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51 deaths ADHD drugs ...
"Mark Probert" wrote in message ... vernon wrote: "Mark Probert" wrote in message ... vernon wrote: "Mark Probert" wrote in message ... vernon wrote: Ilena wrote in message ... P.net!53ab2750!not-for-mail From: "VERACARE" Why has the FDA concealed from the public 51 deaths from ADHD drugs until now? 51 out of around 100,000 per year of miss-prescribed and errors is quite insignificant. You are mistaken in your interpretation of the numbers. The NY Times reported that this was a study of five years of records, 1999 through 2003. The number of deaths is also incorrect. "Twenty-five people died suddenly and 54 others suffered serious unexplained heart problems while taking stimulant drugs like Ritalin from 1999 through 2003, according to reports sent to federal drug regulators." Now, let's take a minute and analyze this. Twenty-five people died over the course of 5 years. That averages to 5 deaths per year. The NYTimes then reports that "...[a]bout 29 million prescriptions were written in 2004 for Ritalin, Adderall and similar drugs to treat attention deficit disorder and hyperactivity, most of them for children." Assume that the average prescription rate is *only* 25,000,000 per year. Since these medications are Schedule II, which means that only a one months supply can be written at a time, approximately 2,083,333 people per month are, on average, being prescribed these medications. Assume that all 5 deaths happened in the same month, and you wind up with a rate of 2.4000003840000614400098304015729e-6. Compare that with the odds of being struck by lightening: http://www.lightningsafety.noaa.gov/medical.htm My younger son attends a special school for physically handicapped students. In the past three years, two classmates have died for no apparent reason, the last being in December 2005. One of the kids in my neighborhood died from running the bases. His father is a DDS and was at the school at the time. He is trained in using a defibrillator and could not resuscitate his son. I would classify this report and just this side of relatively meaningless. That's what I said. Yeah, but not as well as I did... The numbers really do not add up very well. Ever wonder about how many die of no apparent reason? Like I pointed out in the paragraph above, yes, on three occasions in the past 2 years. One boy rode the bus with my younger son and they hung out together outside of school. He did not wake up one morning. One boy was the captain of my son's school's wheelchair basketball team. No arms and two underdeveloped legs. He used one to operate the joystick on his power chair, and the other, the longer of the two, for dribbling, stealing and shooting. His mother thought he was sleeping on the school bus when he came home from school. The third is a neighborhood kid who had just finished running the bases and died. From the little I have seen, it is sickening. Not a conspiracy, but lack of involvement and laws to determine. It is very shocking for parents to sudden lose a child who is in apparent good medical health. Sadly, even on autopsy, the actual cause of death cannot often be determined. I know in the two cases where I know the families well, they still do not know what happened. Both boys, having physical disabilities, had been carefully examined and monitored over the years. It is always pretty close to possible to determine cause if there is a desire. I know parents have a desire, but seemingly are easy to be put off with "We just don't know" I know the medical examiners involved, and they ALWAYS have a desire with kids. Good. It's unusual. |
#82
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51 deaths ADHD drugs ...
In article , "Rich" writes:
Two tablets every four hours, assuming regular strength 325mg, is a safe dose of acetaminophen for a patient with a healthy liver. The proper dosing interval for ibuprofen is every six hours, so two tablets (OTC strength of 200mg) every four hours would probably be an overdose, and might cause gastrointestinal problems. The standard label dosing for ibuprofen is ONE tablet every 4-6 hours, not two. The DO NOT EXCEED dose except under doctors orders is 6 in 24 hours. Last year I had the doctor tell me to take 3 every 4-6 hours. I didn't take them in the middle of the night, so I was doing 12-16 a day. -- Bob Kaplow NAR # 18L To reply, there's no internet on Mars (yet)! Kaplow Klips & Baffle: http://nira-rocketry.org/Document/MayJun00.pdf www.encompasserve.org/~kaplow_r/ www.nira-rocketry.org www.nar.org Guard with jealous attention the public liberty. Suspect every one who approaches that jewel. Unfortunately, nothing will preserve it but downright force. Whenever you give up that force, you are inevitably ruined. -- Patrick Henry, speech of June 5 1788 |
#83
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51 deaths ADHD drugs ...
"Peter Bowditch wrote: "JanD" wrote: "Bob Kaplow" wrote in message ... In article Ss8Hf.790990$xm3.430995@attbi_s21, "JanD" writes: Ritalin 'may cause damage to brains' OK, now I think I understand your problem... It is NOT *MY* problem! It IS a huge problem. http://www.thisislondon.co.uk/lifean...les/8211049?ve... Ritalin 'may cause damage to brains' By Pravin Char, Metro 17 December 2003 Children given Ritalin to control hyperactivity could be permanently brain damaged, it was claimed yesterday. Research suggests the controversial 'chemical cosh' drug No need to read any further. The use of the idiotic expression "chemical cosh" means that it is perfectly safe to ... snip bull**** Restored and MORE, what Peter can't handle: http://www.thisislondon.co.uk/lifean...les/8211049?ve... Ritalin 'may cause damage to brains' By Pravin Char, Metro 17 December 2003 Children given Ritalin to control hyperactivity could be permanently brain damaged, it was claimed yesterday. Research suggests the controversial 'chemical cosh' drug raises the risk of depression and anxiety in adulthood. Ritalin alters the brain's chemical composition so that it has a lasting effect on mental health, US scientists believe. Because these changes take place while a child's brain is growing, they could cause irreversiblle damage The findings will alarm parents using the drug to control a child's attention deficit hyperactivity disorder (ADHD). British GPs dispensed a record 254,000 Ritalin prescriptions last year, up from 208,500 in 2001. One in 20 children is said to have ADHD, which makes them boisterous and unfocused. 'It is vitally important we evaluate the long-term effects of these drugs,' said Dr Nora Volkow, director of the US National Institute on Drug Abuse. Although American studies involved laboratory rats, the doses given were comparable to those used on children. In one test, giving Ritalin to young, healthy rats increased the presence of certain chemicals linked to depression in adults. Asecond study found higher levels of stress hormones and anxietylike behaviours. Last night, Shadow children's minister Tim Loughton urged the Government to investigate Ritalin use. The Royal College of Paediatrics said: 'Ritalin has been used for 40 years. If there was a long-term side-effect, it would have been discovered by now.' Novartis, the company which makes Ritalin, insisted there was no clinical link to depression or anxiety disorders. Now back to the subject. http://www.thisislondon.co.uk/*lifea...es/8*211049?ve... Again, I deleted the article. It is copyrighted; I don't have permission to copy it. Our brains change during development. Change is not the same as damage. IMHO, it has not been shown that methylphenidate and other drugs that help people with ADHD damage the brain. That leads us right back where we started! http://money.cnn.com/2005/07/0*1/news/fortune500/fda_panel.dj*/ Agency asked to proceed with plans for warnings about hallucinations, suicide risk. Good. I am glad that the FDA is paying attention to side effects. Such a pity they did NOT do it BEFORE *organized medicine* decided to start giving it to BABIES!!!!!!!! I do concur that investigations of the long-term effects of the drugs should be done. Jeff And, I do say: Such a pity they did NOT do it BEFORE *organized medicine* decided to start giving it to BABIES!!!!!!!! GOOD GRIEF! Then I back it up! http://www.guardian.co.uk/life*/this...0439*0,00.html Is it safe for children to take Ritalin? David Adam Thursday July 24, 2003 The Guardian If not, then we're storing up a whole heap of trouble. New figures this week show that use of the drug given to calm hyperactive children has soared 100-fold in Britain in the past decade. Doctors dispensed 254,000 prescriptions of it last year, up from 2,000 or so given annually in the early 1990s. Ritalin has been approved for use in children over five years old who suffer from Attention Deficit Hyperactivity Disorder (ADHD), but many doctors prescribe the drug - also known as methylphenidate - for children as young as 18 months. The drug is widely considered safe, but few long-term studies have been done because of the ethical difficulties of experimenting with children. And some scientists are concerned how the drug - a powerful stimulant shown to have a similar effect to cocaine - could affect developing brains. One high profile investigation in 2001 did suggest that Ritalin triggered changes to brain function. But Joan Baizer, who led the research at Buffalo University, New York says its results were largely exaggerated. "It was a preliminary report on basic research in rats _ it doesn't imply anything about a long-term health effect," she says. Dave Woodhouse, who runs an ADHD clinic at the University of Teesside says some evidence is emerging that children taking Ritalin for several years show reduced cognitive ability, but this work is also at an early stage and has not yet been published. A controversial three-year clinical trial of Ritalin use among hundreds of preschool US youngsters diagnosed with ADHD is due to report next year. The study is led by Laurence Greenhill of the New York State Psychiatric Institute and is the first to look at the effects of a drug on children as young as three. http://www.guardian.co.uk/life*/this...0439*0,00.html Is it safe for children to take Ritalin? David Adam Thursday July 24, 2003 The Guardian If not, then we're storing up a whole heap of trouble. New figures this week show that use of the drug given to calm hyperactive children has soared 100-fold in Britain in the past decade. Doctors dispensed 254,000 prescriptions of it last year, up from 2,000 or so given annually in the early 1990s. Ritalin has been approved for use in children over five years old who suffer from Attention Deficit Hyperactivity Disorder (ADHD), but many doctors prescribe the drug - also known as methylphenidate - for children as young as 18 months. The drug is widely considered safe, but few long-term studies have been done because of the ethical difficulties of experimenting with children. And some scientists are concerned how the drug - a powerful stimulant shown to have a similar effect to cocaine - could affect developing brains. One high profile investigation in 2001 did suggest that Ritalin triggered changes to brain function. But Joan Baizer, who led the research at Buffalo University, New York says its results were largely exaggerated. "It was a preliminary report on basic research in rats _ it doesn't imply anything about a long-term health effect," she says. Dave Woodhouse, who runs an ADHD clinic at the University of Teesside says some evidence is emerging that children taking Ritalin for several years show reduced cognitive ability, but this work is also at an early stage and has not yet been published. A controversial three-year clinical trial of Ritalin use among hundreds of preschool US youngsters diagnosed with ADHD is due to report next year. The study is led by Laurence Greenhill of the New York State Psychiatric Institute and is the first to look at the effects of a drug on children as young as three. You also might be interested in the fact, preschoolers were sought for drug studies, back in 2001. http://tinyurl.com/2g575 As a ped doc, I am surprised you do NOT know this. Good thing I am here. Jan (this is a repost, if this links do not work, from here, they still do, as I tried everyone of them, bleow is the tiny url where they were first posted) http://tinyurl.com/b7qhf http://www.bio-medical.com/adhd_0001.htm PRESCHOOLERS ON PSYCH DRUGS By: LEAH GINSBERG, HALLIE LEVINE, and MARILYN RAUBER Alarmed by reports of a dramatic rise in the use of psychiatric drugs for preschoolers, First Lady Hillary Rodham Clinton yesterday weighed into the debate about the use of the stimulant Ritalin. She announced the development by the Food and Drug Administration of new kiddie-dosage warning labels for the drugs and a $5 million federal study into the use of Ritalin by preschoolers. "We just don't know enough" about the effect of mind-altering drugs on young children, the first lady said. "I am no doctor, but I am a parent and I have been a longtime children's advocate, and these findings concern me." Clinton -- who briefly left the New York campaign trail to seize the White House bully pulpit -- also announced a White House conference next fall on child mental-health and said Uncle Sam will start distributing information kits to doctors, parents and schools about Attention Deficit Disorder. Many doctors welcomed Clinton's concern, although some questioned her motives. "I think if Hillary Clinton was not running for congress in New York, this would be dealt with [differently]," said Mitchell Clionsky, the director of Neuropsychology Associates and the ADD Center in Springfield, Mass. While Clionsky agreed with the America Medical Association study that there's been an acute increase (150 percent between 1990 and 1995) in the number of preschoolers taking psychotropic drugs -- particularly Ritalin--he said Washington has overreacted. "[Ritalin] is not a great public health hazard, and it is very helpful for many," he said. "If you want my opinion, it's turning it into something of a cause celebre." Doctors are divided on the subject. Dr. Leon Zacharowicz, a child neurologist at Nassau County Medical Center in East Meadow, L.I., said Ritalin is overprescribed and children are often misdiagnosed with ADD. "I've had parents tell me they were prescribed Ritalin within 30 minutes of coming to their family doctor's office," he said. Zacharowicz blamed a "fast-food approach" to medicine. "The family's primary-care practitioner may be so harried with 30 screaming patients with ear infections in the waiting room that he doesn't have time to properly evaluate the child," he said. Zacharowicz said doctors often prescribe Ritalin without delving into other emotional issues that can affect a child's behavior. "I saw a child recently who was being abused by a neighbor," he says. "His teacher recommended he see me for Ritalin -- but the child was irritable only at home, when his neighbor was around. If we hadn't [talked] to him, that never would have gotten sorted out." Even if a child is eventually diagnosed with ADD, Zacharowicz and other doctors say there are other treatments that should be tried before drug therapies. Dr. Daniel Kuhn, a Manhattan neuropsychiatrist with St. Luke's-Roosevelt Hospital, says he's had success with a technique known as neurofeedback, similar to biofeedback. Kuhn said studies have shown the treatment has a 70 percent success rate -- and none of the side effects of Ritalin. "I'll put a child on Ritalin while starting him on neurobiofeedback. After a while, we reduce the medicines and then stop them entirely. If the child's ADD isn't severe, we don't need medicines at all." Zacharowicz added that Ritalin has many potent side effects --including seizures -- which can be deadly and that its use on the young hasn't been fully investigated. "I've seen some kids turn into, almost, little zombies, or suffer mood changes," he said. "There are also milder side effects ... headaches, lethargy, the child becoming more withdrawn or experiencing a decreased appetite, dizziness, and dry mouth." Zacharowicz said he's concerned that doctors aren't running enough diagnostic tests before prescribing Ritalin. "Kids in New York have been treated for ADD when what they really had was lead poisoning," he explains. "That's dangerous, because if lead poisoning is left untreated, children can get very sick." http://familyeducation.com/article/0...-12687,00.html Should a two-year-old be given stimulants like Ritalin? Should a three-year-old be put on an anti-depressant like Prozac? A new study reported in this week's Journal of the American Medical Association (JAMA) finds the rate at which preschoolers were given such drugs doubled, perhaps even tripled, between 1991 and 1995. Researchers at the University of Maryland School of Pharmacy analyzed 200,000 preschoolers' prescription records from two state Medicaid programs and an HMO in the Northwest over a five-year period. Among the findings: a.. 1.5% of children between the ages of 2 and 4 received stimulants, anti-depressants or other anti-psychotic drugs. a.. In the Medicaid programs, the number of prescriptions for anti-depressants given to preschoolers more than doubled. Although the researchers did not note the conditions children were being treated for, nor the training of the medical staff who prescribed the drugs, the study is being given serious attention because it suggests that nationally, as many as 150,000 children under age five may be taking the drugs. Many are commonly prescribed to older children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Yet few of the medications have been approved by the Food and Drug Administration for use with toddlers and preschoolers. Methylphenidate, the generic form of Ritalin, carries a warning against prescribing the drug to children under six (although it is legal for physicians to do so). "Unresolved questions involve the long-term safety of psychotropic medications (with this age group)," wrote the study's lead author, Dr. Julie Magno Zito. "The possibility of adverse effects on the developing brain cannot be ruled out." Prescription for Debate Some doctors are alarmed by the study's findings. Dr. Joseph Coyle, chairman of psychiatry at Harvard Medical School, warns that even the diagnosis of ADD/ADHD in very young children is considered unreliable, let alone the effects of the drugs on a developing brain. Coyle is among those calling for "much more extensive studies to determine the long-range consequences" of the use of such drugs at young ages. But Dr. Joseph Biederman, chief of pediatric psychopharmacology at Massachusetts General Hospital in Boston, angrily dismisses the study and accuses its authors of having "an ideological bent." "The purpose of the study is to alarm the public," Biederman insists. "When you have a three-year-old devastating the household I don't see any reason why the three-year-old should not be treated. We're talking about serious out-of-control behavior with some of these children, not one temper tantrum." Biederman, who reviewed Zito's research prior to publication, points out that the study does not indicate what, if any, previous treatment the children had received. "If a child has asthma, would you delay treatment until the child is twenty?" he asks. "If a child has a cavity, it needs to be filled, whether the child is four or ten." Moira Munns, parent of a child with ADHD, registered pharmacist, and a member of the board of directors of the parent-run ADD Information Network, has mixed feelings about the study. "I'm a little alarmed," she admits. "I hope parents are working with competent professionals, because anytime you have people who are desperate, they are easily taken advantage of." Munns advises parents to "proceed cautiously" regarding medication to treat ADD and ADHD in children. Behavior management programs or early intervention programs, she notes, are "frequently very effective." "Personally, I always feel that medication is not a best first step," Munns says. "Better to try other things first." http://www.psych.org/pnews/00-12-01/study.html clinical & research news Study to Assess Ritalin Use in Preschoolers with ADHD A groundbreaking federally funded study will inform clinicians about the safety and efficacy of methylphenidate in very young children with attention deficit/hyperactivity disorder. By Christine Lehmann The first multisite study of methylphenidate (Ritalin) in preschoolers with ADHD is finally beginning after intense scrutiny and review. The Preschool Attention Deficit/Hyperactivity Disorder Treatment Study (PATS) has set a high standard for future psychotropic drug studies in preschoolers to follow. "Although Ritalin has been approved by the FDA for use in children aged 6 and up for nearly 40 years, we approached our study as if it was a new drug, because we know so little about its impact on preschoolers," said Lawrence Greenhill, M.D., the study's principal investigator. He described the project at a research forum sponsored by the American Academy of Child and Adolescent Psychiatry in October in New York. The goal of the one-day forum was to recommend optimal strategies for developing and implementing psychopharmacological studies in preschoolers. Funded by the National Institute of Mental Health (NIMH), the three-year pediatric study will answer many questions that researchers, clinicians, policymakers, and members of the public have about methylphenidate's safety and efficacy in preschoolers. The need for more information about the medication's use in preschoolers has taken on a sense of urgency as reports have revealed that physicians are prescribing the drug to an increasing number of youngsters in this age group. Julie Magno Zitto, Ph.D., and her colleagues reported in the February 23 Journal of the American Medical Association that from 1991 through 1995, there was a three-fold increase in the number of Ritalin prescriptions for children aged 2 to 5. The prescription records were from two Medicaid and one private HMO database. This trend exists despite the drug maker's label warning not to use Ritalin in children under age 6 because safety and efficacy information has not been established for this age group. Only a handful of drug studies has been conducted in preschoolers, with inconclusive results. The Zitto report concerned some parents, educators, lawmakers, and clinicians, because the central nervous systems and brain neurotransmitters targeted by methylphenidate are still developing in preschoolers, said Greenhill. The controversy surrounding the drug's safety, especially in preschoolers, led to a study design that has extremely rigorous eligibility criteria. Study Goals About 4,000 children will be recruited and screened for ADHD at six university sites: Columbia, Duke, Johns Hopkins, New York University, and the University of California at Los Angeles and Irvine. Clinicians experienced in treating ADHD and preschool-aged children will evaluate each child and prepare systematic clinical narratives for review by several experts to determine the child's eligibility. The preschoolers must also get an extremely high score on the ADHD symptom rating scale resulting in less than 4.28 percent of a preschool sample being identified. Their symptoms must be present for at least 9 months rather than the 6 months specified by DSM-IV. "We wanted to ensure that we treat preschoolers with severe ADHD whom everyone agrees clearly needs help," said Greenhill. Because of the rigorous eligibility criteria, Greenhill estimates that only 312 preschool (ages 3 through 5) and school-aged (ages 6 through 8) children will make it into the first phase of the study. Sixty-six school-aged children will serve as the control group. Once the children are accepted into the study, their parents will be trained in behavioral management techniques that have been shown to be effective in moderating ADHD symptoms, said Greenhill. He added this component to the protocol because some children may respond well to behavioral therapy. On the basis of a previous large study comparing methylphenidate with behavior therapy in school-aged children, Greenhill estimates that 58 children will respond to the behavioral therapy techniques. He estimates that the remaining 198 preschoolers and 66 school-aged children will be enrolled in the randomized medication trial. Determining the safest and most effective dose for each child is the goal of the first 12 weeks of the trial. Doses of methylphenidate are titrated from 1.25 mg three times daily to 10 mg three times daily during the first three weeks and then increased from 2.5 mg daily to 10 mg three times daily in the following nine weeks. "The review boards wanted us to start with the lowest dose possible for safety reasons," explained Greenhill. Once the best dose is established, subjects are maintained for 40 weeks on Ritalin or placebo and then taken off. The children will be followed for one year. Another goal of the study is to compare the response times and dose responses in preschoolers with those of school-aged subjects. "We know significantly more about the safety and efficacy of Ritalin in school-aged children than we do in preschool children," said Greenhill. Reviews and Revisions Greenhill said that the controversy over prescribing methylphenidate led to numerous reviews of PATS. The process involved the NIMH Special Emphasis Panel, NIMH Council Workgroup on Ethics, NIMH Data Monitoring and Safety Board, the Food and Drug Administration Division of Neuropharmacological Drug Products, and each of the six sites' institutional review boards, according to Greenhill. These were among the recommendations made by the reviewers, which Greenhill and his colleagues incorporated into the final study design: .. Start with the lowest dose possible. .. Obtain informed consent from parents at every stage of the trial. .. Exclude children with bipolar, pervasive developmental, and psychotic disorders. .. Ensure that children can speak English in phrases so they can communicate any problems to adults. .. Have experienced pediatric educators serve as consultants at all sites. .. Have a community and parent representative on each site's Institutional Review Board. .. Provide age-appropriate furniture and toys at the study sites. The researchers also established parental advisory panels at each site. http://www.pbs.org/wgbh/pages/frontl.../dontknow.html In February 2000, University of Maryland researcher Julie Magno Zito published a report in the Journal of the American Medical Association which found that psychotropic medications such as Ritalin and Adderall were being prescribed to preschoolers at alarmingly high rates, especially considering that many of the drugs have not been approved by the FDA for use in children under 6, and there's little research about their effects on young children. Zito examined data from two state Medicaid programs and a health maintenance organization, and found that as many as 1.5 percent of children between the ages of 2 and 4 were being prescribed stimulants, anti-depressants, or anti-psychotic drugs. The findings suggested that prescription rates had increased as much as 50 percent between 1990 and 1995. Although the study did not identify which conditions the children were being treated for, in the Washington Post, Zito said she believed that the rise in prescription rates for very young children was definitely related to the recent national increase in Ritalin prescriptions for school-aged children. Zito's report drew strong media coverage and also attracted the attention of Hillary Clinton, who embarked on a campaign to learn more about the effects of drugs like Ritalin on preschoolers. Subsequently, the National Institute of Mental Health gave $6 million to a consortium of six institutions, led by Dr. Laurence Greenhill of Columbia University, to conduct a five-stage, 40-week study on Ritalin use in preschoolers. This is the first extensive study to be done on this issue. The Preschool ADHD Treatment Study (PATS) will examine dosing issues, side effects questions, and the efficacy of Ritalin in preschool aged children. As of April 2001, the recruitment of children into the study is underway at the six sites across the country. The effort is to find out how well children ages 3-6 do on a trial of methylphenidate in the short term and over the relative long term (1 year). In order to compare how Ritalin affects younger children to older children, the study will also recruit subjects between 6 and 8 years old. Some critics have expressed concerns about the recruitment process, saying that it may be hard to diagnose ADHD in such young children. Dr. Howard Abikoff, who is heading up the study at one of the sites at the NYU Child Study Center, says those concerns, while valid, have been addressed by the design of the study. Subjects are required to show persistent symptoms of ADHD for 9 months, rather than the 6 months required by the DSM-IV criteria. Subjects must be attending a school-type setting, and data must be gathered from a teacher or professional in that setting, rather than parents alone. And finally, before a subject is approved for the study, the parents undergo a 10-week training in behavioral therapy specifically designed for parents young kids with ADHD. The child is then reevaluated, and if he or she no longer meets the criteria, will not be considered for the study. "We are not interested in putting children on medication for whom there is not an obvious need," Abikoff said. The study is designed in the hopes that the resulting data will be extensive enough to meet the FDA requirements for making a ruling as to whether Ritalin is appropriate and safe for use in young children. The researchers are planning to follow up with the subjects of the study over the long term, in order to see how the children treated with Ritalin early in life fare as they grow older. http://www.mindfreedom.org/mindfreedom/levine_c.shtml NEWS: Human Rights & Your Mind - May 9, 2002 Bruce Levine -- psychologist, mental health system critic and author of the book _Commonsense Rebellion_, wrote the below commentary that was published today's main newspaper for Eugene, Oregon, USA. ~~~~~~~~~~~~~~~~ _The Register-Guard_ -- Eugene, Oregon, USA May 9, 2002 - Page 9A - Opinion/Commentary Tide of drugs won't mend mental health By BRUCE LEVINE IS THE HUGE EXPANSION of America's mental health industry about science, or is it about marketing? And is there even a more important concern than pseudoscience and Big Pharma corruption? In the 1970s, approximately 250,000 American children were on Ritalin and Ritalin-like drugs, while today estimates range from 4 million to 6 million kids. Not many years ago, prescribing Ritalin to preschoolers would have been unthinkable, but currently more than 200,000 American preschoolers are on Ritalin and Ritalin-like drugs for attention deficit hyperactivity disorder. Is it scientifically valid to say that a 3-year-old who is "forgetful," "disorganized," "inattentive," and "impatient" - symptoms for ADHD - suffers from a mental disorder? Even if you believe that 3-year-olds can have ADHD, there is no scientifically reliable way of diagnosing them. According to the National Institute of Mental Health and the American Academy of Pediatrics, there are no biological markers for ADHD, and thus it is not diagnosed with lab tests or physical exams, but rather is diagnosed using behavioral checklists - which are notoriously unreliable. ADHD drugs are forms of "speed," among the most abused drugs in the world. In 2001, the Journal of the American Medical Association published this article: "Pay Attention: Ritalin Acts Much Like Cocaine." Just how effective are these drugs? In 1999 the U.S. Surgeon General reported that Ritalin and Ritalin-like drugs "do not appear to achieve long-term changes in outcomes such as peer relationships, social or academic skills, or school achievement." Then there are the selective serotonin reuptake inhibitors, or SSRIs, such as Prozac, Paxil, and Zoloft. Even those prescribing SSRIs, including Harvard Medical School psychiatrist Joseph Glenmullen, admit that SSRIs are linked to neurological disorders indicating potential brain damage. Glenmullen also notes: "Withdrawal syndromes - which can be debilitating - are estimated to affect up to 50 percent of patients." What industrial psychiatry tells us about SSRI effectiveness is also more marketing than science. Most studies show SSRIs to be no better than active placebos (which, unlike sugar pills, affect the body). Why is all this not common knowledge? Follow the money trail. The TV commercials are only the beginning of the trail. Drug companies induce doctors' attendance at their sales pitches by not only picking up the tab for expensive hotels and meals, but also giving large cash payments to these doctors. The American Psychiatric Association and the National Alliance for the Mentally Ill have taken millions of dollars from drug companies, and the legal corruption of U.S. governmental agencies has gotten so bad that Lancet, the highly respected British medical journal, recently described the Food and Drug Administration as "the servants of the drug industry." However, I believe there is another problem besides invalid disorders, unreliable diagnostic procedures, ineffective and dangerous drugs, and Big Pharma corruption. The mental health industry has diverted us from confronting a culture that has grown increasingly toxic to our mental health; it has enabled us to avoid these questions: Has our one-dimensional consumer culture of material growth, efficiency, and productivity played havoc with our mental health? Has our expanding "institutionalization" - the explosion of gigantic, impersonal, bureaucratic, and coercive entities - left us feeling small, frightened, alienated, angry and bored? I believe that our emotional and behavioral difficulties are natural human reactions to the loss of 1) autonomy: self-direction, experience of potency, and capacity and ability to self-govern, 2) community: strong bonds among small groups that provide for economic security and emotional satisfaction, and 3) humanity: the variety of ways of being human, the variety of satisfactions, and the variety of negative reactions to feeling controlled rather than understood. What can we do? First, what has been pathologized needs to be rehumanized. We need to reacquaint ourselves with those aspects of our humanity which - though not fitting neatly into the new world order - are in fact fully human. Next, we must rebel - a common sense rebellion. I recommend we withdraw from the madness of industrial psychiatry, and we begin to help ourselves and each other by regaining our autonomy, restoring our community, and reclaiming our humanity. ~~~~~~~~~ Bruce Levine is a psychologist and author of "Commonsense Rebellion: Debunking Psychiatry, Confronting Society - An A to Z Guide to Rehumanizing Our Lives." ~~~~~~~~~ LOS ANGELES AREA -- SAVE THIS DATE -- SUNDAY -- 19 May 2002 Here's a chance to get into beautiful Santa Monica, meet a few other Support Coalition International members, poke around probably the hippest bookstore in Los Angeles country, and MOST OF ALL, become acquainted with Bruce E. Levine, author of the recently published Commonsense Rebellion: Debunking Psychiatry, Confronting Society (An A to Z Guide to Rehumanizing Our Lives. On Sunday, May 19th, at 2:00 PM, Dr. Levine, a psychologist and mental health dissident, will be speaking at the Midnight Special Bookstore, 1318 3rd Street Promenade in Santa Monica. In Commonsense Rebellion he argues the currently unorthodox position that emotional "disorders," from anxiety to schizophrenia, as well as many other examples of apparent human frailty, such as obesity, alcoholism, and compulsive gambling, are not "diseases like any other diseases," but are rebellious responses to an institutional society which worships speed, bureaucracy, power, and technology at the expense of autonomy, community, and humanity. He suggests that quick fix psychiatry, its diagnostic categories, drugs, and manipulative techniques are no substitute for rehumanizing our lives. Please join us to listen to and dialogue with Dr. Bruce Levine. He's a good guy and an interesting man. And, hey, it's just a few blocks from the beach. Mickey Weinberg and Beverly Jones Dr. Bruce Levine Sunday, May 19, 2:00 p.m. Midnight Special Bookstore -- 1318 3rd St. Promenade Santa Monica 310/393-2923 ~~~~~~~~~~~~~~~~~~~~~~ [Quotes from Bruce Levine:] *** "The psychiatric pharmaceutical industry has created a pseudoscience of invalid disorders, unreliable diagnostic procedures, and ineffective dangerous drugs." *** "Biochemical explanations distract us from examining serious cultural problems." *** "Institutional mental health sees illness to help us 'adjust.' Commonsense Rebellion sees discontent with institutional society and offers a different direction." *** "Reject institutional mental health. Rehumanize our lives. Reclaim our autonomy, community, and humanity." Praise for Levine's national speaking tour: "Everyone thought Levine's presentation was stupendous." Louise Bouta, WellMind of Minn. -- Peter Bowditch |
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51 deaths ADHD drugs ...
"Mark Probert wrote: vernon wrote: "Mark Probert" wrote in message ... vernon wrote: "Mark Probert" wrote in message ... vernon wrote: Ilena wrote in message ... P.net!53ab2750!not-for-mail From: "VERACARE" Why has the FDA concealed from the public 51 deaths from ADHD drugs until now? ALL diversions snipped Back to the subject:: P.net!53ab2750!not-for-mail From: "VERACARE" ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability www.ahrp.org FYI Children have been dying as the FDA looked the other way: Reuters reports that sudden death, high blood pressure, heart attacks and strokes have been reported in people prescribed psychostimulants (i.e., amphetamines) for a controversial behavior disorder--ADHD--a disorder about which there is no consensus. Why has the FDA concealed from the public 51 deaths from ADHD drugs until now? "Through 2003, 24 deaths were reported from 1999 through 2003 among U.S. patients who took Adderall for ADHD, the FDA staff report said. The agency excluded cases that appeared linked to intoxication from multiple drugs or other causes. Another 16 deaths were reported through 2003 in U.S. patients who took Ritalin or other ADHD drugs known as methylphenidates, the report said. Eleven deaths were reported among other drugs besides Adderall in the amphetamine class, it said." "Conclusions about the relative safety of these two stimulant therapies cannot be made on the basis of this analysis," the FDA staff said. Evidence of the FDA's failure for well over a decade to protect children's lives from unsafe, widely misprescribed drugs used to control behavior--as opposed to treat illness--can be analyzed by counting the preventable human casualties. The FDA is convening a long overdue Advisory Committee meeting to address the death toll from ADHD drugs--the very same class of drugs that the Drug Enforcement Agency is at "war" with when consumed without a doctor's prescription. How many parents have been informed that the drugs they feed their child to get him (ADHD drugs are mostly prescribed for boys) to sit still and pay attention--are in the same family as the drugs former First Lady, Nancy Reagan campaigned against urging kids to "just say NO." Parents should be taught to tell doctors who are quick to prescribe psychotropic drugs for children to "Just say NO." AHRP board member, Allen Jones, will be testifying about undisclosed conflicts of interest that undermine the integrity of FDA's advisory committees. The advisory panel members' undisclosed conflicts of interest demonstrate the FDA's complicity in putting financial interests above safety. And it demonstrate's FDA officials' disregard for federal conflicts of interest requirements. It is, perhaps, not just a coincidence that while still under investigation, former FDA Commissioner, Lester Crawford, has joined a lobbying group that promotes food and drug industry interests. Elen Liversidge will be testifying on behalf of the thousands of famileis whose children are casualties of psychotropic drugs--stimulants, antidepressants, and antipsychotics--all of which are dangerous and toxic. It might be more effective if these drugs don't just carry a black box, but a scull and bones. Contact: Vera Hassner Sharav 212-595-8974 http://abcnews.go.com/US/print?id=1595545 FDA reports 51 deaths of attention drug patientsReuters WASHINGTON - Deaths of 51 U.S. patients who took widely prescribed drugs to treat attention deficit disorder prompted regulators to start watching for heart attacks, high blood pressure and other problems in 2004, a report released on Wednesday said. The U.S. Food and Drug Administration staff did not say the drugs were responsible for the fatalities, but they urged close monitoring for "the rare occurrence of pediatric sudden death during stimulant therapy." "These reports themselves do not establish a causal relationship between these medications and cardiovascular adverse events," wrote Dr. Gerald Dal Pan, director of the FDA's Office of Drug Safety, in a separate notice on the agency Web site. The information was released one day ahead of an FDA advisory panel meeting on how best to study potential risks from the drugs, which include Shire Pharmaceuticals Group Plc's Adderall and Novartis AG's Ritalin. FDA staff scientists and experts will provide updated information at the meeting about serious health problems that have been reported, the agency said. Use of drugs to treat attention deficit hyperactivity disorder, or ADHD, was controversial before the cardiac issue emerged, with many doctors and parents arguing the medicines are overprescribed. The FDA said it decided to seek input from an advisory panel after reports of sudden death, high blood pressure, heart attacks and strokes among some of the millions of adults and children who have taken the medicines. Through 2003, 24 deaths were reported from 1999 through 2003 among U.S. patients who took Adderall for ADHD, the FDA staff report said. The agency excluded cases that appeared linked to intoxication from multiple drugs or other causes. Another 16 deaths were reported through 2003 in U.S. patients who took Ritalin or other ADHD drugs known as methylphenidates, the report said. Eleven deaths were reported among other drugs besides Adderall in the amphetamine class, it said. "Conclusions about the relative safety of these two stimulant therapies cannot be made on the basis of this analysis," the FDA staff said. Thirty additional deaths of methylphenidate patients were recorded but they were either non-U.S. cases or occurred outside the review period, the report said. Shire spokesman Matthew Cabrey said data have not shown any correlation between Adderall and the sudden deaths reported among children. He said the company supports the FDA's review of the matter. Health Canada temporarily suspended Adderall sales last year after 20 reports of sudden death in people who took it. The agency allowed Adderall back on the market after concluding it could not prove the drug was more risky than other therapies. Novartis said its own review found no increased risk of cardiovascular problems in patients who took methylphenidates compared with the general population. The FDA also has been studying if ADHD drugs may be related to psychiatric problems. Republican Sen. Charles Grassley charged the FDA had taken a "disjointed" approach to the drugs over the past year. In a letter to the agency, the Iowa Republican suggested a "comprehensive" review of all ADHD medicines. Shares of British firm Shire fell 3.2 percent to 890.2 pence in London trading. Novartis shares gained 5 cents to close at $54.70 on the New York Stock Exchange. Copyright 2006 Reuters News Service. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed. Copyright C 2006 ABC News Internet Ventures http://www.thepinksheetdaily.com/NR/FDC/images/pdly/print_masthead.gif THE PINK SHEET February 07, 2006 Number 004 Grassley Mows Down FDA Handling Of ADHD Drug Safety 14060207004 Senate Finance Committee Chairman Chuck Grassley (R-Iowa) is urging FDA to conduct a comprehensive review of side effects associated with attention deficit/hyperactivity disorder drugs. In a Feb. 7 letter to Acting FDA Commissioner Andrew von Eschenbach, Gr! assley acknowledges that the agency is taking steps to discuss safety concerns related to ADHD drugs, but says that the planned advisory committee meetings are inadequate. On Feb. 9, FDA's Drug Safety Risk Management Advisory Committee will discuss cardiovascular events associated with ADHD drugs. On March 22, the Pediatric Advisory Committee will discuss neuropsychiatric adverse events in the pediatric ADHD population. [Editor's note: To 1sign up for a webcast http://www.fdaadvisorycommittee.com/ or order a video/DVD of these meetings, visit FDAAdvisoryCommittee.com.] Grassley said he remains "concerned that lost between the two meetings is a comprehensive review of all adverse events for this entire class of medication for all populations served." He called FDA's actions thus far "ad hoc and disjointed." Additionally, Grassley added, "While both psychiatric and cardiovascular risk signals have cropped up across this class of drugs this past year, it appears that FDA is just now beginning to 'discuss approaches' for studying these risks." In June 2005, the committee concluded that reports of suicidality with Johnson & Johnson's Concerta and other methylphenidate products did not constitute a new signal for concern. In September, FDA issued a public health advisory on suicidal thinking in children and adolescents taking Lilly's Strattera for ADHD. The agency said it would not add a warning to other ADHD products pending an analysis of post-marketing adverse events from those products (2"The Pink Sheet" DAILY, Sept. 29, 2005 http://www.thepinksheetdaily.com/fdc...o?targetAN=140 50929002 ). "I question why it has taken nearly an entire year for FDA to begin to address these concerns, given the serious nature of the adverse events associated with these drugs," Grassley said. FDA's Psychopharmacologic Drugs Advisory Committee will convene March 23 to review a pending ADHD drug, Cephalon's Sparlon (modafinil), which has the same active ingredient as Cephalon's sleep disorder therapy Provigil (3"The Pink Sheet" DAILY, Jan. 25, 2006 http://www.thepinksheetdaily.com/fdc...o?targetAN=140 60125006 ). One topic the committee will likely address will be how to distinguish Sparlon from other ADHD drugs with regard to potential safety issues. -Kathleen Michael Contents copyrighted C F-D-C Reports, Inc. 2006; protected by U.S. Copyright Law. Former FDA Chief Joins Lobby Shop By Marc Kaufman Washington Post Staff Writer Wednesday, February 8, 2006; A06 Former Food and Drug Administration commissioner Lester M. Crawford, whose sudden resignation last fall after less than three months in office remains a mystery, has joined a lobbying firm that specializes in food and drug issues. Crawford is listed as "senior counsel" to the firm Policy Directions Inc. Among the companies and organizations listed as clients are Altria Group Inc. (formerly Philip Morris Companies), Merck & Co. Inc., the Pharmaceutical Research and Manufacturers of America (PhRMA,) the Grocery Manufacturers of America and the American Feed Industry Association. A spokesman for the firm said neither Crawford nor anyone else wished to discuss his appointment. When he resigned in September, Crawford said simply that it was time for someone else to lead the agency. Sens. Mike Enzi (R-Wyo.) and Edward M. Kennedy (D-Mass.) have asked the Department of Health and Human Services inspector general to look into whether Crawford resigned because of an undisclosed financial conflict of interest. Laura Bradbard, spokeswoman for the office, said yesterday that the investigation is ongoing and that her office has subpoenaed information from three financial firms used by the former commissioner. Crawford is barred from lobbying former colleagues at the FDA for a year, but he can give clients strategic advice about food and drug issues and can lobby members of Congress. Policy Directions was founded by Frankie L. Trull, a prominent defender of animal testing for medical research and critic of animal rights groups. On its Web site, the company says Crawford joined last month but gives no indication what his role will be. FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit. |
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51 deaths ADHD drugs ...
"vernon wrote: ALL diversions snipped ... In article , Mark Probert writes: "Twenty-five people died suddenly and 54 others suffered serious unexplained heart problems while taking stimulant drugs like Ritalin from 1999 through 2003, according to reports sent to federal drug regulators." |
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51 deaths ADHD drugs ...
"Rich wrote ALL diversions snipped , Mark Probert writes: "Twenty-five people died suddenly and 54 others suffered serious unexplained heart problems while taking stimulant drugs like Ritalin from 1999 through 2003, according to reports sent to federal drug regulators --Rich |
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51 deaths ADHD drugs ...
"vernon wrote ALL diversions snipped .. "Brad_Chad" wrote in message oups.com... If conventional doctors had any moral integrity, they would have at least given all their ADHD patients a choice of either medication, or help with finding their Hidden Food Sensitivities. Instead, they go straight for the drugs. They don't tell their patients anything about the Hidden Food Sensitivity controversy. What greedy wimps. They sold their soul to the pharmaceutical companies. Brad_Chad |
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51 deaths ADHD drugs ...
"JanD" wrote in message news:2NsHf.769297$_o.482080@attbi_s71... "vernon wrote: ALL diversions snipped .. In article , Mark Probert writes: "Twenty-five people died suddenly and 54 others suffered serious unexplained heart problems while taking stimulant drugs like Ritalin from 1999 through 2003, according to reports sent to federal drug regulators." AND??? All medications are life threatening. |
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51 deaths ADHD drugs ...
vernon wrote:
"Mark Probert" wrote in message ... vernon wrote: "Mark Probert" wrote in message ... vernon wrote: "Mark Probert" wrote in message ... vernon wrote: Ilena wrote in message ... P.net!53ab2750!not-for-mail From: "VERACARE" Why has the FDA concealed from the public 51 deaths from ADHD drugs until now? 51 out of around 100,000 per year of miss-prescribed and errors is quite insignificant. You are mistaken in your interpretation of the numbers. The NY Times reported that this was a study of five years of records, 1999 through 2003. The number of deaths is also incorrect. "Twenty-five people died suddenly and 54 others suffered serious unexplained heart problems while taking stimulant drugs like Ritalin from 1999 through 2003, according to reports sent to federal drug regulators." Now, let's take a minute and analyze this. Twenty-five people died over the course of 5 years. That averages to 5 deaths per year. The NYTimes then reports that "...[a]bout 29 million prescriptions were written in 2004 for Ritalin, Adderall and similar drugs to treat attention deficit disorder and hyperactivity, most of them for children." Assume that the average prescription rate is *only* 25,000,000 per year. Since these medications are Schedule II, which means that only a one months supply can be written at a time, approximately 2,083,333 people per month are, on average, being prescribed these medications. Assume that all 5 deaths happened in the same month, and you wind up with a rate of 2.4000003840000614400098304015729e-6. Compare that with the odds of being struck by lightening: http://www.lightningsafety.noaa.gov/medical.htm My younger son attends a special school for physically handicapped students. In the past three years, two classmates have died for no apparent reason, the last being in December 2005. One of the kids in my neighborhood died from running the bases. His father is a DDS and was at the school at the time. He is trained in using a defibrillator and could not resuscitate his son. I would classify this report and just this side of relatively meaningless. That's what I said. Yeah, but not as well as I did... The numbers really do not add up very well. Ever wonder about how many die of no apparent reason? Like I pointed out in the paragraph above, yes, on three occasions in the past 2 years. One boy rode the bus with my younger son and they hung out together outside of school. He did not wake up one morning. One boy was the captain of my son's school's wheelchair basketball team. No arms and two underdeveloped legs. He used one to operate the joystick on his power chair, and the other, the longer of the two, for dribbling, stealing and shooting. His mother thought he was sleeping on the school bus when he came home from school. The third is a neighborhood kid who had just finished running the bases and died. From the little I have seen, it is sickening. Not a conspiracy, but lack of involvement and laws to determine. It is very shocking for parents to sudden lose a child who is in apparent good medical health. Sadly, even on autopsy, the actual cause of death cannot often be determined. I know in the two cases where I know the families well, they still do not know what happened. Both boys, having physical disabilities, had been carefully examined and monitored over the years. It is always pretty close to possible to determine cause if there is a desire. I know parents have a desire, but seemingly are easy to be put off with "We just don't know" I know the medical examiners involved, and they ALWAYS have a desire with kids. Good. It's unusual. Maybe where you live. The team I have dealt with on a professional level truly do believe that they are speaking for the dead. They are ALL board certified forensic pathologists, in a setting which is affiliated with a teaching hospital. The training is excellent according to one graduate I bumped into in Michigan. |
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51 deaths ADHD drugs ...
JanD wrote:
"Mark Probert wrote: vernon wrote: "Mark Probert" wrote in message ... vernon wrote: "Mark Probert" wrote in message ... vernon wrote: Ilena wrote in message ... P.net!53ab2750!not-for-mail From: "VERACARE" Why has the FDA concealed from the public 51 deaths from ADHD drugs until now? ALL diversions snipped Back to the subject:: Sorry, but you are diverting. Back to the friendly discussion that you cannot stand. 51 out of around 100,000 per year of miss-prescribed and errors is quite insignificant. You are mistaken in your interpretation of the numbers. The NY Times reported that this was a study of five years of records, 1999 through 2003. The number of deaths is also incorrect. "Twenty-five people died suddenly and 54 others suffered serious unexplained heart problems while taking stimulant drugs like Ritalin from 1999 through 2003, according to reports sent to federal drug regulators." Now, let's take a minute and analyze this. Twenty-five people died over the course of 5 years. That averages to 5 deaths per year. The NYTimes then reports that "...[a]bout 29 million prescriptions were written in 2004 for Ritalin, Adderall and similar drugs to treat attention deficit disorder and hyperactivity, most of them for children." Assume that the average prescription rate is *only* 25,000,000 per year. Since these medications are Schedule II, which means that only a one months supply can be written at a time, approximately 2,083,333 people per month are, on average, being prescribed these medications. Assume that all 5 deaths happened in the same month, and you wind up with a rate of 2.4000003840000614400098304015729e-6. Compare that with the odds of being struck by lightening: http://www.lightningsafety.noaa.gov/medical.htm My younger son attends a special school for physically handicapped students. In the past three years, two classmates have died for no apparent reason, the last being in December 2005. One of the kids in my neighborhood died from running the bases. His father is a DDS and was at the school at the time. He is trained in using a defibrillator and could not resuscitate his son. I would classify this report and just this side of relatively meaningless. That's what I said. Yeah, but not as well as I did... The numbers really do not add up very well. Ever wonder about how many die of no apparent reason? Like I pointed out in the paragraph above, yes, on three occasions in the past 2 years. One boy rode the bus with my younger son and they hung out together outside of school. He did not wake up one morning. One boy was the captain of my son's school's wheelchair basketball team. No arms and two underdeveloped legs. He used one to operate the joystick on his power chair, and the other, the longer of the two, for dribbling, stealing and shooting. His mother thought he was sleeping on the school bus when he came home from school. The third is a neighborhood kid who had just finished running the bases and died. From the little I have seen, it is sickening. Not a conspiracy, but lack of involvement and laws to determine. It is very shocking for parents to sudden lose a child who is in apparent good medical health. Sadly, even on autopsy, the actual cause of death cannot often be determined. I know in the two cases where I know the families well, they still do not know what happened. Both boys, having physical disabilities, had been carefully examined and monitored over the years. It is always pretty close to possible to determine cause if there is a desire. I know parents have a desire, but seemingly are easy to be put off with "We just don't know" I know the medical examiners involved, and they ALWAYS have a desire with kids. |
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