Doctors Ponder Drugs for Sleepless Nights of Adolescence By MARY DUENWALD Published: November 15, 2005 When is it a good idea for an adolescent to take a sleeping pill? There is reason to suppose the answer may be never. No prescription sleep aids are approved by the Food and Drug Administration for use in people under 18, largely because they have not been well studied in children. But children do take sleeping pills. In 2004, more than 180,000 people under age 20 in the United States...up by 85 percent since 2000. The numbers reported by Medco did not indicate why the pills were prescribed for the patients under 18, or which pills were prescribed for them...which makes some doctors worry that the large increase may reflect a certain amount of unnecessary prescribing. (complete story) FDA official frowns on patch for ADHD FDA official says Noven's skin patch treatment for hyperactive kids is unsafe. December 1, 2005: By Aaron Smith, NEW YORK (CNNMoney.com) - A new treatment for hyperactive kids, one that uses a skin patch instead of a pill, is meeting resistance with regulators. A Miami-based drug maker specializing in skin patches, is awaiting a regulatory decision on Methypatch, a treatment for attention-deficit hyperactivity disorder for children ages 6 to 12. But Noven got some bad news from the Food and Drug Administration Thursday morning. Dr. Robert Levin, director of the FDA's division of psychiatry products, wrote that Methypatch is effective in treated ADHD but "cannot be safely marketed, even the with nine-hour wear time," according to documents released by the FDA Thursday. Levin's statement is not considered a final decision. An FDA advisory committee will vote on Friday whether to recommend approval of Methypatch for the treatment of ADHD. The FDA usually follows the advice of its expert advisory panels. "If there's any safety issues, this is not likely to pass muster with the FDA advisory panel," said Ken Trbovich, analyst for RBC Capital Markets who rates Noven neutral. "For Noven, it's particularly bad, because this is now the second instance where the FDA is indicating that their patch technology is not providing a sufficient margin of safety." Noven has not had an easy time trying to get Methypatch approved. The original new drug application was submitted June 27, 2002, but a non-approval letter was sent to the company on April 25, 2003, according to the FDA. Noven submitted the newest drug application on June 28, 2005. Methylphenidate, a stimulant affecting the nervous system, is the same compound used in Ritalin, which has been off-patent for decades, and Johnson & Johnson's Concerta. Methylphenidate is sometimes abused for its euphoric effects, according to the National Institutes of Health. Abusers have been known to chop up the pills and snort them. ADHD affects up to 5 percent of children in the United States, according to the NIH. Children with the disorder show patterns of increased activity, impulsive behavior and inattention. Canada Professor Provides Overview on the Hazards of Genetically Engineered Foods December 01, 2005 Healthy News Service Pat Howard, Simon Fraser University In 2003, government scientists in France reported on studies of five transgenic crops: Monsanto's Round-up Ready soybeans and four Bt insecticidal corn varieties. All five transgenic lines had inserted foreign DNA, whose structure was no longer the same as was originally reported by the company. Not only were the inserted genes rearranged, but the plants' own genomes had also been scrambled around the insertion site. Belgian scientists also conducted similar studies that turned up comparable evidence of DNA scrambling. This signifies that the precise varieties evolving in fields in Canada, the US, China, Argentina, Australia, the Philippines, and elsewhere have not been tested for potential allergenic or toxic effects on the humans and animals that consume them. If the lines are unstable, no amount of testing can guarantee their safety in the future, or when they are subjected to different environmental stresses. In 2004, people living near a field of Bt corn in the Philippines developed respiratory and gastric illness when the corn flowered. Tests of their blood revealed antibodies to the Bt toxin in the corn pollen, which suggested that it might have caused the illnesses. In Germany, between 2001 and 2002, 12 cows, illegally fed a steady diet of Bt corn, mysteriously died. Milk from the herd was tested and found to contain the genes for the bacterial Bt toxin. Neither Canada nor the US conducts tests on milk from cows fed GM feed for the presence of bacterial toxin or viral promoter DNA. How can we know if GM plants are producing dangerous allergens or toxic metabolites as a result of disruptions of plant genomes caused by the insertion of foreign DNA? We are part of one enormous feeding experiment in which none of us have given informed consent. (complete story)

Artificial Sweetener Indicted - Will New Mexico Be First To Ban Aspartame? December 01, 2005 Healthy News Service Aspartame, the controversial artificial sweetener approved in spite of the FDA's scientific doubts, seems to be nearing the end. Not only are consumers getting increasingly angry - but a large multi-year study of a private Italian health research foundation has acutely confirmed what studies in the 1980s had already found: brain tumors and other effects of aspartame consumption. The study, which used laboratory animals to test the cancer hypothesis, has been published by Environmental Health Perspectives (EHP), a monthly journal of peer-reviewed research and news on the impact of the environment on human health. (complete story) Clinical application of single-pulse transcranial magnetic stimulation for the treatment of depression. Psychiatry Clin Neurosci. 2005 Aug;59(4):425-32. Fujita K, Koga Y. Kyorin University School of Medicine Department of Neuropsychiatry, Mitaka, Tokyo, Japan. Transcranial magnetic stimulation (TMS) has been recently suggested for the treatment of patients with major depression. Based on the results of the authors' pilot study showing a possible antidepressive effect of single-pulse TMS, a clinical trial was conducted involving patients with major depression. For the present study single-photon emission computed tomography (SPECT) was recorded for six of the target patients to study the effects of TMS on the local blood flow volume. Twenty-three inpatients meeting the Diagnostic and Statistical Manual of Mental Disorders (4th edn; DSM-IV) criteria for major depression were invited to participate in the study. Depressive symptoms were rated using the Hamilton Rating Scale for Depression (HAM-D). Patients were given 10 stimuli over the frontal area of both sides for a total of 20 stimuli in a session. The subjects had daily TMS session for 5 days as an add-on therapy. In addition, six patients had their quantitative (99m)Tc-ethyl cysteinate dimer SPECT images measured before and after TMS treatment. Compared with the value 2 days prior to the start of TMS therapy (24.2 +/- 4.9), the average HAM-D scale dropped significantly to 15.3 +/- 6.6 on the day after completion of such therapy. The results of SPECT showed that the regional cerebral blood flow (rCBF) of the bilateral frontal region had increased in four out of six patients when comparing before and after treatment. The present study shows that single-pulse TMS, which is widely used as a neurological test method, possesses a wide range of antidepressive effects without inducing adverse reactions. The results suggest that although repetitive TMS is steadily becoming the mainstay technique today, single-pulse TMS also possesses sufficient antidepressive effects. Dupont Knowingly Poisoned Americans for 20 Years with Toxic Coating on Paper Food Packaging November 16, 2005 Healthy News Service Former DuPont Top Expert: Company Knew, Covered Up Pollution of Americans' Blood for 18 Years Glenn Evers, a top chemical engineer involved with designing and developing new uses of grease-resistant, or perfluorinated, chemical-based coating for paper food packaging. Breakdown chemicals from these coatings and related sources are now in the blood of 95 percent of Americans, and the Environmental Protection Agency (EPA) has spent the last several years trying to determine how they get there. Glenn Evers told in detail how his former employer hid for decades that it was polluting Americans' blood with a hyper-persistent chemical associated with the grease-resistant coatings on paper food packaging. Environmental Working Group (EWG) has obtained and today made public a set of internal company documents that support Evers' story. Combined, the Evers story and EWG's documents present a startling chronology of DuPont's actions: Evers describes how, in the mid-1960s, the company negotiated with the Food and Drug Administration (FDA) a weak standard for how much of the paper chemical coating, which is applied to give packaging grease or liquid resistance, could contaminate food. The FDA at the time normally required a two-year study for chemicals it wasn't familiar with, but agreed to base DuPont's approval on a 90-day test with a 1,000-fold safety factor added (complete story)

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