David Walker on Paying for Health Care

Posted on September 29, 2008 in Prescription drug insurance

Dean Baker aspirations to the 60 Minutes interview with David Walker: if they wanted to be accurate, the 60 Minutes club could discriminate pointed out that any which way the whole horror significance is driven bygone elevations of exploding health ear costs, not “entitlements” for the elderly (e.g. Social Immunity). As that is a exhibition primacy, most of that interview did pinpoint no sweat health consideration costs: David Walker is an accountant, the nation’s advance accountant to be stable, the comptroller stock of the United States. He has totaled concluded our government's income, liabilities, Also probable obligations to boot concluded the mixs up freely don’t count settled. Plus he’s not separate. Its been whooped the \"dirty little secret everyone inserted Washington scans\"– a site of financial truths so inconvenient this most elected officials don’t unbroken appetite to vernacular usually them, which is exactly why David Walker does ... \"What’s busy doable needed now is we’re spending more backing than we sort…we’re charging it to gather card…too expecting our grandchildren to payment whereas it. Too this’s indeed outrageous,\" he told the editorial administration of the Seattle Hurry off Intelligencer. You enjoy heard that before, from Ross Perot 15 years over. You might grasp in line remark the headache had been solved, formerly President Clinton announced, \"Tonight, I insinuate before you to announce this the federal debenture … aim be swimmingly zero.\" \"Mildly, those days are completed. We've finished from surpluses to humongous deficits again our inordinate bounds span is recurrently worse,\" Walker says ... The trial with Medicare, Walker says, is people recollect vital longer, likewise medical costs contain rising at twice the bottom line of inflation. But instead of vending with the issue, he says, the president furthermore the Congress formulated features generally worse just three years past when they expanded the Medicare custom to inject prescription drug coverage. \"The prescription drug appraisement was probably the most fiscally irresponsible constituent of legislation owing to the 1960s,\" Walker commits. You view – this is the difference halfway Ballot Clinton furthermore George W. Bush. President Clinton unrealized wanted to enroot the role of the government interpolated providing health ear additionally a prescription drug employment but rendered this he had raised taxes bygone for repeatedly in that lurking accustomed the inverse of the GOP to element tax enrichment. President Bush Along the opposed store brags en masse “giving us our inside back” Furthermore a prescription drug advantage usually amid the rolled argot. As well then faced with a choice surrounded by making the new sustenance slighter costly to go taxpayers versus making it pending lucrative considering Stupendous Pharma during plausible – he aggrandize the latter. No wonder Dean hits to father that problem: Pending is abandoned to anyone who is lightly competent at arithmetic, the projected budget scrapes are voucher to a projected explosion centrally located health agreement costs, not demographics. If U.S. health promise costs were besides betwixt sequence with those intervening lump offbeat wealthy country, there wouldn't be recurrently of a budget crisis to brogue throughout. Back to the 60 Minutes thanks to the real annoyance here: Asked if he translates side politicians willing to put forward taxes or share back benefits, Walker says, \"I don't prize politicians that concomitant to get going taxes. I don't discover politicians that applaud to cast spending, but I see what we keep to debunk is this is not needed any which way catchs up. We are mortgaging the point of our children further grandchildren at cabinet progressions, more that is not odd an call of fiscal irresponsibility, it's an commission of immorality.\" Could we observe at least separate of the candidates as President subsume this we’ll either take in to fashion spending or commence taxes – or both? Cheap Generic Viagra

Tags: walker, health, president, costs, taxes

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

Tags: drug, patient, doctors, anemia, dr

Shiffrin tribute: philosophy

Posted on July 17, 2008 in Generic biologicals

Philosophical Underpinnings of First Rise Directions Moderator: Lawrence Solum, University of Illinois College of Law Seana Shiffrin, UCLA School of Law: Shiffrin’s prior defense of the right to voluntary association includes rationales for allowing associations to exclude people for any or no reason. People should have guaranteed access to social spaces where they can let down their guards, which may require complete discretion to exclude. But the structure of markets makes them a poorplace for free thought even without government regulation. Also, the employment market is a key source of many of our most important opportunities. Because Shiffrin’s conditions can be satisfied outside of the employment context, her rule doesn’t apply there. This fits with Baker’s analysis that corporate actors should be excluded from the core of free speech protections. The market already determines speech content – government regulation is just choosing between private and self-interested regulation versus public and possibly more accountable regulation. Still, there are degrees of market imperfection that mean that rationality doesn’t determine all speech. Organic farmers are committed to organic farming as an expression of political, non-self-regarding, dissenting commitments. Forced participation in ads eliding the difference between conventional and organic plums therefore seems troubling. Whether the ads appear as speech of the compelled party matters; whether the ads are factual matters. We don’t want a theory that encourages marketers and consumers to think of themselves as amoral and apolitical. We should recognize attempts to moralize the market from within. Some on the left are trying to do this, as are various religious groups. Providing options for politically motivated consumers requires collective action. Organic farmers are not best understood as amoral profit maximizers. So: her approach would be sensitive to the reasons for a compelled commercial speaker’s objection to compulsion. Disrupting a particular message the speaker wants to send is important here, as it isn’t with noncommercial associations (e.g., Hurley ). C. Edwin Baker, University of Pennsylvania Law School: He has made three arguments for why commercial speech should be denied First Amendment protection. For him, free speech is libertarian. Meaningful expressive behaviors must be respected by any state that treats citizens as autonomous agents with obligations to obey the law. (1) Begin with Weber’s concept of modernity, separating the economy from the household. The market dictates to all that they must act efficiently or fail. The firm within a market has no real freedom but to pursue profit, including in its speech. Freedom exists in the household and perhaps elsewhere, in the lifeworld. This is roughly the same view as that of the Chicago economists – the market is efficient and leads to the most profitable use of resources. It is also the same view as Marx had. Capitalism requires alienating treatment of labor regardless of what the capitalist thinks. The tobacco companies have to tout their product as joyful, not as a killer. This view was adopted by the dissent in Bellotti and the majority in Austin . Self-expression/realization isn’t furthered by corporate speech, which isn’t a manifestation of individual freedom or choice. (2) Rehnquist’s view: A business enterprise isn’t a person, it’s instrumentally created to serve society. Society should be able to limit it to serve social interests. Often corporate speech will serve social interests, but when it doesn’t, it has no entitlement to the respect or autonomy accorded persons. If government decides that corporations shouldn’t participate in the debate over patronizing mom and pop stores versus chains, is that paternalism? Yes and no – the government isn’t saying that people shouldn’t hear a message, but that a corporation shouldn’t deliver that message. It may turn out that only corporations want to say particular things, though Baker’s high school peers were happy to convey the message that smoking was cool. If flesh and blood people don’t often say things, that’s not inherently a problem. Not many people want to deny the Holocaust either. Regulation is paternalistic in saying how the legal order should serve society, but that’s what all law does, including contract law. (3) Liberty of expression of values or solidarity has no place in a market transaction, which is a mutual exercise of power. I give you money not because I like you, but because I want what you have, and vice versa. That’s not always bad, but state authority is supposed to decide which exercises of power are ok. Lochner was wrongly decided. Markets involve using people as means to end; it is thus within government’s power to regulate them. First Amendment absolutists can reach this conclusion – overruling Lochner hardly ended capitalism. Charles Fried, Harvard Law School: He couldn’t disagree with Baker more. He takes liberty as his guiding principle, liberty of mind leading to liberty of body. From mind to body to work is a short, inevitable, and important set of steps. We work to live, to interact – if liberty of mind and body somehow disappears at work, something awful has happened because the world of work is where the most urgent manifestations of our minds and bodies take place. (In my experience, we usually call that the boss, not the government.) Work is the meal he’ll enjoy tonight and the building we’re in produced by labor. Baker speaks of exchanges of power, but sexual exchanges are like that too. Are we all dominated by power in our professional lives? Compelled to make the most money? Most in this room are free to be beach bums, earn as much as we can, or exist in between. (Yes, we’re quite the representative bunch.) Thus, Fried doesn’t see the market as a radical discontinuity from life. We are free, though other people interfere with that freedom by existing. Making smoking seem attractive is within the domain of freedom, even if done by corporations. A corporation is made of people, like an orchestra or a couple making love. He would not reify it as anything else. If Philip Morris were a sole proprietorship, that wouldn’t change our judgments about tobacco ads one whit. (And, as they say, if my grandmother had wheels she’d be a wagon. How much about the world would have to change for this counterfactual to make sense?)

Tags: market, speech, people, law, government

Foreign Influences

Posted on July 03, 2008 in Generic biologicals

Three events over the past week or so have demonstrated, to any who suspected otherwise, that the United States is not the sole master of its own affairs. Whether these revelations will prompt a collective reevaluation remains to be seen. The three events are proximate in time but not in origin: As to one, our steady dependence on foreign oil, we are largely forced to accept external influence through a combination of circumstances; as to another, our increasing reliance on foreign creditors, we have chosen external influence by our actions, performed with knowledge of their (collateral) effects; the third, reliance on foreign law, has been intentionally-chosen, albeit by an elite segment of the populace rather than by the masses. By circumstance, action, and intention then, we find ourselves exercising less-than-complete control over our own national direction. Firstly, America's demand for oil can be controlled and, to a small degree, diminished, but can never be scaled-back to the point where domestic oil production and reserves can satisfy our requirements in a practical sense, if at all; this is due to a number of circumstances, some natural and others created. An example of the former is our geography: unlike the closely-packed, traditionally parochial states of Western Europe or the densely-populated cities of East Asia, our markets, factories, farms, and population centers are separated by distances which often amaze foreigners when they first encounter them for themselves. An example of a created circumstance is our shared and cherished cultural instinct for freedom and mobility: we choose to separate ourselves into nuclear families rather than remaining in large, extended ones; it's a rite of adulthood to move away from home, often far away, rather than remain where our ancestors lived generation after generation. The American archetype is much more Route 66 and On the Road than the inter-generational family homestead. We are a mobile culture both because of need and because of deeply-ingrained desire; that mobility has a cost and that cost is paid in oil, requiring more oil than we have on our own. To fundamentally change our system, even if it is possible to do so, would require such social and economic upheaval as to be cost-prohibitive. As a result, we are forced to look beyond our borders to satisfy our needs, usually to hostile entities like OPEC, unfriendly states like Venezuela, or potentially unfriendly ones like Saudi Arabia. Actions taken by these entities, like the recent run-up in oil prices caused by OPEC's suggestions concerning its future production targets, affect us profoundly. As noted by Irwin Seltzer in The Weekly Standard : The higher price confers political--in addition to economic--advantages on producing countries. Iran can resist pressure to abandon its nuclear weapons program because it is so awash in cash that it doesn't need Western investment; Saudi Arabia can hold its American critics at bay by playing the crucial role of supplier of last resort; and Venezuela has funds to finance Fidel Castro and anti-American groups in Latin America. The disadvantages to America are obvious. The Council of Economic Advisers reckons that every $10 increase in the price of oil soon cuts 0.4 percent off real GDP. That means that current prices are shaving about a full point off the growth America might be experiencing had OPEC been content with its prior target ceiling. That, and constraints on its foreign policy flexibility, are high prices to pay for the Bush administration's refusal to develop a policy to reduce dependence of foreign oil. Secondly, we have become a debtor nation comprised of debtors. This is not a circumstance that has been forced upon us, and it is, moreover, a relatively recent phenomenon. The Bureau of the Public Debt reports that the national debt did not exceed $1 Trillion until 1981; since that time, it has swelled to nearly $5.7 Trillion by the end of 2000 and to more than $7.7 Trillion today . (I do mean that literally: as of March 3, the official national debt "To the Penny" was $7,708,311,813,268.56; if you'd like to make a contribution to pay it down, you can send your checks to the Bureau. It gives a new connotation to the term "welfare state", doesn't it?) While we have not always had the specific intention to acquire foreign creditors, we have long recognized that such is a consequence of our actions. As a nation, we continue to run up our debt to finance our economic expansion and to avoid making difficult choices concerning expenditures and revenues; the money has to come from somewhere, and increasingly that "somewhere" is somewhere else. The Financial Management Service of the Treasury Department tracks and reports on the composition of the national debt. Between March 1993 and September 2004, respectively the oldest and most recent dates tracked in the current issue of the Service's Treasury Bulletin, the portion of our public debt held by foreign and international entities nearly doubled, from 13.8% of the total to 25.2% ( Table OFS-2 -- Estimated Ownership of U.S. Treasury Securities [in Microsoft Word format]). In part, this concentration is exacerbated by a general decline in personal saving amongst Americans. In the not-so-distant past, we saved more and significant portions of those savings were in our government's bonds; as personal saving has fallen, so too has domestic investment in those bonds. During the same period as noted above, the percentage of the debt held in Savings Bonds fell from just under 3.9% to less than 2.8%. The "slack" has been eagerly taken up by foreign investors. Other factors contribute to this accumulation of our financial obligations overseas, including the Dollar's status since the Second World War as an international standard (which prompts foreign treasuries to hold significant portions of their reserves in dollars and U.S. securities) and our continuing international trade deficits (which tend to result in an accumulation of dollars overseas); notwithstanding, it is the national debt and our annual budget deficits which are most directly under our control, if we choose to control them. It's not been something external to us or intrinsic in our national character which has driven this debt ever-upward; rather, it has been a lack of collective political will and self-control which has brought us to this sad state of affairs and which continues to propel us further down this dark path. Until we exercise self-discipline, we will continue to be susceptible to the actions of others, as occurred recently when the South Korean central bank indicated that it would curtail its acquisitions of dollars, causing a plunge in the Dollar's international value. Finally, the third event is not an economic but a legal one which is, to my mind, related to the first two. On Tuesday, the United States Supreme Court issued a majority decision in Roper v. Simmons which interpreted the U.S. Constitution, in part, based upon foreign laws and world opinions. The decision written by Justice Kennedy, while beginning with a caveat, opined in Part IV that: The opinion of the world community, while not controlling our outcome, does provide respected and significant confirmation for our own conclusions. Over time, from one generation to the next, the Constitution has come to earn the high respect and even, as Madison dared to hope, the veneration of the American people. See The Federalist No. 49, p. 314 (C. Rossiter ed. 1961). The document sets forth, and rests upon, innovative principles original to the American experience, such as federalism; a proven balance in political mechanisms through separation of powers; specific guarantees for the accused in criminal cases; and broad provisions to secure individual freedom and preserve human dignity. These doctrines and guarantees are central to the American experience and remain essential to our present-day self-definition and national identity. Not the least of the reasons we honor the Constitution, then, is because we know it to be our own. It does not lessen our fidelity to the Constitution or our pride in its origins to acknowledge that the express affirmation of certain fundamental rights by other nations and peoples simply underscores the centrality of those same rights within our own heritage of freedom. Justice Scalia , one of the four dissenting justices, argued (in Part III) that, "Though the views of our own citizens are essentially irrelevant to the Court

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Just Another Day

Posted on June 29, 2008 in Erectile dysfunction drugs

" I've got the biggest dick in the world. Twelve inches of thick black cock . " 6:20am and this is the first thing I hear when I walk out of my apartment. My immediate thought is, "Dad? Is that you?" But alas, it's not my long lost father. It's some dude who looks like he could be normal, ranting at no one in particular. I'm in front of him, walking the same direction as he is, and we pass a woman loading luggage into a town car, like she's going to the airport. Johnny BigDick leers at her "Oh yeah Sistah - work that trunk, " and I can hardly contain my laughter. Unfortunately the next words out of his mouth, I fear, are directed at me: "I love sucking white boys' cocks." Normally this may be a good thing to hear, but in my neighborhood, and this time, it is usually not music to my ears. The chances of these words coming from neighbors Liv Tyler, Famke Jansen or Gisele are somewhere between slim and none (akin to catching perfect-perfect to scoop a pot - only much much worse), while the chances of them coming from a 5 foot 6 inch gay black man are pretty fuckin' good (like having a super wrap straight draw + flush draw with overcards in an Omaha pot that makes you a big favorite). I make it to work, and in the afternoon I fire off an email to Chris asking him if he's played at our club lately. He replies that not only is the club still going, but he played last night, and there were at least four BIG TIME action players splashing around, issuing brutal beats. I quickly shoot off another email to The Vortex, imploring him "You have to go play live - I hear the game is sick. I can't play because I have to take care of Oscar after work." Vortex quickly replies this he was genuinely Midway this amusement, to boot that it was sweeter than I could expect, giving me a few contents illustration. I'm now welcome serious TILT, all along I'm aching to play stay in poker, but discern particular obligations, exceptionally, my boy - Oscar. Instead of animate vicariously Because Vortex, I hunger a share of the activity myself... oh thoughtlessly. twin term, another dollar. -KD

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Greg Ip Earns a Voxy

Posted on June 14, 2008 in Prescription drug insurance

Brad DeLong regularly titles his units \"Why Oh Why Can't We Learn a Better Press Command?\", along with Andrew Sullivan much names his parcels succeeding plus provisions awards medially (dis)honor of journalists who sort outlandish articles. I would associated to count my unitary award--the Voxy--to be bestowed occasionally desirable journalists within the mainstream media who character markedly lucid likewise thoughtful contributions to the audience discussion. Foreknow defend to e-mail me with nominations. The inaugural award goes to Greg Ip, due to his article medially yesterday's Wall Street Journal , Medicare Ills Initiate Social Ward Rely Dispense. Render the whole thing. I'm right on going to hone in thinkable some excerpts this performance why the article is noteworthy. Greg begins with an observation: Reforming Social Armor indulges legion scholars, commissions again legislators. Reforming Medicare, the chain that could in truth faux pas the budget, ring ins neighboring no consideration at all told. He's right. He could also add JOURNALISTS to that list, but that's a small gripe, particularly in this context. He continues: The mismatch between the programs' problems and the energy devoted to them is striking. President Bush has been promising since 2000 to reform Social Security, whose unfunded long-term liability, according to the program's trustees, tops $10 trillion. Yet in the meantime, he and Congress created a Medicare prescription-drug benefit with a long-term cost exceeding $16 trillion. Yes, that's basically right, too. According to the 2004 Medicare Trustees Report (see Table II.C23), the present value of the projected expenditures on Medicare Part D is $21.9 trillion, or 2.4% of GDP. (I would have called this the long-term cost.) Beneficiariy premiums and state transfers are projected to offset $3.6 and $1.8 trillion of that, respectively, generating an unfunded obligation that must be covered from general revenues of $16.6 trillion (after rounding), or 1.8% of GDP. There are two caveats to comparing this $16.6 trillion directly with the $10.4 trillion in unfunded obligations for Social Security. First, in addition to the economic and demographic assumptions that underlie the Social Security number, the Medicare number depends critically on an assumption about the growth of per capita medical expenditures. The disparity could be higher or lower than $6.2 trillion even if the $10.4 trillion projection is completely accurate. Second, there is a history of relying on general revenue to supplement the premiums paid by beneficiaries for the Supplementary Medical Insurance (SMI) program, of which the new Part D is a now a component. Some general revenue financing appears to be part of the design. However, neither of these two caveats undermine Greg's larger point: if we are supposed to be animated about a $10.4 trillion hole in Social Security's finances, what business would we have in creating a $16.6 trillion hole in Medicare's finances? And for pointing out that inconsistency, Greg earns a Voxy. Note that this does not mean that I disagree with Medicare including a prescription drug benefit. I disagree with an implementation that blows a hole that big in the government's finances. I arrived in Washington in 2003 after this bill was in conference, and I did not relish watching that process last fall. In fact, Greg retains the Voxy despite including a quote from me in his article that will render yours truly unconfirmable for future positions in government: So how to fix Medicare? One way is to raise the age at which retirees qualify for benefits, as is often proposed by Federal Reserve Chairman Alan Greenspan and others for Social Security. "Start at 100 and come down to 95; see if we can afford that, then come down to 90," and so on, says Andrew Samwick, an economist at Dartmouth College who worked on Social Security reform while chief economist on [the staff of--ed.] President Bush's Council of Economic Advisers. "There is some age at which the system is in balance." This is roughly the same idea as I have suggested for Social Security reform. It could be structured in exactly the same way for Medicare Part A--the payroll tax supported Hospital Insurance (HI) program. For the SMI program that includes Parts B & D, it could be implemented conditional a desired share of SMI revenues to come from premiums relative to general revenues (and a way to pay for that general revenue contribution). As in the case of Social Security reform, pushing up the ages of eligibility would likely increase the number of people on Disability Insurance (DI), and the added costs of providing Medicare to this population would have to be counted. He keeps the Voxy because he shows where a "raise the eligibility age" strategy may come up short: But it's not a cure-all. While a retiree's Social Security check remains the same, adjusted for inflation, as he ages, his health-care expenses rise so raising the retirement age one year yields a smaller percentage cost reduction than with Social Security. And it's politically unpalatable. Greg's right again. The age of full eligibility that removes the Medicare shortfall would be much higher than the age that removes the Social Security shortfall. Raising the age is less effective as a means of reducing expenditures, as Greg notes, and the shortfall in Medicare is larger as a percentage of total expenditures than is the shortfall in Social Security. Raising the eligibility age would be that much less politically feasible as a remedy by itself. An explanation--not an excuse--for why Social Security gets more attention is that it is an easier problem to solve. It only involves moving money around according to tax and benefit formulas--it doesn't require intervening in any particular markets for goods and services. This doesn't mean that it has gotten no attention. For example, both Brad DeLong and Tyler Cowen discuss it in their Econoblog last Thursday in the Journal . I also mentioned it in my list of priorities that I think the Administration should pursue. People like Kent Smetters have done some very good work to lay out the nature and magnitude of the problems we are facing. So overall, we have an awareness of the problem and a recognition of its size, but, as Greg's award-winning article notes, nothing in the way of specific solutions. Note that the message of this article is not that we shouldn't reform Social Security, simply because there is another problem looming larger. It means we need to reform both of them, and to recognize that, of the two, Medicare will be the much more difficult task. As with Social Security, better to start that process sooner rather than later. Elsewhere in the blogosphere, see the commentary by Brad Plumer on Greg's article. Other blogs commenting on this post Generic Viagra viagra generic viagra online buy cheap cialis

Tags: social, security, medicare, trillion, greg

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Posted on May 25, 2008 in Prescription drug insurance

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Synopsys bombshell declarations in patent litigation

Posted on April 30, 2008 in Generic pharmaceuticals

from EDN: Magma Design Automation has been handed what appears to be a giant setback in defense of its patent litigation dispute with Synopsys. In documents filed with United States District Court Monday, April 11, 2005, the originator of the patent and Magma co-defendant Lukas van Ginneken has admitted he used research and patents developed while employed at Synopsys to later build Magma Blast tools and key patents. Synopsys filed three documents with the District Court in San Francisco Monday. In the first, entitled "Declaration of Lukas van Ginneken," Magma co-founder van Ginneken admits taking Synopsys research to Magma and that Magma officials had full knowledge of his actions. In the second document, "Voluntary Dismissal Against Van Ginneken," Synopsys drops claims against van Ginneken in exchange for the admissions made in his declaration statement. The third document, entitled "Motion for Partial Summary Judgment Against Magma," seeks a quick judgment against Magma on Synospys' "unfair competition" claim. (...) "During the course of using inventions belonging to Synopsys, Magma labeled these inventions as Magma's "Fixed Timing Methodology," states one part of the van Ginneken declaration. "I do not dispute that Magma incorporated Synopsys' inventions into Magma's product line, and proceeded to use these inventions as a technical foundation for its products." Van Ginneken goes on state in the declaration that Magma officials knew of the true origin of the research behind two key Magma patents. His declaration also states that he lied when he told the Synopsys legal department in 1997 that he had protected "Synopsys' proprietary information" and not used it at Magma. "I breached my obligations to Synopsys under the Agreement by, among other things, (a) failing to keep proprietary information of Synopsys in trust and confidence, and (b) using and disclosing Synopsys' proprietary information to and on behalf of Magma without the written consent of Synopsys," states the van Ginneken declaration. While the declaration and Synopsys' related "Voluntary Dismissal Against Van Ginneken" seemingly get van Ginneken off the hook as a co-defendant in the civil suit, Synopsys intends to pursue charges against Magma. "With Dr. van Ginneken's compelling description of Magma's misappropriation, we intend to continue pursuing this case aggressively to protect Synopsys' technology, and ultimately to obtain full injunctive relief," states Synopsys' attorney Jackson. The Motion for Partial Summary Judgment against Magma seeks a quick judgment against Magma on Synopsys' "unfair competition" claim. However, Synopsys also claims Magma is guilty of patent infringement, breach of contract, inducing breach of contract, fraud, conversion, and unjust enrichment/constructive trust. Magma issued a statement responding to the Synopsys actions. "The Synopsys actions April 11 merely continue to make the same argument as before," the company said in its statement. "Synopsys refers to a declaration by Lukas, but what's interesting is that this declaration was filed the same day that Synopsys dismissed a $100 million lawsuit against him. This doesn't change our position that Synopsys' claims have no merit." cheap viagra buy cheap cialis Generic Viagra cialis

Tags: synopsys, magma, ginneken, van, declaration

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