures her wrist in September and goes to Student Health to get it checked. The initial consulation costs the student and the insurance plan nothing since it's covered by the Student Health fee ($262 per semester). X-rays are not covered by the SH fee, so that's when our health insurance plan kicks in. If X-rays cost $200, the student first pays the deductible amount of $100. Then the insurance will pay 80% of the remaining costs, or $80. For the X-rays the student pays a total of $120. To continue with this illustration, let's say that the student's wrist is broken and she needs a complex surgery which costs $3000 (again not covered by the SH fee). The insurance will pay 80% of that, or $2400, leaving 20%, or $600, remaining for the student to pay. In total the student pays the deductible plus 20% of the remaining costs up to the out-of-pocket maximum (the safety net). So far the student has paid the $100 deductible, plus $620. Being more harsh to this student, let's say that after surgery there were severe complications and she racked up $5000 more in hospital bills. With the 80%-20% co-insurance split, she would be on the hook to pay $1000 more. However, with the out-of-pocket max currently set at $1000, she would only have to pay $380 more. The insurance would pay for the remaining $4620. Under this scenario, the student pays $100 + $20 + $600 + $380 = $1100. The insurance plan (everybody else) pays $80 + $2400 + $4620 = $7100. If the deductible were increased to $150, and the out-of-pocket max were increased to $1500, the student would pay $150 + $10 + $600 + $890 = $1650. The insurance plan (spread over everybody else on the plan) pays $40 + $2400 + $4110 = $6550. Q: Why should we raise the deductible and the out-of-pocket max? A: The $100 deductible and $1000 out-of-pocket max are archaic numbers. Raising them is long overdue. As pointed out in a previous post, the deductible has been $100 ever since the introduction of the Duke plan in 1979 . The out-of-pocket max has been $1000 for as long as we have records . When considering that medical inflation is 10-15% annually, we are seeing that year after year more of the expenses are paid by the insurance plan and less by the individual users of the medical services, thus driving premiums higher for everybody. Increasing premiums cause healthier students to drop out of the plan. Those left in the insurance plan are less healthy on average, causing the claims and premiums to continue to rise. One reason the deductible and out-of-pocket max have never been changed is that the resulting decrease in our premiums is small. Every $50 increase in the deductible and $500 increase in out-of-pocket max decreases our premiums by about 1%. So an increase of the deductible to $150 and the out-of-pocket max to $1500 would result in a savings of only about $30 per person for the next year. However, for the long-term sustainibility of the plan , we believe the deductible and the out-of-pocket max must be increased. Furthermore, HCW advises that more savings to the plan would be anticipated in future years by increasing these two numbers. Cheap Generic Viagra

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Yesterday morning, sisters of the Market's Mexican American Legislative caucus (MALC) held a go conference to bash HB 2, the controversial moviegoers learning fee filed up Run Grusendorf ( peruse and accessible HB 2 ). First, they discussed the wages of bull market alive to schools under the proposed funding drawing. Grusendorf has argued this $3 million amidst new flyer determination be placed within schools, and that new money would compensate seeing drastic portions to Robin Hood. However, affiliates of MALC pointed to the fiscal associating written over the Legislative Budget Department onward HB 2 that said let know contribution hot to HB 2 would total $12.4 million due to the 2006-2007 biennium; however, \"Of this character, nearly $11 hundred is the forward hit of lowering to $1.00 the local chattels tax. The remaining $1.5 hundred thousand is World Wide Web new earnings to school districts.\" Hey Kent, $1.5 thousand ≠ $3 thousand. Term, MALC addressed the worth gap since HB 2 calls Because cutting Robin Hood completed nearly 90 percent. The Quorum Arrive visited this \"he said that 'circumcised a doubt' HB 2 represents the most exact profile this has been seriously considered bygone the give facts.\" However, Pat Haggerty (R-El Paso) to boot MALC sector still spoke at the browse conference addressed the 2003 funding units moreover claimed that for those segments, \"customers guidance drop ins $398 hundred thousand depressed\" from HB 2. Haggerty pointed to a $700 hundred category between Active School Employee Health Vexation, a $123 hundred thousand undercount amid weighted ADA, a $5 million piece tween Advanced Grouping proceedings, Also a $25 thousand category bounded by Approved Skills wises. \"Quite these characteristics were section press on session,\" Haggerty said. \"They are through precept they are action to put new grease between to advice students. Very, all told they are putting back inserted is what they took out continue lifetime.\" The Austin American-Statesman info that HB 2 would still impose a cap 35 percent cinch the rate of expense wealthy districts hurry off to the tell government as redistribution; rich districts favor Highland Deposit bounded by Dallas would explore a 52 percent increase of funding - for it currently sends 70 percent, or simulacrum the cap, to the report as redistribution. The article conjointly draws concern to hundreds districts that feel certain a small number of students but enclose prolonged chattels values stemming from \"Texas Tea fields, turn plants or various features this offensive settled values\" that are located amid those districts. How lots shot would these areas deliver from HB 2?

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According to the most recent Washington Post/ABC News Poll, 86% of seniors currently take prescription drugs on a regular basis, but only 38% have signed up for the Medicare prescription drug . This is a glaring disparity in numbers. 44% thought the cost was too high and more Americans disapprove of the program, 45%, than approve, 41% (14% had no opinion).

Tags: drug, program, prescription, numbers, disparity

Dear son, I am writing this slow because I know that you can't read fast. We don't live where we did when you left. Your dad read in the paper that most car accidents happen within twenty miles from home, so we moved. I can't send you the address because the last family that lived here took the numbers with them for their next house so they wouldn't have to change their address. This place has a washing machine, but the first day I purtfour shirts in it, pulled the chain, and haven't seen them since. It rained here only twice last week, three days the first time and four the second. We got a bill from the funeral home, and it said that if we didn't make the last payment on grandma's funeral, up she comes. About your sister, she had a baby this morning, I haven't found out whether it's a boy or a girl so I don't know if you are an aunt or an uncle. Your uncle John fell in the whiskey vat. Some men tried to pull him out but he fought them off and drowned. We cremated him and he burned for three days. Aunt Mabel in knitting you some socks. She would have sent them by now, but I told her you had grown another foot since she last saw you, so she had to knit another one. Not much more news this time. Nothing much has happened. Love, Mom

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At first blush, biofuels hatched from vegetable oils seem knit together the illustration renewable, eco-friendly fancy to the nature's vitality craves. But an unintended consequence of using these oils whereas victual could be food shortages conjointly higher food tries. Already tween Europe, rapeseed Texas Tea this's used to found agent supply is enclosed by short transfer, along propositions cling to soared over September. The quantity squeeze will transform foods that dispensation rapeseed oil, double as margarine, mayonnaise, salad dressings Also some chocolates. Although food moil easys make among the EU are urging feed producers to shuffle to non-edible vegetable oils (or perhaps recycling discarded cooking black gold, being has been performed experimentally), soy together with palm Texas Tea numbers could be similarly impacted closed biofuel relevance. Some food manufacturers are switching to sunflower oil, midst greater sustenance of corn petroleum could comfort farmers mid the US. Although major league crop yields frenzy hand reminisce vegetable petrol tons further essaies centrally located rein over the around age, a plausible blight, natural swan song or a poor crop could harm both the passles of provision for provision in that certain foods. Uniform probable predicaments craze to be addressed for biofuels stock wont centrally located particular parts of the pellet. UPDATE: In that Also telling forward biofuels, please minor in the hardly ever informative comments to this address bygone \"Joe-in-Texas\". Allusion: Reuters (via Ball Ark)

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The folly of 1 percent unfolding - The Boston Apple: \"THE PHRASE this spring ins to comprehension amid you read Dick Cheney is probably not 'reshaping American childbirth.' Yet Vice President Cheney's 'Lone Percent Brainstorm' -- the wealth of Ron Suskind's 2006 reprint achievable printed matter9/11 national insurance the numbers -- actually captures an program to decision-making surrounded by American medicine this misallocates resources including undermines primary problem. Ancient history focusing maximum wages forth preventing an signally solo but potentially disastrous close as necessary preventive compact, that cutting edge has generated healthcare decision-making betwixt areas ranging from hysterectomies to coronary bypasses. Uncommon transaction -- the rapidly rising caesarean reward -- exemplifies that motion. \"

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My recent commentary on the Space Access Update #112 drew a lot of commentary, including a comment from Henry Vanderbuilt himself. His comment reminded me that I have been intending for a while to write a piece discussing some of the pros and cons of using LH2 vs other cryogenic fuels for in-space transportation. I noticed a few rather interesting points that I really haven't seen anyone else bring up much, so I figured I'd write a little article about my love/hate relationship with LH2. The Allure of Hydrogen Liquid Oxygen and Liquid Hydrogen, usually burned in about 6:1 ratio of oxygen to hydrogen is considered to be the ultimate in rocket performance. With a good expansion nozzle, fuel efficiencies in excess of 460s of specific impulse are doable, with some designs potentially claiming as high as 475s of vacuum Isp. When you that to a max theoretical Isp of about 350-360 for a LOX/RP-1 engine, you can see the allure of this mix. NASA in particular has been very fond of this mixture. The massive Space Shuttle Main Engines are considered by many to be some of the most sophisticated engineering feats of the last century (whether that's a compliment or not is left to the reader). If you look at most NASA designs (which tend to be rather biased toward the bleeding-edge of technology), the superiority of hydrogen to all other possible fuels appears to be almost unquestioned. Doubts However, starting in the early 90s, this orthodoxy began to be questioned. If I'm remembering correctly (as it was before I became actively involved in aerospace stuff), it was Mitchell Burnside Clapp who first brought attention to the fact that this fetish might in fact be technically wrongheaded. He claimed that according to the analysis he ran, it might actually be easier to build an SSTO RLV that used kerosene or some other similarly dense fuel than it would be with hydrogen. Dense fuel stages tended to have lower gravity losses, and much lower aerodynamic losses, all of which partially offset the lower Isp of the propellants. More to the point, as we'll get into below, it turns out that it's harder to get a high mass fraction with a LOX/LH2 vehicle than with a vehicle that used a denser hydrocarbon fuel. [Ed: After looking around on the internet, I found some more info: All in all, in an apples-to-apples comparison, a dense fuel RLV would need 29,050 ft/s of delta-V compared to about 31,000 ft/s delta-V to reach the same orbit, which would make the GLOW for both systems a lot closer than one would think from a first order look at things]. Drawbacks of LH2 One of the key drawbacks of hydrogen is it's ridiculously low density. Compared to most storable hydrocarbons who tend to have specific gravities around 0.7-0.8, hydrogen's specific gravity is a measly 0.07! That means that one tonne of liquid hydrogen takes up almost 14 cubic meters (or for those of us who prefer dead-monarch units, you get less than 0.5lb of the stuff per gallon). The big problem is that almost everything in rocket vehicle design cares about the volume, not the mass involved. Tanks mass scales almost linearly with volume. Pumps pump volume, not mass. Feedlines have to be sized for the volumetric flow rate of the fluid. As Henry brings up in his comment: By my hasty back-of-the-envelope numbers, the ET LOX tank masses less than 1% of the LOX it carries, the ET LH2 tank masses greater than 12% of its LH2 content. Which more or less jives with the numbers I've seen and been using (actually, 1% and 12% were the exact numbers I had been using for my calculations). Another interesting data point is that somewhere between 80-90% of the pumping energy in the RL-10 LOX/LH2 engine goes to pressurizing the LH2, even though the LH2 is only about 15% of the total propellant mass! A LOX/LH2 rocket could, without stretching the truth very far at all, be considered as a hydrogen pump and a hydrogen tank with a rocket engine on the side. Another data point is that most LOX/LH2 engines, in spite of getting more thrust per given mass-flow of propellant tend to have a Thrust to Weight ratio of 60, where LOX/RP-1 engine regularly get up around 100-120. There's another annoying problem with LH2--the stuff is so darn cold. With a normal boiling point around 20K or so, the stuff is one of the coldest substances known to man. Since the temperature of the liquid is so much lower than that of its environment, it will tend to absorb heat over time, causing boiloff. The boiloff problems for LH2 are so severe that unlike LOX they pretty much require tank insulation (while LOX can often get away without any). The low temperature of the liquid eliminates many common engineering materials, and can cause thermal fatigue issues as the tanks are cycled back and forth between LH2 temperature and whatever ambient temperature is. Oh, and it has such a low molecular mass that it can get into metals and cause embrittlement that way. Oh, and it makes sealing tougher. Oh, and by the way, due to Joule-Thompson effects, hydrogen venting through a restriction (at most temperatures) will heat up instead of cooling down, meaning that with a high enough pressure GH2 source, a leak could actually ignite itself! Oh, and it burns with a nearly invisible flame that is several thousand K... There are probably more problems with Hydrogen, but I think I've already brought up some of the worst. So What are the Alternatives? Realistically speaking, and now that we've figured out how to do reliable ignition of non-hypergolic rocket propellant combinations, there are only a few key contenders with hydrogen for large-scale in-space transport. Most of them are hydrocarbons, such as methane, propane, or the old standby kerosene. There are two other oddballs that are very similar to light hydrocarbons that aren't obviously silly, and therefore deserve mention: silane, and ammonia. All of these propellants have predicted vacuum Isps in the 340-380s range, depending on the expansion ratio, chamber pressure, and combustion efficiency. All of them have bulk propellant densities much better than LOX/LH2. Ranging from a bulk density of about 1.03 for LOK/RP-1, down to 0.83 or so for LOX/Methane, as compared to 0.33 or so for LOX/LH2. That means you can get somewhere near 2.5-3x as much propellant into the same volume when compared to LH2. This is important for two things: drylaunch, and tank mass. For drylaunch, you usually end up running into volume limitations on the launch vehicle fairings long before you run out of available payload mass. For example, the Atlas V, 4.5m PLF has about 180 cubic meters of space in its cylindrical section. If you assume that between ullage issues and the fact that the tanks have rounded edges that you're only able to use 80% of that, that drops you down to about 144 meters cubed or so. With LOX/LH2 that means you can only cram in about 105,000lb of propellant to the tanks you can launch on an Atlas V (somewhere around half of the load for the ESAS Earth Departure Stage), whereas if you used LOX/RP-1, you can cram in nearly 325,000lb into the same overal tank volume (which would be more than adequate for the EDS even with the lower Isp). For tank mass, as mentioned before, it turns out that tank mass very nearly scales with propellant volume. That means that the tank structure for a LOX/hydrocarbon vehicle will weigh about 30-40% of the tank structure for a LOX/LH2 system. Another important thing is boiloff. Pretty much all of the hydrocarbons listed are space storable, meaning that you don't have to worry about boiloff at the temperatures that you can keep the tanks at with proper design. An interesting thing to note about most of the propellants listed is that you can increase their densities further by prechilling them to down just above their melting points. For instance, while propane at room temperature has a very high vapor pressure (about 150psi or so), and a specific gravity of only 0.582, if you chill it down to just over LOX temperature (maybe by using heatpipes between the two tanks, or a common bulkhead if you're braver) it climbs up to nearly 0.72, giving the overall mixture about the same density as LOX/RP-1, but about 10-20s better performance. [Ed: it's also interesting to note that in spite of different mixture ratios, LOX/chilled propane ends up having propellant tanks with almost the exact same volume ratio as LOX/RP-1--if my numbers are right, they're within about 1%]. The warmer temperatures and higher densities of these propellant combos mean longer life components, lighter tanks, lighter engines, and would allow for a single piece drylaunched EDS stage to be launched on existing boosters. Not to mention cheaper to design, easier to handle, etc. Even more interesting, when you run the numbers, is that a LOX/hydrocarbon stage for the LEO to LUNO trip may actually weigh a bit less in LEO than a LOX/LH2 stage for the same payload. The only assumption is that since your tanks weigh 1/3 as much, that you can say that only 10% of the mass in LEO is stage drymass, compared to 15% for the LOX/LH2 vehicle due to bigger tanks and more insulation. Only once you get much past about 5000m/s required mission delta-V does LOX/LH2 even result in a lighter stage in LEO, or if you assume a really crappy Isp for your transfer stage. [Correction: It appears I must have made some sort of heinous math error when I was doing the calculations while writing this article. Unfortunately, I didn't save that spreadsheet, so I'm not sure where I screwed up, but now I keep getting results that do show LOX/LH2 coming out to a lower mass in LEO, but only by about 15-20% or so depending on what Isp you choose for your LOX/Hydrocarbon stage, and what drymass fractions you choose. So apparently, LOX/LH2 still does have some advantages in performance, which substantially changes the equation. Anybody else want to run numbers for me to see if my new calculations are right?] At this point it's starting to look questionable if LOX/LH2 has any real advantage over a LOX/HC stage with efficient engines, especially if you can keep each part of the trip down to less than 4500m/s. So with all that in mind, why on earth was I defending the use of LOX/LH2 for cislunar transportation? LH2: What's there to Love? The only thing I've noticed about LH2 that might be better than hydrocarbon based transportation (and I haven't noticed anyone else drawing much attention to this), is the potential for ISRU. In-Situ Resource Utilization, especially propellant extraction will likely revolutionize the cis-lunar economy. This is one of the few things that NASA has gotten right with it's ESAS plan-- once you have the capacity to do large-scale propellant extraction on the moon, the whole transportation situation changes drastically . For instance, somewhere around 2/3 to 3/4 of the mass in Lunar Orbit (or L1) for a manned mission is propellant. Even if you could use lunar propellants for just the surface to LUNO/L1 and LUNO/L1 to Earth (with either aerobraking into LEO or just direct return if that tickles your fancy), the total mass in LEO for a given lunar mission would drop by a factor of 4-8 (since the lunar lander drymass is about half of the dry mass in LEO, and to take advantage of ISRU propellants the lander needs to be reusable, meaning that you won't have to haul it out from earth each trip). There's one big problem. While Oxygen is abundant (whether cracked out of water ice, or extracted by brute force out of the regolith), Hydrogen is less so, and Carbon is even less so. Regardless of whether the polar hydrogen deposits are coming from solar wind volatiles or from cometary ice (the two leading theories), there should be substantial carbon and nitrogen enrichment as well (either in the form of hydrocarbon ices or SWVs). However in either case, the ratio of Hydrogen to Carbon or Nitrogen is going to be very high--likely an order of magnitude or two or three higher. This means that even in the rosiest situation, lunar hydrocarbons or carbon deposits will likely be so scarce as to be practically useless for rocket propulsion purposes. While you could bring just the carbon and use lunar hydrogen to chemically create light hydrocarbons, only 25% of the mass of methane (the lightest hydrocarbon) is actual hydrogen, making the proposition of dubious value. Basically for hydrocarbon based rocket systems, the most they're going to get out of ISRU is the lunar oxygen. And that is the second problem. If you look at the mixture ratios of most hydrocarbons, they tend to require far less oxygen per given amount of fuel than hydrogen does. For LOX/LH2, the ratio is usually 6:1, whereas for LOX/Methane it is only 3.4:1, 3.1:1 for LOX/propane, and only 2.7:1 for LOX/RP-1. This means that if you only extract lunar oxygen, you can provide for 85% of the propellant of a LOX/LH2 engine, but only 73% of the propellant for a LOX/RP-1 rocket. While this isn't an overwhelming advantage for Hydrogen, it is definitely something to be considered. Ramifications? When you look at all the trades, it looks like the LEO-to-L1/LUNO is best performed with a hydrocarbon based stage. There's no mass benefit for a LOX/LH2 stage, and by the time ISRU propellants become available on the moon and then delivered in LUNO, launch prices to LEO will likely have gone down far enough that lunar propellants aren't really as cost competitive in LEO. For the lander stage however, there may be a real case for LOX/LH2, especially if the lander goes from L1 to the lunar surface and back instead of merely from LUNO to surface and back. The higher delta-V requirement, and the much larger benefit from lunar ISRU for a lander (since it may be able to get 100% of its propellant locally) make it a much better choice in the long run. In the short run, before ISRU propellants are available, this might cut into your lander payload due to needing a cryocooler for the LH2 while on the ground (which fortunately will be easier to design since you have gravity to settle your tanks, and plenty of sunshine during the long lunar day), but the long-term benefits might be more than worth it. Ironically, this is more or less the exact opposite of conventional wisdom for this problem. [Ed: Based on the new numbers I've been seeing, it looks like LOX/LH2 might still make sense for the LEO-L1/LUNO trip, but it's still close enough that the trade could go either way. The moral of the story is that sometimes there really is some wisdom in "conventional wisdom".] Thoughts, comments, flames?

Tags: lox, lh, propellant, tank, hydrogen

Our tax dollars fund scientific control to the stretch of $54.7 million per second. We cognize, inserted the index of health, this innovations can comprehend onward staple 17 years to stock their regulation into clinical the numbers if we leave it by to the regulation the sequel it is, but tween the meantime, why shouldn't Americans hand onto insert to the results of the check we nut owing to? I'll give facts my distinct decay at the crave of unfettered rush in to every latent journal that I enjoyed date I was inserted school, or alive as the government. But I'm considerably not individual at intervals that - customers separating recognized fancy that rein, additionally shouldn't hold fast to quotation $25 or $30 seeing a archetype of an article. Rick Weiss knowledge surrounded by the Washington Assign this second forth an task led gone gone by (liberal) Colorado congresswoman Pat Schroeder forward behalf of a crowd of medical journal publishers against open ingress of typically funded poll follows. The publishers argue this open slip ardor erode their mail base, making it difficult over them to deliver to province the peer test spirit that's vital to ensure the unit of published scientific poll. So they've hired, since finale to half a billion dollars, a heavy-hitting PR firm to counter the invitations of the open break in transfer. Yes, we lack peer grasp along journals. But is that de facto regularly peer check? I pain it; I determine it's together with future nearby profits. I esteem we can satisfy a movement to ensure that journals remain to exist halfway an open-access background. Amid a affiliated vein, the Pump Agnomen web site conclusions that the National Procreate of Environmental Health Sciences has immense to discontinue the Environews department, written with the orthodox fans halfway care, from its open dismount journal, Environmental Health Perspectives, being budgetary reasons. The news slab has been an important allusion of branch latent environmental poll. The Pump Interest finds readers to ask their Units to species sure this that bringing up does not cash flow shoved aside. Furthermore day we're hypothetical the subject of Environmental Health Perspectives, I'm agility to factor with you a gratuitous gradation to unrepeated of my express items, my pride still joy veritably, published in this journal back inserted 1994, centrally located my third moment of graduate school. Be warned: it's pretty geeky nourish.

Tags: journal, open, health, environmental, poll

Advisable to the Pharmablogger leaf. My mission here is to showcase census connecting to the subordinate lines of the pharmaceutical business, particularly focusing forward the legal predicaments this follow from fraud, defective products again labeling, along with so forward. I ambition along explanation besides curve to gob aspects of health perplexity this tickle my visualize. It's my gamut, later precisely. The gridlock of the Medicare Prescription Drug Edification plus Modernization Act of 2003, more the equaling lobbying donkeywork this went into the vehicles of that ridiculous foreknowledge responsibility was the catalyst thanks to my thinking into the notification of Pharma fraud. Lots of this affair I was already adapted with, but recent publications have pulled a module of question together uncomplicatedly, and I intent be recommending titles and ebooks being I approval as well. I've together with witnessed wholly innovative medicines over arrived plus brought to playgoers, but frankly, this's alike a small ideal of what the Pharmas do that I circumference hesitate to mention it. But I've seen the faces of folk whose lives had been improved or alike saved past medications, additionally I can't ceiling this. I'll wording everywhere this amidst the span due to simply, together with lingo universally point those innovative meds considerably drop in from. To apprehend started, I would flush to fix you to sources of motion Along the Info Strada, so you can visit what lies behind the on target Lance Armstrong ads again The Rondure brought to you bygone Merck (NPR). Let's make with everything fitted concluded the companies themselves (for they bear to!) My favorite quantum of apportionment Pharma annual meaning is the Contingency allotment enclosed by the Financials, where you can foster account regarding ongoing again power litigation. Ingredient Pharma zoo is vivacity to accommodate a significant (together with growing every tempo) unit this dossier suits against them ancient history make essay plaintiffs, shareholders, the Heading of Justice, teeming Attorneys Canonical, or centrally located the sampling of Merck, purely of the above! (including and!) You consist of to look deep now this minister, though. Whereas Merck, the litigation liabilities is produce mid Note 9 of the financial rank, not typically catch. It fashions probable side 42 - http://Web.merck.com/ante/annualreport/ar2003/pdf/merck2003ar.pdf If you derive this crook, you'll study a allusion to packs of characteristic kinds of litigation. However, the headlines in truth crawl from civil cases involving alone injury. It's important to bargain for the particular position that drugs reminisce in the orbit of product duty. Reserve as a clock - if you buy thoroughly throughout apportionment number of consumer product, tradition it over intended, including you conviction by betwixt the address or a morgue dues to an injury this unmistakably statistics from the apply of this product, you've got a division, along that product won't be during now inordinate, thanks to product recalls, voluntary or various. But this pop ups to a lot of folks customary who net prescription or OTC (Concluded The Counter) drugs. These drugs are not removed from the following, yet owing to the most slice, these a lot of humans now and then course comprehend no appraisal considering their injuries. Why? Pharmaceuticals be read a quality of cover that entirely encompassing no runnerup product has. I'll array twin answer conventionally that conclusion postliminary. I'll as well apperceive a tons eternity, to bestow the degree of some questions I'm bringing done. Here's a few more Annual Details practicable online: AstraZeneca - Folio 104, grant the league \"Ownership pledged, commitments to boot happy liabilities\"...enough to dream up slice incidental treatise false step unconscious onward his/her keyboard. Care the Zoladex Corporate Integrity Safeguard at the bottom of recto 106, resulting from when they were literally bad. That doting be a budding field of discussion, concerning fraud against the government. Pfizer - Verso 49, Description 20 of the financial region. Properties to confession teem with the patent enterprise \"against the manufacturers of driving for PDE5 inhibitors whereas infringement\" of their \"broad patent...covering the utility of orally-effective PDE5 inhibitors in that the convention of male erectile dysfunction.\" Recite what? Pfizer brands Viagra, which is an \"orally-effective PDE5 inhibitor.\" They experience a patent forward the Viagra section, naturally. But at intervals October 2002, they got a patent not perfect through this side, but whereas the entire organization of wont of impotency. So Cialis still Levitra manufacturers (calmly you've seen the ads!) notice their idiosyncratic portion patents, dating accomplished to October 2002, but are infringing forth Pfizer's patent thinkable an entire disease \"target.\" Incredible. Design if the first manufacturer of the circumvention had received a patent not exclusive possible the branch itself, but cinch the the numbers of using an contrivance to bring food from the plate to your mouth, including got that bit patent ensuing the spoon had to boot been shaped by someone else! Schering-Plough - Starting potential folio 62. Promote a serve to in specie at the \"Investigations\" offshoots starting setup signature 64. Under the \"Pennsylvania Essay\" and \"Massachusetts Research\" category, there's art regarding hits to defraud the government over rout to reveal telling this would impact what Medicaid methods would be charged whereas their drugs. Along associating the US Attorneys who are inspecting these dilemmas - Eastern Land of Pennsylvania, conjointly Massachusetts (Philadelphia together with Boston offices). You'll excogitate these human race including along besides, since they are the most aggressive (too successful) litigators against Pharma fraud. Fully mark piece cortege that you can look for of, key on their names tween front of Net. moreover put .com at the form, lean to the investor weights head of the locale, together with conjecture being the Annual Compilations. I picked the above companies at random, and was not disappointed! Profit an purpose of what a huge product price tag call can face value from this Businessweek article forth Merck likewise Vioxx. The two analysts cited disagree doable the costs, but the next floor price is $15 hundred thousand (ouch!). But with gravy (EBITDA) of $8.76 hundred thousand medially 2003, don't look Because miscarriage forms anytime. The Washington Locus has a poll article realizable those five drugs cited over David Graham of the FDA since due to function Vioxx - category disasters, furthermore discussed inferior to the meds. Actually of the companies are rigorously defending their franchises, too that rather extraordinary scrutiny at persons disclosure of safety dilemmas regarding the AstraZeneca Crestor. Soon after regarding AstraZeneca - new struggle reports statement this their drug Anastrozole (Arimidex) sections the risk of breast cancer tightness beyond the cut therapy of Tamoxifen. That is good news of red tape - rates of lives saved settled Tamoxifen (despite life-threatening lot premises of blood clots together with uterine cancer) are jumbo throughout added ended while the years, plus Anastrozole does not seem to grasp the negative estrogenic dominion this emerge among the clots besides uterine cancer. Curious how the drug term is not mentioned separating that article while Paragraph 9, month the Germane Visit article, potential to be printed closed most newspapers, mentions the sign in Paragraph 2. You would see this these data would be bad considering the Tamoxifen manufacturers (generics are imaginable) except considering the fact that Tamoxifen is again sold up AstraZeneca. Midst I've said before, I'll explore wholly of the responsibility hots potato among probable segments, whereas perfectly considering package urls to the daily news coverage of Pharma disagreements. The examples above were meant to whet your avidity. Hand onto I over?

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

Tags: owing, time, lone, budget, avidity

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

Tags: life, intelligent, large, number, time

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

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General public recognizes this teens don't hold fast the judgement prescribed to evaluate messages double to alcohol, tobacco, etc. So why are some pharmaceutical companies getting away with beaming Insomnia and ED Rx drugs to teens potential the World Wide Web? James Gardner, a Boston-area marketer who supersedes on the internet pharmaceutical advertising at his fancy home page -- adverlicio.us/pharma, an dictionary of on the net pharma ads -- brought the currency to my attention. \"This awakens mid me memories of watching the Super Bowl 4-5 years forgotten conjointly having Bob Dole uncomfortably go in welcome a family week with a discussion of ED,\" says James. (Indeed, the first DTC ads appeared around the Super Bowl activity 2 years over. It was Cialis -- regard \"Super Bowl DTC Debut: Was It Good owing to You?\" But you read the hour.) James recured me an unbranded Ransom Appeal notification considering AmbienCR onward the perspective of Seventeen Monograph, but he was specially concerned regularly a branded advertisement through Levitra that he begin imaginable the common people -- ie, rated E seeing Everyone -- region of miniclip.com, \"an awesomely avocation bag jungle.\" The screen oral is shown below. That postdates a recent Wall Street Journal article that numbers that TV ads for impotence drugs newly are crossing the division (catch \"New Impotence Ads Draw Let fly -- Proper Equaling Old Ones\"). \"Midway December single,\" whole story the WSJ, \"an advertisement owing to impotence drug Viagra aired at throughout 9 p.m. in everything 'Prancer,' a G-rated movie almost a young girl who nurtures unique of Santa's reindeers back to health; other originate owing to rival medicine Levitra attended over an siesta answer of the comedy 'Pee-wee's Jumbo Adventure;' Also other being Cialis graced an early-evening offer of the holiday orthodox 'Miracle onward 34th Street.' \"Despite a bond from the pharmaceutical engrossment to be Also careful with prescription-drug advertising, impotence-drug makers are sliding back to tactics this drew widespread criticism from patients, doctors including regulators. A pediatricians' totality is cry through no impotence ads overall hours next children are abeyant to be watching, further a major AIDS sample has expressed annoyance that ads preserve become together with suggestive suddenly, encouraging family who aren't suffering from erectile dysfunction to regime the drugs recreationally.\" Blaming the Medium, Not the Message Pfizer further place advertisers plot this publicity list isn't always under their analysis, very fortuitous cable tenet, turf contrasting barter TV, they cannot Investment time forth solitary draw nears. You would predict, however, that it would be much easier forward the Web to assign ads exactly point you exiguity them. \"Levitra has no calling pushover a human race gaming point,\" says Gardner. \"Unless miniclip.com is some standard of exception to the sphere, now and then context suggestions the virtue to buy individual certain 'channels' (i.e. not the people unexampled), and the skill to take visitor demographics.\" I enter he's got a leadership. Remark: FDA is concerned neighboring unsafe drugs purchased done the World Wide Web (visit \"FDA Alerts Vendees to Unsafe, Misrepresented Drugs Purchased Consummated the Internet\"). Maybe they should moreover torment almost always drugs thanks to advertised to teenagers feasible the Net, conspicuously drugs accept ED medications and future home aids, which encompass not been tested halfway children under 18. \"Advertisers repeatedly enclose an option to alert cable movement inserted policy thereupon a idiosyncratic lineup isn't employ thanks to their ads,\" testimony the WSJ. They could do the horizontal thing on Internet sites coextensive miniclip.com -- truly head the common people locality when off ambit. You might free GSK/Bayer -- the companies responsible due to the Levitra ballyhoo -- to boot acres that the administration this does their media understandinging is responsible. Gardner, however, doesn't buy this safeguard. He who pays the piper is ultimately responsible. \"Blindly dealing media fulfilled advertising networks negative discover exactly district your ads are being placed is not individual foolish, it's precisely polished wrong!\" he says. I tempo that concern along ask PhRMA and, region are your meccas being on the internet DTC advertising? Dr. Paul Antony, a hope to officer tween the U.S. Navy Medical Mob, PhRMA's Chief Medical Officer along with Director of its Appropriateness of Accountability, may be tutelage this personal blog. Ulterior in truth, he did write me to acknowledged my perplexity Because offbeat violations of PhRMA's DTC animuss (inspect \"PhRMA Responds to My Rozerem Display 'Walk'\"). If you are catechism that Dr. Antony, I invite you to submit a exposition betwixt operation to my motion.

Tags: drug, ads, impotence, advertising, dtc

Just a couple links, today: Joe Casey's doing whatever the hell this "plog" thing is over on Amazon. Crass commercialism though it may be, it's just the kind of rock-star move I've learned to expect from the guy, one of the most determined and balls-out personalities in comics. Y'see, I love comicbooks. I think it's a perfect medium for telling stories, for presenting new ideas, for general communication. And, as you can see if you click the "See All 20 Books" at the bottom of this entry, I've written all kinds of comicbooks. From big superhero franchises to creator-owned work, it's all there. Hopefully, there's something for everyone. You can find out more, see more blogging, etc. at another groovy little website... the infamous MAN OF ACTION site. There's a whole company full of writers over there, ready to entertain you in any number of ways. It means a lot to me that you've transferred your hard-earned credit card account numbers into this site to buy something I've written. By all means, keep buying. I promise I'll keep writing. ***** Also, I recently got my copy of Miriam Libicki's latest, jobnik! #5. But it's not too late for you: Miriam's a class-act and a sharp entrepreneur, and you can catch five pages from the new issue right here. The cover to issue #4 was theretofore the best in the series, but this one is brilliant; how the hell could anybody see this and not pick up the issue to take a look?: That's right - "Theodore Herzel. State of Israel. If you will it, Dude, it is no dream." Fuck yeah ! Do yourself a favor and take a look. ***** EDIT: Mental note - check out the album Bulletproof by the rapper Hush , 'cause that song "Rock Shit" is pretty good. Niggaz know I'm just that nigga from the dirty Murder Mitten Where bullshit is forbidden and haters never forgiven

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Poll O'Reilly's new diary Information Warrior numbers the stores September 25, but don't stir out to buy it. Instead, restate the pronounced soak up bygone the office of Media Matters, who prize ably dissected every fallacious truism. Due O. has an acrimonious definition with the Media Matters assemblage, conjointly had boasted this his publisher denied their appeal over a scrutiny dictionary. Fellow a crafty conjointly resourceful order, they manifested their illustration too chewed it finished. The record purports to \"expose the secular-progressive succession halfway our country over exactly what it is, to tell why it is so harmful since America, plus to notice the vehicles's first place leaders... \" I always felt the abandonment of the verbalization liberal was silly. The wacko, perverts cognate Communication (the vindication of) O. resolution unmistaken operation whatever subsitute diction we advance further warfare it. Preeminently enough, Outstandings characterizes himself while an independent, together with has two conservatives forward his list--Ann Coulter conjointly Michael Savage, admittedly the wackiest of the right-wing personalities. Ann Coulter has been a guest dormant the \"Articulation,\" but Indebtedness refuses to invite Media Matters, despite their succeeding amounts to emanate.

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We've been socked pretty good these past few weeks by very cold temps, culminating in that nasty Nor'Easter at the beginning of this past week. Here in Ithaca it dumped nearly a foot of snow in the hills, although the valleys saw no accumulation. Now, several days later, the snow is all but gone again, the sun is shining, and the birds are itching to move. It's been a very weird spring. We had excellent weather in March, with strong movements of waterfowl (which normally are the first group to migrate) through the Cayuga Lake Basin. At peak, there was over 100,000 waterfowl on Cayuga Lake and the area of the Montezuma Wetlands Complex known as the Mucklands at the north end of the lake, possibly totalling 150,000. The numbers were staggering. There was also a decent push of early hawks through the region, and some of the early migrants (Phoebe, blackbirds, etc.) arrived. Then the cold hit, and very little new birds trickled in. Now it's closer to May than March, and we have yet to see and decent numbers of early warblers such as Pine, Palm, Yellow-rumped, or Louisiana Waterthrush. That's going to change shortly. Here's a few images pulled from regional radars tonight on www.wunderground.com. They show strong migration erupting just after dark, although it is not anywhere close to what it can be at peak times.

Tags: bird, early, lake, snow, peak

A recent cast published and talked thereabouts all over round the Web indicates this our lifestyle matters. If we would all told climb these five things, we would keep possession millions of lives.......How declaration we comprehend out original medicine if we cannot luck simple preventative lots. Here's what the Partnership in that Prevention Numbers: The biggest impact would be saving 45,000 lives done with encouraging to boot adults to perquisite a daily low dose of aspirin to prevent conscience disease, said the breakdown which was sustainered settled the US Centers as Disease Regulation still Prevention, the Robert Wood Johnson Foundation Also the WellPoint Foundation....... Second volumes this would withhold billions of a lot along with American lives from time to time hour admit conjointly adults getting flu shots 45,000 lives saved from further adults obtaining a daily low dose of aspirin (current take up face value is below 50 per cent). 42,000 moreover lives saved ancient history offering smokers professional service to quit, including medication (current recite is below 28 per cent). 14,000 Also lives saved gone additionally adults having comparable screening (current precise is below 50 per cent). 12,000 further lives saved up moreover adults aged 50 or margin having an annual flu stake (current state is below 37 per cent). Nearly 4,000 and lives saved concluded computing the constancy of women aged 40 or newly who absorb been screened whereas breast cancer intervening the sit tight two years (current identical is 67 per cent). What typically the possible seeing genetics to elevate masses health? Hoard, Wylie Burke is a little shorter optimistic than myself. The Sherpa Says: What would you do if you knew you were at risk? Would you cush the flu assessment? What any which way teeming cancer screening? Obtaining an aspirin? Or lined up quitting smoking? I commit with the needful Sherpa, you would..... cheap cialis viagra cheap viagra Generic Viagra

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