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Tag search results for: "false advertising"
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.


Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD): Patient/Parent Support Group or Mental Health Industry/Big Pharma Front Group?


The event was sponsored by the local chapter of Children and Adults with Attention Deficit Disorder (Chadd), the nation’s primary advocacy group for A.D.H.D. patients... The evening opened with the local Chadd coordinator thanking the drug company Shire — the manufacturer of several A.D.H.D. drugs, including Vyvanse and extended-release Adderall — for partly underwriting the event. An hourlong film directed and narrated by two men with A.D.H.D. closed by examining some “myths” about stimulant medications, with several doctors praising their efficacy and safety. One said they were “safer than aspirin,” while another added, “It’s O.K. — there’s nothing that’s going to happen.”


Sitting in the fourth row, Mr. Fee [whose son took his own life while strung out from Adderall addiction]raised his hand to pose a question to the panel, which was moderated by Jeffrey Katz, a local clinical psychologist and a national board member of Chadd. “What are some of the drawbacks or some of the dangers of a misdiagnosis in somebody,” Mr. Fee asked, “and then the subsequent medication that goes along with that?”


Dr. Katz looked straight at the Fees as he answered, “Not much.” Adding that “the medication itself is pretty innocuous,” Dr. Katz continued that someone without A.D.H.D. might feel more awake with stimulants but would not consider it “something that they need.” “If you misdiagnose it and you give somebody medication, it’s not going to do anything for them,” Dr. Katz concluded. “Why would they continue to take it?”


Excerpts from Drowning in a Stream of Prescriptions, New York Times, Feb. 2, 2013

Alan Schwarz's poignant New York Times article about the heart-breaking tragedy of a young man's promising life ended prematurely by an addiction to ADHD medication, and his parents' anguish as they tried in vain to stop professionals from prescribing more medication while their son continued to spiral downward, raises important questions about the role of so-called patient/parent associations in promoting controlled stimulants and other ADHD drugs to the general public.


That the risks of ADHD medications would be minimized at a Shire-sponsored event is not exactly ground-breaking news. Shire's advertising and marketing of its ADHD medications has a long history of running afoul of the U.S. Food and Drug Administration (FDA) Division of Drug Marketing, Advertising and Communications (DDMAC). The FDA has sent warning letter (Nov. 9, 2000), after warning letter (Sept. 25, 2008), after warning letter (June 22, 2010), after warning letter (May 6, 2011) to Shire for its false advertising and marketing of its ADHD drugs Adderall, Adderall XR, Intuniv and Vyvanse respectively.


A day before Schwarz's article appeared in the New York Times, Business Week reported that Shire "agreed to pay about $57.5 million to resolve a federal investigation into the marketing of its drugs for treating attention deficit hyperactivity disorder." Shire's 10-K filed with the SEC states, "On September 23, 2009 the Company received a civil subpoena from the US Department of Health and Human Services Office of Inspector General in coordination with the US Attorney for the Eastern District of Pennsylvania seeking production of documents related to the sales and marketing of ADDERALL XR, DAYTRANA and VYVANSE. The investigation covered whether Shire engaged in off-label promotion and other conduct that may implicate the civil False Claims Act. On February 1, 2013 the Company announced it had reached an agreement in principle to resolve this matter. The Company has recorded a $57.5 million charge comprised of the agreement in principle amount, interest and costs... Discussions between the Company and the US Government are ongoing to establish a final resolution to the investigation."


In fairness to Shire, though, they are not the only pharmaceutical company to engage in false advertising and marketing of ADHD medications. The FDA has also sent a warning letter or notice of violation to Strattera manufacturer Eli Lilly & Company, Methylin manufacturer Mallinckrodt Inc., Focalin XR manufacturer Novartis, and Concerta manufacturer Johnson & Johnson.


The FDA's repeated false advertising and marketing complaints against ADHD drug manufacturers often involve the following misleading practices: overstatement of efficacy, broadening of indication, unapproved uses, ommission or minimization of risk information, omission of material fact, unsubstantiated claims and unsubstantiated comparative claims.


While pharmaceutical companies misleading consumers is not exactly news-making, what is revelatory and indeed troublesome about Schwarz's article is that a so-called patient or parent association, through its Board member who is also a licensed psychologist, is reported to have engaged in similar misleading practices, ie. downplaying the risks of ADHD medications.


This is not the first time concerns have been raised about so-called "parent associations" advocating the use of stimulant medications. As early as 1995, in their annual report, the United Nations (UN) International Narcotics Control Board (INCB) asked U.S. authorities to investigate "whether article 10, paragraph 2, of the 1971 Convention [on Psychotropic Substances], prohibiting the advertisement of controlled substances to the general public, is not being undermined by the activities of 'parent associations' advocating the use of methylphenidate [the active ingredient in the ADHD drugs Ritalin, Concerta, Daytrana, Quillivant XR, etc.]."


It is understandable why the U.S. government might not want to seriously look into these allegations, as they would in effect be investigating themselves. What Schwarz doesn't tell you in the article is that the part of the CHADD meeting not underwritten by Big Pharma, was underwritten by - wait for it - you. That's right, CHADD has received $12,412,919 of your tax money in grants from the U.S. Department of Health and Human Services (HHS) to reportedly facilitate the promotion of controlled stimulants to the general public, while simultaneously downplaying their risks, in seeming violation of the 1971 Convention on Psychotropic Substances, which the U.S. signed on February 21, 1971 and ratified on April 16, 1980, and the False Claims Act.


Quite the self-sustaining eco-system: Shire pays HHS $57.5M to end a federal investigation into alleged false claims about their ADHD medication, and meanwhile HHS pays out $12.4M to CHADD, which reportedly makes false claims about Shire's ADHD medications at patient/parent meetings. However, the pharmaceutical industry's financial support of CHADD goes far beyond the apparent indirect conduit via HHS, and includes direct contributions to CHADD as an organization, as well as personal payments to individual members of CHADD's Board of Directors and CHADD's Professional Advisory Board.


From 2006 through 2009, ADHD drug manufacturers contributed $7,078,050 to CHADD as an organization. Pharmaceutical companies have also personally paid current CHADD Board of Directors member Anthony Rostain, current CHADD Professional Advisory Board Member Craig Surman, and past CHADD Professional Advisory Board members Rahn Bailey, Marcus Griffith, Patricia Quinn, Adelaide Robb and Timothy Wilens to the tune of $743,646 collectively. (Source: ProPublica.org Dollars for Docs).


The cited figures are by no means exhaustive, and merely represent the contribution and personal payment amounts that the pharmaceutical companies and CHADD have chosen to report thus far. While the full scope of the payola from Big Pharma to CHADD may not be ascertainable at this time, the data that is available attests irrefutably to Big Pharma's significant financial support of CHADD as an organization, as well as its considerable financial support of individuals with authority and influence inside CHADD.


With so much Big Pharma money ending up in CHADD's bank account and in the pockets of CHADD leaders, it really begs the question as to whether patient or parent association is even an accurate description of the true nature of the organization. Remember, Schwarz refers to CHADD as "the nation's largest advocacy group for A.D.H.D. patients." CHADD is an advocacy group alright, but for whom exactly?


A review of CHADD's tax documents dispels any remaining illusion that it is an advocacy group for, by or of ADHD patients or their parents. CHADD's tax returns tell the real story: "THE ORGANIZATION'S MEMBERS DO NOT HAVE POWER TO VOTE. THEY PAY DUES THAT ENTITLE THEM TO... CHADD UNA DISCOUNT PRESCRIPTION CARD..."


So if ADHD patients and their parents are not calling the shots inside CHADD, who is? A review of CHADD's income and expenditures from 2001 to 2009 (the only years available) reveals that Celltech (UCB Pharma), Cephalon, Eli Lilly, Janssen (Johnson & Johnson), McNeil (Johnson & Johnson), Novartis, Pfizer, Shire and UCB Pharma have contributed to CHADD over the years, though CHADD won't say exactly how much.


What does all that Big Pharma money buy? If we take Shwarz's account of one CHADD event as an example, apparently it buys plenty - a poorly disguised direct promotional pitch of ADHD drugs to patients and parents, where even CHADD Board of Directors member Jeffrey Katz gets in on the act, throwing the weight of his psychology license behind a campaign to promote ADHD drugs that minimizes their risks to both patients and parents alike in the audience.


This type of apparently false direct-to-patient and direct-to-parent advertising campaign cloaked as grassroots "Parent-to-Parent: Family Training on AD/HD" sponsored by Big Pharma (see, for example, CHADD's income and expenditures reports and Big Pharma's donations to "CHADD Public Education and Outreach," "Parent to Parent: Family Training on AD/HD," "CHADD Education Initiative on AD/HD," etc.) appears to be a clever attempt to circumvent the jurisdiction of the FDA's DDMAC, which according to its own literature is limited to reviewing labeling and advertising distributed by the manufacturer.


The tight alignment of finances and mutual interests between Big Pharma and CHADD seems to be paying dividends for the ADHD drug manufacturers. In the two plus decades since CHADD's inception, prescriptions for stimulant medications used to treat ADHD have increased more than ten-fold, from 4 million per year in 1990 to 45 million per year in 2010 (Source: National Institute on Drug Abuse, Prescription Drugs: Abuse and Addiction).


Sounds like a reason to celebrate. So it shouldn't be a surprise that Big Pharma footed the $114,950 bill for CHADD's 20th Anniversary Gala.