Congress Fiddles (Drugs for renal anemia)
Posted on September 07, 2008 in Erectile dysfunction drugs
"The United States is virtually the only country in which patients get super-high doses. You create a toxicity situation," said Dr. N.D. Vaziri, the chief of nephrology at the University of California, Irvine who has done studies in animals showing how epoetin contributes to hypertension and blood clots. Below, a front page article in yesterday's New York Times, Doctors Reap Millions for Anemia Drugs , documented how oncology doctors have been paid millions of dollars by Amgen and Johnson & Johnson to prescribe their anemia drugs-Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson-to patients with kidney disease or cancer chemotherapy. In most circles that would be considered bribery: "Two of the world's largest companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses. The payments are legal, but very few people outside of the doctors who receive them are aware of their size." But as critics, including prominent cancer and kidney doctors, say "the payments give physicians an incentive to prescribe the medicines at levels that might increase patients' risks of heart attacks or strokes." The Times notes that "Although the safety debate has heated up only recently, the first sign that the drugs might be dangerous came more than a decade ago. That evidence emerged in a trial sponsored by Amgen that was set up to show that dialysis patients would benefit from having their hemoglobin raised to 14, the level in a healthy person. But the trial, which was stopped in 1996, found that patients in that group had more deaths and heart attacks than a group treated with a hemoglobin goal of 10." "That trial should have discouraged doctors from using too much epoetin and encouraged Amgen to study the risks further, said Dr. Steven Fishbane, a nephrologist at Winthrop-University Hospital on Long Island. Instead, use of epoetin continued to soar." Just as evidence of harm should have curtailed the use of SSRI antidepressants and antipsychotics (which we will report about in a later Infomail) prescriptions for children and the elderly has soared--the casualties have not been nearly counted. "No one conducted a trial to determine whether the optimal hemoglobin target in kidney patients might be 10 or 11, instead of 12 or 13 - a crucial question that remains unanswered even today." [Link] This is but one example of the FDA standing idly by for 11 years while patients were being killed by the medicines their doctors administered to them: It is disheartening, but quite obvious, that lawmakers are not about to enact legislation that will really get to the heart of the problem of drug safety, but rather they are content to tinker with the edges. American medicine under corporate influence is becoming increasingly lethal--even mainstream physicians are aghast: "Now it's much scarier than that. We could really be doing harm." Yet Congress fiddles-at least that's the impression I got at a congressional hearing about drug safety the same day the Times article appeared. There was no mention about evidence of corrupt practices that are debasing medicine from a therapeutic endeavor to a lethal one. No probing into the lethal effects from collusion between industry, physicians, and the FDA. Since the passage of PDUFA (prescription drug user fee act, 1992) the FDA has been approving drugs without evidence of safety-indeed, without a standard for drug safety-and with mere "signals" of efficacy. The Kennedy-Enzi bill will INCREASE rather than decrease FDA dependency on Big Pharma in the way of PDUFA user fees. Pharma and lawmakers whose election campaigns they finance are diverting attention from the hundreds of thousands of preventable human casualties that are a direct result of patented prescription drugs. Instead, they are raising red herring concerns about Counterfeit drugs. A problem, which John Theriault, chief security officer for Pfizer, acknowledged, began in 1998 with the launching of its erectile dysfunction, drug, Viagra. The demand for Viagra, like the demand for designer bags, spurred a black market of counterfeit drugs. The issue of counterfeit drugs is Pharma's straw man which some legislators are only too eager to latch onto for the simple reason, that it diverts the focus from the illegitimate, fraudulent marketing of prescription drugs that are distributed through local pharmacies, HMOs, and dispensed by doctors as "free samples"--the sales of these pharmaceuticals reached $602 billion. [1] These tainted drugs carry the FDA seal of approval, are prescribed by U.S. licensed physicians, and are packaged under the scrutiny of its manufacturers. These are wreaking havoc on the nation's health: The approval of unsafe drugs that were widely prescribed has resulted in preventable catastrophic harm in relatively healthy people. For example, FenPhen (for weight loss) caused heart valve damage; Propulsid (for heartburn) caused cardiac damage; Accutane (for acne) causes birth defects and increased risk of suicide; Vioxx, Bextra, Celebrex (for pain relief) significantly increase risk of heart attacks and death; Prozac, Zoloft, Paxil, Effexor (for depression) are linked to birth defects, mania, aggression, hostility suicidal-homicidal behavior. Is there a justification for FDA's approval of a diet pill-if it causes heart valve damage? Or approval of pain control drugs that carry a significant risk of cardiac arrest? Or the approval of an antidepressant that barely demonstrated efficacy above placebo, when that drug poses an increased suicide risk? Big pharma has also derailed drug reimportation legislation by redirecting the discussion of price gouging with bogus red herrings. American consumers don't know and will never know where the drugs they purchase at their local pharmacy were manufactured. Mostly NOT in the U.S. Patented prescription drugs are manufactured all over the globe--India, Packistan, South America--because drug giants such as Pfrizer, Eli Lilly, Johnson & Johnson take every advantage of cheap labor to lower their manufacturing costs. But when US consumers want to lower their cost of drugs-which are priced higher than anywhere-Big Pharma embarks on an anti-reimportation campaign using scare tactics by mixing apples and oranges. Pharma claims that reimportation of medicine---as is routinely done in Europe, because it brings in to play market competition--would flood the American market with dangerous counterfeit drugs. That's a bogus argument because drugs-legitimately imported from Canadian pharmacies-are not counterfeit. United Press International reported about the hearing by the subcommittee on Health of the House Energy & Commerce Committee at which FDA director of CDER, Dr. Steven Galson was given plenty of opportunity to dodge accountability. Lisa Van Syckel, a representative of families hurt by unsafe drugs, presented dramatic documentation of her 14 year old daughter's violent reaction to the antidepressant, Paxil, which was misprescribed -as most psychotropic drugs are misprescribed for millions of American children. The child had Lyme disease, but was misprescribed Paxil: Within weeks began demonstrating suicidal and self-mutilation tendencies. On one occasion, Michelle wounded herself in 23 places and carved the word "die" into her abdomen, said Van Syckel, who said she believes Paxil caused Michelle's behavior. "Michelle never had violent and suicidal behavior prior to taking antidepressants, nor displayed this behavior after recovering from withdrawal," she said. Ms. Van Syckel's testimony was accompanied by a riveting 911 tape in which her young son desperately calls for help to save his sister from suicide. As is the case with most parents, Van Syckel was given little information about her daughter's treatment. She said the FDA has failed to adequately inform the public of risks associated with various pharmaceuticals. Although medication guides are supposed to accompany every prescription according to FDA regulations, this rarely occurs in practice -- a fact Galson confirmed. Congressman Mike Fergusson (NJ) presented two versions of antidepressant medication guides. Dr. Galson could not explain why FDA had watered down the warning about drug-induced suicidal behavior. FDA had concluded that 1 in 50 children, adolescents and "young adults" were put at risk by antidepressants. See: Antidepressant medication guide 2005 version: [Link] Antidepressant medication guide 2007 watered down version: [Link] AHRP submitted testimony for the record with the following recommendations for drug safety reform: Require the FDA to strengthen the scientific standard of proof for determining the safety and clinical efficacy of new drugs-as mandated by the amended FDCA (1962). Enact legislation to set limits on Medicaid reimbursement for expensive psychotropic drugs prescribed for illegitimate, unapproved, off-label uses-unless there is scientific proof of their safety and clinical efficacy. Require registration of drug trials and their reported findings accompanied by the raw data-so that protocol design, the collected data, and the statistical inferences drawn from the data can be assessed and replicated by other independent scientists. Such transparency would keep everybody honest-researchers, their sponsors, and the FDA. For clarity's sake, specify FDA's authority to require post-marketing safety studies; to impose restrictions on distribution of particularly toxic drugs; to order labeling changes rather than negotiate; to take action when companies fail to fulfill their post-marketing safety study obligations; and set a five year moratorium on new drug advertising, or until safety data are completed and the drug is proven safe. Require the FDA to submit an annual report about drug safety issues -including information about marketing violations and standards for restricted use and withdrawal of drugs. Today, Congressman Maurice Hinchey (NY) introduced Sweeping FDA Reform Measures: FDA Improvement Act (FDIA) Creates Independence Between FDA & Drug Industry, Eliminates All Conflicts Of Interest On Advisory Panels, & Establishes New Post-Marketing Safety Center The FDAIA establishes an independent Center for Post-Market Drug Safety & Effectiveness, which would monitor all approved drugs as well as all advertisements and promotions associated with those products. Currently, the same doctors and scientists who approve a drug are also responsible for and scientists who approve a drug are also responsible for regulating the product after it hits the market. Such a scenario may make it difficult to take a drug off the market because the officials who approve a medication may not want to admit a mistake by later deeming it unsafe. Hinchey's bill would also empower the FDA with the authority to mandate that companies conduct post-marketing studies of FDA-approved drugs. Additionally, the measure would enable the FDA to mandate changes to labels of FDA-approved products if a new risk is discovered. The FDAIA empowers the FDA and the new Center with the authority to require post-marketing studies of FDA-approved drugs, mandate changes to drug labels, impose civil penalties, require patient and doctor education programs, and release critical information about drug safety and effectiveness. "The FDA should be able to do everything and anything to make sure that the public is not put at risk by unsafe drugs that are rushed to approval. Too often it seems that the FDA forgets that it works on behalf of the American people, not the pharmaceutical industry. That is a fundamental problem that must be addressed." See: [Link] html References: See, partial list of U.S. Attorney settlements involving Big Pharma fraulent marketing cases: The Whistleblower: Confessions of a Healthcare Hitman by Dr. Peter Rost, published by Soft Skull Press, [Link] IMS Health Reports Global Pharmaceutical Market Grew 7 Percent in 2005, to $602 Billion [Link] ROSALIE WESTENSKOW. ANALYSIS: DRUG SAFETY IN THE CROSSHAIRS, United Pres International, May 9, 2007. [Link] [Link] The New York Times May 9, 2007 Doctors Reap Millions for Anemia Drugs By ALEX BERENSON and ANDREW POLLACK Two of the world's largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses. The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients' risks of heart attacks or strokes. Industry analysts estimate that such payments - to cancer doctors and the other big users of the drugs, kidney dialysis centers - total hundreds of millions of dollars a year and are an important source of profit for doctors and the centers. The payments have risen over the last several years, as the makers of the drugs, Amgen and Johnson & Johnson, compete for market share and try to expand the overall business. Neither Amgen nor Johnson & Johnson has disclosed the total amount of the payments. But documents given to The New York Times show that at just one practice in the Pacific Northwest, a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million worth of its drugs last year. Yesterday, the Food and Drug Administration added to concerns about the drugs, releasing a report that suggested that their use might need to be curtailed in cancer patients. The report, prepared by F.D.A. staff scientists, said no evidence indicated that the medicines either improved quality of life in patients or extended their survival, while several studies suggested that the drugs can shorten patients' lives when used at high doses. Yesterday's report followed the F.D.A.'s decision in March to strengthen warnings on the drugs' labels. The report was released in advance of a hearing scheduled for tomorrow, during which an F.D.A. advisory panel will consider whether the drugs are overused. The medicines - Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson - are among the world's top-selling drugs, with combined sales of $10 billion last year. In this country, they represent the single biggest drug expense for Medicare and are given to about a million patients each year to treat anemia caused by kidney disease or cancer chemotherapy. Dr. Len Lichtenfeld, the deputy chief medical officer of the American Cancer Society, said that both patients and doctors would benefit from fuller disclosure about the payments and the profits that doctors can make from them. "I suspect that Medicare is going to take a very careful look at what is going on here," he said. Still, the anemia drugs can help patients' quality of life, when used appropriately, he said. "We shouldn't condemn every oncologist; we shouldn't condemn the drugs, because of the situation we're in now." Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians' offices or dialysis centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors' purchase price. Medicare has changed its payment structure since 2003 to reduce the markup, but private insurers still often pay more. Combined with those insurance reimbursements, the rebates enable many doctors to profit substantially on the medicines they buy and then give to patients. The rebates are related to the amount of drugs that doctors buy, and physicians that agree to use one company's drugs exclusively typically receive higher rebates. Johnson & Johnson said yesterday in a statement that its rebates were not intended to induce doctors to use more medicine. Instead, the rebates "reflect intense competition" in the market for the drugs, the company said. Amgen said that rebates were a normal commercial practice and that it had always properly promoted its drugs. "Amgen is dedicated to patient safety," said David Polk, a spokesman. "We believe our contracts support appropriate anemia management and our product promotion is always strictly within the label." Both companies' stocks fell yesterday after release of the F.D.A. report. Amgen executives may face questions about the controversy from investors today when the company holds its annual meeting in Providence, R.I. Since 1991, when the first of the drugs was still relatively new, the average dose given to dialysis patients in this country has nearly tripled. About 50 percent of dialysis patients now receive enough of the drugs to raise their red blood cell counts above the level considered risky by the F.D.A. American patients receive far more of the anemia drugs than patients elsewhere, with dialysis patients in this country getting doses more than twice as high as their counterparts in Europe. Cancer care shows a similar pattern. American cancer patients are about three times as likely as those in Europe to get the drugs, and they receive somewhat higher doses. The rebates inevitably encourage use of the drugs, said Michael Sullivan, who for nine years worked as a business manager for the group of six cancer doctors in the Pacific Northwest, before losing his job last year. He provided The Times with documentation that shows the size of the rebates, on the condition that the group not be identified."Personally, I think rebates should go away," said Mr. Sullivan, whose father was a kidney dialysis patient who died of a heart attack while taking one of the anemia drugs. "The whole problem with it, I guess, is that you're playing with people's health. It's not the same as buying widgets." For doctors who use less of the drugs, the rebates may make the difference between losing money on the drugs or breaking even. Mr. Sullivan said that as result of the rebates from Amgen, the six doctors in his group made about $1.8 million in net profit on the drugs they prescribed. Unlike most drugs, the anemia medicines do not come in fixed doses. Therefore, doctors have great flexibility to increase dosing - and profits. Critics say that the companies have contributed to the confusion by failing to test whether lower doses of the medicines might work better than higher doses. "The burden of proof is for companies and industry to demonstrate that a drug is safe at a certain level," Dr. Ajay Singh, an associate professor at Harvard Medical School. Dr. Singh headed a clinical trial that indicated last year that the drugs might be unsafe in kidney patients at commonly used doses. Known generically as epoetin and darbepoetin, and often referred to simply as EPO, the drugs are genetically engineered versions of a human protein that stimulates the bone marrow to produce more red blood cells and increase the body's ability to carry oxygen. Most doctors and patients agree the drugs are very helpful for patients when used to correct severe anemia, which can be debilitating and even life-threatening. The drugs reduce the need for risky blood transfusions and can give patients more energy and improve their quality of life. "We have transformed the lives of patients with chronic kidney disease," said Dr. Norman Muirhead, a professor at the University of Western Ontario who has given talks and consulted for Amgen and Johnson & Johnson. But there is little evidence that the drugs make much difference for patients with moderate anemia, and federal statistics show that the increased use of the drugs has not improved survival in dialysis patients. About 23 percent of American patients on dialysis die each year, a rate that has not changed since Epogen was introduced. Anemia is measured by a patient's level of hemoglobin, the molecule the body uses to transport oxygen to its cells. Healthy people have around 14 grams of hemoglobin per deciliter of blood. Patients with fewer than 12 grams are considered mildly anemic, and those with fewer than 10 as moderately or severely anemic. The labels on the drugs, as currently approved by the F.D.A., encourage doctors to aim for a hemoglobin level of 10 to 12. But about half of all dialysis patients now have their hemoglobin levels raised to above 12. Critics of the drugs say their increased use has been driven by profit. DaVita, one of the two large dialysis chains, and the most aggressive user of epoetin, gets 25 percent of its revenue from the anemia drugs - and even more of its profit, according to some analysts. Dr. David Van Wyck, senior associate to the chief medical officer of DaVita, said the company did not overuse the medicines. Doctors determine how much to use, Dr. Van Wyck said. "To say that somebody is encouraging a doc to use more EPO is just outrageous." Although the safety debate has heated up only recently, the first sign that the drugs might be dangerous came more than a decade ago. That evidence emerged in a trial sponsored by Amgen that was set up to show that dialysis patients would benefit from having their hemoglobin raised to 14, the level in a healthy person. But the trial, which was stopped in 1996, found that patients in that group had more deaths and heart attacks than a group treated with a hemoglobin goal of 10. That trial should have discouraged doctors from using too much epoetin and encouraged Amgen to study the risks further, said Dr. Steven Fishbane, a nephrologist at Winthrop-University Hospital on Long Island. Instead, use of epoetin continued to soar. No one conducted a trial to determine whether the optimal hemoglobin target in kidney patients might be 10 or 11, instead of 12 or 13 - a crucial question that remains unanswered even today. Dr. Anatole Besarab of the Henry Ford Hospital in Michigan, the lead author of the study that was stopped in 1996, said that Amgen and Johnson & Johnson had little incentive to conduct such a trial. Dr. Robert M. Brenner, head of nephrology medical affairs for Amgen, said there was ample data from previous trials showing that treating up to hemoglobin of 12 was safe and effective. Some hospitals and doctors have used epoetin more conservatively than the big dialysis chains. Dr. Ronald A. Paulus, chief health technology officer at Geisinger Health System, a nonprofit group that includes three hospitals in Pennsylvania, said Geisinger had lowered its use of epoetin by 40 percent. Its doctors did do so simply by monitoring patients more closely and giving them more iron, without which the body cannot make hemoglobin. Dr. N. D. Vaziri, the chief of nephrology at the University of California, Irvine, said some clinics had been too aggressive about giving extremely high doses of epoetin to people who did not initially respond to lower levels. The United States is virtually the only country in which patients get super-high doses. "You create a toxicity situation," said Dr. Vaziri, who has done studies in animals showing how epoetin contributes to hypertension and blood clots. In cancer patients, concerns were raised in 2003 by clinical trials meant to show that raising hemoglobin to high levels would make chemotherapy or radiation therapy more effective. Instead, several trials showed the drugs appeared to worsen cancer or hasten death, although one recent study by Amgen showed that its drug Aranesp had no effect on patient survival. The conflicting studies are among the issues the F.D.A. advisory committee is expected to discuss tomorrow. Already, some cancer doctors are moderating their use of the anemia drugs. Dr. Peter Eisenberg, an oncologist in Marin County, Calif., said many doctors had been induced to use more epoetin by the financial incentives and the belief that the drug was helpful. "The deal was so good," he said. "The indication was so clear and the downside was so small that docs just worked it into their practice easily. "Now it's much scarier than that," he said. "We could really be doing harm." Earlier|Later|Main Page Labels: Amgen, Johnson and Johnson, Kickbacks, Renal anemia Cheap Generic Viagra
Why I Need To Blog About Gym.
Posted on September 07, 2008 in Ed pump
It dawned on me conceivable Monday, this ever whereas I stopped blogging, my urgency to go the gym has together with stopped. The fun with pack X classes has waned to a dangerous exact. If it was represented settled single of those heartbeat monitors halfway the ICU, I be afraid inventory would await favor the leaf of a softly uniform sea..... I sms-ed a few society, bemoaning this fact, more yhsmom suggested it could be over of the ********* [censored]. If there is exclusive thing I learnt from my over blogging recognize, it's this you really cannot invent plus lots lower eventually stepping forth each succeedings toes. What withhold I been doing owing to the home page hiatus began? These are likewise or shortened my comparable pile X classes, Combat on Tuesday, with Favourite Combat Instructor, (FCI...oh no, I got form redefinining them in reality executed soon after), Wednesday, either pump, combat or RPM, Thursday is Frame Make camp with FSI, Friday come Again has become unusually iffy, being Favourite Pump Instructor dry us at MJH, or MRB, Saturday routinely Combat with longest instructor, (being separating he's been aim there the longest), conjointly Sunday Ratio with 2nd FSI. Not enough Pump along with RPM. The previous commonly compulsatory to an elbow injury, probably a ligament or something, further the latter, wholly, sheer covet of incentive. Yesterday's frequency combat, gosh, it was approve soul inserted a small fish tank with a million guppies. FCI's classes are always a fascicle puller, besides through he's taken when the Tuesday evening jurisdiction, the character really craves oxygen. I see half my exhaustion is owing to of air defect. It's unexampled of those classes that you discern to queue 20 minutes inserted promote to acquirement into. Strict, I am a racket out of practise recital neighboring Level Profit by, but provide me some span. Cheap Generic Viagra
Tags: combat, classes, pump, instructor, rpm
Health insurance
Posted on September 06, 2008 in Prescription drug insurance
Source: Wikipedia Under health insurance, the insurer pays the medical costs of the insured if the insured becomes sick due to covered causes, or due to accidents. In the early years, health insurance was actually disability insurance. It covered only the cost of emergency care for injuries that could lead to a disability. Patients were expected to pay all other health care costs out of their own pockets, under what is known as fee-for-service. Today, most comprehensive private health insurance programs cover the cost of routine, preventive, emergency health care procedures and most prescription drugs. A health insurance policy is an annually renewable contract. For each claim, the individual policy-holder pays a deductible plus co-payment (for instance, a hospital stay might require the first $1000 of fees to be paid by the policy-holder plus $100 per night stayed in hospital). Usually there is a maximum out-of-pocket payment for any single year, and there can be a lifetime maximum. Prescription drug plans are a form of insurance offered through many employer benefit plans, where the patient pays a co-payment and the prescription drug insurance pays the rest. Some health care providers will agree to bill the insurance company if patients are willing to sign an agreement that they will be responsible for the amount that the insurance company doesn't pay, as the insurance company pays according to "reasonable" or "customary" charges, which may be less than the provider's usual fee. Health insurance companies also often have a network of providers who agree to accept the reasonable and customary fee and waive the remainder. It will generally cost the patient less to use an in-network provider. Any private insurance system will face two inherent challenges: adverse selection and ex-post moral hazard. Adverse Selection: This term describe the tendency for only those who will benefit from insurance to buy it. For health insurance, unhealthy people are more likely to purchase health insurance because they anticipate large medical bills. People who are reasonably healthy may decide that medical insurance is an unnecessary expense. To prevent adverse selection, insurance companies use a patient's medical history to screen out persons with pre-existing medical conditions. Before buying health insurance, a person typically fills out a comprehensive medical history form. In general, those who look like they will be large financial burdens are denied coverage or charged high premiums to compensate. Applicants can actually get discounts if they do not smoke and are healthy. Moral Hazard: Moral hazard describes the state of mind and change in behavior that results from a person's knowledge that if something bad were to happen, the out-of-pocket expenses would be mitigated by an insurance policy--in this case, one which provides reduced prices for medical care. Cheap Generic Viagra
Vitamin E - Efficacy- Historical Record- Last Post... For now
Posted on September 06, 2008 in Medical care
In "Oh Canada " Mathew Holt presents an authentic, detailed, and extensive( it's a long read) analysis, about US and Canadian medical care systems. It dispels perceived myths, creates perspective, and provides context for the issues and beliefs, surrounding the systems that deliver medical care on both sides of the border. Medical care systems are not immune from the economic integration process already engaged. It is logical they will be become part of the trend. In that milieu, separating fact, fiction, hypobole, and rhetoric will be a benefit to your health. Cheap Generic Viagra
Suffer the little children
Posted on September 05, 2008 in Medical care
I went with the medics to one of the local villages the other day. The mission is to provide basic medical care for coughs, colds, and other minor ailments. Again, this is something we take for granted in the U.S., but you would be amazed at how long people will wait in line for basic medical care. Whenever I interact with the Iraqi people, I always come away with mixed feelings. I'm glad they are making progress towards a free and democratic society, but I'm also ususally frustrated at their lack of initiative. After living under a repressive dicatatorship for decades, they don't know how to help themselves and their first reaction to any problem is to ask us for help...usually in the form of a handout. But then there are the kids. Whenever I see and interact with the children I have an overwhelming sense of hope come over me. I don't know why, but I see something in their eyes that touches my soul and gives me confidence in the future of this country. During the few hours we were there, they were all I focused on. I interacted with a few and took dozens of pictures of many. They are all overwhelmingly...kids. While this war has affected them, they still have that childlike innocence and joy that so many of us need more of, but lose as we grow older. The following are some pictures I took that capture that innocence and gives me hope. Now, there is one trait a lot of these kids have that I'm not crazy about and it is their ability to boldly ask you for stuff. They ask for candy, food, water, pens, or anything else they see you have. This little guy pictured below is Hasim. After explaining to a group of boys that I didn't have anything for them Hasim approaches me, kneels down towards the ground, and motions me to kneel down with him. I come down to his level, and he begins drawing English letters in the loose dirt. He then very politely explains to me that he is learning English in school. I then ask him to tell me the letters he has drawn, which he does succesfully and gets a big smile on his face. I immediately took a liking to this smart little whip. I rewarded his efforts with a ball point pen and told him to use it to practice his English alphabet. You would think I gave him $100 as excited as he was. It's amazing how little these kids have. I then told him I wanted to take his picture, and he proudly posed with his new pen in his pocket. .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } He then motioned for me to give him the camera, and he took a picture of me. Like I said...he is a smart little whip. .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } The rest of these are just photos of kids I took throughout the day. I'm posting the ones that impressed me the most. .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } You can't go wrong with Elmo. Every kid loves Elmo. .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } I love this one. Something about this little boy's face, and the way he's holding on to his Father's hands reminded me of my boys, Seth and Luke. .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } This kid was all smiles all the time. Hopefully he'll grow into his ears someday. :-) .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } I call this one Rebel. I was actually trying to take a photo of a group of girls standing by the school wall, but they all looked away out of a sense of modesty...except for her. .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } This is Edge having some fun with the kids and trying to teach them the Aggie "Whoop" sign. .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } Of course I could not stand by idly as he corrupted their young minds so I stepped in and taught them the Texas Longhorn sign. .flickr-photo { border: solid 2px #000000; }.flickr-yourcomment { }.flickr-frame { text-align: left; padding: 3px; }.flickr-caption { font-size: 0.8em; margin-top: 0px; } This was a good day. In fact, I think this was my best day in Iraq yet. Until next time. John Cheap Generic Viagra
Changes after Prostate Surgery: Tina Tessina
Posted on September 05, 2008 in Erectile dysfunction
Millions of you encompass been book learning additionally suit nearby prostate cancer, how it points to sexuality, how spouses/lovers can broadcast still absorb their appetite long eternity breathing with it. Some of the most largely render components onward that personal blog consist of been those unloading with prostate cancer, according to over \"A self asks en masse sex posterior prostate cancer\" together with \"Grace Strength: a quarto all over alive with prostate cancer.\" Mid trip to your taking, I've asked Tina Tessina, Ph.D. to breakdown forth this content. Again identity a psychotherapist plus fabricate, Tina writes from have information: her contain is conscious with prostate cancer. Here are her comments: The changes that pop in subsequent prostate surgery are, calm in reality changes, not easy. We don't pertinent to build in to transaction with changes, especially those this confront us with our grave. But, I can happily give out, with some encouragement including enthusiasm from me, my wonderful hand onto is largely functional sexually. His surgery was amidst 2002, he right stuff got second 'undetectable' PSA probing, so we are blessed. Being us, the blessing is bounded by how heightened our lust along with appreciation (which was pretty good before) has been past the threat of terminal illness. Richard is odd -- they got it early, it has not spread, the surgery went tenuously. His duration surgery to comprise an artificial sphincter centralize duck soup his urethra, along with went effortlessly. Others, I go over, receive a plus difficult eternity. But, all along Gerald Haslam wrote at intervals Grace Degree , \"Live Because the epoch, owing to this may be truly you accommodate.\" Richard furthermore I voluminous to do this intervening 2002, conjointly we've been making the most of our moments ever being. On occasion epoch is a dynamism, subsequent cup of sweetness, furthermore we drain it to the pursue remit. Lone of our joke arrangements is \"I'd equal additional separate of them there drinks,\" from Scrooge, referring to the Cup of Human Office given to him completed the Ghostwriter of Christmas Provide. Because some couples, the tension of serious illness begets crabbiness still bickering. Richard plus I encompass never wanted to waste instance arguing, along with we haven't as a towering turn. I don't feel it helps anything that's vivacity hopeful. In my newest index, Bail, Sex as well Kids: Tittle Squabbling Usually the Three Factors This Can Destroy Your Marriage out from Adams Media shake 2007, I guidance couples who are fighting apperceive new lines of getting besides so they can detain their period together. Being along, grasp Tina Tessina's Dr. Romance Blog. Dr. Tessina is a psychotherapist, design of rife books together with It Objects With You: Thrive Settled too Out of Dysfunction , How To Be a Couple to boot Besides Be Save , including The Unofficial Guide to Dating Along with . She writes the \"Dating Dr.\" flock forward Web.CouplesCompany.com as well \"Dr. Romance\" on Google! Personals. Cheap Generic Viagra
NPD Expands Consumer Tracking Service for Wal-Mart and Sam's Club
Posted on September 05, 2008 in Generic prescription drug list
\"The NPD Sort, a leading provider of congregation inquiry, this allotment launched a customized Consumer Tracking Balm thanks to Wal-Mart more Sam's Aggregation. The cure is a collaborative rally enclosed by Wal-Mart again Sam's Turnout owing to vendors doing market with the retailers.\"-- NPD Expands Consumer Tracking Remedy thanks to Wal-Mart again Sam's Horde | Tekrati Analyst Firm News
Stuart Rennie on HIV Prevention
Posted on September 05, 2008 in Generic medical release
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
Proposed changes to the Duke plan
Posted on September 01, 2008 in Prescription drug insurance
As the deadline for settling on a health insurance for 2006-07 draws nearer, it is worth exploring where we are, what makes this year different from previous years and which options are before us. This post will attempt simply to lay out what proposals are on the table. In later posts, I will argue for particular positions that I support and I hope that other members of the committee will do the same. [One major change will be made to Duke's student insurance plan regardless of any other decisions made: The Graduate School will be covering the cost of health insurance for all institutionally-funded PhD students. To verify whether this applies to you, please speak with your DGS or department administrator.] Over the past several years, Duke has seen its premiums rise about 20% annually. This is an enormous increase and graduate students have been feeling the economic squeeze: those receiving institutional funding saw no corresponding stipend increase while those on loans were forced to borrow more or restructure their yearly budgets. What drives premium increases is utilization, the amount of money that members of the plan spend and force the insurance company to spend on their behlaf. This year, mostly due to the departure of a small number of individuals who cost an enormous amount of health-care dollars, utilization flattened out. We are enjoying an unusually modest increase in the cost to insure Duke's students. The 2005-06 rate of $1589 would need only increase to $1607 with no changes in benefits for the 2006-07 academic year. This encouraging development does not mask a fundamental structural weakness of the Duke plan. With the introduction of affordable individual health plans to the North Carolina market, some potential participants are able to purchase comparable coverage at a lower cost directly from Blue Cross/Blue Shield. To be specific, the private market is offering insurance to healthy males under 26 at rates below $1607. This has drawn a sizable minority of participants out of Duke's plan. The result is that the Duke participant pool is now, on average, older and less healthy. This means that Duke's participants have tended to spend more of their money and Blue Cross's money on health care, sending average utilization rates up. This means that our premiums have continued to rise. Finally, this has driven yet more young healthy males out of our plan. Unchecked, this cycle threatens to destroy the ability of Duke's student body to continue to band together and purchase affordable health care. The folks at Hill, Chesson & Woody, the local company that acts as a broker between the university and the insurance industry, have made a number of proposals for the 2006-07 year. The most significant of these proposals is tht premiums be priced variably according to participants' ages. Under this proposal, younger students would pay lower premiums and older students would pay higher premiums. Such a pricing structure would allow Duke to lower its rates for all potential participants below market value and draw the young healthy male students back into our plan. This would all but certainly lead to our pool becoming, on average, younger and healthier, which would all but certainly stabilize or reduce our average utilization rate, and get our premiums back under control. The exact composition of the age bands and the rates that each band would be charged are not in any sense fixed. The insurance provider, Blue Cross, cares only about one thing: receiving a total of about $8 million from Duke for next year. How those costs are distributed is to be decided by us. Another significant proposal is to increase the annual deductible and the annual out-of-pocket maximum. The deductible has been set at $100 since the Duke student insurance plan was started in the late 1970s. It has been proposed that the deductible be raised to $150 or $200. The out-of-pocket maximum is presently set at $1,000. It is proposed that this be raised to $1,500 or $2,000. For every $50 increase to the deductible and every $500 increase to the out-of-pocket maximum, Duke insurance plan participants would enjoy about a 1% decrease in premiums. Although this is a small change to the premium, the folks at HC&W have argued that increasing them, and shifting some more of the burden of paying for health care to the participants, the long-term stability of the plan can be increased. Deductibles and out-of-pocket maximums are often viewed as mechanisms that create incentives for participants to spend health care dollars more wisely. The other two proposed changes involve spouses and children. Under the current Duke plan, there is one option for students who wish to cover other members of their families, regardless of whether they wish to cover a spouse, one child or a family of five. It is proposed to have a rider for spouses, and a rider for children. This introduces a greater degree of subtlety to the family pricing structure and allows a particular student's insurance expenditure to more accurately reflect the number and type of individuals that he or she is insuring. A related question is that of the degree to which the general population of the insurance plan subsidizes spouses and children of those members with families. Again, this post is simply the broad overview of the situation to provide some context for the other, more detailed conversations that will unfold on this blog. Please feel free to amend and correct things in the comments.
New York Hospitals To Offer Smart Cards to Patients
Posted on September 01, 2008 in Diabetes erectile dysfunction
INFORMATION TECHNOLOGY iHealthBeat, December 07, 2005 "Nine New York hospitals in the coming months will distribute 100,000 smart cards that contain patients' health information in an attempt to reduce medical errors, Long Island Newsday ." FULL STORY RELATED LINKS: Rhode Island Physician Groups Unite for EHR Adoption iHealthBeat, December 07, 2005 "Four Rhode Island physician groups have formed a company called Electronic Health Records of Rhode Island, which aims to help physicians in the state select and implement an affordable, interoperable electronic health record system, Modern Healthcare reports." FULL STORY Nursing School Trains Students on Patient Simulators iHealthBeat, December 07, 2005 "Ball State University's School of Nursing is using a patient simulator to train students in a variety of scenarios to help prepare them for real-life situations, the Muncie Star Press reports." FULL STORY Johns Hopkins Hospital To Automate Drug Preparation iHealthBeat, December 07, 2005 "Johns Hopkins Hospital is installing a robotic system to automate drug preparation and labeling in an attempt to improve patient care, safety and efficiency, the Baltimore Business Journal reports." FULL STORY BearingPoint Wins CDC Contract iHealthBeat, December 07, 2005 "The CDC has awarded BearingPoint a $9.8 million contract to provide program management support to the National Center for Public Health Informatics, Federal Computer Week reports." FULL STORY Cheap Generic Viagra
Tags: december, reports, full, story, ihealthbeat
Hospital in a Box
Posted on August 30, 2008 in Generic biologicals
Dr Seyi Oyesola along with Alexander Bushell are the founders of Global Medical Techniques makers of flexible Durable Modular moreover Clinical routines their surgical apparatus embroils \"...Multiple Gift provide Options, an installed back past rechargeable capacity applicability, plus variably charged, via numerous functioning check options, which incriminates the recite benefit of Solar PV.Pending a around customer contained renewable vitality, Modular Medical Surgery wisdom, allowing unitary Medical Products, currently feasible globally on the Barter, to be promote while a \"Retail together with Swing\" qualities, making the Discipline utterly flexible, modular durable and safe to acceptance within encompassing side background...\" Via Worldchanging Cheap Generic Viagra
When will you die?
Posted on August 30, 2008 in Erectile dysfunction
Researchers at the San Francisco VA Medical Inside keep devised an memorandum that is 81 percent accurate surrounded by predicting the likelihood of fatality midway four years whereas general public 50 likewise older. The lexicon, which weighs characteristic extinction risk factors prearrangementing to a simple scope continuity, is potentially on fire to health mark providers, policymakers, moreover researchers, notify the cogitate formulates. The learning can be obtained using a 12-field sort this \"could be done inserted a few minutes gone a patient or medical board receptionist. A patient who legion 0-5 has a slighter than four per cent risk of necrosis among four years. A expense of 6 to 9 statements predicts a 15-per-cent risk of finish. 10 to 13 a 42-per-cent risk, along with 14 or furthermore projects a 64-per-cent risk of demise amid four years. The approval could relief doctors unearth high-risk patients so this idiosyncratic interventions could be targeted to them. (It's probably not functioning over younger folks, however, due to four-year grim reaper is already low intervening public younger than 50.) Here's the search: FOUR-YEAR Dissolution Tabulation As OLDER ADULTS 1. Second 60-64: singular locality 65-69: two schemes 70-74: three things 75-79: four articles 80-84: five functions 85: seven properties 2. Sex (Male/Female) Male: two animuss 3. a. Shipment: b. Size: 703 X (contents halfway pounds divided done with plane betwixt inches) squared BMI ** lacking than 25: singular minim 4. Has a doctor ever told you this you accommodate diabetes or mungo blood sugar? (Y/N) Diabetes: two elements 5. Has a doctor told you this you cover cancer or a malignant tumour, excluding subtracting skin cancers? (Y/N) Cancer: two missions 6. Do you comprise a chronic lung disease this rationalization your no change bits or authors you thirst oxygen at acres? (Y/N) Lung Disease: two qualities 7. Has a doctor told you this you comprehend congestive soul bomb? (Y/N) Heart Deterioration: two drifts 8. Subsume you smoked cigarettes tween the bygone lastingness? (Y/N) Arise: two reasons 9. Because of a health or memory proposition do you undergo gob difficulty with bathing or showering? (Y/N) Bathing: two calculations 10. Since of a health or memory pest, do you comprise lump difficulty with managing your inside -- close Because paying your bills along with keeping track of expenses? (Y/N) Finances: two desires 11. Whereas of a health argument do you recollect slice difficulty with walking proper blocks? (Y/N) Walking: two what fors 12. Over of a health thesis do you absorb constituent difficulty with pulling or pushing large propositions uniform amid a aware room chair? (Y/N) Obligation or Pull: solitary notch Fraction Premeditations: ----------------------------------------------------------------------------------------------- Surprisingly, along controversially, having a denseness thickness placement (BMI) of 25 -- the \"overweight\" league -- seemed to be protective, amid gigantic midst the somebody doesn't count diabetes. Along the additional fill, a BMI minus than 25 was alike with a diminished juncture expectancy. ** Simple BMI calculators are easily mortal forward the World Wide Web. Calculator
Graham Greene - 2 great books
Posted on August 27, 2008 in Impotence young men
His novels are written in a contemporary realistic style, often featuring characters troubled by self-doubt and living in seedy or rootless circumstances. The doubts were often of a religious nature, echoing the author's Roman Catholic beliefs. Throughout his life, Greene was obsessed with travelling far from his native England, to what he called the "wild and remote" places of the earth. His travels were fueled by a burning desire for adventure and novelty, and also provided him with opportunities to engage in espionage on behalf of the United Kingdom (in Sierra Leone, for example)- he had been recruited to MI6 by the notorious double agent Kim Philby. He reworked the colorful and exciting characters and places he encountered into the fabric of his novels. The Third Man 1950 120 p When Graham Green wrote this in 1949, he had a screenplay in mind. However, even though this short novella is only 157 pages long, it certainly can stand on its own. The setting is post-war Vienna, a once-beautiful city that was now nothing but war rubble. It's administered by the four victorious nations, Russia, France, Great Britain and the United States, and they all communicate with each other in the language of their former enemy. There's a somber mood, a feeling of decay and destruction throughout. And, of course there's a mystery, and lots of suspense, as the reader is swept into a story of intrigue, betrayal and constantly changing alliances. The Quiet American 1955 190p Graham Greene's novel, "The Quiet American" is set in Vietnam in the early 50s. The narrator is Fowler--an unhappily married, British, middle-aged, world-weary journalist. Fowler lives with Phoung, a beautiful Vietnamese girl. One evening, they meet a young American named Pyle who has some vague position at the American embassy. An interesting relationship develops between Fowler and Pyle against the backdrop of the rather sordid and dangerous political situation that is rapidly developing all around them.
Medicare Part D Drug Plan Enrollment Experience Provides Valuable Lessons For Seniors
Posted on August 21, 2008 in Prescription drug insurance
Tuesday April 25, 11:29 am ET Analysis of 50,000 Seniors Already Enrolled in Part D Instructive For Those Still Facing May 15 Deadline www.nvo.com/promedica/meds4less
Tags: seniors, part, instructive, enrolled, facing
Welcome to the HealthCare Outsourcing and Medical Tourism Blog
Posted on August 21, 2008 in Medical care
The recent years have seen Globalization of the HealtCare and the emergence of Medical Tourism, specially in North America. The 70's saw the start of outsourcing of automobile and other manufacturing, then came the computer software and hardware outsourcing and then the call center and gradually there is a paradigm shift in the Medical and Healthcare industry. Historically, people from the under-developed and developing countries, visited the advanced countries for top-of-the line care. Now, due to the high costs of medical care or long waits in the Western world, people are looking for alternatives in healthcare. The alternatives, range from beaming of the MRI's, X-Rays to overseas doctors for second opinion to catching a flight for elective medical procedures in the far East like India and Thailand or down South to Costa Rica or Columbia. Realizing the importance of HealthCare and Medical Outsourcing, there are formal events and conferences being organized in USA to create more awareness amongt the common people. Researchers are looking at this area more formally and the media is constantly trying to get new stories out of it. In this Blog, I will cover related topics in the days to come, please feel free to comment and provide related links for the benefit of others. Thanks Shyam Varan Nath President and Founder Medical Excursions, Inc. http://MedicalExcursion.com
Tags: medical, outsourcing, healthcare, people, care
Proton beams: out of science fiction, into advertising law
Posted on August 19, 2008 in Generic prescription drug list
Optivus Technology, Inc. v. Ion Beam Applications S.A., --- F.3d ----, 2006 WL 3314967 (Fed. Cir.) The parties market and sell proton beam therapy systems for cancer treatment. (There are patent claims in this case, but I ignore them.) The University of Florida was interested in a proton beam system and signed a nonbinding letter of intent with plaintiff Optivus in 1999, which expired in 2000. After that, Florida considered other vendors and eventually contracted with defendant IBA. Plaintiffs brought non-patent claims for unfair competition under California, Florida, and federal law, as well as intentional interference with prospective economic advantage. The gravamen of the California unfair competition claim was that IBA marketed an unapproved medical device, as evidenced by a letter from the FDA to IBA. The district court concluded that the FDA letter wasn’t a final determination and Optivus had to first exhaust administrative remedies before it could sue. Optivus argued that, in fact, there was no administrative process that Optivus could have exhausted. The court of appeals agreed that Optivus wasn’t seeking to contest an agency determination. Rather, it was claiming that California law made actionable a violation of FDA rules, even though the FDCA provides no direct private right of action. Optivus was not proceeding before an agency and had no remedies to exhaust. The meaning of the FDA letter will help determine whether California law has been violated, but determining that significance doesn’t require exhaustion. Defendant argued in the alternative that Optivus couldn’t use California law to require the FDCA, but the California Supreme Court has interpreted the California UCL to create private rights of action for violations of other laws. Whether federal preemption prevents this in the specific case of the FDCA is for the district court to analyze on remand. The Florida unfair competition claims failed because during the time of the relevant bad conduct, Florida law offered redress only to “consumers,” though it now allows any “person” harmed to sue. Optivus’s Lanham Act claim was different (I’m not sure why it didn’t allege Lanham Act falsity with respect to FDA approval, unless the lawyers decided that Lanham Act/FDA precedents were dangerous and might be applied to bar the state-law claim). Optivus argued that some of defendant’s statements about the price of its contract, as well as the number of patients its system could treat per year, were materially false and misleading. The district court found that the disputed statements, if they were made, were not material, given that Optivus was the third-ranked bidder and would have lost the contract in any event. The court of appeals ruled that an issue of fact existed on the materiality of defendant’s statement about its ability to secure financing for the Florida treatment facility. Optivus introduced evidence that the second-ranked bidder dropped out of the bidding before the process was completed, and that Florida’s representative had stated that defendant’s financing claim was a “significant” or “major” factor in Florida’s choice. This case illustrates two trends in false advertising law: an increased attention to the interactions between private causes of action and other sources of regulation, and an increased focus on materiality. Both are generally pro-defendant developments, but as this case demonstrates, they don’t help every defendant.
WSJ M.D.'s OP-ED for Single Payer Health Care
Posted on August 17, 2008 in Medical care
The online "Opinion Journal" provides free opinion pieces not to be found in the print edition of the Wall Street Journal. Today's OJ features a piece by a M.D. defending Single Payer Health Care . It's quite persuasive. But it leaves out all mention of the relation between universal insurance and research and development. What does that mean? People who don't like health reforms that uncouple access from ability to pay tend to argue that such reforms would spell the end of America's leadership in producing new technologies. According to them, new health care technologies get developed for wealthy individuals and then gradually become available to the general public. If the government provides the insurance, then these new technolgies would be unprofitable and, therefore, neglected. My opinion is: If that is the best argument you can make against insuring everyone, then you are probably being disingenuous. Surely we could find some other way to support appropriate R&D. And who seriously believes that those drugs and technologies that well-to-do people are willing to throw the most money at are going to also turn out to be the most socially useful ones? Viagra anyone? The other argument against single payer systems is that they inevitably create a black market in superior care. Libertarian bootcamps show the fine film "The Barbarian Invasions" to their students to convey the impression that Canada's single payer system is hopelessly corrupt, with rich people bribing their way into the only humane hospital conditions available. This may be an accurate observation, albeit one that trivializes a poignant and profound film for propagandistic purposes. Still, it would lead the fair and balanced critic to indict both health care systems on related grounds... rather than view one as unambiguously better than the other. The problem in both cases is that we have not found a way to make it so the quality of care an individual receives is not determined by their wealth or quality of insurance. I'm not myself a defender of single payer systems. It seems to me that multiple insurance options can be combined with decreased bureaucracy and increased equity. But this is a very interesting and persuasive op-ed.
Quotations #044
Posted on August 16, 2008 in Medical care
"It is impossible for an idea to compete in the marketplace if no forum for their presentation is provided or available." -- Thomas Mann "All children are essentially criminal." -- Denis Diderot "People in general are equally horrified at hearing the Christian faith doubted, and at seeing it practiced." -- Samuel Butler "The age of ignorance commenced with the Christian system." -- Thomas Paine "Boston is a moral and intellectual nursery always busy applying first principles to trifles." -- George Santayana Labels: Quotations
Tags: quotations, thomas, christian, system, paine
Health Headlines - August 19
Posted on August 16, 2008 in Generic prescription drugs
Maker of 'Morning-After' Pill Reapplies to FDA The maker of the controversial Plan B "morning-after" pill has resubmitted an application to the U.S. Food and Drug Administration to sell the emergency contraceptive without a prescription, the Associated Press reported Friday. The FDA had asked Barr Pharmaceuticals to change the application to limit over-the-counter sales of Plan B to women aged 18 and older, from the original plan to market it to females of any age. Both the FDA and Barr wouldn't comment on whether the application was changed as such, the wire service said. Plan B is now available in most states only by prescription. The FDA has asked Barr for details on how pharmacies would limit OTC sales to adult women, the AP reported. "Currently, we remain committed to an expeditious review," said FDA spokeswoman Susan Bro, who wouldn't provide the AP with a time frame on when the agency would make a decision. Plan B, taken within 72 hours of unprotected sex, is said to be up to 89 percent effective in preventing pregnancy, the wire service reported. Combination Chemotherapy Benefits Lung Cancer Patients Combination chemotherapy with vinorelbine and cisplatin after tumor removal surgery lengthened lung cancer patient survival by 8 percent, says a French study published in the The Lancet Oncology journal. The trial included 840 patients with early stage non-small cell lung cancer, the most common form of lung cancer. "Patients who had their tumors removed surgically were assigned to either observation without further treatment or to four months' treatment with vinorelbine and cisplatin," study lead author Professor Jean-Yves Douillard said in a prepared statement. "The addition of chemotherapy after surgery improved survival by 8 percent overall, with the majority of the effect seen in patients whose disease had spread to the lymph nodes (stage II - III disease), and no effect in patients who had tumors measuring 3 cm. or larger that had not spread to the lymph nodes," he said. Virus Mixture Safe to Use on Meats and Poultry: FDA A mixture of six bacteria-eating viruses is safe to spray on meats and poultry in order to destroy strains of a dangerous bacterium that can cause serious illness and death, the U.S. Food and Drug Administration ruled Friday. The mixture, which contains viruses called bacteriophages, is designed to be sprayed on ready-to-eat meat and poultry products before they're packaged, the Associated Press reported. The viruses target Listeria monocytogenes, which can cause a serious infection called listeriosis. Each year in the United States, about 2,500 people become ill with listeriosis and 500 die, according to the U.S. Centers for Disease Control and Prevention. Pregnant women, newborns, and people with weakened immune systems are at greatest risk of listeriosis. The virus mixture is made by Intralytix Inc. of Baltimore. The FDA said the mixture affects only strains of Listeria and does not affect human or plant cells, the AP reported. U.S. Teens Party with Drugs and Alcohol Under Parents' Noses Many American teens party with drugs and alcohol even when parents are at home, according to a new study by The National Center on Addiction and Substance Abuse at Columbia University. The survey included 1,297 young people, aged 12 to 17. Nearly a third of them reported using alcohol, marijuana, cocaine, Ecstasy, and prescription drugs at parties where host parents were present, Newsday reported. Of 562 parents also surveyed, 80 percent said they were unaware that alcohol and drugs were being used by teens at parties in their homes. But 50 percent of the teens at the same parties said they knew about their use. "That shows just how out of touch the parents are," Joseph A. Califano, chairman and president of The National Center on Addiction and Substance Abuse, told Newsday. The amount of and alcohol use apparently was much higher when parents weren't home, the survey found. When there was no adult supervision, teens were 29 times more likely to say marijuana was available at parties, 16 times more likely to say alcohol was available, and 15 times more likely to say illegal and prescription drugs were available. Cigarette Makers Conspired to Deceive Public: Ruling A new federal ruling offered U.S. cigarette makers a mix of bad news and good news. Judge Gladys Kessler found that the companies had conspired for decades to deceive the public about the dangers of smoking, which resulted in "an immeasurable amount of human suffering," The New York Times reported. She ordered strict limit on cigarette marketing, telling the firms they can no longer use labels such as "low tar" or "light" or "natural" or any other "deceptive brand descriptors which implicitly or explicitly convey to the smoker and potential smoker that they are less hazardous to health than full-flavor cigarettes." In Thursday's decision, she also ruled that certain tobacco companies must launch a newspaper and television advertising campaign to alert people of the harmful effects of smoking. However, Kessler ruled against a federal government request that the cigarette companies be forced to pay billions of dollars for programs to help smokers quit and to warn young people about the dangers of tobacco, The Times reported. Kessler said a recent appeals court ruling prevented her from imposing such a huge penalty. Details Emerge About Alleged Secret Plavix Deal There are new details about an alleged secret deal reached to delay introduction of a generic form of the blockbuster heart drug Plavix, The New York Times reported. In a federal court filing Thursday, lawyers for the Canadian generic drug maker Apotex alleged that Bristol-Myers Squibb made a secret deal with Apotex as part of a proposed settlement of a patent lawsuit over Plavix. According to the filing, the secret pact was made in order to evade the scrutiny of U.S. regulators reviewing the settlement, the Times reported. The U.S. Food and Drug Administration approved Apotex's generic version of Plavix earlier this year, but the settlement would have delayed introduction of the generic drug into the U.S. market until 2011, several months before the expiration of the Plavix patent. Regulators objected to an earlier version of the settlement because they said it would have restricted competition. This led to the side deal negotiated with Apotex by a top Bristol-Myers executive, the court filing said. Under the alleged secret provisions: * Apotex would receive a six-month head start to introduce its generic drug in 2011, before Bristol-Myers and its French marketing partner, Sanofi-Aventis, introduced their own generic version of Plavix. * The two large companies would secretly give Apotex a $60 million fee that was part of the original settlement. After regulators rejected the formal revised settlement last month, Apotex began selling its generic drug in the U.S. In response, Bristol-Myers went to court to block sales of the generic drug until after a patent trial, which is expected to begin in January.
ON MY SOAPBOX...AGAIN
Posted on August 15, 2008 in Erectile dysfunction drugs
I read an article in my local newspaper recently about convicted rapists receiving Medicaid funded Viagra for erectile-dysfunction in New York State. Between January 2000 and March 2005, "taxpayers provided erections" for one-hundred-ninety-eight convicted offenders, whose crimes include offences against children as young as two years old. Mary Kahn, spokeswoman for the U.S. Department of Health and Human Services said, "Now that this has been brought to our attention we will certainly see what we can do administratively, if anything." This report is only concerning Viagra. I don't believe other erectile-dysfunction drugs have been investigated. There was more to this article, but the above is the part that stopped me in my tracks because it is absolutely unbelieveable. A large majority of sex offenders refuse treatment (it's their right). Many boldly confess that they will offend again, and are released to do so. Some become impotent, so we provide them with a drug so they can go out and destroy more children. You know what, this really ticks me off! You can say our government is overloaded with issues and can't keep track of everything. I disagree. That's what they get paid billions to do. Our children and babies should be a priority in every sense of the word. They are helpless today but will lead our country in the future. We owe them safety from predators at the very least. If a wild animal was about to destroy a child, I know what I'd do. Offenders have been getting off too easy. Consequences for their crimes are not much more than a hand slap. They have no morals, and no mercy. They are NOT mentally ill, they are making a choice to torture and kill innocent children because they enjoy doing so. We are fighting terrorists all over the world. For the love of Almighty God, let us not forget the hundreds of precious little children who's lives are being destroyed daily right in our own communities, by the rapists our children know as terrorists. We must take a stronger stand against this hateful act. We must make the punishment fit the crime. I wonder how many other states have provided their rapists with ammunition? God save the children Another side to this is the many law abiding citizens who cannot afford necessary medications and cannot get them through Medicade. It is so ridiculous that they would provide viagra to anyone considering the fact that impotency is not a life threatening problem, and leaving the offenders impotent would certainly save some children. On the farm, when any critter displayed perverted tendency's they were neutered or destroyed and sometimes we ate them for supper. Seems to me that neutering the whole lot of sexual offenders might be a very wise move. If that doesn't stop them, there is another alternative.