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The Congressional Energy and Commerce Health Subcommittee held a hearing on Rep. Tim Murphy's Helping Families in Mental Health Crisis Act (HR2646) earlier this week.

Paul Gionfriddo, CEO of non-profit Mental Health America (MHA), was among the witnesses called to testify.  It should be noted that MHA, formerly known as National Mental Health Association or NMHA, has received millions of dollars of funding from the pharmaceutical industry.

Mr. Gionfriddo testified that two-thirds of individuals screened on MHA's website screen positively for mental illness.  If true, this is an alarming percentage, and is less indicative of a mental illness epidemic than it is of the inaccuracy of screening tools used to diagnosis mental illness.  Referring to the latest version of psychiatry's Diagnostic and Statistical Manual of Mental Disorders, National Institute of Mental Health Director Thomas Insel, M.D. wrote, "The weakness is its lack of validity... Patients with mental disorders deserve better... That is why NIMH will be re-orienting its research away from DSM categories."

With the unreliable and inaccurate diagnostic tools available today, increased early identification screening of children for mental disorders proposed in HR2646 would almost certainly exacerbate already out-of-control misdiagnosis and over-medication of children in our country.  This is a decidedly American problem, with the rate of diagnosis of ADHD among children twenty times higher than in other developed countries.  Geographic disparities in diagnosis rates are attributable to subjective, unscientific diagnostic tools.  In the U.S., according to the CDC, children in Florida are almost twice as likely to be diagnosed with and medicated for ADHD than children in California, Nevada or Colorado.

Nowhere does the disturbing trend of misdiagnosis and wrongful medication of children seem more manifest than in Mr. Gionfriddo's own family story.  In the Washington Post, Mr. Gionfriddo wrote, "The school’s evaluations suggested [my son Tim] had what was then called attention deficit disorder... And it turned out that Tim probably didn’t really have attention deficit disorder."  Nonetheless, Mr. Gionfriddo also wrote in his book, "The pediatric neurologist started Tim on Ritalin... It turned out that neither Tim's teacher nor we could see any difference in his behavior, attention, or focus when he was on Ritalin.  The reason, as we would discover later, was that ADHD wasn't really his problem."

In what has now become an all-too-familiar and sad refrain involving people put on perhaps unnecessary, the wrong or harmful psychotropic medications, Mr. Gionfroddo reported, "On Wednesday, November 20, 1996, my son Tim brought a gun to school."  Like Mr. Gionfriddo's son who was put on the ADHD drug Ritalin, attorney Myron May was on the ADHD drug Vyvanse when he brought a gun to his alma mater and began shooting FSU students on November 20, 2014.

While fortunately neither Mr. Gionfriddo's son or other students at his school were harmed during that particular firearm at school incident, after starting on methylphenidate, Tim was later reportedly arrested in a meth lab bust.  Like methamphetamine, methylphenidate (Ritalin) is also a Schedule II controlled substance.  Methylphenidate carries an FDA-mandated Black Box warning - the strongest possible - for drug dependence.

Equally disturbing, years after Ritalin was approved and Mr. Gionfriddo's son was placed on the drug, the FDA released a post-marketing review, in 2006, of adverse event reports to the agency, warning that the data demonstrated children with no risk indicators, on regular doses of any of the stimulants approved for ADHD, experienced hallucinations, psychosis and mania.  According to minutes of the March 22, 2006 FDA Pediatric Advisory Committee meeting, Dr. Andrew Mosholder of the FDA's Division of Drug Risk Evaluation noted that "symptoms of psychosis or mania were estimated to occur [on ADHD stimulants] at a rate of 2 to 5 per hundred person-years... This rate (greater than 1%) cannot be considered rare..."  Like other children seemingly misdiagnosed with ADHD and put on psychosis-inducing stimulants, Mr. Gionfriddo's son would eventually be diagnosed with schizophrenia, a condition often involving hallucinations and psychosis.

It's time for America to step off the misdiagnosis and over-medication roller-coaster.  Due to the profit motive of some and despite the good intentions of others, early mis-indentification of mental illness and wrongful interventions are worsening, not solving the problem.  During a mental health forum sponsored by Rep. Gus Bilirakis on December 16, 2014 in Land O' Lakes, FL, the bill's author Rep. Murphy stated, "Forty percent of the time a person with psychiatric problem [sic] is on the wrong types or level of medication."

HR2646 is old wine (HR3717) in a new bottle.  It's bad for America, and it's bad for our kids.  Parents are intelligent enough to make the right mental health decisions and seek the right mental health care if needed for their children.  They do not need more intrusive, wildly inaccurate and unscientific diagnostic screening thrust upon them or their children.

Our nation's over-reliance on pharmacological answers to life's challenges is manifestly not working for our veterans and military personnel, either.  The Army's report on the 2 April 2014 Fort Hood shootings concluded that the mental health care Spc Ivan Lopez received did not deviate from the standard of care.  Time to rethink the standard of care, which included in Lopez's case an untested polypharmacy cocktail of the psychotropic medications Celexa, Wellbutrin, Ambien and Lunesta.  Our service personnel and veterans deserve better than being treated as guinea pigs, experimented upon with risky, ineffective psychotropic polypharmacy. 

On the topic of Evidence-Based Treatment (EBT), can we agree that four dead and twelve others shot is not evidence of a good outcome of medication management?  It should be noted that Army records indicate that Spc Lopez attended at least ten counseling sessions dutifully over ten months prior to the shooting; met with a social worker therapist, four psychiatrists, and a nurse practitioner; sought multiple medication refills voluntarily on a walk-in basis (Jan 14, 2014; March 6, 2014; March 10, 2014), had psychotropic medications in his blood stream at the time of death per his autopsy, and had even scheduled a follow up mental health appointment prior to his death during a walk-in visit seeking medication.

The problem is not a lack of access to mental health care, a lack of access to medications, anosognosia, medication non-compliance or treatment non-compliance.  The nature of the problem is American psychiatry's fascination with an as yet unproven chemical imbalance theory whereby mental illness is genetically hardwired into individuals.  Dr. Jeffrey Lieberman's exuberant hearing testimony espousing the benefits of psychotropic medications, suggesting they can prevent or eliminate mental illness, should be tempered by his comments that his faith in pharmacologic manipulations is rooted in his first LSD trip.  Patrick Kennedy's impassioned testimony eschewing any moral component of mental illness ignores man's soul, argues fatalistically that we're all just chemical soup, and removes the element of free will.  It's no wonder depression can turn into despair, when psychiatrists tell patients fate has dealt them a hopeless genetic hand.

Harvey Rosenthal testified in the hearing that people need to be offered a promise of hope and recovery, and that Assisted Outpatient Treatment (AOT) is synonymous with medication.  Nowhere is this more evident than in the push to erode the privacy rights of patients. Undermining confidentiality, so long a foundational tenet of mental health care, is a chilling indicator that the page is indeed being turned, some would say forcibly, away from proven yet more time-consuming psychotherapeutic and recovery modalities, in favor of quick but ineffective medication management.  In light of Rep. Murphy's stunning admission that doctors are wrong about psychiatric medications forty percent of the time, we're now going to take away patient privacy in the name of medication compliance?  To comply with the wrong medications?  So that caregivers - often parents who previously forced their children to take the wrong medications under poor medical advice - can continue to harm their kids well into adulthood?

Let parents parent their minor children without intrusion.  Let adults make mental health care decisions for themselves.  We need less, not more, government intrusion into mental health care.

In his determination to erode privacy rights as well as the centuries-old legal protection against false imprisonment afforded by habeas corpus - based upon shaky psychiatric diagnoses and worrisome doctor prescribing habits -  Rep. Tim Murphy claims with great dramatic effect that the mentally ill are dying with their rights on. 

Actually, they're dying with psychotropic medications in their corpses, and often taking others with them.  Spc Ivan Lopez died with antidepressants and sedatives in his body, and took three others with him.  Elliot Rodgers died with Xanax (alprazolam) in his body, and took six others with him.  Myron May died with Vyvanse in his veins, almost taking six others with him.  Andreas Lubitz, Germanwings co-pilot, took 149 other souls with him when, according to the BEA's preliminary report, he committed suicide by intentionally crashing a plane into the Alps, after being prescribed antidepressants.

In the U.S., antidepressants carry an FDA-mandated Black Box warning for increased risk of depression and suicidal thoughts.  Again, on the topic of EBT, can we agree that 150 lost souls is not evidence of a positive outcome of antidepressants?  Can we agree that the aforementioned deadly mass shootings are not evidence of positive outcomes of psychotropic medications?

Ironically, as the HR2646 hearing was closing, testimony of Aurora theater shooter James Holmes' psychiatrist Dr. Lynne Fenton was just getting underway in Colorado.  She testified that Holmes was on a psychotropic cocktail of 150 mg of Sertraline (Zoloft), .5 mg of Klonopin (Clonazepam), and 10 mg of Propanolol.  DA: "Did he ever tell you that he wanted to stop Sertraline?" Dr. Fenton: "No."

The assertion that medication non-compliance is the reason people with a mental illness become violent is simply not true. Medications are not the panacea that Rep. Murphy portrays them to be, and in fact there is credible scientific evidence to suggest that they may be doing more harm than good.

Perhaps Murphy's bill would be more aptly named the Helping Big Pharma and Mental Health Industry Act.
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.