Posts Tagged ‘Pfizer’

Pharma Backed Australian of the Year Psychiatrist Wants Millions in Government Funding for Brave New World of “Pre-Drugging” Kids

Monday, March 15th, 2010

By CCHR Int
March 15, 2010

Who is Patrick McGorry and what does he promote?  He’s a psychiatrist just named Australian of the Year for his work in “youth mental health reform.”  What does that reform consist of?  What he calls a “new form of climate change.” It sure is.

[See TIME Magazine Article "Drugs Before Diagnosis?"]

He not only promotes youths being put on antipsychotics and antidepressants, cited by international drug regulatory agencies as causing hallucinations, hostility, personality change, life-threatening diabetes, strokes, suicide and death, McGorry goes a giant step further—drug them before they’ve even developed a “psychiatric” disorder.

The Association for the Accreditation of Human Research Protection Programs (AHRPP) likens such concepts to “performing mastectomies on women who are at risk of—but do not have—breast cancer.”[i]

The UN Committee on the Rights of the Child has expressed “serious concerns” about child drugging and Senate investigations in the United States have found high profile psychiatrists who were pharmaceutically funded and using fraudulent research being among the heaviest promoters of psychiatric drug use on children. While the rest of the world is experiencing serious alarm at the rampant use of deadly psychiatric drugs on children, McGorry pushes full steam ahead to increase the amount of children being needlessly subjected to psychiatry’s most powerful drugs—antidepressants and antipsychotics.

His theory and practices are so controversial that even his colleagues in the United States have backed away from it.  And a parallel study done in the United States based on the same theory that McGorry uses was considered an abject failure—even by the investigators themselves.  Other psychiatrists have criticized McGorry’s pre-drugging practice as unethical and harmful to adolescents.  More on that later.

This is especially so as the “symptoms” McGorry and cohorts invented to “pre-label” youths as potential candidates for psychosis and “schizophrenia” (to start with) are, according to one U.S. psychiatrist, “remarkably common…adolescence is a period of life that is normally marked by tumultuous changes in personality.”

And what was the first thing he did to capitalize on his winning his “Australian of the Year” award?  He demanded the Australian government hand over another $200 million to fund more of his centers where he can drug more children.  Worse, the government is entertaining the idea.

Yet, for who ever nominated him—apparently an “anonymous supporter”—due diligence wasn’t done on what McGorry advocates.

A cursory look at his research shows that while behavioral symptoms are evaluated and, on a hunch, drugged to see if they “prevent” the onset of a “mental” disorder, there’s no mention of the teens being given full and searching physical exams to first rule out undiagnosed and untreated medical conditions that may be causing it.  Yet dozens of physical conditions can manifest as behavioral problems.

  • Australia, like the U.S., has recently seen major media and legislative exposure of the conflicts of interest between psychiatrists and the pharmaceutical industry.  McGorry has received unrestricted research grant support from Eli Lilly, Janssen-Cilag, Bristol Myer Squibb, AstraZeneca, Pfizer, and Novartis.

  • He is also a paid consultant for, and has received speaker’s fees from all or most of these companies.[ii] His recent report on “early intervention” for young people acknowledges AstraZeneca, Janssen, Eli Lilly, Novartis, Sanofi, Bristol Myers Squibb and Pfizer.[iii] [Since 2001, the U.S. Federal and state governments have recovered more than $4 billion from many of these companies that settled criminal or civil charges of fraud and misleading advertising filed against them.]

  • Even Big Pharma is bowing out of psychiatric drug research. In February, the CEO of GlaxoSmithKline said it was dumping antidepressant research because it is too hard to prove that antidepressants work because “patient improvement is measured by subjective mood surveys” and not by any blood or biological test used to confirm medical diseases. AstraZeneca followed with the head of development, Anders Ekblom, announcing it would no longer research and develop drugs for depression, bipolar, anxiety and schizophrenia, saying the decision reflects the unpredictable and risky nature of clinical trials to assess medicine working on the brain. [emphasis added]
  • Yet, despite the unpredictability and risk of these drugs, McGorry wants to go full steam ahead, increasing the funding to increase the number of children being placed on them.

A Closer Look at McGorry’s Brave New World

  • In 1996, Patrick McGorry and fellow pharmaceutical company-funded researcher Alison Yung set up a clinic in Australia to monitor young people considered at a “high risk” for developing psychosis.  They invented a subjective method for assessing symptoms that, while not based on science—claimed to predict early onset of psychosis or schizophrenia called prodromal (early symptoms), and drugged the teens and young adults.  In other words, gave them toxic chemicals for a mental disorder they did not have.[iv]
  • The theory wasn’t McGorry’s alone, but he decided to test it in a world-first trial that had psychiatry’s skeptics and even psychiatrists themselves aghast.  The Australian program inspired the development of similar programs worldwide.[v]
  • A follow up study was conducted in 2002, funded with an unrestricted grant from Janssen-Cilag pharmaceuticals, and supported by psychiatric-pharmaceutical front groups NARSAD and Stanley Foundation, as well as several Australian agencies.  McGorry and colleagues said that risperidone (Risperdal)—made by Janssen—reduced the risk of “transition to psychosis” in young people.[vi]
  • Risperdal has been linked to diabetes and, more specifically, Type 2 diabetes. Other serious side effects include Neuroleptic Malignant Syndrome (NMS), a potentially fatal syndrome involving muscle rigidity, and irregular blood pressure and pulse.[vii]
  • McGorry’s friend and colleague, Yale University professor of Psychiatry, Dr. Thomas McGlashan, conducted a parallel study (1997-2003), the results of which were published in the American Journal of Psychiatry.   Eli Lilly funded the experiment.  Sixty adolescents, who did not meet any criteria for a diagnosis of mental illness, were prescribed Lilly’s antipsychotic Zyprexa (olanzapine).[viii]
  • The experiment failed to demonstrate any significant benefit of Zyprexa, and 54.8% of adolescents prescribed the drug compared to 34.5% on placebo refused to complete the study (the 20% difference indicating substantial intolerable safety problems with the drug).[ix]
  • Even McGlashan later admitted to The New York Times in May 2006 that, “the drugs were more likely to induce weight gain than to produce a significant, measurable benefit….” Those on medication gained an average of about 20 pounds. The entire process changed Dr. McGlashan’s thinking.[x]
  • In fact he distanced himself from McGorry in a TIME Magazine article the same year on McGorry titled, “Drug Before Disorder?”  “There may be gold in the early-intervention hills,” McGlashan conceded, “but the data are not plentiful enough and the findings not replicated enough for us to recommend anything more than further research at this point.”[xi]
  • Undeterred, and buoyed by an Australian government $A54 million funding of a National Youth Mental Health Foundation, McGorry plowed on to expand his unproven and potentially risky methods to the early diagnosis and treatment for “a range of mental health problems in young people: substance abuse, personality disorders, bipolar—the whole lot, really.”[xii]
  • Richard Warner, MB, DPM, director of Colorado Recovery in Boulder, Colorado, and professor of psychiatry at the University of Colorado, completely debunks McGorry’s theory, writing: Medicating at the earliest appearance of symptoms, without thought for the natural history of the condition, may lock the person experiencing a brief psychosis into a long-term career as a psychiatric patient.”[xiii]
  • Further refuting McGorry’s theory, Honorary Professor Anthony Pelosi from the Department of Psychiatry, Hairmyres Hospital, East Kilbride, wrote, “So far, evidence from randomized trials does not support the use of psychological therapies or drugs as preventive interventions.”[xiv]

No Science to “Pre-Disorder” Screening

  • Dr. Warner counters any idea that science drives McGorry’s pre-disorder assessment: “As for the claim that we can prevent psychosis by intervening before the illness has become fully evident, this effort requires effective screening to detect those at risk.”  Something that McGorry clearly doesn’t have.
  • “Patrick McGorry and colleagues at the PACE clinic in Melbourne…report that their screening instrument is capable of 80 per cent accuracy in their clinic.  But the instrument is not that accurate in routine use.  In the PACE sample, 35 per cent developed psychosis within one year.  Probability theory tells us that if the same instrument were used to screen a general population sample…it would be correct only seven per cent of the time.”
  • “In fact, in another Australian clinic, the PACE instrument only achieved nine per cent accuracy. False-positive rates of the order of 70 to 90 per cent are clearly unrealistic for intervening with medication or other forms of treatment.”

Harmful Drug Outcomes

  • Further, the antipsychotic drug interventions McGorry suggests as one intervention approach are dangerous. Given the expected number of false positives, the potential for harm is significant,” Dr. Warner stated.[xv]

  • Dr. Pelosi concurs: “[M]ost patients who enter these specialist programs will unnecessarily receive potentially dangerous treatments.  Data are emerging from the clinics of early intervention enthusiasts that illustrate nicely what they have been warned about for years.  When psychiatrists referred selected patients to a schizophrenia prodrome clinic, about half went on to develop a psychosis.  After teachers, college counselors, and families were encouraged to refer young people with possibly prodromal symptoms directly to the same clinic for the same care plans…almost 90% were receiving unnecessary ‘preventive’ interventions.”[xvi]
  • Dr. Jerald J. Block, a U.S. psychiatrist, writing in Bioethics Forum, says that “preventive pharmacology” (what McGorry is practicing) is “ethically questionable territory” because the treatments given “frequently have side effects and complications” and you are potentially harming people.  Further, 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.”[xvii]
  • He says, “[I]t is unclear how the quality of one’s life will be affected during and after one year of getting daily neuroleptic,” especially for a condition you haven’t even developed. “Forming and solidifying new relationships occupies much of the time in adolescence and young adulthood.  As neuroleptics affect cognition and emotionality, we might expect [an antipsychotic] to influence one’s ability to build relationships, for better or worse.”[xviii]
  • Moreover, Dr. Warner points out, if left untreated, the person exhibiting so-called “prodromal” symptoms is likely to recover without drug treatment. “The Soteria projects in California and Berne, Switzerland, and a multi-center study in Finland demonstrated that medication is not essential for good outcome.”[xix]

Despite the Failure, Keep Lobbying for the $

  • Dr. Pelosi points out that when the leaders of the early intervention movement are pinned down, while they accept the criticisms against them, “this has not stopped their skilful lobbying of politicians, journalists, patients, and carers with upbeat messages about the prevention and attenuation of schizophrenia.”
  • Which is precisely what McGorry is doing now—using his award and unquestionably unscientific theories to advocate for more funds.[xx]

Australia’s Joseph Biederman?

  • McGorry has been equated with America’s Dr. Joseph Biederman, the psychiatrist who came under U.S. Senate Finance Committee investigation for failing to disclose more than $1.6 million he’d earned in consulting fees from drug makers while conducting research for universities.  Biederman was on the Advisory Board of Eli Lilly, which manufactures antipsychotics and antidepressants. The New York Times said that Biederman helped to fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric “bipolar disorder” and corresponding increase in children taking antipsychotics.
  • How much McGorry may have impacted on pediatric and youth prescriptions of antipsychotics and antidepressants in Australia is unknown, but certainly warrants a closer look. As do the outcomes of his studies and what, if any, influence the drug companies that funded him may have had.
  • Australia’s Therapeutic Goods Administration (TGA) has received reports of 26,506 adverse reactions linked to antipsychotics, including 477 deaths.  That’s since they were introduced over many years.  By January 2009 there were 36,804 adverse reactions reported to the TGA linked to antidepressants, including 217 deaths, of which 4 were from the 10 to 19 age group.
  • But add to that the Food and Drug Administration’s adverse drug reaction reports (ADRs) during a five-year period alone (2004-2008) and the magnitude of where the potential risk of this “Drugs before Disorder” practice is heading.  For antipsychotics, there were 91 deaths for those under 18.  For antidepressants, there were 321 deaths, of which 251 were suicides. As these reports represent between one and ten percent of the ADRs, that figure could be as high as 3,210 deaths, and for antipsychotics, nearly 1,000.

Australia’s health care system ranks well internationally, and preventative measures may seem the way to enhancing it; however, the last thing the country needs, then, is a psychiatrist banner heading the idea that children and youths should be gotten to early and drugged on the precept that they might become mentally ill.  Rather, they need proper medical—not psychiatric—care and educational solutions.  The last thing they need is $200 million of taxpayers’ dollars funding what could be a lifetime sentence to taking mind-altering drugs.

Someone needs to care for Australia’s children and youth, but it’s definitely not Patrick McGorry.


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

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

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

[iv] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2632176/.

[v] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2632176/.

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

[vii] http://www.coreynahman.com/atypical-antipsychotic-lawsuits.html.

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

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

[x] http://www.nytimes.com/2006/05/23/health/psychology/23prof.html?pagewanted=3&_r=1.

[xi] http://www.time.com/time/magazine/article/0,9171,1205408,00.html#ixzz0i0DykBNV.

[xii] http://www.time.com/time/magazine/article/0,9171,1205408,00.html#ixzz0i0NMJQyd.

[xiii] http://www.camh.net/Publications/Cross_Currents/Winter_2007-08/futureorfad_crcuwinter0708.html.

[xiv] 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.

[xv] http://www.camh.net/Publications/Cross_Currents/Winter_2007-08/futureorfad_crcuwinter0708.html.

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

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

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

[xix] http://www.camh.net/Publications/Cross_Currents/Winter_2007-08/futureorfad_crcuwinter0708.html.

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

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Its about time…With drug companies paying criminal fines of $7 billion, FDA to increase prosecution of Pharma Execs

Tuesday, March 9th, 2010

Pharmalot
By Ed Silverman
March 4, 2010

The FDA plans to increase misdemeanor prosecutions of industry execs as it looks to refocus its Office of Criminal Investigations (see this letter to the Senate Finance committee). The move comes in response to a new report from the General Accountability Office that the OCI suffers from lax oversight, despite increased in funding and staffing over the past decade. In fact, the FDA hasn’t reviewed most OCI offices in more than three years. The OCI investigates counterfeit drugs and other bad stuff, as well as misconduct by FDA employees.

The GAO concluded the FDA “has relied largely on the OCI director to determine which aspects of OCI’s operations and investigations are made known to FDA’s top management.” The GAO found assessments of six OCI field offices aren’t being done on a timely basis. Of 24 total office assessments that should have been completed by August 2009, only 7, or about 30 percent, were completed and one office hadn’t been assessed in over 10 years.

In addition, the FDA lacks performance measures that could enhance oversight by allowing it to assess OCI’s overall success. A few more facts: the OCI has a 230-person operation with more than $41 million in funding. In 2008, the group’s investigations led to more than 400 convictions. The OCI budget rose 73 percent between 1999 and 2008 to $41 million, and the number of employees increased by about 40 percent.

The GAO study, which was first reported by The Wall Street Journal, was requested by Chuck Grassley, the ranking Republican on the US Senate Finance, who has been probing drug safety issues, among other things. A report on GlaxoSmithKline’s Avandia noted that several drugmakers – Pfizer, Lilly, Bristol-Myers Squibb – have recently paid large criminal fines totaling $7 billion. Among the infractions – off-label promotion.

Read entire article:  http://www.pharmalot.com/2010/03/fda-oversight-of-criminal-investigations-is-lax/

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Pharma Funded FDA’s Christmas Present to Drug Companies: Approving use of deadly antipsychotic drugs for kids

Thursday, December 31st, 2009

Martha Rosenberg
OpEdNews.com
December 30, 2009

You couldn’t get much naughtier than Eli Lilly in 2009 who agreed to pay $1.42 billion for mismarketing Zyprexa and Pfizer who agreed to pay $2.3 billion for Bextra, Geodon, Lyrica and Zyvox fraud.

Pharma will continue to dole out such payouts and consider them a slap on the wrist says a Bloomberg article until prosecutors and judges “use the ultimate sanction, a felony conviction that would render a company’s drugs ineligible for reimbursement by state health programs and federal Medicare.”

Nor did the mismarketing and fraud only enrich drug companies and loot Medicaid and Medicare tax dollars.

Doctor have also cleaned up like Chicago psychiatrist Michael Reinstein who received $500,000 to promote a drug that Medicaid records say he prescribed 41,000 times according to Chicago Tribune and Propublico, figures Reinstein disputes.

And Miami psychiatrist Fernando Mendez-Villamil who wrote 97,000 psychoactive prescriptions for Medicaid patients over 18 months says the Miami Herald –153 prescriptions a day. His prescribathon even drew a letter from Sen. Charles Grassley, ranking member of the Senate Finance Committee.

Read entire article: http://www.opednews.com/articles/-Naughty-Pharma-Still-Got-by-Martha-Rosenberg-091230-724.html

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Op Ed: New Year’s Resolutions for the Drug Industry for 2010

Wednesday, December 23rd, 2009

Martha Rosenberg
OpEdNews.com
December 23, 2009

There was only one thing worse than being unemployed in 2009: working for the drug sector.

Not only did the two biggest drug settlements in US history occur in 2009–Eli Lilly’s $1.42 billion for mismarketing Zyprexa and Pfizer’s $2.3 billion for Bextra, Geodon, Lyrica and Zyvox fraud–the Supreme Court ruled people can sue if they’re harmed by a prescription drug even if it had FDA approval.

No wonder Wyeth and Pfizer and then Merck and Schering-Plough formed defensive mergers in 2009, the former timed to knock out headlines about the Bextra settlement.

High profile suicides also occurred in 2009 prompting the FDA to add black box warnings to the asthma drugs Singulair, Accolate and Zyflo, the antismoking drugs Chantix and Zyban and authorities to question the antidepressants given to 80 percent of Iraq war veterans with post traumatic stress disorder.

The open secret of industry subsidized journal articles and Continuing Marketing, sorry Medical Education courses (CMEs) also came under Congressional investigation in 2009–as did the drug industry ties of faux grassroots groups like the National Alliance on Mental Illness (NAMI) and high flying researchers like Harvard’s Joseph Biederman, MD.

Read entire article: http://www.opednews.com/articles/New-Year-s-Resolutions-for-by-Martha-Rosenberg-091223-751.html

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Let Them Eat Zoloft “Pfizer exists to serve the interests of their executives and shareholders-not the public”

Tuesday, November 17th, 2009

James Ridgeway
Mother Jones
November 17, 2009

As the Senate takes up health care reform, we’re sure to be treated to yet more scenes of our elected officials bending over backwards to kiss the gold-plated butts of the pharmaceutical and insurance industries. So far, just about every new turn in the health care battle is confirming what many have known for some time: The US health care system is run largely for the benefit of these corporate giants, rather than for the American people, and no piece of legislation is likely to change that fact.

But to fully appreciate the license these industries have been given to run roughshod over the public interest, you have to take a trip to Connecticut. The state is a longtime home base for the insurance industry, with 72 companies and the nation’s highest concentration of insurance jobs. It also has more than its share of drug and biotech companies. What luck then, for these industries, that the man who appears to hold a swing vote on health care reform is their own Senator Joe Lieberman, who has enjoyed enormous financial support from the insurance companies and plenty from Big Pharma, as well.

While Connecticut may be loyal to its health care companies, the opposite clearly is not true. This week the giant drugmaker Pfizer sent shock waves across the state when it announced its decision to shut down its huge research facility in New London. While some workers will be transferred to a facility in a nearby town, the closure represents a devastating loss of industry and tax base for this working-class coastal city. It also marks the disintegration of an elaborate publically financed urban development scheme that began a decade ago.

Read entire article: http://www.motherjones.com/mojo/2009/11/let-them-eat-zoloft

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Pharma’s Drug Ads: From Million Dollar TV Ads to $1.7 Billion Internet Marketing Campaign

Monday, November 16th, 2009

On November 13th, 2009, Pharmaceutical companies flocked to a two-day FDA hearing into online drug advertising, which could influence their use of social media on the net. 1  Already, the explosive growth in online advertising has intensified public concerns: the pharmaceutical industry spent more than $1 billion on Internet ads last year and is projected to spend $1.7 billion on such marketing efforts in 2012, according to the Direct Marketing Association.2

Both Eli Lilly and Merck have received warning letters this year from the FDA accusing them of misleading online advertisements.3  But while the FDA scrambles to monitor online ads, who monitors the psychiatric-pharmaceutical industry’s use of front groups to indirectly market their products?

A Washington Post article of June 16, 2009 reported that an increasing number of pharmaceutical firms are turning to social media tools, such as Facebook, YouTube, Twitter and MySpace, to market their products.  It cites how a community site sponsored by drugmaker McNeil called “ADHD Allies”—aimed at adults with ADHD—was established and offered an online podcast on financial advice and an “ADHD self-assessment tool.”4

British psychiatrist Joanne Moncrieff explains how this ultimately increases drug sales because only a biomedical approach is promoted: “Drug companies…provide funds for pro drug patient and carer groups and address advertising or disease promotion campaigns to the general public…This influence has helped to create and reinforce a narrow biological approach to the explanation and treatment of mental disorders and has led to the exclusion of alternative” treatments.5

Such websites do not mention company’s product but rather market the “disease.” In advertising, it can be accomplished through a strategy known as “condition branding,” where “mental illness” can be pitched just like cars, beer or laundry detergent.  Witness the brand name “bipolar” and “social anxiety disorder” that drug companies marketed at a fever pitch.

John Read, PhD, Psychology Department, University of Auckland did an analysis of 54 random “advocacy” groups for Post Traumatic Stress Disorder (PTSD) through the Internet. The results, published in the Journal of Trauma & Dissociation this year, found 42% of the websites received drug company funding. The researchers found:

  • “Patients tend to trust these organizations to act in an unbiased manner” but as earlier researchers argued in some cases “patient organizations have become a mouthpiece for the pharmaceutical industry in influencing regulatory authorities.”
  •  “Drug company influence within the area of mental health is prevalent and now extends to the Internet. This influence is not always transparent. This study suggests that drug company sponsorship of websites leads to a greater emphasis on pharmacology in the treatment of PTSD,” Dr. Read’s report concludes.6

ADHD Allies/ADHD Moms

In June 2008 Concerta was given an expanded indication by FDA and is now indicated for patients aged 6 to 65.7 In July 2008, McNeill Pediatrics—a subsidiary of Ortho-McNeill Pharmaceuticals—launched what they called an “unbranded group” called “ADHD Moms.” ADHD Moms markets the trademarked name “Mom-bassadors” to get mothers into the Facebook page. 8

  • McNeill spuriously claims “the group is not product-specific, nor are there any advertisements for the company’s ADHD drug Concerta (methylphenidate).” Well not directly, but providing material for the site is a Dr. Quinn, a paid consultant and speaker for McNeil Pediatrics. 9  April White, who also provides content is a paid spokesperson for McNeil Pediatrics.10
  • On April 22 2009, McNeill launched a second ADHD-focused Facebook page called “ADHD Allies,” this time targeting adults.  The “Allies” are board members of another front group Attention Deficit Disorder Association (ADDA), funded by McNeill.11
  • The pharmaceutical company has trademarked “ADHD Allies” and “ADHD Moms.”  ADHD Allies was responsible for a “2008 Harris Interactive survey of 1,000 adults with ADHD.” Not surprisingly, the survey found the condition significantly affects them. 12

Log onto The Bipolar Journey: Living With Bipolar Depression website and while it does show AstraZeneca on the home page, there’s no mention of its blockbuster antipsychotic drug Seroquel, approved by the FDA in 2006 for “bipolar.”  The site looks like a patient information site providing facts about the “disease” and misleadingly saying that it may be caused by a chemical imbalance—for which there is no evidence.

It refers people to the National Alliance for the Mentally Ill (NAMI) that has received $23 million recently from at least 18 drug companies. The site shows that of 17 cites for the exhibit’s showing in 2009, 12 are conferences or events put on by NAMI.

It also links to The Depression and Bipolar Support Alliance, a group that received close to $1 million in pharmaceutical company funding in 2007.

According to an August 27 2009 press announcement, AstraZeneca launched its interactive exhibit, endorsed by New York psychiatrist Janet Taylor. The press release does not mention that Dr. Taylor has financial ties to the company.13

In 2005, global sales for Seroquel reached $2.8 billion.  October 20, 2006, company announced Seroquel was FDA approved for bipolar.14 Within a year, sales reached $3 billion and then soared again in 2008 to $4.66 billion.15

By funding social media front groups that talk only about the “disorder,” drug companies can overcome fears of running afoul of FDA regulations that govern drug advertising and “are embracing social networks to help brand and position their companies in a positive light with consumers and practitioners.”  The top 10 drug companies using social media are: Pfizer, Johnson and Johnson, Novartis, Boehringer Ingelheim, AstraZeneca US, Bayer, GlaxoSmithKline, Sanofi-Aventis, Roche, and Merck.16

This post was written by CCHR International.
Coming next from CCHR Int: Psycho Pharma Front Groups

1 “FDA Addresses Drug Ads in Online Social Media,” Red Orbit, 13 Nov. 2009.

3 “FDA Addresses Drug Ads in Online Social Media,” Red Orbit, 13 Nov. 2009.

5 Joanne Moncrief, in a “Study of the Influence of the Pharmaceutical Industry on Academic and Practical Psychiatry,” http://www.critpsynet.freeuk.com/pharmaceuticalindustry.htm

6 http://www.isst-d.org/jtd/mansell_&_read_ptsd_drug_cos_&_internet%20.pdf; Journal of Trauma & Dissociation, 10:9–23, 2009

12 “Adults ‘Facing’ ADHD: ADHD Allies™ Offers Unique Online Community for Adults with ADHD on New Facebook® Page,” http://multivu.prnewswire.com/mnr/concerta/36533/

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Despite criminal conviction – Drug makers again violated federal law with “off-label” marketing of antipsychotics

Monday, November 9th, 2009

David Evans
Bloomberg
Nov. 9, 2009

Prosecutor Michael Loucks remembers clearly when lawyers for Pfizer Inc., the world’s largest drug company, looked across the table and promised it wouldn’t break the law again.

It was January 2004, and the attorneys were negotiating in a conference room on the ninth floor of the federal courthouse in Boston, where Loucks was head of the health-care fraud unit of the U.S. Attorney’s Office. One of Pfizer’s units had been pushing doctors to prescribe an epilepsy drug called Neurontin for uses the Food and Drug Administration had never approved.

In the agreement the lawyers eventually hammered out, the Pfizer unit, Warner-Lambert, pleaded guilty to two felony counts of marketing a drug for unapproved uses.

New York-based Pfizer agreed to pay $430 million in criminal fines and civil penalties, and the company’s lawyers assured Loucks and three other prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes.

What Loucks, who’s now acting U.S. attorney in Boston, didn’t know until years later was that Pfizer managers were breaking that pledge not to practice so-called off-label marketing even before the ink was dry on their plea.

On the morning of Sept. 2, 2009, another Pfizer unit, Pharmacia & Upjohn, agreed to plead guilty to the same crime. This time, Pfizer executives had been instructing more than 100 salespeople to promote Bextra, a drug approved only for the relief of arthritis and menstrual discomfort, for treatment of acute pains of all kinds.

Record High Fine

For this new felony, Pfizer paid the largest criminal fine in U.S. history: $1.19 billion. On the same day, it paid $1 billion to settle civil cases involving the off-label promotion of Bextra and three other drugs with the U.S. and 49 states.

“At the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct in 2004, Pfizer was itself in its other operations violating those very same laws,” Loucks, 54, says. “They’ve repeatedly marketed drugs for things they knew they couldn’t demonstrate efficacy for. That’s clearly criminal.”

The penalties Pfizer paid this year for promoting Bextra off-label were the latest chapter in the drug’s benighted history. The FDA found Bextra to be so dangerous that Pfizer took it off the market for all uses in 2005.

Across the U.S., pharmaceutical companies have been pleading guilty to criminal charges or paying penalties in civil cases when the U.S. Department of Justice finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of chest infections, heart attacks, suicidal impulses or death.

Read entire article: http://www.bloomberg.com/apps/news?pid=20601109&sid=a4yV1nYxCGoA&pos=10

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$28 million Pharma gave NAMI doesn’t include payments to NAMI’s 50 state chapters. Senator now demanding this data.

Friday, October 23rd, 2009

Jared A. Favole
NASDAQ.com
October 23, 2009

WASHINGTON -(Dow Jones)- A probe by Sen. Charles Grassley, R.-Iowa, into the ties between pharmaceutical companies and a leading patient advocacy group, the National Alliance on Mental Illness, may show their relationship goes deeper than previous thought.

Grassley’s investigation shows the national group has received more than $28 million from pharmaceutical companies in the last four years. However, that number doesn’t include pharmaceutical contributions given to NAMI’s 50 state chapters or related foundations. Grassley is now demanding that information, according to documents obtained by Dow Jones Newswires.

Earlier this month, Grassley staffers wrote letters to the state chapters of the group demanding they turn over financial information detailing how much they receive from pharmaceutical companies. The investigation is part of a broad look into conflict of interests and how industry influence might be driving prescription drug use.

But more than conflict of interests are at stake. Pfizer Inc. (PFE) is facing a whistleblower lawsuit in federal court in Massachusetts where a former employee alleges the company used NAMI to illegally promote its schizophrenia drug Geodon off label. A company representative wasn’t immediately available to comment.

Read entire article: http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=200910221848dowjonesdjonline001058&title=grassley-probe-of-health-group-may-show-deeper-pharma-ties

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Grassley’s NAMI Invest Should Include Whistleblower Suit: Claims NAMI promoted off label use of antipsychotics in kids

Thursday, October 22nd, 2009

Jim Edwards
BNET
October 22, 2009

Sen. Charles Grassley is investigating the National Alliance for the Mentally Ill, the New York Times reports. He might want to look into Pfizer’s $2.3 billion Bextra settlement as one of the suits within it made some juicy claims about how NAMI works.

NAMI is supposed to represent mentally ill people, not drug companies, but executive director Michael Fitzpatrick agrees Big Pharma’s influence over the organization has been excessive. The Times:

“I understand that NAMI gets painted as being in the pockets of pharmaceutical companies, and somehow that all we care about is pharmaceuticals,” Mr. Fitzpatrick said. “It’s simply not true.”

To underline the point, the Times describes this NAMI gala at the Andrew W. Mellon Auditorium in Washington:

Tickets were $300 each. Before a dinner of roasted red bell pepper soup, beef tenderloin and tilapia, Dr. Stephen H. Feinstein, president of the alliance’s board, thanked Bristol-Myers Squibb, the pharmaceutical company.

Read entire article: http://industry.bnet.com/pharma/10004934/grassleys-nami-probe-may-want-to-look-at-pfizer-whistleblower-suit/

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In wake of Pfizer scandal Congresswoman introduces bill: Deny federal funds to drug companies with felony convictions

Tuesday, October 20th, 2009

Ed Silverman
Pharmalot
October 19, 2009

Now that Pfizer agreed to pay $2.3 billion for illegally marketing several drugs, including Bextra, Zyvox, Geodon and Lyrica, over several years, one Congresswoman wants to punish stop such behavior – at least among those that do business with the federal government.

And so Betty McCollum, a Democrat from Minnesota, has introduced a bill that prohibits companies with a felony conviction from receiving any federal funding for five years after a conviction; prohibits corporate felons from making federal campaign contributions for five years, and limits the lobbying the corporation can do during that period to $1 million.

She calls her legislation the ACORN Act, or Against Corporations Organizing to Rip-off the Nation Act of 2009. Why? A significant target of recent Congressional action is the better-known ACORN, a non-profit that trains and advocates for poor and working-class Americans. Over the past 15 years, ACORN has received $53 million in federal funds. By contrast, Pfizer won $73 million in federal contracts in 2007, as The Nation notes, but has largely escaped Congressional wrath.

Read entire article: http://www.pharmalot.com/2009/10/congresswoman-deny-pfizer-any-federal-funding/

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