THANKS TO BERNARD LORD??? LARGE DRUG COMPAGNIES WILL CONTINUE TO MAKE MONEY ON BEHALF OF THE KIDS!!!

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With Bernard Lord as Premier? The drugging and the killings of our children will continue!!!!
Ped Med: The ADHD treatment tradeoff
By LIDIA WASOWICZ

SAN FRANCISCO, April 5 (UPI) -- In the end, treating attention-deficit/hyperactivity disorder comes down to a tradeoff.

For hyperactive children with severe disability, a pharmaceutically induced, fast-action reversal of fortune may appear like a godsend, no matter any excess baggage. For the many more with less limiting problems, weighing the benefits against the risks may prove a much tougher call.

Studies indicate stimulant drugs, the treatment option favored by most doctors, can improve the core problems of hyperactivity, inattention, impulsivity, flagging self-control, aggression, low productivity and even certain physical difficulties, such as poor handwriting. But the medications, which come saddled with potentially serious side effects, have not been documented to make any major mark on antisocial behavior, reading skills or academic achievement.

The other catch is the drugs do not discriminate, producing pronounced effects in the attention-deficient and full-facultied alike. So much so, researchers warn against using reaction to the chemicals as a measure of the existence of the disorder.

"(T)he ADHD diagnosis cannot be reliably confirmed or excluded based on a positive or negative stimulant response," notes a 2001 review of methods employed to evaluate and treat the condition.

Provided they are properly dispensed and their takers closely monitored, the compounds are generally viewed as safe by most mainstream practitioners. However, as with all medicines, they can cause adverse reactions, even in the short term. These can cover a wide range -- nervousness, weight loss, anorexia, insomnia, headache, rapid heart rate, nausea, tics, stomachache, increased anxiety and/or irritability, among others. A dose adjustment may spell relief in most cases, doctors say, but some 5 percent of children suffer such intolerable side effects, they have to switch treatments.

With prolonged use, the drugs' darker side, either unforeseen or unreported in the pre-marketing phase of testing, may pop to light.

"We know nothing about the long-term safety of ADHD drugs," said

William Pelham Jr., Distinguished Professor of Psychology and director of the Center for Children and Families at the University at Buffalo, who helped develop Concerta and Adderall and conducted numerous trials involving other ADHD stimulant drugs, including the initial testing of a new methylphenidate skin patch designed to be worn during school and homework hours.

"I remain concerned that the medications are used too frequently (nearly 5 percent of children in the U.S. are medicated with one of these drugs), at doses that are unnecessarily high (three times higher than needed) and for much too long a duration for most children (years rather than months)," he said.

U.S. regulators found the connection too far-fetched to warrant action at the time, but Canadian health officials last year temporarily suspended the sale of the one-a-day version of the best-selling amphetamine Adderall, marketed by Shire Pharmaceuticals Group, because of a suspected link to sudden or heart-related deaths in 14 minors and six adults and 12 cases of stroke, including two in children.

Since then, eerily similar findings came to light in a preliminary Food and Drug Administration report that drew a tenuous line between stimulant treatments and sudden deaths, strokes, heart attacks, high blood pressure and other serious complications in a tiny number of users. These included children, although none was younger than 7.

Researchers stressed the results were tentative and theoretical. The review did not determine whether all the patients were actually taking the ADHD medicines at the time or account for such confounding factors as preexisting health conditions. However, the regulators considered the risk high enough to warrant immediate monitoring and further study.

Overall, 25 sudden deaths, including 19 in children ages 7 to 16, and 54 cases of serious, though not fatal, cardiovascular or cerebrovascular adverse events, 26 of them in minors under 18, occurred in patients taking the drugs between 1999 and 2003, according to the report. Those who died included 11 children treated with Adderall, one with Adderall XR, three with Ritalin and four with Concerta, the study showed. The death rate was less than one person per 1 million prescriptions, but could, in fact, be higher because "it is not known to what extent under-reporting of cases may result in an underestimate of the incidence of these events," the report stated.

The study of some 676,000 patients also found children prescribed stimulants suffered a higher-than-expected number of strokes, although their rate of heart attacks was lower than anticipated.

What role, if any, the drugs played is difficult to assess because some of the youngsters had underlying heart conditions that could have contributed, the report concluded. Nevertheless it advised: "Under the assumption that there is an independent association between stimulant therapy and pediatric sudden death, it would be prudent for approved product labeling to recommend that clinicians consider the benefit versus risk of stimulant therapy in patients with established structural cardiac abnormalities."

Although the authors stressed no final conclusions about stimulant safety could be drawn from the analysis, released Feb. 8, the following day, an FDA panel took the highly unorthodox step of veering off its assigned course to call for strong new warnings on the drugs' labels and in their advertisements.

The committee -- convened merely to advise the FDA on designing studies to assess ADHD drug risks -- voted 8 to 7, with one abstention, to urge the FDA to order the most serious alerts possible. It unanimously agreed, with one abstention, to recommend the agency include "medication guides" with all the drugs to notify users of the potential dangers.

Drug manufacturers' immediate response ranged from assurance of the adequacy of current labeling to insistence on a lack of evidence against the drugs' relative safety.

The FDA is planning a new study of ADHD drugs expected to take approximately 18 months, meaning more answers may be coming in the summer of 2007.

Last month another FDA-commissioned committee, this one focusing on children's medical issues and looking into reports of psychosis among a small percentage of stimulant users, also urged a beefed-up warning on the drugs' labels -- though not the most dire "black box" type favored by the earlier panel. The specialists took the softer approach in part because of testimony by psychiatrists and mental health officials concerned about frightening families away from needed treatment. They said pediatric patients have a very low overall risk of heart ailments, although they, too, recommended youngsters with cardiovascular problems stay away from the medications.

Both panels agreed patients, parents and physicians should receive clearer information about the potential for such side effects as heart problems, psychotic symptoms, including hallucinations of snakes, worms, spiders, roaches, bugs, jellyfish and other creepy crawlies, manic episodes or aggressive behavior -- effects the drug companies say are no more prevalent among medicated patients than among the general population.

Reports of suicidal thoughts or behaviors also have cropped up in some children and adolescents on ADHD medications, particularly Strattera, a non-stimulant drug that already carries a black box notice of the potential risk.

The FDA is now free to follow the prescription of either or neither of the panels. The decision will come at a time of experimentation with an altered format the agency is adopting for its prescribing literature. New features will include a "highlights" section that details key drug information and a patient-friendly medication guide.

The FDA also is looking into early findings from a small University of Texas study that tentatively linked the stimulant Ritalin to a heightened cancer risk. The researchers from the M.D. Anderson Cancer Center detected chromosomal abnormalities in 12 children just three months after they started taking the medicine. The investigators emphasized the results were preliminary and larger studies were needed to confirm them.

Next: Dealing with addiction.

(Editors' Note: This series on ADHD is based on a review of hundreds of reports and a survey of more than 200 specialists.)