ADHD patch approved Thursday 4/6/06

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ADHD patch approved Thursday 4/6/06
	2006-04-09 19:27:34

[Note that despite the FDA panel convened to look into the deaths caused by methylphenidate and other stimulants, it has gone ahead and approved yet another product of this type and approved it for ages 6-12. ; How long will we let them get away with murder?  Watch this particular drug delivery method carefully. It won't be long before the reports of death triple. I've found an article to support my concern.  It is pasted below the first article. --Catherine] FDA approves sale of ADHD patch South Florida Business Journal - 4:25 PM EDT Friday Noven Pharmaceuticals said regulators have approved the sale of its attention deficit hyperactivity disorder (ADHD) drug for children ages 6 to 12 years. The Miami-based drug maker said Shire is the global licensee for its Daytrana patch product. Noven (NASDAQ: NOVN) said it expects Shire, which it called a market-share leader in the ADHD category, to launch the product in the first half of this year. Robert C. Strauss, Noven president, chairman and chief executive officer, said Daytrana is the first non-oral medication for ADHD. "For Noven, the approval advances our goal of commercializing our patented transdermal technology in diverse therapeutic markets with strong partners," he said. "For Shire, it adds an important new methylphenidate product to their portfolio of ADHD products, and reaffirms their position as the ADHD support company. And for patients, parents and physicians, Daytrana represents a new once-daily therapy for children diagnosed with ADHD."; Upon receipt of U.S. Food and Drug Administration approval, Noven said it became due to receive a $50 million milestone payment from Shire. Noven also said it has the opportunity to earn up to $75 million in additional milestone payments, depending on the level of Shire's Daytrana commercial sales. Noven also noted it expects to earn a profit on the manufacture and supply of finished product to Shire. ========================================= ADHD skin patch treatment approved WASHINGTON, April 7 (UPI) -- A skin patch to treat attention deficit hyperactivity disorder in children has won approval from drug regulators, the first to replace oral medications. The patch made by Shire Pharmaceuticals Group PLC and Noven Pharmaceuticals Inc., is designed to treat ADHD children ages 6 to 12. It will be sold under the brand name Daytrana, reports the Wall Street Journal. The patch will be attached to a person's skin for up to nine hours every day. The Food and Drug Administration had previously rejected the patch because of concerns it might overmedicate children, reported the Journal. Miami-based Noven and Shire, a British company, changed the duration for wearing the patch to nine hours from 12 hours. And more propaganda... ============================================ ABC 7 News goes to bat for the drug industry. Research Summary: ADHD Patch Apr. 7 - abc7news.com BACKGROUND: According to the American Academy of Pediatrics, ADHD is one of the most common chronic conditions of childhood and affects between 4 percent and 12 percent of all school- age children. About three-times more boys than girls are diagnosed with ADHD. Attention Deficit Hyperactivity Disorder, or ADHD, is a dysfunction in certain parts of the brain. Researchers believe ADHD originates in the impulse control areas of the brain's frontal lobes. It's these areas that seem to be responsible for regulating the rest of the brain. Children with ADHD may experience significant functional problems such as school difficulties, academic underachievement, troublesome relationships with family members and peers, and behavioral problems. Medications including Ritalin, Adderall, Dexedrine, and Cylert are used to treat the disorder. NEW OPTION: A new patch system, named DAYTRANATM, delivers methylphenidate -- the main ingredient in some of the ADHD drugs -- throughout the day. It is the first drug that does not have to be taken orally. UNDER STUDY: New research reveals the patch works at least as well as standard ADHD drugs. Sharon B. Wigal, Ph.D., director of clinical trials at the Child Development Center at the University of California, Irvine, led one of the studies. Study investigators gave the patch to 80 kids with ADHD between ages 6 and 12. Half the kids received an inert placebo patch and later switched to a real patch. The other half started with a real patch and later switched to a placebo. When getting the real patch, the children's ADHD was significantly better than when they got the fake patch. Their behavior and attention, tested throughout the day, improved. They also did better on age-adjusted math tests. Children in the study are continuing to use the patch for a full year. In another study out of University Hospitals of Cleveland, Robert L. Findling, M.D., director of child and adolescent psychiatry, and colleagues, compared the patch with placebo as well as with methylphenidate pills. The patch and methylphenidate pills improved 6- to 12-year-old kids' ADHD better than placebo. ADHD scores actually improved more with the patch than with the pills, although the difference was not considered significant. WHY USE IT? The patch approved just received FDA approval on may allow clinicians to formulate doses to individual patients and offers parents more control over how long they want the stimulant medication to last. Even though Wigal's study involved removing the patch after nine hours, parents may opt to remove it earlier or later once they administer it themselves, as the patch continues to work after the 12-hour point and possibly up to as long as 16 hours. Researchers say it looks as though the patch must be removed for three hours before its effects wear off. SIDE EFFECTS: The patch does have side effects -- comparable to what is seen with other stimulant drugs. These include effects on sleep and skin reactions. PRESS RELEASE: DAYTRANA, the first and only non-oral medication for ADHD, will be available in 10 mg, 15 mg, 20 mg and 30 mg dosage strengths. This patch form combines the active ingredient, methylphenidate, with Noven's patented DOT Matrix" transdermal technology. This transdermal delivery system was designed to provide continuous medication release throughout the day and the drug is delivered directly through the skin into the bloodstream. The patch is designed to stay on during the normal daily activities of a child. Because DAYTRANA is not swallowed, physicians can manage the duration of its effect and potential side effects by having the patient wear the patch for a shorter time period on a given day. ADHD affects approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, according to the U.S. Centers for Disease Control and Prevention (CDC). FINDINGS: DAYTRANA Significantly Controls ADHD Symptoms. Data from phase II and phase III clinical trials demonstrated statistically significant improvements in the primary and secondary endpoints analyzed for children treated with DAYTRANA compared to children treated with placebo. The phase II analog classroom study included 79 children with ADHD. The patch was worn for nine hours, and efficacy was assessed throughout the day for 12 hours. DAYTRANA demonstrated statistically significant improvement over placebo on the measures tested. Behavior, which was measured using the Swanson, Kotkin, Agler, M-Flynn, and Pelham-Deportment (SKAMP-D) scale, was improved with DAYTRANA overall (mean score 3.2 for DAYTRANA versus 8.0 for placebo) and at all time points assessed throughout the day (P < .01). In the phase III naturalistic trial with 270 participants, investigators found that DAYTRANA worn for nine hours reduced the children's overall symptoms of ADHD, compared to a placebo (P < .0001), as measured by scores on the ADHD Rating Scale (ADHD-RS). By the study's end, mean ADHD-RS scores declined 24.2 points (56%) from baseline for children treated with DAYTRANA versus a decline of 9.9 (24%) for those treated with placebo (P < .0001). ADHD-RS assesses 18 individual symptoms of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision®, a publication of the American Psychiatric Association. In both studies, DAYTRANA was generally well tolerated during both the dose optimization and double blind phases. Common adverse events seen in clinical trials included: decreased appetite, insomnia, nausea, vomiting, weight loss, tic, and affect lability (mood swings). Shire and Noven Pharmaceuticals, Inc. submitted an amended New Drug Application (NDA) for DAYTRANA to the FDA in June of last year. Noven licenses DAYTRANA globally to Shire ================================================== Relax, It's Just a Patch The Chicagoist http://www.chicagoist.com/archives/2006/04/07/relax_its_just_a_patch.php "The patch"; has become a popular substitute for some of the most popular drugs and treatments. The patch can help you stop smoking, keep you from getting knocked up and even help you lose a few pounds. (Seriously though, that weight loss patch is some scary shit. The shakes, man, it gives you the shakes.) There's something about the patch that makes it a little more fun that regular drugs, kind of like the pot sucker, only not really. There hasn't really been a patch that kids can enjoy. That is, until now. Yesterday, the FDA approved the first patch to treat attention deficit hyperactivity disorder, also known as ADHD. It's called Daytrana, it's essentially the same as Ritalin, and it can be worn for nine hours - which will get the kid through the school day without an embarrassing trip to the nurse and the inevitable "Did you forget to take your meds?"; question from nosy peers. Because, really, everyone knows what's up when you go to the nurse every day in the middle of fourth period. Plus, kids like stickers. They probably won't even realize they're being drugged, er, medicated. Despite the social advantages, we're still a little weirded out by this new patch. Is it really necessary to make it easier to medicate for ADHD? Nearly 3.3 million Americans age 19 and younger say no. And then there's the issue of the warning label and potential side effects. FDA panels have recommended that the drug's label caution of side effects that include stroke and hallucinations in addition to insomnia, decreased appetite and nausea and sensitization. Anal leakage, anyone? ================================================ Evelyn Pringle -- a voice of sanity in a sea of insanity writes:   ; April 7, 2006     Kids On ADHD Drugs - Dangerous Path To Addiction     by Evelyn Pringle http://www.opednews.com Experts say the stimulant drugs prescribed for the treatment of ADHD are not only dangerous, they are highly addictive. And although no drug has been approved for the treatment of autism, drugs are routinely prescribed off-label to treat autistic children. According to the National Center for Health Statistics, over the period of 5 years between 1997 and 2002, the number of children between the age of 3 to 17, diagnosed with ADHD went from 3.3 million to 4.4 million. In direct correlation, the number of children prescribed ADHD drugs also rose steadily. In fact, spending on these types of medications for children is now higher than spending on antibiotics and asthma drugs. In February 2006, the FDA revealed that between 1999 and 2003, seventy-eight million prescriptions for ADHD drugs were written for children between the ages of 1 to 18. Terry Davis, a member of an FDA advisory committee, has said prescriptions for ADHD drugs filled annually have a value of $3.1 billion. According to Dr Peter Breggin, author of "Talking Back To Ritalin, "parents and teachers and even doctors have been badly misled by drug company marketing practices," he warns. "Drug companies have targeted children as a big market likely to boost profits and children are suffering as a result." What critics say is most alarming, is the fact that very young children are being placed on drugs. A study published in the Journal of the American Medical Association in 2000 provides some insight into this trend. The study found that fifty-seven percent of 223 Michigan Medicaid patients younger than 4, diagnosed with ADHD, received at least one psychotropic drug during a 15-month period in 1995 to 1996. Additionally, the study found that in the Medicaid population in Midwestern states, there was a 3-fold increase in the prescribing of stimulant drugs between 1991 and 1995 for children between the age of 2 and four. More recent statistics show a 369% increase in spending on ADHD drugs for children under five. From 2000 to 2003, the rise in the use of attention deficit drugs by children under 5 contributed to an overall 23% increase for all children, according to an analysis by the nation's largest prescription benefit manager, Medco Health Solutions. The debate over the drugging of children in this country has been raging on for years. Schools have been accused of promoting the use of drugs to control normal but active children. At a September 26, 2002, Reform Committee hearing on the "Overmedication of Hyperactive Children," Chairman, Rep Dan Burton (R-IN), asked pediatrician, Dr Mary Ann Block, "what have you found that the schools do specifically to encourage the use of medications for attention and behavior?" Dr Block said, "parents that come to me report consistently that the teachers and the principals and even the school nurses pressure them to go to a physician and get their child labeled and drugged." "Some schools," she said, "are giving lectures to parents, inviting parents to come hear talks about diagnosing and drugging their children for ADHD."; Congressman Burton pointed out what he considered to be inadequate and unscientific methods of diagnosing ADHD: "When you take your child to a doctor, instead of blood tests and a thorough medical evaluation, you have a conversation with a doctor about the school's checklist. And you leave a few minutes later with a prescription for your young child for a psychotropic drug."; "Did the doctor test your child for a thyroid disorder? Did your doctor test your child for a heavy metal toxicity? Did you doctor talk to you about your child's allergies? "Did your doctor even mention nutrition or possible food sensitivity? Did your doctor ask if your child's IQ had been tested and if he was gifted? Probably not," he said. Sandra Lucas testifies at FDA advisory committee hearings on behalf of the Citizens Commission on Human Rights, a psychiatric watchdog group. She produced a copy of a January 20, 2005, pamphlet used at a training seminar for teachers composed by Susan Barton, who billed herself as the "Founder of Bright Solutions for Dyslexia," located in San Jose California. Under Medication for ADD, Ms Barton states: "Medication is the most often an essential component to effective treatment for the ADD child." ";As I've said many times now," she told the teaches, "ADD is a neurobiological disorder and needs to be treated as such."; Ms Barton also says that without medication, other interventions are ineffective, and claims: "This medication does not cause illegal drug use or addiction." Dr Fred Baughman, author of "The ADHD Fraud - How Psychiatry Makes Patients of Normal Children," and one of the nation's leading experts on the issue, vehemently disagrees. He calls the medical practice of ADHD a fraud - "one in which the FDA was fully complicit," he says. "ADHD doesn't exist--it is not a physical abnormality," he explains, "and as such bears no risk of causing physical injury or death as does every drug used in its treatment," he says. In testimony on behalf of the International Center for the Study of Psychiatry and Psychology, at the March 22 and 23, 2006, FDA advisory committee hearings on the dangers of ADHD drugs, Dr Baughman asked the panel of experts to "give us the reference, cite to the article, giving proof that ADHD is a disease." He also asked the committee to give the reference, or cite the literature, that describes the test that provides objective evidence that children diagnosed with ADHD have a disease. The silence in the hearing room was deafening. According to Dr Baughman, no one answered the questions because there is no study, test, or scientific literature to back up the assertion that ADHD is a disease. "ADHD is not a disease," Dr Baughman says. "This being the case,"; he maintains, "giving such drugs for ADHD is not "help" or "treatment"." He makes the point "that all practice of medicine begins with diagnosis." "Informed consent," Dr Baughman explained, "demands not just a description of the drugs or surgery to be used but of the condition they are to be used on--its prognosis and how that natural course/prognosis is likely to be altered by the treatments to be applied." At the March 2006, FDA advisory committee hearings, it was noted that no other countries are drugging children with stimulants. In fact, psychiatrist, Dr Grace Jackson, who also testified at the hearing, explains in her book, "Rethinking Psychiatric Drugs," how in 1996 and 1997, the World Health Organization issued press releases about the rise in the use of the stimulant, Ritalin, in this country, "noting that the United States was responsible for 90% of the drug's production and consumption." At the time, the International Narcotics Control Board identified a number of concerns about America's use of the drug, including the dangers of: "inappropriate diagnosis of ADHD; widely divergent prescribing patterns; off-label prescribing to children under six; and excessive duration of treatment," Dr Jackson reports. A report by the FDA released in February 2006, said that between 1999 and 2003, there were 25 deaths in persons using ADHD drugs, including the deaths of 19 children. The FDA also reported receiving more than 50 cases of cardiovascular problems, including stoke, heart attack, hypertension, palpitations and arrhythmia. Because only between 1 and 10% of adverse events are ever reported to the FDA, the numbers above represent an extreme understatement of actual cases of harm, critics point out. According to the Drug Abuse Warning Network, there were only 271 Ritalin-related emergency room visits in 1990, but there were 1,478 Ritalin-related emergency visits recorded in 2001. In 1999, the National Institute of Drug Abuse, found some 165 Ritalin-related poison calls in Detroit and 419 cases in Texas. Of the nearly 600 calls, only 114 cases involved intentional misuse or abuse. Dr Breggin maintains that ADHD drugs actually bring on the symptoms they are supposed to treat such as hyperactivity, impulsivity and inattention, which can lead to a vicious cycle of incorrect and dangerous dosage increases, he warns. In addition, Dr Breggin says, stimulants can cause "agitation and irritability, anger, hostility, disinhibition, hypomania and mania." A recent review of data by the FDA seems to verify Dr Breggins assertions. The FDA found that children on ADHD drugs had an increased the risk of psychosis, a mental disorder characterized by the inability to distinguish between real and imaginary events. The most important finding, the FDA said, was that signs of psychosis or mania, particularly hallucinations, occurred in patients with no risk factors, at the usual doses of any of the drugs used to treat ADHD. The FDA found a "substantial portion of the psychosis-related cases were reported to occur in children 10 years or less,"; an age group which does not typically suffer from psychosis, the FDA said. From January 2000, through June 30, 2005, FDA identified nearly 1,000 reports of psychosis or mania possibly linked to the drugs, including Ritalin, Adderall, Concerta, and Strattera. Most of people who have investigated the matter seem to agree that heavy metal poisoning is by far the most likely cause of the epidemic in autism spectrum disorders that erupted in the 1990s. Studies show that the mercury-based preservative, thimerosal, that was used in all childhood vaccines until recently, is the likely culprit. Beginning in the late 1980s, the CDC began adding more and more vaccines to the immunization schedule but failed to keep track of the toxic levels of mercury that children would receive as each new shot was added to the list or the amount of mercury that infants would receive when 3-in-one shots were injected. Nancy and Tim Hokkanen are the parents of Andy, a 6 year-old boy who was diagnosed with autism but who is now recovering from mercury poisoning. In June 2002 a neurologist prescribed Adderal for Andy. "My son became psychotic," Nancy said, "for four days by mid-afternoon he had to be held down in a dark quiet room while he screamed himself limp."; Next the neurologist prescribed Ritalin, saying, "Usually if one drug doesn't work, the other one does,"; Nancy continued. "My instincts told me that this was another disaster in the making," she said, "so I quit seeing that neurologist and began reading studies." Nancy discovered the theory of mercury poisoning published by chemistry experts, Boyd Haley, PhD and Andrew Hall Cutler, PhD, in the study, "Autism: a novel form of mercury poisoning," which documents about 100 matching symptoms. In November 2002, when Andy was 4 and-a-half, tests were done on Andy's hair, blood, urine and stool samples, and the test results showed mercury toxicity as well as high levels of copper and other metals, and various nutritional insufficiencies. Within 2 weeks of giving Andy supplement including Vitamin B-6, zinc, manganese and magnesium, he showed drastic improvements in mood, behavior and abilities, Nancy says. "We had an almost-normal Christmas," she reported, "without tantrums and bizarre behavior." The Hokkenans estimate that their insurance company was billed about $100,000 for therapy to treat autism. "However, we never noticed any drastic improvement until we began biomedical treatment, which has cost about $2,000," Nancy says. "Strangely," she notes, "our insurance company wouldn't cover the costs of those medical tests." Nancy says that since public health officials realized their error of failing to keep track of the toxic mercury levels in vaccines in 1999, she views the failure to restrict the use of mercury in vaccines as a form of fatal entrenchment -- "when an unhealthy practice or norm is allowed to continue, she explained, "simply because it has been done that way for so long." In addition to all the other side effects associated with ADHD drugs, Dr David Stein, author of "Unraveling the ADD/ADHD Fiasco," says stimulant drugs are "near the top of the heap of potentially addictive drugs." He says, "we have no way of knowing which child has a potential risk for becoming addicted to drugs." Recent studies have shown that more and more students are using the drugs illegally. In 2004, a nationwide University of Michigan study on non-medical use of amphetamines, found 4.9% of 8th graders had used stimulants in the previous year, 8.5% of 10th graders had used the drugs, and one in 10 seniors admitted to non-medical use of amphetamines. The Partnership for a Drug Free America, released the results of a survey in 2005, that polled more than 7,300 teenagers, and found one in 10 teenagers, or 2.3 million young people, had tried ADHD drugs without a doctor's prescription, and that 29% of those surveyed said they had close friends who had abused the drugs. Experts agree that the wide-spread prescribing of stimulants will lead many children down the path to addiction and they warn of the perils that will follow. "Psychology and psychiatry have extremely poor track records for treating abuse and addiction problems," Dr Stein notes, "and therefore the very drugs they are recommending can trigger a problem from which there may be no return." If medical professionals begin telling children at a very young age that they can change the way they think, feel, and behave by simply taking a pill, they will logically continue to take drugs in attempt to mood-alter whenever they have problems in life. Evelyn Pringle evelyn.pringlesbcglobal.net (Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing corruption in government) Regards, Catherine "Every science touches art at some points while every art has its scientific side; the worst man of science is he who is never an artist, and the worst artist is he who is never a man of science." [Armand Trousseau]

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