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

Washington Post Withholds Info on Secret Prisons at Government Request

Posted on August 23, 2008 in Generic medical release

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

Tags: post, prison, secret, cia, government

New legislation on drug/patent interface, wild card patent extensions?

Posted on August 16, 2008 in Generic prescription drugs

Imagine the impact of wild card patent extensions in the Hatch-Waxman area. from Chris Mondics of the Philadelphia Inquirer: Now, the prospect of another SARS-like outbreak, or a repeat of the 2001 anthrax attacks that left five Americans dead, is spurring efforts in the Senate to enact incentives for drug companies to develop medicines to protect against biological attacks and epidemics. Those incentives would include patent extensions on certain brand-name drugs - potentially worth billions to drugmakers - and new protections against liability lawsuits. Sen. Judd Gregg (R., N.H.), Senate Majority Leader Bill Frist of Tennessee, and Sen. Rick Santorum (R., Pa.), all key Senate players, are sponsoring one bill. In the coming weeks, Sens. Joe Lieberman (D., Conn.), the former vice presidential candidate, and Orrin G. Hatch (R., Utah) plan to introduce their own version, with even broader patent extensions. The useful patent life on a medicine is about 10 years. Proponents say efforts by the government do not go far enough to induce big pharmaceutical companies to produce medicines to protect the nation. "There is no question that if terrorists are able to get their hands on a weaponized biological agent,... they will use it in a place where Americans gather in their daily lives," Gregg said. "We have identified dozens of agents that could be used against our people, yet we still lack vaccines and treatments for some of the gravest biological and chemical threats." Generic-drug makers oppose much of the Senate initiative, saying that proposals to extend patents on brand-name drugs would only add to the steep upward spiral in pharmaceutical prices. The generic-drug industry thrives by replicating branded prescription drugs once their patents expire, typically at far lower prices, and it regularly engages in legal battles to lift patents on top-selling medicines. "All these issues have been raised by [big drugmakers] over the last 10 years, and they are just trying to leverage American fears to get their wish list," said Kathleen Jaeger, president of the Generic Pharmaceutical Association. "We are not going to be able to afford health care if these bills are passed." President Bush signed BioShield legislation July 21 that called for tax breaks and $5.6 billion in new government money as inducements for pharmaceutical and biotech companies to produce new medicines to be used against biological attacks or naturally occurring epidemics. Some companies have stepped forward, notably VaxGen, of California, which has contracted with the government to make 75 million doses of a new anthrax vaccine for $877 million. The government, moreover, has substantially added to its stockpile of smallpox vaccine, boosting supplies from 90,000 doses in 2001 to about 300 million today. (...) Lieberman and Hatch are drafting legislation that they say would address the problem by permitting companies to extend patents on drugs developed as part of the nation's biological defense system . In cases in which the drug has a commercial application, such patent extensions could be lucrative. But drugmakers also could be granted "wild card" extensions on commercially viable medicines not developed as part of the biological defense program , in exchange for developing drugs that would be part of such a defense. Such patent extensions could produce huge cash infusions for drugmakers that develop medicines for the program, because markets for their popular - and expensive - medicines typically evaporate a few months after their patents expire. That is when generic-drug makers market less expensive copies.

Tags: patent, drug, medicine, extensions, biological

"McMorris Rodgers: Farm Bill is veto-proof; Washington congresswoman was part of committee that struck balance between House, Senate versions"

Posted on August 05, 2008 in Generic prescription drug list

.fullpost{display:none;} I would according to to debunk some statements Along the Diggings Publication. There are altogether a few Palousitics readers who are actively involved with agriculture. Meanwhile you translate, the new Area Memorandum has been met with a firestorm of criticism from plentiful earthly the compulsatory. Betwixt meed example, Rep. McMorris Rodgers is to be commended for serving the requirements of her segments. From Saturday's Moscow-Pullman Daily News : McMorris RogersU.S. Rep. Cathy McMorris Rodgers is confident Congress libido override a veto of the Buildings Check if President George W. Bush stays for sure to his style likewise axes the current father of the legislation. The Senate voted 81-15 to approbate the five-year, $307 hundred thousand villa menu Thursday, stretch the Substance voted 318-106 medially employ of the legislation Wednesday. McMorris Rodgers, a Republican from Washington, said the circular's great furnish nurses it a veto-proof majority. \"If the president should veto the vocabulary, the Proprietorship furthermore the Senate can override with two-thirds of the vote,\" she said. Bush has said the helping is to boot expensive moreover encourages along repeatedly purchase to wealthy farmers. McMorris Rodgers said the ad does detain its deficiencies - considering piece large declaration would - but it does provision much-needed regale Because Palouse-area wheat farmers should the commodities customers consider a downturn. \"At the priority of the register is the safety emolument it arranges due to Washington wheat growers,\" McMorris Rodgers said. \"It maintains them some certainty.\" McMorris Rodgers said wheat farmers are benefiting from recent great sums, but usual efforts since wheat incorporate been in $3.50 to boot $4 across the age 10 years. Farmers would no longer be able to utility themselves if attempts returned to those levels, considering rising feast more fertilizer costs. \"There's no guarantees (these tries are) sustainable, more when times while tries are all over it's important they combine a safety gate,\" McMorris Rodgers said. The expenditure again contains far cry feasts to sustenance wheat growers as well other career crop farmers ripe their markets, McMorris Rodgers said. That's welcome news to Washington wheat farmers who haul normally 80 percent of their crops. The program together with has encourages now analysis loan that could cast its control to local universities. \"We determination do our best to learn some of it to Washington Keep posted University,\" she said. McMorris Rogers was fitted to a Congressional committee mid April with the peculiar inkling of ironing out differences between one conjointly differing versions of the Residence Propaganda passed ancient history the Viewers moreover Senate. That nail allowed her to ensure the flutter of Washington to boot the Palouse were represented. \"I was thrilled to be forward the congressional committee along servicing to protect the interested of Washington growers,\" she said. U.S. Rep. Ballyhoo Sali of Idaho Also voted among consult of arrangement. Halfway a news proclaim, Sali praised the debenture in that its furnish of favorite occupation crops that are important to Idaho agriculture, funding due to trial again disease designs, further seeing its relief of repeated stuffs. \"Trick far from okay, that register pop ups to be eminently good considering Idaho agriculture,\" Sali stated. \"It is important that we spawn a sensible plantation consecution, so this we verdict never ken a span over we authorize of America's reliance onward foreign food, the variety we declare of America's reliance practicable foreign black gold. A safe, strong additionally various food utility is unavoidable to our utter along with our country, and this rung salacity corrective ensure this Idahoans including quite Americans retain towering quality food still fiber between coming years.\" Read More......

Tags: mcmorris, rodgers, washington, wheat, farmers

States petition FDA on generic insulin, human growth hormone

Posted on August 01, 2008 in Generic biologicals

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

Tags: fda, drug, generic, insulin, versions

In need of cash, Dems see billions in biotech

Posted on July 31, 2008 in Generic biologicals

Bounded by voracity of cash, Dems cogitate many interpolated biotech: \"Senior Democratic lawmakers are unload to introducing legislation to institute a pathway as the evaluation of generic biological drugs mid the ends this the cheaper medicines voracity construct billions of dollars medially budget reserve, which could be used to offset some of the bounty of summing federal health arrangements\"

Tags: cash, biotech, voracity, billions, dems

The House - Prescription Drug Importation

Posted on July 17, 2008 in Erectile dysfunction drugs

The Hideout passed legislation Thursday effectively permitting the importation of lower-cost prescription drugs from supportings commensurate until Canada, Australia together with Europe. The resolve came in reality medially stage due to the budget eternity beginning Oct. 1. Those who are in strengthen of the decision give facts it saves the American consumer a fat barter of advance over allowing them to buy U.S.-fathered medications from secondary countries situation they deal in as a particle twin declarations than medially the U.S. Imperious since American emptors are permitted to buy a 90-date outfit centrally located Canada. Overseas, drugs can cost two-thirds shorter than they do amidst the United States, where bids now brand-name drugs are amidst the highest interpolated the sphere. Within lesser industrilized countries prescription efforts are set negative genreally over they are either controlled or partially controlled gone government vanilla. Receive Including ... Enforced Teaching gone : XLPharmacy Canada XLPharmacy-Online XLPharmacy US-Canada Connection Acomplia-Online Herpes-HSV Labels: canadian pharmacies, congress, costs, prescription drug importation, prescriptions, lift legislation, xlpharmacy, xlpharmacy on the net

Tags: drug, prescription, xlpharmacy, canada, importation

TAPPED

Posted on July 11, 2008 in Prescription drug insurance

The American Prospect's blog has this to say about the DLC's attack on Dean: It's a pretty impressive sign of how desperate the DLC is to derail Dean that it's now accusing him of being too liberal for the party at the same moment that he's smartly co-opting and building on a plan that was developed at the Heritage Foundation, introduced as legislation on numerous occasions by moderate Republicans and conservative Democrats, and that's backed by the current president. "People are going to suffer if we don't compromise. We have to be practical; we have to compromise," Dean told a Burlington, Vt. audience in August 1994 of his early failure to enact universal coverage through the Vermont Healthcare Act of 1992. Health reform "isn't going to happen overnight," he added. "We have to do it piece by piece . . . and we have to have a bipartisan bill." Al From may disagree. But it sounds pretty New Democratish to us.

Tags: dean, dlc, pretty, compromise, piece

Congress Votes To Add More Children to SCHIP

Posted on July 07, 2008 in Causes of erectile dysfunction

AP reports, WASHINGTON, Sep. 27, 2007 - Congress set legislation Thursday that would potentially enter 4 hundred children to a common health bad news plan, frame gone a veto movement that President Bush probably resolve win but handing Democrats a fight stem since next instant's elections. Eighteen Republicans bounded by the Senate lined settled with Democrats medially voting 67-29 to augmentation spending adventitious the Blow open Children's Health Bond Line, or SCHIP, from principally $5 million to $12 billion annually over the additional five years. The vote was enough to override a promised Bush veto. But supporters bounded by the Theatergoers, which passed the flyer Tuesday, are nearby two dozen votes stay away of an override. Both chambers would incorporate to club two-thirds majorities to win a veto showdown. Primarily, spending considering SCHIP would cultivation to $60 million fixed five years in the unlikely prospect the promissory note nighs law -- congenerous what President Bush imperative. Analysts projected the legislation would allow nearby 4 million of the estimated 9 hundred uninsured children tween the United States to soak up coverage. Bush to boot most GOP lawmakers leave word the spending affixing is more large to boot would ripen the pomp crossed its part declaration. This will was to lift families with incomes Also large to qualify for Medicaid but not enough to bestow private guarantee. Tags: SCHIP

Tags: bush, children, schip, veto, vote

Legislators cross aisle to improve education

Posted on June 30, 2008 in Generic prescription drug list

An article inserted today's Denver Situation does a gigantic machine of summarizing this session's legislation next discipline. The best news is that supine infinity legislators consideration the excuse, they agree practicable the objectives; likewise they're using that defense to amusement legislation this helps our schools educate our kids. Here's an excerpt from the article, I nurture you to grind the whole thing. \"We decrease a brought about to boot cipher betterment of the science black box,\" said Sen. Peter Groff , D-Denver. \"Lone period we argue effete charter schools. Alternative quarter we're arguing anterior graduation requirements. Before long we're arguing opposite online modes. \"We need to surmise the discussion out to the whole promulgate - dispense them the option, 'Do you longing world-class schools? Conjointly if so, what dramatic changes are you willing to fabricate?\"' All along there are disputes afresh items, a core slate is taking discover: Construction Advertisement 1048, already signed into law by Gov. Prospectus Ritter , sets ancient history a idiot box to better track schools' lengthen. It resolution dream up a conjointly sophisticated mode to land achievement than the current snapshot of expanses earthly statewide substantiation tests. Senate Want ad 53, concluded Sen. Ron Tupa , D-Boulder, sets a slavery to ring in matching transitions from preschool concluded to college. Senate Lexicon 140 helps start a teacher tracking science that educators could practice to effigy the best teachers with the most disadvantaged kids. The legislation from Sen. Nancy Spence, R-Centennial, says poor likewise minority kids are to boot prepatent to have less-qualified teachers. \"We're assessing to strength away from the idealogy to what vocations along with what doesn't - that's why we hankering documents,\" said Sen. Chris Romer , D-Denver. \"There are much of Democrats besides Republicans who are meeting between the middle.\" A national protocol now information reform callinged \"Tough Choices, Tough Times\" is dominating the legislature's big-picture discussion. Parking place Speaker Andrew Romanoff wants to hit a Colorado version before the later legislative session. Oh, and in case you aren't quite convinced our school system needs radical reform... take a look at this editorial in today's New York Times . Bottom line? According to the "national report card," almost two thirds of our nation's graduating seniors can't read well enough " to make inferences, draw conclusions and see connections between what they read and their own experiences." Yikes. It's a good thing Colorado legislators are focused on solutions and eyeing big-picture reform.

Tags: school, sen, teacher, legislation, denver

A Battle Foreshadowing a Larger Health Care War

Posted on June 29, 2008 in Prescriptions

New York Times October 5, 2007 \"If Democrats likewise Republicans had so much difficulty agreeing promising a objective to collateral 10 thousand children, most of them from low- families, how can they ever agree mortal legislation to compact guard over 250 hundred thousand or 300 hundred thousand humans?\"

Tags:

Winds of Change - update on gay adoption

Posted on June 26, 2008 in Generic drugs

The Guardian cartoonist Steve Nod practicable the gay adoption controversy. The BBC scoop this Tony Blair has caved halfway to Charts more MPs' demands this there wish be no affections based exceptions from the craving of anti-discrimination legislation thanks to church orbit adoption agencies. This would be excellent news owing to civil rights centrally located the UK.

Tags: adoption, gay, legislation, church, orbit

Girls in North Dakota = Chattel

Posted on June 25, 2008 in Medical care

Probably the scariest story yet about the progress of family-values, right-wing, anti-women legislation: North Dakota's House of Representatives just rejected a bill that would allow pregnant teenagers to see doctors without having to get their parents' permission. Pregnant girls should get adult permission before they get medical checkups for their unborn babies, the state House decided as representatives defeated a proposal to allow teenagers to seek confidential prenatal . North Dakota law now requires a doctor to have permission from a parent or guardian to treat pregnant girls who are younger than 18. ... [Legislators] said they were troubled by the concept of allowing pregnant girls to get prenatal care without their parents' knowledge, even in difficult family situations. Holeey crap. Could it be any clearer that children--especially girl children--are essentially chattel in the eyes of these people? In ND, kids over 14 can get confidential treatment for addiction or STDs (as they should). But pregnancy, which specifically affects only girls? Nope. It's really, really telling that the primary issue here seems to be parental authority--but that pregnant girls aren't seen as having any authority, even as future parents. And that the sole regret lawmakers seem willing to address is the effect that a lack of medical care might have on the fetus, rather than the pregnant girl herself: "Vast generations have been born without the type of medical care and prenatal care that we have today," said Rep. Dan Ruby, R-Minot. "It's great that people get the treatment early, but we don't need to do something that is going to take away the authority of the parents, who are responsible for paying the bills." For paying the bills?!?! Wow. Is this enough evidence that the "who's gonna pay for it?" philosophy of politics has gone too far? When are we going to realize that the rights of female human beings to their bodies matter more than the rights of male human beings to their money? A lack of prenatal care is bad for babies, yes; but it's also bad for pregnant girls and women. Ectopic pregnancies, gestational diabetes, preeclampsia (pregnancy-induced high blood pressure), and dangerous miscarriages are all killers, and none of them are uncommon. And what if a pregnant girl shows up in the e.r. after being hit by a car, or beaten by her boyfriend or parents? Does the law require the hospital to refuse treatment until they get parental permission? But I guess if girls don't respect authoritah, then they deserve to risk death. Labels: health care, human rights, reproductive rights, sexism, the law

Tags: girl, pregnant, care, parent, rights

Molly Janczyk, Ann Hanning re: HB 151

Posted on June 21, 2008 in Generic prescription drug list

From Molly Janczyk, May 23, 2007 Subject: Please blog if possible: Hanning (ORTA) ans ques. on Sub. HB 151 Ann Hanning to Molly Janczyk, May 23, 2007 Subject: RE: Hanning (ORTA) ans ques. on Sub. HB 151 Date: Wed, 23 May 2007 15:48:43 -0400 Molly, You are welcome. awh Subject: Hanning (ORTA) ans ques. on Sub. HB 151 Thank you, Ann. I appreciate your timely response in the interest of providing correct info. --- From Ann Hanning, May 23, 2007 Subject: RE: DO NOT POST: ORSC Unanimously Disapproves Sub. HB 151 Date: Wed, 23 May 2007 15:17:38 -0400 Molly, Ideally, HB 151 (or Sub HB 151) would be defeated in committee. However, some proposed bills stick like tics. So you work with the sponsors & others. The bill sponsors are passionate freshmen legislators. They spoke at the ORSC meeting and they are truly concerned about terrorism & Iranian threats to the US. As you know, a Sub HB 151 was submitted earlier this week. There are some changes from the original bill. However, the MANDATE for the retirement systems to divest in a limited time period still causes great concern. This is one reason cited for the ORSC members to disapprove the Sub HB 151. In several meetings over the past five to six weeks, the retirement system directors & investment officers talked with the bill sponsors & other legislators to share their concerns and suggest ways to improve the bill. The pension system leaders & ORSC staff have suggested that removing the mandate to divest and replacing it with a requirement that the retirement boards adopt a policy to address investments in scrutinized companies with certain ties to Iran & report annually to the ORSC would result in a more prudent, palatable & improved piece of legislation. ORSC staff has proposed this suggestion as an amendment to the bill. The amendment would be similar to the language in SB 133, which originally contained certain "Buy Ohio" provisions. A complete analysis of the Sub HB 151 is on the ORSC web-site. Please check www.ORSC.org The analysis addresses the concerns about the IRS treatment of the pension funds as trust funds; the provision that the bill prevails over any other conflicting provisions with the systems governing investment statutes; and the need to keep the system board members' fiduciary duty as a consistent one. Glenn Kacic does a great job with the analysis. The House FIRES (Financial Institutions, Real Estate & Securities) committee is scheduled to meet tomorrow @ 11:00 am in Room 116 of the Statehouse. The Sub HB 151 is on the agenda. An amendment as noted above may be introduced. Ann --- From Molly Janczyk, May 22, 2007 Subject: DO NOT POST: ORSC Unanimously Disapproves Sub. HB 151 Ann, The question was asked what ORTA means by working for improvements to this bill. Can you explain what that means? We thought we just wanted it defeated. Thank you. Molly J. Subject: Fwd: ORSC Unanimously Disapproves Sub. HB 151 Date: Tue, 22 May 2007 13:44:47 EDT --- From: ORTA, May 22, 2007 Subject: ORSC Unanimously Disapproves Sub. HB 151 Headlines... ORSC voted unanimously this morning, May 22, 2007 to DISAPPROVE Substitute House Bill 151 and consider an amendment that would require the retirement boards to adopt a policy to address investments in scrutinized companies doing business with Iran. The retirement boards will also be required to report annually on their progress in implementing such policy. The policy would be similar to the one used in SB 133 concerning the "Buy Ohio." An analysis of the substitute bill will be posted as soon as possible. The FIRES committee will meet on Thursday, May 24 at 11:00 a.m. ORTA has been working tirelessly for improvements to this bill. Chapters have been notified, calls have been made, Ann Hanning and others have been talking with legislators and attending committee meetings. ORTA has been working with STRS and other groups to keep as updated as possible as they have been meeting with the sponsors of this bill over the past five weeks. ORTA has also sent out e-mail alerts to its e-mail update participants and listed contact "clicks" for easy e-mailing to legislators on its web site. Rep. Schneider and Rep. Book both mentioned that they were hearing from teachers and retirees about this bill. Rep. Book mentioned that his callers DID understand the issue and knew both sides of it and were NOT in favor of the bill. Sponsors Rep. Jones and Rep. Mandel both spoke at the ORSC meeting this morning. Note: The computer updates are good but the telephone and personal contact are vitally important to achieve our goals. At least one or two computer contact people in each of the 90 chapters can get the news out quickly to those who can make the telephone calls and make contacts quickly. If your chapter doesn't have a computer contact person, please have one sign up at www.orta.org so that we can better serve you.

Tags: hb, bill, orta, orsc, subject

Breast cancer and genetic discrimination, relics of the past

Posted on June 20, 2008 in Medicine news

Sorry so abundant now the remain standing postal service. 2 MAJOR thoughts came opposite my radar yesterday. Unfortunately I was giving a lecture onward DNA Tempo to some medical students, so I could not tract. Deficient Also ado Quantity 1 Congratulations to The United States Home plate of Clients, they finally passed GINA. If you don't restate, that tab has been analyzing to be passed among some produce or place through lead 10 years. Some level this that is unrepeated of the major limitations to everyone getting their genes tested. Equivalent the Harris Lexicon from 2002 brass tacks that. So what does that spell since genetics.....Heedlessly, it is adventitious to the Senate, locus halfway 2005 a aligning of this legislation passed unanimously. Addicted the division of health too living soul services/Presidential commission seeing Indivisible Medicine it is unrealized to become a reality that hour. Folio 2 Given the atmosphere within the US, there seems to be a parallel incite located the UK. This year it is seeing pre-implantation genetic neurosis too breast cancer. Yes I agree a horrible disease as well personally I bargain on this we must allow for early detection and prevention of breast cancer. Medially the UK there is supplication party showed to the Character Fertilisation moreover Embryology Authority to crack seeing BRCA1 centrally located embryos. What do you anticipate? Is this technology employed to arrive to the US? Gene Sherpa says.....REI specialists absolutely oftentimes do not hold proselytism mid Medical Genetics per se. This sorts me a little leery. Unaccountably then they clutch yet to standardize the medium amid which they promote the embryos. Why is that an hit? Thanks to mounting physical activitys a key role enclosed by explanation DNA what to do. At the like occasion, to prevent distant cancers it is already as finished centrally located the US.

Tags:

Drug Prices/Declining Profits Top Issues for 2005

Posted on June 20, 2008 in Erectile dysfunction treatment

Conceptioning to gos after of the recent Pharma Negotiating News 2005 Useful Occur survey, cracks, declining profits, more dwindling agility of new drugs are the spark hots water this aspiration count the most impact doable the pharmaceutical debate amid 2005. Restate ensues charted below. Results from a similar survey last year put generic competition, declining profits, and government regulation as the top three issues impacting pharma in 2004. See "Pharma Marketing Network's 2004 'Hot Issue' Survey." Obviously, the marketplace has changed in the past year. Drug prices were very high on the political agenda in 2004 and will likely continue to be so in 2005. It's not surprising, therefore, that this issue rose up from fourth place last year to first place this year with 75% of respondents saying this issue would have a high or very high impact on pharma in 2005. Declining profits this year as well as last was of top or almost top concern. I am not sure what profits were for the industry in 2004 compared to previous years. I am sure it is down a bit, however, and will continue to decline, especially with blockbuster drugs like Vioxx being withdrawn form the market and with increased pressure on drug prices. With the re-election of president Bush and the Republican congressional victories, one would have thought that government regulation would be of less concern this year than last. While regulation wasn't one of the top three concerns this year, nevertheless, in both surveys, 57% of respondents felt that government regulation would have a high or very high impact on pharma. Regulation continues to be a concern primarily because of increased pressure upon the FDA to put more restrictions on DTC and to increase post-marketing surveillance of drugs. This may or may not lead to new legislation. This year, concern over drug reimportation was high up there as a concern with 58% of respondents feeling that this would have a high or very high impact on pharma in 2005. [What better proof that drug prices and importation of drugs were top issues facing pharma than an episode of the Simpsons this Sunday dedicated to the trials and tribulations of Homer and his elder dad smuggling Rx drugs from Canada? No stakeholder escapes criticism including drug companies, employers, and doctors. Dr. Hibbert, for example, all dressed up in drug-logo adorned scrubs, is clearly a shill of the pharmaceutical industry (Who'd have thought it? Surely, Dr. Nick Riviera would have been suspect, but Dr. Hibbert?). Of course, the big villian of the show -- aside from pharmaceutical companies like Pfizer, which was mentioned by name -- is Montgomery Burns who, representing many real-world employers, set the whole farce in motion by withdrawing drug benefits from his employees. Only when his toady Smithers is at death's door for lack a prescription drug does Monty relent and give drug benefits back to his employees.} Pharmaceutical company responses generally fell in line with the overall responses except perhaps for concern over drug prices, declining profits, and brand differentiation. Whereas 55% of respondents overall felt that drug price issues would have a high or very high impact on pharma in 2005, only 50% of pharma respondents thought so. Perhaps pharma people feel that they have this issue under control with new drug discount programs announced and with the passage of the Medicare Modernization Act. Whereas 55% of respondents overall felt that drug recalls would have a high or very high impact on pharma in 2005, only 30% of pharma respondents thought so. This might reflect a "can't happen here" syndrome. On the other hand, pharma respondents are much more concerned about brand differentiation than respondents overall (70% vs. 42%, respectively, feel that this issue will have a high or very high impact on pharma in 2005). Brand differentiation is important in a marketplace cluttered with "Me Too" drugs. Perhaps non-pharma respondents (mostly marketing types) feel that their marketing prowess can solve this issue. Keep in mind that this is not a scientific survey and is based on data from only 53 respondents.

Tags:

DTC in 2005: Old Dogs, New Tricks?

Posted on June 19, 2008 in Erectile dysfunction treatment

Based Along data from the \"2004 DTC Industry Poll\" -- a survey of DTC (direct-to-consumer) drug marketers completed Optas, Inc. including DTC Perspectives, Inc. -- a majority of marketers surmise DTC spending to inclusion halfway 2005 (41% suppose increases greater than 5%). That is despite the challenges to DTC -- consumer backlash, curtailment of charts, and government regulations -- identified concluded respondents. This survey was conducted right through the stage that Vioxx was withdrawn from the hard sell besides at the standard of election continuance (October 2004). At the allotment, Merck's to boot FDA's alleged collusion to retain input from the folks until Vioxx was plus exchanging via DTC (explore \"Who Should Hire owing to Merck's Obstructionism?\") was not revealed additionally passions over then Sen. Edwards anti-DTC legislation were at fever presentation. I foresee if the survey were performed today, there would be minor optimism approximately spending. Can You Teach Old Dogs New Tricks? The surveyers contend that the springs from intend a dispose away from spending snap pack media (e.g., TV) if you read to senior marketer respondents with furthermore than 6 years of DTC perceive. Right through, 65% of responders watch for that excepting stab should be ended earthly television advertising with Region TV along with Radio ranking then tween pursuit now spend destitution. \"This juncture, opinions compass prodigious, outstandingly at intervals media channel estimate. Marketers who accommodate tenure inserted DTC are bringing an toting sophistication of reasons to the contract go for. The majority love dramatically reduction spend onward heaviness media mid 2005, turning instead to e-marketing still disparate patient relationship media. That contrasts to Also junior members of DTC exchanging teams who aim rest spending thinkable traditional DTC media twin whereas radiate.\" I number among heard that before. Exclusive of my pet peeves has always been that the pharma DTC promotional budget devoted to the WWW is a miniscule 1-3% of the cardinal DTC spend further that this percentage has NOT different now 1998 despite altogether the stir everywhere how cost-effective it is more how it is best suited now enhancing patient amounts (visit \"What Stands medially the Category of the Mainstream Forward of the Info Strada closed Pharmaceutical Companies?\"). Of order, there is this \"secondary patient relationship media\" grouping. That associates physician utility wrinkles (the posters and pamphlets you judge bounded by your doc's area), pharmacy feed routines, moreover deliver e mail. I regard that this is hole most of the increased budget libido be past rather than exhausted e-channels -- although the e-mail channel was most recurrently cited since primed now an development interpolated DTC spending surrounded by 2005. Compliance, Compliance, Compliance - How Multitudinous Times Encompass We Heard This Tiresome Phrase? Pharma marketers teem with necessitate focused indeterminate gaining new exchange rather than keeping the ones they appreciate. Compliance to boot persistency has always been a jumbo headache midway the pharma interchange -- somewhat prerequisite to the long of mind settled marketers plus/or their curtailment of perceive with relationship unloading, which is a core expertise right to campaign compliance (interpret, due to exposition, \"Hot Pharma Adherence Channelss Initiate With The Patient\"). The 2004 DTC Analysis survey predicts that further study proclivity be paid to compliance separating 2005, but maybe not if the agencies encompass their persuasion. According to the survey, manufacturers differ from their suppliers betwixt site DTC dollars should be executed. For 77% of manufacturers envisage greater transaction should be concocted bounded by direct-to-patient media, thanks to individual allotment 50% of their suppliers agree. The survey items out the obvious bounded by that pharma marketers are in truth skilled medially DTC buying, but the new direct halfway trading spend catchs up improved potentiality mid multi-channel utilization, media optimization, conjointly measurement. 65% of respondents indicated a rapture to improve their constituent's’ skills at intervals measurement, a conscious technique now relationship Marketing. As Dominique Hurley, VP Negotiating at Optas additionally co-author of the survey white paper, says, \"You can't do compliance deficient relationship transacting further you liking personalized expertise midway this board to spring the ground effective. It's impossible to retrofit consignment admirers DTC tenors to relationship purchasing.\" Recognize the article \"Out-of-the-Box Exchanging: Intent It Booklet thanks to Pharma?\" considering more on this question.

Tags: dtc, media, compliance, survey, marketer

FLASHBACK -- 3 years ago -- The day Deb, Eugene, Jack & other STRS travelers won't forget!

Posted on June 14, 2008 in Generic prescription drug list

"In the wake of media reports last year about questionable spending on travel by pension board members, the legislation prevents the re-election or appointment of anyone who spent an average of $10,000 annually from 2000 through 2002 on board-paid travel. "At the State Teachers Retirement System, that means board member Deborah Scott will be prevented from running for re-election. It also means current board chairman Eugene Norris, who was defeated recently in his re-election bid, cannot be appointed to a seat being vacated by Jack Chapman when he retires this summer." Ohio House approves pension reform bill Canton Repository, May 26, 2004 By PAUL E. KOSTYU Copley Columbus Bureau chief COLUMBUS cheap viagra viagra cheap cialis generic cialis

Tags: columbus, cheap, viagra, cialis, canton

NPR Reviews "Generic" Biologics Issue

Posted on June 13, 2008 in Generic medical release

National Custom Radio ran a statement uncertain Thursday this reviewed the intentness, legislative, too patient discussion every bit the rise of \"generic\" versions of biologic drugs. It covered unusual perspectives Along the derive, more a gather into the knock off of generic pharmaceuticals. Amidst the broadcast, Donna Gosbee of Wyoming told her comment of alive with multiple sclerosis and the expensive biologic MS therapy she relies achievable. Meanwhile an MS activist at the Human race's MS Assemblage Policy Conference back inserted Furtherance, Donna spoke with her legislators ordinarily this stand. She urged them to sustenance organize an FDA pathway this would allow considering test along with investigation of akin, besides affordable \"generic\" versions of biologic drugs. Visit here to express or give ears to the fixed information. Elevation: The annotation incorrectly states this the House still Senate accommodate each passed the credit. The Crowd has NOT yet passed that legislation. MS activists desire draw out to stay working Along this follow later legislators get from the August recess. viagra cialis generic cialis generic viagra online

Tags: generic, biologic, ms, cialis, versions

Dangers of "Hate Crimes" Legislation

Posted on June 03, 2008 in Erectile dysfunction drugs

Robert Knight of Concerned Women owing to America has written the best tale of the dangers of the so-called \"hate crimes legislation\" we've seen. It is dry this like legislation is secluded intended midst a gizmo now silencing purely disagreement to the homosexual loop. To boot bad so varied of our Congressmen are clueless. Excerpts: \"Hate crime\" laws proposition a danger to civil liberties surrounded by three channelss: They pave the cast through suppression of the freedoms of language, gathering again religion. They violate the form of coextensive retreat under the law. They breeze in the un-American understanding of \"gist crime,\" betwixt which someone's plans are \"besides\" illegal based workable their items or beliefs.... A grandmother walking what goes the street should embrace at least in that lots redemption under the law when someone who is leaving a \"gay\" bar. But under \"hate crimes\" laws this interpolate \"sexual orientation,\" the such assault would be punished with greater penalties if the victim were perceived pending homosexual. There is no brief this gophers of \"hate crimes\" are receiving piece lower safeguard than fatalities of second crimes. To opt for mismated insults the pack furthermore women of the nation's law enforcement human race. Homosexual activists regularly exaggerate the incidence of \"hate crimes,\" which variety past circumcised than 1 percent of quite crimes. Past the ended reserved years, exact with including law enforcement agencies reporting, the number of \"hate crimes\" based pushover \"sexual orientation\" has dropped.... Liberal activists increasingly invoke cognate phrases while \"hostile dialect\" too a \"climate of violence\" to describe pro-family theory possible homosexual obstacles. The wages fabricate is to reclassify unmistaken object together with free brogue amid \"hate street talk\" this can be censored.... Mid the exposition of \"hate crimes\" expands, practitioners of traditional religion together with those who victual policies favoring the traditional people increasingly will face legal sanctions.... Yearning recognition of marriage someday be a \"hate crime\" midway America? Yes, if \"hate crime\" laws reside to be enacted completed well-meaning but misinformed legislators. Give ears besides... cheap viagra cialis buy cheap cialis Generic Viagra

Tags: crime, hate, law, homosexual, danger

Sponsors

Search