Posts Tagged ‘New Orleans’

Glaxo Still Haunted by Faked Paxil Studies in Kids; Crooked psychiatrist expected to plead guilty to criminal charges today

Thursday, August 19th, 2010

“The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.”

BNET
By Jim Edwards
August 19, 2010

A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.

The two cases are technically completely separate, but they’re both about data manipulation. GSK has been accused of sitting on data showing risks on both drugs; and the FDA previously shut down one of GSK’s factories where both drugs were made.

Thus, the expected guilty plea of Dr. Maria Carmen Palazzo today is a reminder to managers everywhere that cutting ethical corners can cause unwanted chickens to return to their roosts, even years later.

Palazzo was indicted in 2007 on 40 counts of defrauding Medicare and Medicaid at her New Orleans clinic, and 15 counts of conducting fraudulent clinical trials. The charges followed an FDA accusation that she had enrolled 26 children in studies of Paxil for obsessive-compulsive disorder and major depressive disorder. She included children in the trial — which was given the cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not have the diagnoses being studied. GSK gave her more than $5,000 for each child she enrolled.

At trial, Palazzo was convicted on 39 counts of healthcare fraud and was sentenced to 87 months in prison and forfeiture of $655,000. The clinical trial fraud charges were thrown out, but prosecutors appealed and won a ruling this year reinstating those charges. That appears to be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.

Read entire article here:  http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

Read more about Palazzo here:
http://medicaresmostwanted.blogspot.com/2007/06/dr-maria-carmen-palazzo-has-been.html

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American Psychiatric Association Called Upon to Cut Drug Company Ties and Put Lives of Children Before Profits

Friday, May 21st, 2010

Also see: DSM Panel Members Still Getting Pharma Funds

By CCHR International
May 21, 2010

NEW ORLEANS – As psychiatrists from around the world flood the area this weekend to take part in the Annual Meeting of the American Psychiatric Association (APA), psychiatric watchdog Citizens Commission on Human Rights (CCHR) is demanding that the APA sever all ties to pharmaceutical company interests and that psychiatrists stop killing children with harmful drugs.

The APA is expected to release its guidelines to reduce pharmaceutical industry ties at its convention, but it is likely to be self-serving and occurred only after public and legislative pressure forced the issue.

The US Senate Finance Committee has investigated at least 16 APA psychiatrists over their undisclosed financial ties to drug companies, including the APA’s own President, Alan Schatzberg who has stepped down as principal investigator of a National Institute of Health (NIH) funded study after months of Congressional scrutiny into his ties to the drug he was studying.  He was found to have actually initiated the patent application of the drug he was studying to “treat psychotic depression.”

Other notable APA members under scrutiny by the Senate Finance Committee and scheduled to present in New Orleans are Thomas Spencer, Assistant Director of the Pediatric Psychopharmacology Unit at Massachusetts General Hospital and Dr. Joseph Biederman, Chief of the Program in Pediatric Psychopharmacology, Massachusetts General Hospital.

Dr. Spencer reportedly failed to disclose at least $1 million in earnings from drug companies between 2000 and 2007. Dr. Biederman earned $1.6 million in consulting fees from drug makers during the same period, most of which was not disclosed to Harvard University officials. In March 2009, court documents showed Biederman promised Johnson & Johnson in advance that his studies of their antipsychotic risperidone (Risperdal) would prove effective when used on preschool age children. Risperdal has been linked to potentially life-threatening diabetes and Neuroleptic Malignant Syndrome.  The FDA database from 2000 to 2004 found at least 45 deaths in children under 18 with newer antipsychotics and 1,328 reports of other serious side effects, some life-threatening.

Former APA president Nada Stotland stated: “We are in the midst of a revolution caused by public and legislative concern about the influence of the for-profit sector….” [Emphasis added].  Part of that public pressure for the APA to disclose its conflicts of interest with pharmaceutical companies was driven by Lisa Cosgrove Ph.D. et al’s study of DSM-IV and DSM-IV-TR committee members, which found that of the 170 members, 56% had one or more financial associations with companies in the pharmaceutical industry.  Pharma’s psychotropic drug profits have soared commensurately with the increased numbers of disorders voted into the DSM.

While APA leaders and members profit from their industry connections to the drugs they are promoting; children are being killed by these same drugs.

Also see:  Meet the Psychiatrist Pushing For A Brave New World of Pre-Drugging Kids—Patrick McGorry

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Meet the Psychiatrist Pushing For A Brave New World of Pre-Drugging Kids—Patrick McGorry

Friday, May 21st, 2010

By CCHR International
May 21, 2010

One of the most controversial proposed disorders for the upcoming revision of psychiatry’s billing bible of mental disorders, (the DSM-5) is Psychosis Risk Syndrome (PRS) a “mental disorder” that, if voted into DSM, would confirm the allegations that psychiatry is manufacturing a Brave New World for itself—heavily backed by Big Pharma—of drugging children before they develop a “mental illness.” Already criticized for the millions of children being needlessly drugged and the lack of scientific criteria to substantiate any mental diagnosis as a legitimate medical condition, some psychiatrists now want the power to pull out their crystal ball and predict the onset of a psychosis and drug it before it has even occurred. And perhaps the strongest proponent is Australian psychiatrist Patrick McGorry.

Even psychiatrist Allen Frances, former chairman of the previous DSM task force expressed alarm over the proposed diagnosis and its repercussions should it be legitimized, stating, PRS “stands out as the most ill-conceived and potentially harmful.” The Syndrome fails badly on all 3 counts, he says:

“1. It would misidentify many teenagers who are not really at risk for psychosis;

2. The treatment they would most often receive (atypical antipsychotic medication) has no proven efficacy; but,

3. It does have definite dangerous complications.”

Frances adds: “Drug company marketing would influence parents and clinicians to be especially alert to any strangeness in teenagers.” False positives could be as high as 70-90 percent.[i] This can only lead to greater numbers of children and adolescents being harmfully drugged—already one of the major criticisms against psychiatry and a point of contention among many psychiatrists today.

Australian psychiatrist Patrick McGorry, speaking at the APA convention in New Orleans, as a cheerleader for “early intervention” (i.e. pre-drugging) is undeterred. Despite the unpredictability and risk of the drugs prescribed to treat PRS, McGorry wants to go full steam ahead, increasing the number of children being placed on extremely dangerous and even lethal drugs. It should come as no surprise that McGorry is a paid consultant for, and has received speaker’s fees from AstraZenecca, Janssen-Cilag, Eli Lilly, Novartis, Sanofi, Bristol Myers Squibb and Pfizer.[ii]

The theory of PRS wasn’t McGorry’s. He credits Dr. Ewen Cameron, the Canadian psychiatrist who became infamous in the 1980s after it was revealed he had performed cruel and brain-damaging experiments on his patients in the 1950s and 1960s with funding from the CIA.[iii] However, McGorry tested it in a world-first trial. Another study he conducted in 2002 was funded with an unrestricted grant from Janssen-Cilag and supported by pharmaceutical company-funded groups NARSAD and the Stanley Foundation, as well as several Australian agencies. McGorry and colleagues predictably found that risperidone (Risperdal)—made by Janssen—reduced the risk of “transition to psychosis” in young people.[iv] Risperdal has been linked to Type 2 diabetes.

  • In Australia, McGorry’s Early Psychosis Prevention and Intervention Center’s (EPPIC) preventive treatment center for young people, PACE, receives drug company funding from Janssen-Cilag. Much of the policy development embodied in the Australian Clinical Guidelines has come out of EPPIC research programs. As Richard Gosden, Ph.D., a highly respected Australian author and academic stated: “This may have paid off handsomely for the company…. It may not be coincidental that a half page of the Clinical Guidelines is dedicated to dosage recommendations for using risperidone in first-episode psychosis. The Clinical Guidelines do not extend these dosage recommendations to include other schizophrenia drugs and the recommendations for risperidone give the appearance of an official endorsement of the drug.” [v]

McGorry’s theory has psychiatry’s skeptics and even psychiatrists aghast:

  • One respected American research group equated the practice of pre-drugging children to “performing mastectomies on women who are at risk of—but do not have—breast cancer.” [vi]
  • Honorary Professor Anthony Pelosi from the Department of Psychiatry, Hairmyres Hospital, East Kilbride, stated, “So far, evidence from randomized trials does not support the use of psychological therapies or drugs as preventive interventions.”[vii] Further, “After teachers, college counselors, and families were encouraged to refer young people with possibly prodromal [early] symptoms directly to the same clinic for the same care plans…almost 90% were receiving unnecessary ‘preventive’ interventions.” [viii]
  • Fellow Australian psychiatrist Niall McLaren says the diagnostic criteria for PRS “has no scientific validity whatsoever…it can never be reliable and…will have huge unforeseen consequences.” Essentially, it means “putting large numbers of teenagers and young adults under the long-term supervision and control of psychiatrists” and that “supervision” includes the “aggressive, indefinite prescription of antipsychotic drugs.” It is the “clearest example I know of pseudoscience.  Not since [lobotomies] has psychiatry stumbled so far from the principle of Primum, non nocere. First, do no harm.” [ix]
  • Dr. Richard Warner, professor of psychiatry at the University of Colorado, counters the idea that science drives McGorry’s pre-disorder assessment, stating that the screening instrument he uses “is not that accurate in routine use.” Further, “McGorry speculates that a variety of interventions may be effective in preventing schizophrenia in high-risk cases…. Given the expected number of false positives, the potential for harm is significant,” stated Dr. Warner. [x]
  • Dr. Jerald Block, a US psychiatrist writing in Bioethics Forum, reported that “preventive pharmacology” (which McGorry, et al. practice) is “ethically questionable territory” because the treatments given “frequently have side effects and complications” and “you are potentially harming people.” The symptoms used to identify them as at risk of schizophrenia are “also remarkably common…adolescence is a period of life that is normally marked by tumultuous changes in personality.” [xi]
  • Melissa Raven, psychiatric epidemiologist and policy analyst, adjunct lecturer in Public Health at Flinders University, South Australia, and David Webb, board member of the World Network of Users and Survivors of Psychiatry and working with the research/policy office with the Australia Federation of Disability Organizations, were published last month, writing: “McGorry’s campaign is part of a wider push to promote the medicalization of mental health (for which psychosocial wellbeing is a better term).” “Further doubts must be raised about McGorry’s agenda when you see the substantial funding his organization (Orygen Youth Health) receives from the pharmaceutical industry and also from the US Stanley Foundation, which is notorious for its particularly aggressive approach to the detention and mandatory treatment of people labeled with psychiatric disorders.” He has “personally received funding from many manufacturers of antipsychotics, frequently reports no conflicts of interest, particularly in his many recent Medical Journal of Australia articles, including a supplement on early intervention that repeatedly advocates the use of antipsychotics.” [xii]

Psychosis Risk Syndrome is nothing more than psychiatrists with conflicts of interest drumming up more business at the risk of teenage lives, while increasing the profits for the pharmaceutical industry they serve.


[i] Allen Frances, M.D., “DSM5 ‘Psychosis Risk Syndrome’–Far Too Risky,” Psychology Today, http://www.psychologytoday.com/blog/dsm5-in-distress/201003/dsm5-psychosis-risk-syndrome-far-too-risky.

[ii] http://www.mhanet.ca/documents/2008/Research-Colloquium/0920%20-%20Keynote%20MCGORRY.pdf; http://www.bmj.com/cgi/content/full/337/aug04_1/a695.

[iii] Richard Gosden, Ph.D., “Pre-Psychotic Treatment for Schizophrenia: Preventive Medicine, Social Control, or Drug Marketing Strategy?” Ethical Human Sciences and Services, Vol 1, No. 2, Summer 1999, pp. 165-177, http://sites.google.com/site/richardgosden/ehss.

[iv] Arch Gen Psychiatry, Vol 59, Oct. 2002, http://www.meb.uni-bonn.de/psychiatrie/zebb/literatur/mcgorry.pdf.

[v] Richard Gosden, Ph.D., “Pre-Psychotic Treatment for Schizophrenia: Preventive Medicine, Social Control, or Drug Marketing Strategy?” Ethical Human Sciences and Services, Vol 1, No. 2, Summer 1999, pp. 165-177, http://sites.google.com/site/richardgosden/ehss.

[vi] http://www.ministryoflies.com/pdf-articles/Yale-Lilly.pdf.

[vii] Anthony Pelosi, “Head to Head, Is early intervention in the major psychiatric disorders justified? No,” BMJ 2008;337:a710, http://www.bmj.com/cgi/content/full/337/aug04_1/a710.

[viii] http://www.bmj.com/cgi/content/full/337/aug04_1/a710.

[ix] Niall McLaren, M.D., “Psychosis Risk Syndrome (PRS),” 14 May 2010 (soon to be published).

[x] Richard Warner, MB, DPM, is director of Colorado Recovery in Boulder, Colorado, and professor of psychiatry at the University of Colorado, “Early intervention in psychosis: Future or fad?” Centre for Addiction and Mental Health website, http://www.camh.net/Publications/Cross_Currents/Winter_2007-08/futureorfad_crcuwinter0708.html.

[xi] http://www.ahrp.org/cms/index2.php?option=com_content&do_pdf=1&id=386; http://ww.bioethicsforum.org/ethics-of-preventive-psychopharmacologic-treatments.asp.

[xii] David Webb, Melissa Raven, “McGorry’s ‘early intervention’ in mental health: a prescription for disaster,” Online Opinion, http://www.onlineopinion.com.au/view.asp?article=10267.

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