Posts Tagged ‘Shire Pharmaceuticals’

The business of ADHD

Wednesday, May 25th, 2011

SFGate.com City Brights Blog
By Winston Chung, Child Psychiatrist
May 24, 2011

Psychiatrists convened in sunny Honolulu for the 164th Annual Meeting of the American Psychiatric Association (APA) last week, discussing, among other things, moving forward with plans to make the diagnostic criteria for ADHD less stringent: proposed changes include reducing the number of required symptoms from 6 to 4, for adults and teens, and increasing the age-of-onset criteria from 7 to 12.

Russell Barkley, Ph.D., and Joseph Biederman, M.D., have written about abandoning or generously broadening age-of-onset criteria, arguing that the current, precise age-of-onset criteria poses “unwarranted practical problems for the study of older adolescents and adults.” These two men are considered ADHD experts and contributed to the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for ADHD, which serve as guidelines by which most child psychiatrists practice.

According to a story from the New York Times, Joseph Biederman did not tell university officials about more than a million dollars received from drugmakers from 2000 to 2007, and he promised Johnson & Johnson research results that would benefit the drug company. On the list of AACAP Conflicts of Interests for Practice Parameters not listed in the Practice Parameters, Russell Barkley receives or has received research support, acted as a consultant and/or served on a speaker’s bureau for Eli Lilly and Company and Shire Pharmaceuticals Group.

Shire Pharmaceuticals Group has a substantial focus on ADHD meds, and they have been pulling out all the stops to try and turn a profit in the face of competition from generic drugs.

Earlier this month, Reuter’s Health described how drugmakers, including Shire, have raised prices to make up for lack of new products and loss of patent protection.

“Prices were just shoved up every year to make more money and meet earnings, to be blunt,” Shire (SHP.L) Chief Executive Angus Russell said.

Shire’s CEO also indicated that the FDA is supporting their plan to study the use of their ADHD drug, Vyvanse, for use in depression and schizophrenia, hoping for billions of dollars in extra sales through expansion of potential indications. Amphetamines for schizophrenia? Hmmmm…..

Jim Edwards of BNET wrote about Shire increasing the price of one of their own ADHD drugs, Adderall XR, to encourage users to switch to their branded, cheaper and newer ADHD drug, Vyvanse, leading to increased sales.

Shire somehow sold more ADHD drugs during a recent, national shortage of ADHD medications – their sales of Adderall XR increased 21 percent in the first quarter of 2011 – a time when many of the patients in San Francisco’s public mental health system were unable to receive their regular ADHD medications.

BNET posted excerpts of separate lawsuits filed by Impax and Teva, manufacturers of generic forms of Adderall XR. They claim that Shire did not honor their contracts and hoarded product for themselves during this recent shortage. In the Wall Street Journal, the associate director of FDA’s drug shortages program reported that this national ADHD drug shortage mostly affected generic forms of ADHD meds. Coincidence?

Other ways of getting around stagnant drug development and generic competition include taking an old drug or active ingredient, and changing the delivery system or duration of action and presenting it as a new, patent-protected product. Here are a few examples that have been associated with Shire:

- Vyvanse: Also known as lisdexamfetamine, Vyvanse is a prodrug of dextroamphetamine. Dextroamphetamine has been used since 1937 to treat hyperactivity in children, so it is hardly new. Vyvanse was marketed as having lower abuse potential – specifically, preventing abuse from snorting, since the prodrug requires digestion to release the active form. In my clinical experience, most abuse of stimulants is due to people taking it without a prescription or shaping their symptoms to get a prescription, and a prodrug likely does little to curb college students from seeking stimulants to study for exams.

- Daytrana: The transdermal methylphenidate (methylphenidate is the active ingredient in Ritalin) patch is worn on the skin and was developed as a way of bypassing the digestive tract, and my experience prescribing this drug was met with equivocal reports from patients and families. I guess there is a reason I can’t remember anyone saying it worked – Shire gave up on the ADHD patch after 9 product recalls and a federal probe.

- Intuniv: An extended release form of guanfacine, Intuniv is touted as a new, non-stimulant treatment for ADHD. But child psychiatrists have been using guanfacine in ADHD for years, and this ‘extended-release’ form has a half-life of about 18 hours, while generic guanfacine has a half-life of about 17 hours – not a robust difference, in my opinion.

I liken these approaches to gimmicks utilized in the mass-produced, beer market: color changing labels to let you know if your beer is cold, wide-mouth beer cans, or vortex bottles. Do any of these ‘innovations’ really change the fact that you’re drinking cheap beer?

As the DSM-V looms closer to becoming a reality, I can’t help but think of words from the man who chaired the committee for the DSM-IV. Allen Frances, M.D., wrote in the in the LA Times:

As chairman of the task force that created the current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), which came out in 1994, I learned from painful experience how small changes in the definition of mental disorders can create huge, unintended consequences.

Our panel tried hard to be conservative and careful but inadvertently contributed to three false ‘epidemics’ – attention deficit disorder, autism and childhood bipolar disorder. Clearly, our net was cast too wide and captured many ‘patients’ who might have been far better off never entering the mental health system.

The DSM-IV was and the DSM-V will be published by the APA. The same APA that, in 2010, rejected internal recommendations – led by an APA past-president – to regulate or curtail individual psychiatrists’ relationships with the pharmaceutical industry.

Loosening the diagnostic criteria for ADHD, as proposed, will no doubt lead to more people being diagnosed and, inevitably, taking more ADHD drugs. I like to think that the APA and their doctors pushing for the changes are motivated by helping patients and not drug company profits.

After all, if anyone can identify and address unconscious conflicts or psychologically-defended, aggressive drives, it’s a psychiatrist, right?

Read article here:  http://www.sfgate.com/cgi-bin/blogs/wchung/detail?entry_id=89494

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Australian Psychiatrist Patrick McGorry Wants His Pre-Drugging Agenda to Go Global

Wednesday, June 16th, 2010


“Australia is a place that can actually change the world in mental health, provided we get the right government support to do so.” — Patrick McGorry

By CCHR International
June 16, 2010

A Public Service Announcement on Australian TV features Australian of the Year, psychiatrist  Patrick McGorry,  claiming that nearly half the population will experience mental ill-health during their lifetime. Considering that after World War II, psychiatrists claimed that one in 20 people had a mental disorder, and now it’s every second one of us, that’s a damning 1000 percent failure rate for psychiatrists in reducing “mental illness.” Let’s get real; the reason psychiatrists claim more people are mentally ill is because they can keep  inventing new ways to label them mentally ill—but the press and governments are  starting to catch on, evidenced by all the controversy surrounding psychiatry’s upcoming edition of their Diagnostic and Statistical Manual of Mental Disorders (DSM)—better known as psychiatry’s billing bible. Yet of all the proposed “mental disorders” ranging from overeating to kids throwing tantrums, no proposed model of mental disorder is more  insidious and dangerous than that of Patrick McGorry, who promotes diagnosing people before they develop a so-called mental disorder—drugging them before they become “mentally ill.” Yet the Australian government has bought into it hook, line and sinker—despite the fact McGorry’s plan is so outrageous, even his peers, such as psychiatrist Allen Frances, former Chair of the DSM task force, have called it ”the most ill-conceived and potentially harmful.”

Make no mistake, the pre-drugging agenda is Patrick McGorry’s baby—his dream for a new paradigm in mental health, one that has the power to diagnose and drug people before they become mentally ill—welcome to the Brave New World of Patrick McGorry. And he isn’t stopping with Australia; his plan is to go global. As he recently stated, “Australia is a place that can actually change the world in mental health, provided we get the right government support to do so.”[1]

The fact that McGorry’s agenda is so controversial—it even has other psychiatrists protesting it—has not deterred the Australian government from funding this “ill-conceived” plan. A recent letter to Citizens Commission on Human Rights states, “The Australian Government is providing $25.5 million over four years from 2010-2011 to expand Early Psychosis Prevention and Intervention Centre (EPPIC) model,” developed by McGorry who founded EPPIC and the Orygen Youth Health in Victoria, Australia.

The Australian Government has already been criticized for massive expenditure on psychotropic drugs increasing more than 660 percent during the last decade—with a whopping 3,100 percent increase on antipsychotic drugs (with at least 15 Australian deaths in the under 19 year olds as a tragic consequence of this).  This can only get worse when under McGorry’s plan, with an enormous client base that can be prescribed drugs despite the fact they are not yet  “mentally ill.” It’s called prodrome (prodromos meaning the forerunner of an event)—referring to “a period of prepsychotic disturbance” that may or may not develop into psychosis or “schizophrenia”[2]—in other words, the crystal ball theory.

Australia Meets the US in Pre-Drug Scam

McGorry’s plan for Australia to “lead the change” in world mental health is happening—to the detriment of those who may be forced to undergo drug treatment based on a psychiatrist’s hunch that they might, one day, become ill. In the U.S., on May 13, 2009, the Department of Health and Human Services convened a Technical Expert Panel (TEP) discussed “emerging evidence around psychopharmacological interventions for first episode schizophrenia” citing the research efforts of McGorry and others.[3]

The push for pre-diagnosing and pre-drugging has even those within the psychiatric profession calling foul; Dr. Richard Warner, professor of psychiatry at the University of Colorado, counters the idea that science drives McGorry’s pre-disorder assessment, stating, “Given the expected number of false positives, the potential for harm is significant.”[4]

However, as Anthony Pelosi, honorary professor, Department of Psychiatry, Hairmyres Hospital, wrote in a counter to McGorry in the British Medical Journal last year, “this has not stopped their skillful lobbying of politicians, journalists, patients, and carers with upbeat messages about the prevention.”

“Skillful lobbying” is right.

In 2006 McGorry and other researchers, including psychiatrist Michael Berk, Karen Hallam, Craig McNeil, Linda Kaler and psychologist Melissa Hasty reported in the Medical Journal of Australia, “Evidence increasingly indicates that earlier identification may allow for appropriate pharmacological and psychosocial treatments….”[5]

Could they have a Pharma incentive behind this agenda? Berk is financially linked to AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen-Cilag, Lundbeck, Organon, Novartis, Mayne Pharma, Servier, Sanofi-Synthelabo, Solvay, and Wyeth and Pfizer.[6] Hallam disclosed received speaker fees from Janssen-Cilag; McNeil received consultancy fees, speaker fees and travel assistance from Eli Lilly, Janssen-Cilag and Sanofi-Aventis; and Hasty and Linda received financial assistance to attend conferences from or Janssen-Cilag, maker of the antipsychotic Risperdal (resperidone).[7]

McGorry has received grant support from Eli Lilly, Janssen-Cilag, Bristol Myers Squibb, Astra-Zeneca, Pfizer, and Novartis.[8] He is a paid consultant for, and has received speaker’s fees from all or most of these companies.[9] Studies published in the British Medical Journal in 2005 and 2008 declared McGorry’s “early intervention studies have received partial support in the form of investigator-initiated unrestricted research grants from Janssen-Cilag.”[10]

The U.S. has already begun adopting the “early intervention” fad, which looks more like a trade in children’s lives and a business opportunity for increased pharmaceutical sales. In March 2010, the Department of Health & Human Services Substance Abuse & Mental Health Service Administration Center for Mental Health Services announced $16.5 million in funding for “Mental Health Transformation Grants,” including the “Early Detection and Intervention for the Prevention of Psychosis Program (EDIPPP).”[11]

EDIPP is the American sister of McGorry’s EPPIC.  It was originally bankrolled by a $14.4 million grant from the Robert Wood Johnson Foundation. According to investigative journalist Evelyn Pringle, “The founder of RWJF, Robert Wood Johnson, was chairman of Johnson & Johnson for over 30 years, from 1932 to 1963, as a member of the drug maker’s founding family. Throughout the years, the majority of the Foundation’s money has come from investments in J&J stock.”

In an article in Behavioral Healthcare, in 2008, the Mid-Valley Behavioral Care Network (MVBCN), an intergovernmental Medicaid government insurance-managed healthcare organization situated in Oregon, was recommended to study EPPIC used at Orygen and EDIPPP.

Based on EDIPP and EPPIC, the MVBCN developed the Early Assessment and Support Team (EAST) in 2001.  In 2003, the Oregon state legislature allocated $4.3 million to disseminate early psychosis intervention statewide.  By March the following year, new programs had begun in 12 counties.[12]

EDIPPP also replicates the “Portland Identification and Early Referral,” or “PIER,” a treatment research program at the Main Medical Center, in Portland, Maine.[13] People typically are referred to PIER by high school guidance counselors, pediatricians, or other clinicians who attended presentations about PIER’s work, says Pringle. “Virtually every person entering the PIER program is prescribed antipsychotics, such as Risperdal or Invega, marketed by Johnson & Johnson,” she added.

Both PIER and EDIPPP are promoted in McGorry’s 2002 book, Implementing Early Intervention in Psychosis: A Guide to Establishing Early Psychosis Services.”[14] The book’s foreword is written by Dr. Jeffrey Lieberman, Professor of Psychiatry, Chairman Department of Psychiatry, Columbia University College of Physicians and Surgeons.[15] Lieberman has taken consulting fees and research grant support from AstraZeneca, Bristol-Myers Squibb, Upjohn Pharmacia, Novartis, Eli Lilly, Janssen, Pfizer, Hoechst AG, & AstraZeneca. He’s on the Speakers Bureaus for Astra Zeneca, Janssen, Eli Lilly and Pfizer.[16]

Lieberman is also the Vice President (North America) of the McGorry instigated group International Early Psychosis Association (IEPA), which was officially incorporated in Victoria in 1998.[17] McGorry is currently Treasurer of the Association.[18] Lieberman is a member of the psychiatric-pharmaceutical company front groups, National Alliance for the Mentally Ill (NAMI) and National Alliance for Research on Schizophrenia and Depression (NARSAD).

Between 1999 and 2003 IEPA received unrestricted education grants from Janssen-Cilag and AstraZeneca.[19] EIPA’s conferences are supported by Janssen-Cilag, AstraZeneca, Eli Lilly, and Bristol-Myers Squibb.[20]

The IEPA lists the “who’s who” of Pre-Psychosis Risk Syndrome (the official label given pre-psychotic symptoms) and many of its board or members disclose manufacturers of antipsychotics as companies they’ve received financing from.

On July 29-30, the First international Youth Mental Health Conference is being held in Melbourne, with keynote speakers, including McGorry. The conference is described by one advocate as an “important and innovative event, attracting the best in the business/industry to discuss the emerging issues of youth mental health.”[21]

It couldn’t have been more adequately stated: business and industry. Herein you see McGorry’s pitch again that Australia is a global leader in this latest psychiatric fad. His invitation online states, “This is an important event for Australia and the mental health field. We expect this to be the first of many similar conferences, bringing together innovators, practitioners, researchers, young people and families to showcase the best of youth mental health innovation from around the globe.”[22] [Emphasis added]

There’s no doubt that this conference, like his Australian award, will be used to demand more funding to increase the business stakes and drive more income into psychiatry’s pre-drugging efforts.  Despite the government already allocating $103 million to McGorry, including the $25 million to further research EPPIC, he continues to call for another $800 million in funding for programs for youth mental health over the next four years.[23]

McGorry recently stated, “You have to be able to give something of yourself to people, if you are going to help them.”[24] McGorry’s brand of “helping” entails stigmatizing children with psychiatric labels that have no basis in science or medicine and then drugging them. That does not qualify as “help.” It’s betrayal. If this agenda to pre-diagnose, and pre-drug is allowed to take hold, we will truly have entered a Brave New World; Patrick McGorry’s.


[1] http://sydney.edu.au/medicine/museum/mwmuseum/index.php/McGorry,_Patrick

[2] http://www.mentalhealth.com/mag1/scz/sb-prod.html

[3] U.S. Department of Health and Human Services, “ASPE Technical Expert Panel on Earlier Intervention for Serious Mental Illness: Summary of Major Themes,” The Lewin Group, 13 May, 2009.

[4] 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.

[5] http://www.mja.com.au/public/issues/187_07_011007/ber10341_fm.pdf

[6] http://www.mja.com.au/public/issues/187_07_011007/ber10341_fm.pdf

[7] http://www.mja.com.au/public/issues/187_07_011007/ber10341_fm.pdf

[8] http://www.mhanet.ca/documents/2008/Research-Colloquium/0920%20-%20Keynote%20MCGORRY.pdf

[9] http://www.bmj.com/cgi/content/full/337/aug04_1/a695

[10] http://bjp.rcpsych.org/cgi/content/full/187/48/s108; http://www.bmj.com/cgi/content/full/337/aug04_1/a695

[11] http://www.opednews.com/articles/Tracking-the-American-Epid-by-Evelyn-Pringle-100602-668.html

[12] http://www.behavioral.net/ME2/dirmod.asp?sid=9B6FFC446FF7486981EA3C0C3CCE4943&nm=Archives&type=Publishing&mod=Publications%3A%3AArticle&mid=64D490AC6A7D4FE1AEB453627F1A4A32&id=BFCD36BFD75E447CA63F662A633F41FB&tier=4

[13] http://www.opednews.com/articles/Tracking-the-American-Epid-by-Evelyn-Pringle-100602-668.html

[14] http://books.google.com.au/books?id=lyLfMPsnvJ0C&pg=PA136&lpg=PA136&dq=Portland+Identification+and+Early+Referral+McGorry&source=bl&ots=lEp9tdT8ZV&sig=_zlnHeFk8oqxTHSjbvLf0XQmlY4&hl=en&ei=lP0RTKThLMWPcMnSzNAH&sa=X&oi=book_result&ct=result&resnum=1&ved=0CBQQ6AEwAA#v=onepage&q&f=false

[15] http://69.5.18.33/ahrp/cms/index2.php?option=com_content&do_pdf=1&id=345

[16] http://69.5.18.33/ahrp/cms/index2.php?option=com_content&do_pdf=1&id=345

[17] http://www.iepa.org.au/ContentPage.aspx?pageID=10

[18] http://www.headspace.org.au/about/headspace-board/

[19] http://www.iepa.org.au/ContentPage.aspx?pageID=59

[20] http://www.iepa.org.au/ContentPage.aspx?pageID=59

[21] http://www.iymhconference.com.au/why-attend/

[22] http://www.iymhconference.com.au/

[23] Mental Health Update, GetUp! Action for Australia, 21 Apr. 2010, http://www.getup.org.au/blogs/view.php?id=1936&dc=1086,21560,1

[24] http://sydney.edu.au/medicine/museum/mwmuseum/index.php/McGorry,_Patrick

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US Kids Represent Psychiatric Drug Goldmine

Monday, December 14th, 2009

Truthout
Evelyn Pringle
December 12, 2009

Prescriptions for psychiatric drugs increased 50 percent with children in the US, and 73 percent among adults, from 1996 to 2006, according to a study in the May/June 2009 issue of the journal Health Affairs. Another study in the same issue of Health Affairs found spending for mental health care grew more than 30 percent over the same ten-year period, with almost all of the increase due to psychiatric drug costs.

On April 22, 2009, the US Agency for Healthcare Research and Quality reported that in 2006 more money was spent on treating mental disorders in children aged 0 to 17 than for any other medical condition, with a total of $8.9 billion. By comparison, the cost of treating trauma-related disorders, including fractures, sprains, burns, and other physical injuries, was only $6.1 billion.

In 2008, psychiatric drug makers had overall sales in the US of $14.6 billion from antipsychotics, $9.6 billion off antidepressants, $11.3 billion from antiseizure drugs and $4.8 billion in sales of ADHD drugs, for a grand total of $40.3 billion.

The path to child drugging in the US started with providing adolescents with stimulants for ADHD in the early 80s. That was followed by Prozac in the late 80s, and in the mid-90s drug companies started claiming that ADHD kids really had bipolar disorder, coinciding with the marketing of epilepsy drugs as “mood stablizers” and the arrival of the new atypical antipsychotics.

Read entire article: http://www.truthout.org/1213091

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