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Tag search results for: "false claims"
Myths # 1-7: ADHD Drugs Improve Academic Performance (1) and Social Relationships (2); Reduce Depression (3), Substance Abuse (4), and Driving Accidents (5); and Promote More Stability in Employment (6) and Extra-Curricular Activities (7)

Mallinckrodt Methylin patient brochure: "Without diagnosis and proper management, ADHD can have devastating consequences, including failure in school, depression, violent behavior, substance abuse, relationship problems, and failure to keep a job."

FDA Response: "While the presentation excerpted above does not directly assert that Methylin will correct the problems of untreated ADHD, it is nevertheless misleading because it implies, in the context of the piece as a whole, that Methylin may reduce the likelihood or severity of the consequences of untreated ADHD listed above (i.e., poor academic performance, poor social-emotional development, violent behavior, substance abuse, and employment problems) when this has not been demonstrated by substantial evidence or substantial clinical experience. While Methylin is approved for the treatment of attention deficit disorders based on a demonstration of bioequivalence with the reference listed drug (RitalinCI (methylphenidate hydrochloride)), we are not aware of substantial evidence or substantial clinical experience demonstrating a positive effect of treatment with Methylin (or of treatment with the reference listed drug) on the outcomes listed above (i.e., academic performance, depression, violent behavior, substance abuse, and stable employment). If you have such data, please submit them to FDA for review."

Novartis Focalin XR web page: "Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD), if untreated, are at risk for poor academic performance. Teen pregnancy, problems with peers, car accidents, and physical injuries occur at a higher rate. Untreated, children and teens with ADHD are also at risk of conduct disorders, delinquency, and drug or alcohol abuse. Typically, adults with untreated ADHD experience academic hardships. These often start in childhood and are likely to worsen during college years. Untreated adults take longer to complete learning degrees. They are likely to have lower economic status, lower rates of employment, and more work-related problems. Untreated adults also have more problems in their relationships, more driving accidents, and more addiction—from alcohol to gambling. Living with ADHD doesn't have to be this way. People with ADHD have treatment choices. The results of untreated ADHD are serious and should not be ignored. There is no cure for ADHD. Proper treatment can help control symptoms, helping to reduce these risks."

FDA Response: "While these presentations do not directly assert that Focalin XR will correct the problems of untreated ADHD or lead to the hoped for outcomes, they are misleading nonetheless because the only sensible interpretation of placing the consequences of untreated ADHD in pieces promoting the use of Focalin XR for ADHD is to imply that Focalin XR may reduce the likelihood or severity of the consequences of untreated ADHD listed above (i.e., poor social–emotional development and job success, poor academic performance, impaired driving, smoking and substance abuse) and induce the desired treatment outcomes when this has not been demonstrated by substantial evidence or substantial clinical experience... While Focalin XR is indicated for the treatment of ADHD, FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Focalin XR can help patients avoid these consequences."

Johnson & Johnson Concerta professional convention panel: "CONCERTA® helps children improve academic performance throughout the day."

FDA Response: "This presentation is misleading because it implies that use of Concerta will lead to an improvement in academic performance throughout the day when this has not been shown by substantial evidence or substantial clinical experience."

Johnson & Johnson Concerta web page: "Adolescence is a time of greater independence and responsibility. For most teens, the after-school hours are filled with plenty of activities, including: sports, clubs, part-time jobs, socializing with friends, household chores, and, of course, homework. ADHD can have an impact on all of these activities, so you want to be sure your teen's medication is doing its job. CONCERTA® provides consistent symptom management throughout the day, for up to 12 hours, helping your teen focus and manage behavior. This may benefit your teen's ability to socialize with family and friends, and pursue interests and hobbies outside of school. You also won’t have to worry about whether your teen needs another dose of medication, because a single dose in the morning is all it takes. As a parent, you naturally want your teen to do well in all areas of his or her daily life. With once-daily CONCERTA®, you can be confident that symptoms are being managed no matter what he or she is doing."

FDA Response: "This presentation is misleading because it asserts improvement with Concerta in a broad array of adolescent after school activities, such as athletics, clubs, and performance in part-time jobs, when this has not been demonstrated by substantial evidence. While Concerta has been shown to improve total scores on the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS), which measures ADHD symptoms such as fidgeting, not listening, and talking excessively, what has not been shown is that this improvement in ADHD-RS total scores is correlated with a positive effect on adolescents’ ability to pursue interests and hobbies outside of school and to do 'well in all areas of [their] daily life.'"

Myth # 8: People Treated With ADHD Drugs Are Less Likely To Commit Suicide

BMJ study: "At the population level, drug treatment of ADHD was associated with an increased rate of suicide related events (hazard ratio 1.31, 95% confidence interval 1.19 to 1.44)."

Myth # 9: ADHD is genetic, or neurobiologic, or caused by a chemical imbalance in the brain.

WHO study: "An average of 50% of children with ADHD (range: 32.8%–84.1% across countries) continued to meet DSM-IV criteria for ADHD as adults."

If ADHD is genetic, neurobiological or due to a hard-wired chemical imbalance in the brain, then why do half of children diagnosed with ADHD outgrow it by the time they reach adulthood? Can you outgrow Down syndrome? Cerebral Palsy?

Myth # 10: Only ADHD Drugs Reduce ADHD Symptoms.

Journal of Developmental and Behavioral Pediatrics
study: "One meta-analytic review of the effects of stimulant medication on ADHD children found an average effect size of 0.32 for response to administration of a placebo, indicating that there was approximately 30% improvement in children with ADHD who were given a placebo compared with children with ADHD who were given nothing, although results across studies were highly variable. Several other independently conducted reviews of stimulant medication for children with ADHD also report that the average rate of positive response to placebos ranges from about 20% to 30%."

What? A sugar pill will improve ADHD symptoms by 30%? Without the dangerous side effects?

How can that be?  The study goes on to explain...

"Evidence suggests that parents and teachers tend to evaluate children with ADHD more positively when they believe the child has been administered stimulant medication and they tend to attribute positive changes to medication even when medication has not actually been administered."

The study reveals the fatal flaw with diagnosing ADHD in the first place and when measuring the effects of stimulant medication on ADHD symptoms, namely that it's all in the eye of the beholder, ie. subjective... 

"The fact that subjective measures are the most widely used measures of treatment response in children with ADHD argues for the need to better understand how medication expectancies influence these measures and argues for the need to design trials that can accurately assess the direct pharmacologic effects separately from placebo effects."

NIMH 3-year follow-up study and 8-year follow-up study find that ADHD medication is no more effective than non-medication therapy.