Mental Health Watchdog Says Unethical Psychiatric Drug Trials Putting Children at Grave Risk

LOS ANGELES, May 2, 2018 (Newswire.com) - With more than eight million American children prescribed psychotropic drugs, including antidepressants linked to suicide and addiction and stimulants as powerful as cocaine, Citizens Commission on Human Rights (CCHR) has called for an overhaul of pediatric clinical drug trials and accountability for any misleading or unethical studies that may result in child endangerment. The mental health watchdog opposes psychiatric drug trials using children due to potential substantial risks and because the drugs are often prescribed for behavioral control, not a medical disease. CCHR said the lack of accountability for those researchers skewing outcome results in clinical trials that could further put children at risk has prompted its call for immediate government intervention.

The group cited independent researchers and scientists who wrote in response to one antidepressant clinical trial that allegedly covered up suicidal thoughts found in children given the drug, stating that with SSRI antidepressants “many thousands of children and adolescents have been harmed, some of them killed.”[1] More than two million American children and adolescents prescribed antidepressants may also suffer debilitating withdrawal effects, according to a recent New York Times article.[2] Several high-profile cases involving heinous crimes and SSRI antidepressants focused media attention on the undisclosed risks of these drugs,[3] with a leading psychopharmacologist and psychiatrist, Professor David Healy, estimating that 90% of school shootings, over more than a decade, were linked to SSRI antidepressants.[4]

CCHR wants the Federal government to intervene with policy that would protect children and consumers from willfully misleading drug or psychiatric device research and to prohibit pediatric psychiatric drug trials, instead of driving it with financial incentives for researchers and their universities.

CCHR International

CCHR said a recent media report in the Chicago Sun Times has brought the issue to a head. As Jodi S. Cohen reported in a ProPublica, Illinois investigative report, for nearly two decades, the University of Illinois at Chicago (UIC) had touted a child psychiatrist and researcher as one of its stars: She founded a renowned clinic to treat children labeled with “bipolar disorder” and secured millions of dollars in federal funding. This helped boost the university as a leader in the field of child psychiatry.[5]

But then it was determined that the professor of psychiatry violated research rules by testing the powerful psychotropic drug lithium on children younger than 13 even though she was told not to, failed to properly alert parents of the study’s risks and falsified data to cover up the misconduct, records show. The university was forced to repay $3.1 million it received for the study from the National Institute of Mental Health (NIMH). The violations included enrolling children younger than 10 though the study was approved only for boys and girls 13 to 16 and included children who were previously given psychotropic drugs though that should have made them ineligible.

According to documents obtained by ProPublica Illinois, federal officials concluded that the psychiatrist’s “serious and continuing noncompliance” with rules to protect human subjects violated the terms of the grant. NIMH said she had “increased risk to the study subjects” and made any outcomes scientifically meaningless. The research is also under investigation by two offices in the U.S. Department of Health and Human Services: the inspector general’s office, which examines waste, fraud and abuse in government programs, according to court records obtained by ProPublica Illinois, and the Office of Research Integrity, according to university officials.[6]

University officials halted the psychiatrist’s lithium research in 2013 and also shut down two other federally funded projects she ran, returning nearly $800,000 that hadn’t yet been spent on those two studies. Three of the psychiatrist’s journal articles were later retracted after she told the editors that UIC had concluded she had “intentionally and knowingly made false statements” about participants’ medication histories and that the falsehoods “seriously compromised” the results and conclusions, as further reported in the Chicago Sun Times. The retractions were covered in about a half-dozen posts on the Retraction Watch website, which monitors scientific misconduct.[7]

Yet, the same year the UIC halted the research, it gave the psychiatrist its “scholar award” and $30,000 for excelling in research and teaching. They allowed her to keep her prestigious position as a faculty chair and paid her a base salary of nearly $200,000 a year, plus bonuses, according to Cohen. Over the past five years, they also allowed her to treat and oversee the care of more than 1,200 children and teens. [8]

The psychiatrist has been on the speaker’s bureau for a pharmaceutical company which makes an antipsychotic which is approved as a treatment for bipolar mania in children. She has also collaborated with an antidepressant maker on a study involving its drug lamotrigine in the treatment of pediatric bipolar.

It’s not the first time that research psychiatrists have had a mere slap of the wrist over potentially dangerous studies that could have put children at risk, while increasing sales of the drugs for the psychiatric-pharmaceutical industry.

• A Harvard medical professor and Massachusetts General Hospital researcher, examined prevalence of bipolar disorders in children, which The New York Times said helped lead to a fortyfold increase in such diagnoses from 1994 to 2003 and a massive increase in antipsychotic drugs prescribed to children.[9] Columbia University’s Dr. Mark Olfson reported the numbers increased from roughly 20,000 such diagnoses in 1994 to about 800,000 in 2003 and also found that “nearly one in five psychiatric visits for young people included a prescription for antipsychotics.”[10] Between 2000 and 2007, the Harvard psychiatrist also received $1.6 million in speaking and consulting fees—some of them undisclosed to Harvard—from pharmaceutical companies, including makers of antipsychotic drugs prescribed to children who might be labeled with bipolar disorder, a U.S. Senate investigation found. One of those companies gave more than $700,000 to a research center that was headed by the psychiatrist.[11] He allegedly promised the drug maker that upcoming studies of its antipsychotic would “support the safety and effectiveness” of the drug in a pediatric population.[12] The only reprimand the psychiatrist faced over failing to report his conflicts of interest was a university sanction requiring him to refrain from all paid industry-sponsored outside activities for one year, with an additional two-year monitoring period during which he had to obtain approval before engaging in paid activities. He also faced a “delay of consideration for promotion or advancement.”[13]

• On June 27, 2016, The New York Times reported about New York University’s medical school shutting down eight studies at its prominent psychiatric research center after finding a series of violations in a study of an experimental, mind-altering drug under the lead researcher and psychiatrist.[14] Investigators with the Food and Drug Administration (FDA) found that records had been falsified and researchers had failed to keep accurate case histories. The violations “jeopardize subject safety and welfare and raise concerns about the validity and integrity of the data collected at your site,” the FDA said in a letter.[15] In several instances, the agency found the psychiatrist had falsified documents by signing a fellow investigator’s name on reports. There was no penalty leveled at the researchers, other than the university placing the psychiatrist on leave, after which he submitted his resignation.[16] The psychiatrist had received consulting fees from the manufacturer of the drug that was being tested. [17]

• In September 2015, The British Medical Journal published concerns by experts about an antidepressant study which many prominent psychiatrists had put their name to. Based on the study, the drug was marketed as safe and effective for adolescents when manufacturer executives were aware that a number of studies had shown that the drug was no better than placebo and caused thought disturbance and suicidal behavior in some youngsters. There was a decade-long effort by other researchers to uncover the truth about the safety of the antidepressant, paroxetine, for use by adolescents; they found it caused increased harm in this population.[18] The independent researchers believed children and adolescents could have been harmed by antidepressants and the non-disclosure of potential suicidal risks.[19] Although the specific antidepressant has never been FDA approved for use in any pediatric population, the study was used to encourage doctors to prescribe the drug to adolescents, a Los Angeles law firm reports. In a deposition, the lead author of the study admitted he’d never looked at the raw research data but only summaries provided by the manufacturer.[20] Jon Jureidini, professor and research leader of critical and ethical mental health at the University of Adelaide, charged that the authors of the original study “deliberately misrepresented the outcomes of the study” and changed the protocols of the study without following the proper procedures to do so, as reported by TIME.[21]

Dr. Malcom Kendrick, a Scottish doctor and author, questioned, “where the hell is the outrage?…None of the named authors had intervened to correct the record.” Therefore, “surely someone, somewhere, got punished? No they did not.”[22]

CCHR said this could be avoided if psychotropic drug trials excluded children and adolescents. While the Creating Hope Act of 2011 provides market incentives to pharmaceutical companies to develop new drugs for children with rare pediatric diseases, such as childhood cancers and sickle cell anemia, this should never include psychiatric drugs that are prescribed for conditions for which no medical test can confirm their existence. As Thomas Insel, Director of NIMH noted in 2013, psychiatry’s diagnostic system “lacks validity.” Further, “Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM [Diagnostic & Statistical Manual of Mental Disorders] diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure.”[23]

That brings with it more need for accountability, CCHR says. They point to comments made by Richard Smith, a former editor of The British Medical Journal (BMJ). He explained why researchers should not be above the law: “A man who steals a milk bottle may face a criminal charge. In contrast, a scientist who invents data, defrauds funders, and publishes fabricated data that may lead to patient harm is highly unlikely to face criminal charges.” He further pointed out: “It’s deeply uncomfortable for scientists to think that their colleagues may sometimes behave criminally in their work, but nobody should be beyond the law.”[24]

Alexander McCall Smith, emeritus professor of medical law, University of Edinburgh, argues that research misconduct (the gentlemanly phrase for scientific fraud) should be a criminal offence. Adds Richard Smith: “Fraudsters escape because of the incompetence of the institutions, whereas investigation and collection of admissible evidence is the daily job of the police. It’s time, sadly, to criminalize research fraud.”[25]

CCHR wants the Federal government to intervene with policy that would protect children and consumers from willfully misleading drug or psychiatric device research and to prohibit pediatric psychiatric drug trials, instead of driving it with financial incentives for researchers and their universities.

CCHR is a mental health industry watchdog organization that works for patient protections and encourages the public to take action against mental health abuse. In the course of its 48 years it has helped get more than 180 laws enacted, including the ban of ECT use in children in several U.S. states and in Australia and the prohibition of schools forcing children to take psychotropic drugs as a requisite for their education in the U.S. As a nonprofit, CCHR relies on memberships and donations to carry out its mission and actions to curb psychotropic drug use in foster care. Click here to support the cause.

Contact: Amber Rauscher, [email protected] or (323) 467-4242.

References:

[1] “BMJ Publishes Study Revealing How Flawed Drug Research Fails a Trusting Public,” BMC, 16 Sept. 2015, http://study329.org/bmj-publishes-study-revealing-how-flawed-drug-research-fails-a-trusting-public-2/.

[2] Benedict Carey, Robert Gebeloff, “Many People Taking Antidepressants Discover They Cannot Quit,” The New York Times, 7 Apr. 2018, https://www.nytimes.com/2018/04/07/health/antidepressants-withdrawal-prozac-cymbalta.html?partner=rss&emc=rss.

[3] “Antidepressant lawsuits,” Injury Lawyers News, http://injurylawyer-news.com/antidepressants/antidepressant-lawsuits/.

[4] “Psych meds linked to 90% of school shootings, WND, 18 Dec. 2012,
http://www.wnd.com/2012/12/psych-meds-linked-to-90-of-school-shootings/#i1JviHwg3g2T7KSt.99.

[5] Jodi S. Cohen, ProPublica Illinois, “$3 million research breakdown at UIC, where a star psychiatrist put kids at risk,” Chicago Sun Times, 29 Apr. 2018, https://chicago.suntimes.com/news/3-million-research-breakdown-at-uic-where-a-star-psychiatrist-put-kids-at-risk/.

[6] Ibid.

[7] “Retraction notice to Deficits in emotion recognition in pediatric bipolar disorder: The mediating effects of irritability [JAD 144/1–2 (2013) 134–140],” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5220580/; “Retraction notice to ‘Where, when, how high, and how long? The hemodynamics of emotional response in psychotropic-naïve patients with adolescent bipolar disorder,’” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5220586/; “Altered affective, executive and sensorimotor resting state networks in patients with pediatric mania,” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4622639/.

[8] Ibid.

[9] Duff Wilson, “Side Effects May Include Lawsuits,” The New York Times, 2 Oct. 2010, https://www.nytimes.com/2010/10/03/business/03psych.html; “Psychiatric drugs fail us and our children,” toledoblade.com, 2 April 2006.

[10] http://pathwaystofamilywellness.org/Informed-Choice/the-pill-merchants-the-relentless-and-tragic-marketing-of-psychiatric-drugs/Further-into-the-Abyss.html.

[11] Op cit., Duff Wilson.

[12] Martha Rosenberg, “There is Money in Dosing Kids,” OpEd News, 25 Sept. 2017, https://www.cchrint.org/2017/09/26/there-is-money-in-dosing-kids/.

[13] Liz Kowalczyk, “Harvard doctors punished over pay,” boston.com, 2 July 2011, http://archive.boston.com/news/local/massachusetts/articles/2011/07/02/three_harvard_psychiatrists_are_sanctioned_over_consulting_fees/.

[14] Benedict Carey, “An N.Y.U. Study Gone Wrong, and a Top Researcher Dismissed,” The New York Times, 27 June 2016, http://www.nytimes.com/2016/06/28/health/nyu-cannabis-ptsd-psychiatry.html.

[15] Alexander Neumeister, “Inspections, Compliance, Enforcement and Criminal Investigations,” 19 Feb. 2016, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm493086.htm.

[16] Op. cit., Benedict Carey.

[17] Robert H Pietrzak, et al., “Cannabinoid Type 1 Receptor Availability in the Amygdala Mediates Threat Processing in Trauma Survivors,” Neuropsychopharmacology, 11 June 2014, http://www.nature.com/npp/journal/v39/n11/full/npp2014110a.html.

[18] “BMJ Publishes Study Revealing How Flawed Drug Research Fails a Trusting Public,” BMC, 16 Sept. 2015, http://study329.org/bmj-publishes-study-revealing-how-flawed-drug-research-fails-a-trusting-public-2/.

[19] Ibid.

[20] https://www.baumhedlundlaw.com/misleading-paxil-study-exposed-in-new-bmj-study/; http://www.browndailyherald.com/2015/09/22/reanalysis-of-paxil-study-sparks-new-round-of-criticism/.

[21] Alice Park, “Paxil Is Not Safe or Effective For Teens, Finds New Analysis of Major Study,” TIME, 16 Sept. 2015, http://time.com/4037075/antidepressant-depression-teens/.

[22] Dr. Malcolm Kendrick, “Study 329 – where the hell is the outrage?” https://drmalcolmkendrick.org/2015/10/01/study-329-where-the-hell-is-the-outrage/.

[23] Thomas Insel, “Transforming Diagnosis,” NIMH Website, 20 Apr. 2013, http://www.nimh.nih.gov/about/director/2013/transforming-diagnosis.shtml.

[24] Richard Smith, “If Volkswagen staff can be criminally charged so should fraudulent scientists,” The BMJ, 28 Sept. 2015, http://blogs.bmj.com/bmj/2015/09/28/richard-smith-if-volkswagen-staff-can-be-criminally-charged-so-should-fraudulent-scientists/.

[25] Richard Smith, “Should scientific fraud be a criminal offence?” The BMJ, 9 Dec. 2013, http://blogs.bmj.com/bmj/2013/12/09/richard-smith-should-scientific-fraud-be-a-criminal-offence/; http://www.law.ed.ac.uk/people/alexandermccallsmith.

Source: Citizens Commission on Human Rights