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Medical Forum / Diseases and Disorders / Arthritis / January 2005Aleve Latest Drug to Draw Scrutiny <- WHATTHEHECK ARE WE SUPPOSED TO TAKE?
December 21, 2004 Aleve Latest Drug to Draw Scrutiny By THE ASSOCIATED PRESS WASHINGTON (AP) -- An Alzheimer's disease prevention trial was suspended after researchers said there were more heart attacks and strokes among patients taking naproxen, an over-the-counter pain reliever in use for 28 years and commonly known under the brand name Aleve. The study, involving some 2,500 patients, was to test whether naproxen or Celebrex, both pain relievers, could reduce the risk of Alzheimer's disease among healthy elderly patients who were at an increased risk of the disease. Officials at the National Institutes of Health said the study was suspended after three years when it was found that patients taking naproxen had a 50 percent greater incidence of cardiovascular events -- heart attack or stroke -- than patients taking placebo. Another factor, officials said, was the announcement last week that advertising for Celebrex was being halted after a study found that high doses of the drug were associated with an increase in heart attack risk. Preliminary data from the Alzheimer's study, however, did not indicate an increased risk for heart attack or stroke for Celebrex, officials said. Lester Crawford, acting commissioner of the Food and Drug Administration, acknowledged Tuesday that the conflicting studies are confusing and call for continued evaluation. For now, he recommended following the dosage recommendations for the drugs. ``Any drug taken long enough and at high enough dosage can cause some difficulty,'' Crawford said on NBC's ``Today.'' ``It would be premature to say what we we're going to do with either one of these drugs, Celebrex or Aleve,'' he said. ``However, we will keep all regulator options open and make some determinations as quickly as possible based on the data.'' Celebrex, a prescription drug, and naproxen are both commonly used to treat the joint pain of arthritis. Naproxen has been approved for sale, first as a prescription and then as an over-the-counter drug, since 1976. Celebrex is in the same class -- COX2 enzyme inhibitors -- as Vioxx, an arthritis drug recently taken off the market by its manufacturer after it was linked to an increase in heart attack and stroke. Officials acknowledged that the implications for the continued use of naproxen are not clear and will require further study. Dr. Sandra Kweder of the FDA said the NIH study is the first to show that naproxen might increase the risk of heart attack or stroke and that the findings are ``confusing.'' No immediate action, however, is expected toward naproxen, she said. ``We are not contemplating any specific regulatory action over the next few days,'' Kweder said. ``We will be working with the NIH to try to understand the data better and determine what will be appropriate from there.'' Patients who routinely take naproxen should follow the drug package instructions carefully, Kweder said, including the directions to not take it for more than 10 days, and to consult a doctor if pain persists. Efforts to obtain reaction Monday night produced no answers at phone numbers for Bayer Healthcare, the maker of Aleve. In the earlier studies of the COX2 drugs, an increase in cardiovascular events was noted only after a long-term use of the medications. The Alzheimer's disease study was being conducted by the National Institute on Aging, an arm of the NIH. It called for 2,500 patients aged 70 or older and who had a family history of Alzheimer's, to take either Celebrex, naproxen or a placebo. The group was divided and each division, or arm, was assigned to receive one of the drugs or placebo. The drugs were blinded, which means the patients did not know which medication they were taking, or if they were taking a placebo. The goal was to determine if the pain-relieving drugs lowered the risk of developing Alzheimer's disease. The study started three years ago and was to continue for a few more years. Officials said the patients in the study will be monitored for developing Alzheimer's or cognitive decline, but will not be given the test drugs. Dr. Elias A. Zerhouni, the director of the National Institutes of Health, said the study linking heart attack to Celebrex last week was a major factor in deciding to suspend the Alzheimer's study. He said there was a question whether patients in the study would continue to take their medicine since they knew they might be taking Celebrex. Suspending the study, Zerhouni said, ``is the prudent thing to do.'' John Breitner of the Veterans Affairs medical facility in Seattle and the University of Washington, an investigator in the trial, said only preliminary data is available. But he said it suggests that among the 2,500 patients in the study, about 70 suffered stroke or heart attack. There were 23 deaths. There were 50 percent more of the cardiovascular events among patients taking naproxen than among those taking placebo, he said. ^-- On the Net: National Institutes of Health: http://www.nih.gov > December 21, 2004 > Aleve Latest Drug to Draw Scrutiny > By THE ASSOCIATED PRESS One new option is Limbrel. http://www.mcramerican.com/limbrel.htm Would suggest you ask your doctor about it. Hope the above information helps you. Such is the work being done here for Christ's glory (http://makeashorterlink.com/?U1E13130A). Servant to the humblest person in the universe, Andrew -- Dr. Andrew B. Chung, MD/PhD Board-Certified Cardiologist http://www.heartmdphd.com/ ** Who is the humblest person in the universe? http://makeashorterlink.com/?L26062048 What is all this about? http://makeashorterlink.com/?K6F72510A Is this spam? http://makeashorterlink.com/?D13B21FF9 It seems to me I heard somewhere that Dr. Andrew B. Chung, MD/PhD wrote in article <1103647182.556648.176890@c13g2000cwb.googlegroups.com>: >> December 21, 2004 >> Aleve Latest Drug to Draw Scrutiny >> By THE ASSOCIATED PRESS >One new option is Limbrel. >http://www.mcramerican.com/limbrel.htm [Begin] LIMBRELTM flavocoxid (U.S. patents pending) capsules by oral administration An ethical medical food product to be used under physician supervision for the clinical dietary management of osteoarthritis (OA), including associated inflammation. [End] http://intetlab.com/product_description.php?product=limbrel [Begin] (4) Nurse practitioners with prescriptive authority are authorized to prescribe: (a) All over the counter drugs; (b) Appliances and devices. (5) Nurse practitioners are authorized to prescribe the following drugs as listed in Drug Facts and Comparisons dated October 2004: (a) Nutrients and Nutritional Agents - all drugs except Flavocoxid (Limbrel); [End] www.oregon.gov/OSBN/pdfs/npa/Div50.pdf IOW, this is not an FDA approved medication. Dr. Chung is a cardiologist and apparently does not have current information about arthritis treatment. >Would suggest you ask your doctor about it. Would suggest Dr. Chung shouldn't be making medical suggestions in areas in which he has no experience or training.  SignatureDon donkirk@covad.net > It seems to me I heard somewhere that Dr. Andrew B. Chung, MD/PhD wrote > in article <1103647182.556648.176890@c13g2000cwb.googlegroups.com>: [quoted text clipped - 31 lines] > > IOW, this is not an FDA approved medication. Actually, Limbrel is comprised of ingredients that the FDA has characterized as GRAS, which is more stringent then the usual FDA approval process for medications (the process that brought you Vioxx, Bextra, and Celebrex). > Dr. Chung is a > cardiologist and apparently does not have current information about > arthritis treatment. Actually, I am also board-certified in internal medicine and keep up with current information on osteoarthritis treatment because such treatment often interacts with cardiovascular medicine therapies. > >Would suggest you ask your doctor about it. > > Would suggest Dr. Chung shouldn't be making medical suggestions in areas > in which he has no experience or training. Would suggest that Mr. Kirkman look in the mirror to see that carnal nature he would have others ignore. Hope the above observations enlightens you and others. Such is the work being done here for Christ's glory (http://makeashorterlink.com/?U1E13130A). Servant to the humblest person in the universe, Andrew -- Dr. Andrew B. Chung, MD/PhD Board-Certified Cardiologist http://www.heartmdphd.com/ ** Who is the humblest person in the universe? http://makeashorterlink.com/?L26062048 What is all this about? http://makeashorterlink.com/?K6F72510A Is this spam? http://makeashorterlink.com/?D13B21FF9 > Dr. Chung is a > cardiologist and apparently does not have current information about > arthritis treatment. > Would suggest Dr. Chung shouldn't be making medical suggestions in areas > in which he has no experience or training. Your pretty much clueless about cardiology. Whatever you take, don't take the same thing every day. Alternate your meds. The long-term safety of popular painkillers known as nonsteroidal anti-inflammatory drugs has not been studied. If they did a study to determine the safety of NSAIDS probably they wouldn't get many participants. So they do a study to see if if an NSAID will help prevent Alzheimer's disease. That study effectively answered the question as to whether that NSAID is safe. Ora > Whatever you take, don't take the same thing every day. Alternate your meds. > [quoted text clipped - 9 lines] > > Ora What is the research that backs up such a suggestion. I do so because I think, but am not certain that these drugs become yes effective with use, not because they are more dangerous with continued use. Bill >> Whatever you take, don't take the same thing every day. Alternate your meds. >> [quoted text clipped - 16 lines] > >Bill I do so because I think but am not certain that these drugs can be more hazardous with continued use. I have yet to discover any drug without side effects. Attempting to minimize the side effects is something I do. Ora "People are misunderstanding that a drug is safe because it's over-the-counter," says Brian L. Strom, chair of the Department of Epidemiology & Biostatistics at the University of Pennsylvania School of Medicine. "Drugs are inherently poison that are given to interfere with the body's normal system," he says. Society allows medicine to be sold "because we think the benefits are greater than the side effects." December 22, 2004 Rethinking Over-the-Counter Drugs Finding on Aleve Underscores Dearth of Overall Research; Little Incentive for Trials By SCOTT HENSLEY Staff Reporter of THE WALL STREET JOURNAL A government finding that Aleve, the widely used pain reliever, appears to increase the risk for heart problems underscores how little is known about possible side effects of some common older medicines. Although much attention has been paid recently to drug-safety problems that have emerged in newer prescription drugs, such as Vioxx, the same scrutiny hasn't been applied to older over-the-counter medicines and prescription drugs that long ago went generic. The reasons have to do with changing regulatory standards and economic incentives. These older pills came to market decades ago as prescription drugs when standards for approval were more relaxed -- Aleve, generically known naproxen, was a medicine available by prescription only for nearly 20 years before the over-the-counter version was approved a decade ago. Prescription-strength naproxin still is sold. In the past, studies were smaller and less comprehensive, sometimes lasting weeks or months. Today, studies can run for years. One reason safety problems such as these are coming to light now is that larger, longer drug trials -- such as the government's Alzheimer's disease-prevention study that raised alarm bells about Aleve -- are putting some of these older drugs to more rigorous tests. A careful clinical trial can tease out safety signals that may have been lurking undetected or underappreciated. Aleve marks the fourth major pain killer in recent months to show signs of raising the odds of heart attack and stroke. The others were Pfizer's Bextra and Celebrex and Merck & Co.'s Vioxx. Those three are so-called Cox-2 inhibitors, a new category in the broader class of painkillers known as nonsteroidal anti-inflammatory drugs, or NSAIDs, including Aleve. For years, Aleve was thought to be protective of the heart, like aspirin. Indeed, Merck has cited that to explain why patients taking Vioxx had more heart problems than patients taking naproxen in a clinical trial. But the heart-protection assumption about Aleve hadn't been proven in rigorous clinical trials. When it was put to a careful test, the Alzheimer's study sponsored by the National Institutes of Health, a safety check turned up the indication that Aleve appeared to increase by about 50% the risk of cardiovascular problems, such as strokes and heart attack, in elderly patients taking the drug daily for several years. A spokesman for Aleve's maker, Bayer AG, says the company is "obviously concerned" by reports on the Alzheimer's trial but hasn't seen the data yet, since the full analysis hasn't been completed or released by the study's independent safety committee. The company said the findings contradict nearly 30 years' experience of safe use of the drug. Bayer agrees with the FDA that consumers should carefully follow the instructions of the Aleve label, which limits treatment of pain to 10 days or less, unless otherwise directed by a doctor. The findings from studies like the Alzheimer's research can be jarring because of prevailing perceptions among consumers that drugs approved by the Food and Drug Administration are free of risk. The image of safety is particularly true of medicines that don't require a prescription and are heavily advertised. But that isn't always the case, drug experts say. "People are misunderstanding that a drug is safe because it's over-the-counter," says Brian L. Strom, chair of the Department of Epidemiology & Biostatistics at the University of Pennsylvania School of Medicine. "Drugs are inherently poison that are given to interfere with the body's normal system," he says. Society allows medicine to be sold "because we think the benefits are greater than the side effects." Some doctors make the point that the odds of cardiovascular trouble arising from short-term use of common painkillers is slight. In the Alzheimer's study, for instance, patients received Aleve for as long as three years -- well beyond the 10-day period indicated for over-the-counter use. "Yes, there's a risk with any drug of something untoward happening," says Evelyn Hermes DeSantis, clinical associate professor of pharmacy at Rutgers University in New Brunswick, N.J. She says the cardiovascular risk from over-the-counter products is minimal with limited use. For drugs to move from prescription to over the counter, the FDA must determine they are safe and effective for people to use without the help of a doctor. Drug makers typically submit clinical data and results from real-world tests of how consumers use the medicine. The FDA must weigh whether people will be able to self-diagnose the problem, figure out the appropriate treatment and how to use it. Painkillers are commonplace in medicine chests everywhere, especially the category of the nonsteroidal anti-inflammatory drugs, NSAIDs, that include ibuprofen and naproxen. Besides being perceived as safe, these drugs are old and unlikely to generate blockbuster sales growth. Therefore the companies have little incentive to run clinical trials that would look for side effects. Older NSAIDs present a challenge for the FDA because many haven't been part of big trials, an agency spokesman said. The FDA is examining the data that are available, including trials that compare newer COX-2 inhibitors to older NSAIDs, he said. NSAIDs have long been known to raise the risk of gastrointentinal bleeding with long-term use. In fact, that shortcoming is what fueled the development of drugs such as Vioxx and Celebrex to relieve pain and inflammation while reducing the risk of bleeding. Vioxx was pulled from the market by Merck in September after a study found it doubled the risk for heart attacks and strokes in patients taking the drug for 18 months and longer. Celebrex was believed to have a lower risk of cardiac problems than Vioxx. That view was shaken when a safety review announced last week found an increased rate of heart attack and strokes in patients taking the drug as part of a study in colon cancer prevention. Yesterday, British authorities advised doctors by letter to switch from Celebrex to drugs other than Cox-2 inhibitors, especially for patients with cardiovascular risk. The regulators cited the emerging evidence on the drug class, including the new data on Celebrex. CLEARING THE BAR Some of the requirements for approval for over-the-counter drugs: · The FDA must determine they are safe and effective for people to use without the help of a doctor. · Drug makers typically submit clinical data and results from real-world tests of how consumers use the medicine. · OTC drugs must have little potential for abuse or addiction. Drugs are indeed "poison". Even multivitamins (in large doses). People should remember this That's stretching the meaning of words. It would be more accurate to say that many if not most things can be poisonous in high enough doses. But it's not true that all drugs are poisons by any reasonable definition. >December 21, 2004 >Aleve Latest Drug to Draw Scrutiny [quoted text clipped - 108 lines] > >National Institutes of Health: http://www.nih.gov I live on these. The generic naproxen, since it's cheaper. That is the only over the counter pain killer I have found that controls my daily migraines. I have been eating them daily for several years. The doctors prescribed me some drugs that cost almost $200 a month. With no insurance, I just could not afford them, and the naproxen works much better and costs me less than $10 a month. I also got dizzy spells from the prescribed stuff and not the naproxen. I always add some caffein (coffee, or no-doz pills). That combination seems to work the best for the migraines. George > I live on these. The generic naproxen, since it's cheaper. That is > the only over the counter pain killer I have found that controls my [quoted text clipped - 5 lines] > add some caffein (coffee, or no-doz pills). That combination seems to > work the best for the migraines. If a NSAID such as naproxen controls your headaches, what you're getting are *not* migraines. NSAIDs have been proven in dozens of formal studies to be useless against migraine. As a matter of fact NSAIDs have more often found to be a migraine *trigger* than a prophylactic. You could be experiencing tension headaches, cluster headaches or headaches from a thousand different possible sources -- everything from environmental factors to eyesight problems. Are you sure about that? The ones I've seen indicate that certain NSAIDs in various combinations are quite effective against migraine: rizatriptan/clotam, sumatriptan/naproxen, and even the old standby acetaminophen/aspirin/caffeine all being more effective than the currently favored triptan drugs alone. Unfortunately one of the best combinations in the studies, rizatriptan/rofecoxib (the late Vioxx), is now a dead letter. SignatureChris Green December 23, 2004 Some Scientists Say Aleve's Dangers May Be Overblown By ANTONIO REGALADO and RON WINSLOW Staff Reporters of THE WALL STREET JOURNAL Fevered reaction to a recent warning from the National Institutes of Health that the over-the-counter painkiller Aleve might cause heart attacks may be overblown, some medical experts say. According to doctors and officials close to the study of Aleve, made by Bayer AG, the risk involved was small enough that it was initially noted without alarm, and wasn't the reason why the study halted treatment. Doctors instead say they stopped giving Aleve largely because the patients involved, reacting to news reports about other pain relievers including Celebrex being linked to heart problems, started refusing to take their medications. "Kafka couldn't have written it better," says John Breitner, a researcher at University of Washington, Seattle, who led the study comparing Aleve (generic name: naproxen), Pfizer Inc.'s Celebrex and a placebo in the prevention of Alzheimer's. "There was a tremendous degree of public panic." Yesterday, in an interview, Dr. Breitner said that evidence of naproxen side effects in the randomized study was "not really" statistically significant. Only by combining several side effects and "splicing and dicing" the data was it possible to detect an effect, he says, and then only for nonfatal side effects. Among those patients taking naproxen or the placebo, only two or three actually died from heart attacks and none from stroke, he said. "So there is no inference you can draw," says Dr. Breitner. That's certain to bolster criticism that officials overreacted in announcing the naproxen findings. In a conference call Monday with reporters, the NIH said that naproxen was associated with a 50% increased risk of heart issues over a placebo and said that 70 patients out of the approximately 2,400 elderly people in the study suffered heart attacks and strokes. But the officials didn't provide actual numbers of effected patients broken down by what drug they took. Dr. Breitner says this is because the data weren't yet fully audited. That left researchers, doctors and patients to guess what the implications might be for individuals. Christopher Cannon, a cardiologist at Brigham and Women's Hospital and Harvard Medical School in Boston, says he wished the data had been presented in a "more rigorous fashion." The way the data are coming out, he says, is "adding to the confusion and may be creating some harm." Without more detailed information, it is possible that people will decide to go off a drug that is helping them or start new ones that could create new side effects, Dr. Cannon says. For example, he says, if cardiac patients who take aspirin as a preventative measure switch their headache medicine from naproxen to ibuprofen out of fear of heart risks, they could actually end up increasing their risk because ibuprofen can block the heart benefits of the aspirin. Elias Zerhouni, director of the National Institutes of Health, says the decision to curtail the Alzheimer's trial was made by the doctors involved, and at that point the institute had no choice but to share the results widely. "Transparency is key," Dr. Zerhouni says, adding that because patients involved were healthy volunteers who didn't yet have Alzheimer's, the level of acceptable risk was low. It remains unclear whether naproxen has heart risks or not. Additional data could emerge that bolsters either side of the issue. Generally, if results of clinical trials don't clear certain statistical hurdles, known as P values, it heightens the likelihood that the results are due to chance and not because of the effect of a treatment. The side-effect scare began when Merck & Co. Inc. withdrew its painkiller Vioxx from the market in September, after learning from a large trial that the drug doubled the risk of heart attack and stroke if taken for 18 months. That prompted the NIH to begin scrutinizing studies it had under way, specifically those involving Pfizer's Celebrex, a painkiller pill similar to Vioxx. Last Friday, the NIH called a press conference to say it had found an increased risk for Celebrex in another cancer trial, prompting taking those patients off the drug. Although other studies contradict that finding, the NIH announcement caused some elderly patients in Dr. Breitner's Alzheimer's study to stop taking their pills, fearing they might be taking Celebrex instead of naproxen or a placebo, says Susan Molchan, director of the Alzheimer's disease clinical trials program at the NIH's National Institute on Aging. "People were voting with their feet. They were walking out of the trial," says Dr. Molchan. The trial organizers called an emergency meeting. Between losing patients and the new information about the risks of Celebrex, they felt they couldn't dispense the Pfizer drug any longer. But that led to another dilemma, since preliminary data analyzed just a week earlier had indicated something entirely different: no increased risk for Celebrex, but a potential increased risk for naproxen. The team decided to suspend all the treatments. "We tolerate so little risk that we ended up for nonscientific reasons stopping the trial," says Dr. Molchan, who attributed the move to "a series of unfortunate events." Researchers say they will try to salvage what data they can from the trial. But it's not just a potential scientific loss: Dr. Breitner notes the NIH had already spent around $26 million on the Alzheimer's study. Concerns about painkillers are spreading to other countries. Europe's chief pharmaceuticals regulator said it would accelerate its safety review of the drugs after seeing the recent study data involving Celebrex. The European Medicines Agency, or EMEA, cited data that indicated "an increased risk of serious cardiovascular events" that may be related to the dose and duration of treatment with Celebrex. The EMEA was referring to the same data that Pfizer disclosed last Friday-a U.S. government-sponsored study of Celebrex in cancer prevention that found high doses were linked to an increased cardiovascular risk. The EMEA has now decided to accelerate a safety review begun in October of the class of drugs. It is asking all makers of the pills to submit by early January results of all human trials they have carried out with the drugs. The EMEA will then hold a hearing with all the companies to discuss the data. Previously, the agency expected to hold the hearing in February or later. The EMEA said it is trying to determine whether more safety studies are needed. ===================================================== December 23, 2004 Drug Risk Can Pale Next to Pain Prescriptions for Celebrex Sink, But Many Doctors Want Choice By THOMAS M. BURTON and KEVIN HELLIKER Staff Reporters of THE WALL STREET JOURNAL Daniel Derman, a Chicago internist, has stopped prescribing certain painkillers in recent days, concerned about the possible cardiovascular risks. But Mark Box, a rheumatologist in Kansas City, Mo., is continuing to recommend a set of controversial anti-inflammatory drugs to patients, including his 82-year-old mother. Indeed, he takes them himself. "I have tendonitis in my foot," he says. The recent onslaught of indications that some anti-inflammatory painkillers may increase the risk of heart attack or stroke has prompted tens of thousands of arthritis sufferers to besiege their physicians for advice. Nearly 100 patients this week have called Dr. Box, he estimates. But in fielding such calls, physicians have no guide to follow except their own interpretations of newly available studies, some of which contradict other studies. Medical societies have remained mum on how their members should interpret the data. The American Medical Association is merely directing inquiries to the Food and Drug Administration's Web site, where the studies are described. For physicians, any attempt to draw conclusions is complicated by the fact that each of the suspect painkillers was the subject of a different study, and the studies don't appear to be equally valid. Yet it is clear that for all doctors, prescribing painkillers is a trickier task than it was only a week ago. And this already is showing up in prescription data. According to data from ImpactRx, a drug-promotion research firm in Mount Laurel, N.J., new prescriptions for Pfizer Inc.'s Celebrex and Bextra have seen a dramatic falloff in light of the recent studies linking Celebrex to increased risk of cardiac events. While both drugs saw an uptick after Merck & Co. withdrew Vioxx on Sept. 30 -- also amid worries about cardiovascular risk -- prescription patterns have swung another way since then. ImpactRx's prescribing data, a sample of 1,800 primary-care doctors, show that Celebrex's share of new prescriptions for painkillers sank to 3% Dec. 21, based on a three-day rolling average, down from a high of 20% Oct. 2. Bextra's share of new prescriptions for painkillers slid to 1% for the same period, down from 17% in the period immediately following Vioxx's withdrawal. Mary Frank is president of the American Academy of Family Physicians, but she emphasizes her position on so-called Cox-2 inhibitors such as Celebrex and Bextra reflects only her own interpretation of the data on those drugs. As a family practitioner in Rohnert Park, Calif., Dr. Frank says she isn't greatly concerned about young patients without apparent cardiac risks. "But if you're 58, I'm going to tell you you should be on something else," she says. But a Chicago physician who specializes in the treatment of young arthritic patients finds that any rational position tends to crumble amid the onslaught of parents terrified about the cardiac health of their offspring. "Parents are pulling the plug on these medicines," says Charles H. Spencer, a University of Chicago pediatrics professor who works at Chicago's La Rabida Children's Hospital. An estimated 250,000 U.S. children suffer from juvenile rheumatoid arthritis -- a painful and often debilitating condition. Painkillers such as Celebrex and naproxen, which is sold by BayerAG under the brand name Aleve as well as in generic form, have been crucial in tamping down the inflammation that can cripple these children. Celebrex in particular has been useful because many children find it kinder on the stomach than the older painkillers, yet it is now under a cloud. And earlier this week alarm bells were rung about Aleve, although some medical experts argue the findings have been overblown. As many as 10 parents a day are calling Dr. Spencer and demanding an alternative to painkillers like Celebrex, which was found in one study to have a greater cardiac risk when compared with a placebo. "I have been switching them off onto other drugs," Dr. Spencer says. "It's a real mess for us, because we're not really sure how bad the risk is." Dr. Derman, the president of a large physician group affiliated with Northwestern Memorial Hospital in Chicago, says his reading of the studies that prompted Merck to pull Vioxx off the market this autumn raised big concerns about the safety of Celebrex and Bextra. All are in the Cox-2 class. "I was concerned enough about it being a class effect that I did not switch Vioxx patients to Celebrex" or Bextra, he says. "Then, lo and behold, the information comes out on Celebrex, and it's concern enough to say I would not use that product," Dr. Derman says. "I would be shocked if it's not off the market soon." But to Dr. Box, the Vioxx data looked significantly more alarming than did the studies on Celebrex, Bextra or Aleve. Also, Dr. Box shakes his head at cardiologists he has seen on TV recommending that patients switch to Tylenol or ibuprofen. He says he wonders whether cardiologists understand how crippling severe arthritis can be, and he notes that nearly all treatments have risks with benefits. "I'm telling people that based on all the evidence I've seen, Celebrex remains a safe option," he says. How in this day and age could people suddenly be asking what alternatives are there? Go to your local health food store and ask. There are many, many options. People come back month after month to replnish their supplies BECAUSE THE OPTIONS WORK. Nothing works for everybody. So some experimentation may be required. If you want double blind studies for your proof, please contact the makers of Vioxx, Celebrex, and Alleve -- they probably have shredders full of them. >How in this day and age could people suddenly be asking what >alternatives are there? [quoted text clipped - 4 lines] > >Nothing works for everybody. So some experimentation may be required. And don't forget to bring your wallet, we'll be glad to empty it for you whilst experimenting! >>How in this day and age could people suddenly be asking what >>alternatives are there? [quoted text clipped - 7 lines] > And don't forget to bring your wallet, we'll be glad to empty it for > you whilst experimenting! Exactly what the drug companies have been doing for years and years. But the experiments are finishing now, aren't they ? Cheers, Rod. > How in this day and age could people suddenly be asking what > alternatives are there? [quoted text clipped - 8 lines] > makers of Vioxx, Celebrex, and Alleve -- they probably have shredders > full of them. Could it be that unsatisfied customers come back dead? Bill I agree. I personally like to know who PAID for the study. Usually you can tell what the result will be if you know where the money is coming from. If a study is done on meat causing cancer, if PETA paid for the study..I can tell you what the result will be. > I agree. > [quoted text clipped - 3 lines] > If a study is done on meat causing cancer, if PETA paid for the > study..I can tell you what the result will be. I belong to *P*eople for *E*ating *T*asty *A*nimals, and we do not fund studies. If you want to see how tasty meat it, buy it yourself. > > I personally like to know who PAID for the study. Usually you can tell > > what the result will be if you know where the money is coming from. > > > > If a study is done on meat causing cancer, if PETA paid for the > > study..I can tell you what the result will be. Yes, this is true. But that doesn't mean studies are invalid. You have to read each study in detail to see whether its conclusions are valid. Recently in the news was a study funded by the Pravachol folks which showed that Lipitor was superior. > I belong to *P*eople for *E*ating *T*asty *A*nimals, and we do not fund > studies. If you want to see how tasty meat it, buy it yourself. I guess that's funny, but it doesn't say anything pertinent. Are you saying studies are unnecessary? Well that's not true. We aren't going to try medicines on patients without testing them first. I am not saying they are invalid. Just that no study tells the whole story. No study can say how EVERY person will react to a drug. There are just to many factors. The consumers that are running around in a tizzy over Aleve probably never have read an insert with a medication or read side effects for their other drugs. How many people have died from side effects from Bayer, Midol, Tylenol?? Aleve has been around for a long long time. They just recently did a study to see if it would prevent Alzheimer's. The results of that study indicated that Aleve was most likely unsafe. Ora >I guess that's funny, but it doesn't say anything pertinent. Are you >saying studies are unnecessary? Well that's not true. We aren't going >to try medicines on patients without testing them first. >Aleve has been around for a long long time. They just recently did a study to >see if it would prevent Alzheimer's. The results of that study indicated that >Aleve was most likely unsafe. Well, they do need to crunch the numbers first. I see it as a knee jerk reaction to recent announcements about COX-2 inhibitors. The participants in the ADAPT study were over 70 and had a family history senility, but were allowed to take 81mg of aspirin per day. The preliminary results showed a 50% increased risk of cardiovascular events in the naproxen group over the placebo group. On the other hand, another study showed that taking aspirin and ibuprofen had nearly twice the risk of death from any cause -- and a 73% increased risk of death from heart disease. So, depending on how many of the participants took aspirin daily, the results MAY just show that naproxen, like ibuprofen, reduces the effectiveness of aspirin. > >Aleve has been around for a long long time. They just recently did a study to > >see if it would prevent Alzheimer's. The results of that study indicated that [quoted text clipped - 13 lines] > of the participants took aspirin daily, the results MAY just show that > naproxen, like ibuprofen, reduces the effectiveness of aspirin. I believed the investigators have controlled for the aspirin use. At His service, Andrew -- Andrew B. Chung, MD/PhD Board-Certified Cardiologist ** Suggested Reading: (1) http://makeashorterlink.com/?L26062048 (2) http://makeashorterlink.com/?O2F325D1A (3) http://makeashorterlink.com/?X1C62661A (4) http://makeashorterlink.com/?U1E13130A (5) http://makeashorterlink.com/?K6F72510A (6) http://makeashorterlink.com/?I24E5151A (7) http://makeashorterlink.com/?I22222129 >> >Aleve has been around for a long long time. They just recently did a study to >> >see if it would prevent Alzheimer's. The results of that study indicated that [quoted text clipped - 15 lines] > >I believed the investigators have controlled for the aspirin use. The NIH clinical trials abstract on the ADAPT trial specifically stated that aspirin dosage up to 81mg per day was permissible for inclusion in the study. http://clinicaltrials.gov/show/NCT00007189 Just a little research on the internet shows that 10,000 Americans die from aspirin every year (not including accidental overdose by children) and that it raises your risk of pancreatic cancer by 86%. Should we ban aspirin? Wall Street Journal January 4, 2005 What You Should Know About Painkillers Before Clearing Out the Medicine Chest By TARA PARKER-POPE Few health issues have been more confusing than the barrage of news reports during the past three months linking popular pain relievers with heart attacks. After warnings about the popular arthritis drugs Vioxx, Celebrex, Bextra and naproxen, the drug in Aleve, health authorities are now reviewing dozens of studies of at least 18 anti-inflammatory medications, including household names such as aspirin and Advil. But many scientists and public health experts think the risks for the general population have been exaggerated, and that far more study is needed before we have definitive answers. At the same time, the Food & Drug Administration has been criticized for not reacting to concerns soon enough. Before you clear out your medicine cabinet, it's worth taking a closer look at what we know and don't know about the real health risks of these and other drugs. Here are some answers. - What is the evidence against these popular pain drugs? The first real evidence against Vioxx came in March 2000 from a study of 8,000 rheumatoid arthritis patients. It showed 0.5% of the group taking Vioxx suffering heart attacks, compared with 0.1% of the group taking naproxen. That was five times the risk of heart attack, but a low overall risk. Last September, a three-year study of patients with a genetic polyp disease showed that the patients who took Merck's Vioxx for more than 18 months were twice as likely to have heart attacks or strokes. Then, in December, the National Cancer Institute stopped another polyp study using Pfizer's Celebrex after finding Celebrex users had twice the risk of heart attack. Days later, the National Institutes of Health stopped a study of 2,400 Alzheimer's patients, citing higher risks from naproxen. Questions have also emerged about Pfizer's Bextra. - Can we conclude that these pain killers are dangerous? The evidence sounds compelling, but the truth is, we still know very little about the risk associated with these drugs, notes Brooks S. Edwards, cardiologist at the Mayo Clinic in Rochester and editor-in-chief for Mayoclinic.com. None of these studies were specifically designed to assess cardiovascular risk, and each involved several variables, such as aspirin use in the Alzheimer's study, that could influence risk. And people with polyp disease and Alzheimer's may have significantly different cardiovascular risk than the rest of us, so it's impossible to draw any broad conclusions for the rest of the population. In addition, some of the data is in conflict. For instance, two studies -- the Alzheimer's study that raised questions about naproxen and a second polyp study -- showed Celebrex didn't carry a higher heart risk. - Are such serious health risks unusual for approved drugs? Every day, consumers assume serious risks when they take common drugs. For instance, taking aspirin daily to prevent heart attack puts the user at a 40% higher risk for a hemorrhagic stroke. In the real world, that translates to one additional stroke over five years for every 1,000 patients taking aspirin. For every 200,000 nonsmoking women under the age of 35 who use birth control pills every year, one will die as a result of a deadly blood clot in the lungs. About one in every 20,000 patients who takes a cholesterol-lowering statin is hospitalized for the potentially deadly muscle problem called rhabdomyolysis. "The patient rightfully wants to be protected from a dangerous drug," notes Dr. Edwards, who has been an investigator for Pfizer on a Viagra study. "Patients also have to understand that there is no medication out there that is 100% safe and effective. Every prescription I write carries some risks." - Why would some pain drugs raise heart risk when we know that aspirin protects the heart? Aspirin and other older pain killers block two enzymes -- Cox-1 and Cox-2 -- that are involved in inflammation and pain. The main drugs now under scrutiny are Cox-2 inhibitors -- that means they only block the Cox-2 enzyme. This is both bad and good. It is the blocking of the Cox-1 enzyme that leads to the serious gastrointestinal bleeding that kills as many as 17,000 patients a year. But blocking Cox-1 may also lower heart attack risk. So drugs like Vioxx that don't block Cox-1 may save the user from gastrointestinal problems but don't offer the same heart protection. It is also possible that Cox-2 inhibitors suppress a protein linked with healthy blood vessels and could promote clotting, thus increasing heart attack risk. - So why are we worried about naproxen, which isn't a Cox-2 inhibitor? Many researchers think naproxen has been wrongly caught up in the heart-risk hysteria. The National Institutes of Health halted the Alzheimer's study because of concerns about naproxen and heart risk. But the real problem may have been that study participants, panicked by the news, stopped taking the medication. It has since been shown that the risk of heart attack in that study was actually about the same for both placebo and naproxen. Other studies suggest that fears about naproxen are probably unfounded. An August 2004 Lancet study of 18,000 patients compared serious cardiovascular problems among users of ibuprofen, naproxen and Prexige, a new Cox-2 inhibitor being studied by Novartis. There was no difference in heart risk. "It was reasonable to stop the Alzheimer study, but it was unreasonable to suggest that naproxen increases the risk of cardiovascular disease for the general population," says Robert Snodgrass, a pediatric neurologist at Harbor-UCLA Medical Center. ---------- WORTH THE RISK? Some risks and benefits associated with common drugs. Aspirin Risks: With daily use over five years, triggers four serious health problems per 1,000 patients. Benefits: With daily use over five years, prevents 14 heart attacks per 1,000 high-risk patients. Cholesterol drugs Risks: Annual risk of hospitalization due to rhabdomyolysis: one in 22,727. Benefits: Over five years, statin use will prevent 18 cardiovascular deaths per 1,000 patients. Oral contraceptives Risks: Deadly pulmonary embolism: one in 200,000 for nonsmoking women under 35 annually. Benefits: More than 99% effective in preventing pregnancy. Source: WSJ reporting The most important pain reliever was left out: lifestyle and behaviour modification; including weight loss, exercise and pain management techniques learned from a physical therapist. Zee > Wall Street Journal > January 4, 2005 [quoted text clipped - 121 lines] > Benefits: More than 99% effective in preventing pregnancy. > Source: WSJ reporting I have an interesting little story about weight loss. I used to be obese. I was denied insurance for many reasons, but one of the reasons was my weight. When I lost the weight, I was denied. I was told that losing weight implied illness! Okay, Vioxx, Celebrex and Aleve are all out. What about Bextra? Every year I pull a neck muscle doing Macedonian dancing at GreekFest. I take Bextra for it (along with Valium). My personal opinion, is that all drugs have side effects. For some people it is worth the risk. Kara Tyson Lyme Disease Support Group of AL Director > Every year I pull a neck muscle doing Macedonian dancing at GreekFest. > I take Bextra for it (along with Valium). [quoted text clipped - 4 lines] > Lyme Disease Support Group of AL > Director How do Macedoneans dance? I thought they disappeared along with Alexander the Great. Why have you not yet learned not to? :=) Bill I need to learn not to, but it is so enjoyable. I must be fairly good at it since 3 men asked me for my number afterwards! :) They say Alexander The Great fell in love with his wife after watching her dance. As to whether Macedonians have gone away, I suppose it depends on who you ask, a Greek or a Turk. Kara |
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