Evelyn "Evie" Pringle

Evelyn Pringle

It is with great sadness that I announce the death of the extraordinary investigative journalist, Evelyn Pringle.

'Evie', as I knew her, was the key reason I started writing this blog back in 2006. We would later correspond and help one another with various articles.

I first became aware of Evie's work after reading the excellent, Drip, Drip, Drip, Paxil Info Leaks Out, a superb piece of investigative journalism. I highly recommend you read it. The expose is from 2006 but it gives you an insight into Evie's brilliant mind and investigative skills.

Some years down the line we made contact after she learned about this British blogger guy linking to her articles.

In 2010, I received a 58-page document from the Federal Aviation Administration. It was regarding a Freedom of Information request I had submitted in relation to a proposal that will allow pilots to control aircraft whilst on certain SSRI medications.

Much of 2010 was taken up with me reporting on the Sara Carlin inquest, to be honest, I reached the point of burn-out once the inquest had finished.

I, therefore, forwarded the 58-page document on to Evie. I didn't really know anyone else who could do it justice.

Here is the result of Evelyn Pringle's study of the 58-page document: SSRIs Render Unfriendly Skies

Some years later Evie became a talk-show host covering such topics of government corruption and paedophile rings in Hollywood. She was never one to mince her words.

Evie's work is spread far and wide across the internet and after contacting me I helped her catalogue her articles so she could put them all in one place. Evelyn Pringle's Catalog of Articles was a result of that collaboration.

My one regret in life is that I never got to meet Evie in person, we corresponded and spoke on the phone, for those who never knew her, she was an extremely funny individual who swore like a docker and who was passionate about unveiling corruption. We lost touch as the years wore on and I didn't know she had been suffering an illness.

Fly high, sister, and thank you for giving me a voice and nurturing my skills as an investigative researcher. I shall live forever in your debt.

Your friend,

Fid

--

Bob Fiddaman

Obama Shuns Public Opinion on Psychiatric Drugs

If you are landing on my blog for the first time you'll probably have arrived here via a search engine, chances are you typed in "Paxil withdrawal" or "Seroxat side effects". In fact many visitors arrive here using the search terms Paxil or Seroxat combined with words such as "aggression", "mood swings", "suicidal thoughts", etc.

The recent Connecticut school shootings highlighted, for me at least, just how dangerous psychiatric drugs can be. It also highlighted how the public in general perceive 'mental illness'.

Adam Lanza, it is believed, shot and killed 27 people, 20 of whom were children, this before turning the gun on himself in an act of suicide.

This, obviously, outraged the public and comments on websites, forums and social networking sites were littered with opinion about Lanza's state of mind. "Nutter", "Crazy", "Madman", "Evil" all being examples of words used to describe Lanza.

Sure, I'd agree with most of the above descriptions but I wouldn't/couldn't just leave it there.

What made Lanza crazy?

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician

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BACK STORIES

PART I

PART II

Part III of this series shows how GlaxoSmithKline are using the services of an expert statistician in the up and coming UK Seroxat Group Action.

It's a name that took me by surprise and one that has been mentioned throughout blog land on numerous occasions. The name of the witness is synonymous with names such as Joseph Biederman, David Dunner, Graham Emslie, Daniel Geller, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer and Karen Wagner.

Most of the above played a major role in the ghost written articles regarding the safety and efficacy of Paxil [Seroxat] in children.

It would appear that his views on SSRi use for children remains positive, despite much evidence to the contrary.

Step up to the witness box, Dr. Robert Gibbons, Glaxo's expert statistician they will be using in the up and coming UK Seroxat Group Action.

Gibbons pretty much wrote his own destiny when he was the co-author of a study that appeared in the American Journal of Psychiatry in 2007

Gibbons co-authored study claimed there was a correlation between a 22% decrease in SSRI prescriptions and a 14% increase in youth suicide rates between 2003 and 2004, after warnings were issued by the FDA. However, the study was criticised by many.

Respected British Columbia researcher, Jon Jureidini, said the Gibbons study "incorrectly analyzed the relationship between U.S. selective serotonin reuptake inhibitor (SSRI) prescription rates and suicide rates among children."

"As it turns out," Dr Jureidini wrote, "preliminary figures are now available from the Centers for Disease Control (CDC), which show that fewer people under age 25 committed suicide in 2005 (when prescribing did decrease) than in 2004."

"In the year in which suicide rates rose sharply," he said, "there was no significant drop in SSRI prescribing."

Despite his critics, Gibbons said at a 2009 Medscape Continuing Medical Education seminar, sponsored by Lexapro and Celexa maker, Forest Labs, "we have seen in 2004 and 2005, the years for which CDC [Centers for Disease Control] has available data on youth suicide rates, the largest increases in youth suicide rates in history since they initially were monitored."

The disclosure section for the seminar shows Gibbons had served as an expert witness for Zoloft maker, Pfizer, and Wyeth Pharmaceuticals, maker of the antidepressants, Effexor and Pristiq.

Gibbons is a Professor of Biostatistics and Psychiatry and Director of the Center for Health Statistics at the [UIC] University of Illinois at Chicago College of Medicine, according to his bio on the Department of Psychiatry's webpage.

In 2007, the American Foundation for Suicide Prevention, and Seroxat maker, GlaxoSmithKline, donated between $10,000 and $24,000, to UIC College of Medicine, according to the Spring 2008 "UIC Medicine," newsletter.

Gibbons study received further criticism particularly after a Newsweek article entitled "Trouble in a 'Black Box", where Gibbons stated, "I think the FDA has made a very serious mistake. It should lift its black-box warning because all it's doing is killing kids."

After reading the Newsweek article, Dr Barry Duncan, a clinical psychologist, noticed the problematic claims being made.

He wrote a letter to both the author of the article and the Newsweek editors pointing out the problems with the article.

Duncan wrote:

Dear Editor:

Please find below our letter in response to the article, “Trouble in a Black Box.”

Our examination of the study forming the basis for the article revealed a glaring inaccuracy–the study’s results do not match the findings reported in the Newsweek article. Given that very few individuals read or understand research, we believe it important for Newsweek readers to be aware of this discrepancy to evaluate the necessity of the Black Box warning:

Tony Dokoupil’s Trouble in a ‘Black Box’ (July 16) importantly addresses the risks and benefits of prescribing antidepressants to children. However, the referenced study is far from “compelling” evidence for removing the FDA Black Box warning and such an interpretation of its findings is misleading. An inspection of this industry funded study reveals that the precipitous drop in SSRI prescriptions did not occur, as reported, from 2003 to 2005 but rather from February to October of 2005 (over 85% of the drop in the last 6 months of the reported time). The so-called “parallel development” of increased suicides occurred between 2003 and 2004 and therefore had no relationship to the drop in prescription rates reported in this study. Given that the decrease in prescription rates and increase in suicides occurred in different time periods, it begs the question of how such unsubstantiated statements could be made by the experts cited in the article.

Only 3 of 15 clinical trials have shown antidepressants to be superior to a sugar pill on primary measures. Children and parents in those 15 studies reported no advantage of antidepressants over a sugar pill. Data from the FDA and its British counterpart demonstrate that children and adolescents taking antidepressants are twice as likely to experience suicide-related events. Given the meager results and increased risk for suicide-related events (as well as other serious adverse events), antidepressants are not a good first choice for youth struggling with depression a conclusion reached after an extensive risk/benefit analysis conducted by the American Psychological Association’s Work Group on Psychotropic Medication

Barry Duncan, Psy.D., Jacqueline Sparks, Ph.D. & Scott Miller, Ph.D.

It could be argued that that Glaxo's expert statistician isn't that expert after all. His study has come under fire from many, as have his statistics.

Gibbons CV can be read here.

Special thanks to investigative journalist, Evelyn Pringle, for passing on documents regarding Dr. Robert Gibbons, many of which, have been forwarded to the solicitors representing the plaintiffs in the UK Seroxat Group Action.

Coming soon: Part IV - Another Glaxo expert witnessed revealed...along with his ties to Glaxo and it's huge donations.

Related links:

Suicide Syndrome

SSRI Pushers under Fire - By Evelyn Pringle

Paxil Study 329: Paroxetine vs Imipramine vs Placebo in Adolescents - Healthy Skepticism

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Tracking the American Epidemic of Mental Illness - Part II - By Evelyn Pringle

Part I HERE

Part II of a 5 part series

Investigated and written by Evelyn Pringle.

Reproduced with kind permission from the author, Evelyn Pringle




Tracking the American Epidemic of Mental Illness - Part II



Tax dollars are being used to fuel the American epidemic of mental illness by promoting the preemptive drugging of persons supposedly at risk of developing mental disorders, to the great benefit of the pharmaceutical industry.


In March 2010, the US 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," one of SAMHSA's services grant programs.

"In order to complement but not duplicate the efforts of other CMHS programs, FY 2010 funding for MHTG will focus on services for adults with or at-risk for serious mental illnesses," the agency noted. Applications were required to implement evidence-based or best practices that would create or expand capacity to address one or more of five Strategic Initiatives, including: "Prevent mental illness through outreach, screening, and early interventions for adults with early signs of mental illness or who are at risk, and promote wellness through holistic treatment approaches."
An evidence-based practice, or EBP, refers to approaches to prevention or treatment that are validated by some form of documented research evidence. As an example of a practice that could be implemented, SAMHSA listed under "Prevention and Wellness: Early Intervention," the "Early Detection and Intervention for the Prevention of Psychosis Program (EDIPPP)," along with a link to its website http://www.changemymind.org/.


EDIPPP is a national program replicating the "Portland Identification and Early Referral," or "PIER," a treatment research program at the Main Medical Center, in Portland, Maine.


On a webpage for PIER on the Center's Website, under "Project Overview," it states: "The goals are to improve outcomes and prevent the onset of the psychotic phase of illnesses like Bipolar Disorder, Major Depression, and Schizophrenia."


"This is the first program in the United States to identify the entire population of at risk young persons and offer them treatment," PIER said in a September 26, 2005 press release.


EDIPPP was funded through a $14.4 million million grant for the "National Demonstration of Early Detection, Intervention and Prevention of Psychosis in Adolescents and Young Adults," from the Robert Wood Johnson Foundation, and is "designed to prevent psychosis in teens and young adults," according to an April 10, 2007, announcement on RWJF's launch of the program.


"The national program is expanding PIER's success during the past seven years in identifying and treating young people experiencing subtle and early symptoms that herald the onset of serious mental illness," a November 2007 report in Behavioral Healthcare, by Dr James Maier, a research psychiatrist with PIER, notes.


EDIPPP works with people between the ages of 12 and 25, with an average age of persons entering the program between 15 and 16.


"Widespread dissemination of this early intervention model throughout the United States offers tremendous hope and optimism for combating some of the most devastating and costly illnesses that can afflict young people and their families," Maier claims.


The RWJF grant set up additional EDIPPP sites in Sacramento, California; Salem, Oregon; Ypsilanti, Michigan; and Glen Oaks, New York. A site in Albuquerque, New Mexico was added in 2008.


RWJF also funds a booklet for professionals, on how to prevent mental illness with early detection titled, "Recognizing and Helping Young People at Risk for Psychosis: A Professional’s Guide," which can be downloaded free off the internet.


From the start, PIER has always been primarily funded by RWJF, according to its website. However, on October 13, 2003, Mental Health Weekly reported that the program had received a $3.9 million grant from the National Institute of Mental Health, and a parallel $2 million grant from the Center for Mental Health Services intended for a related program in early identification of non-psychotic disabilities.


In Portland, young people typically are referred to PIER by high school guidance counselors, pediatricians, or other clinicians who attended presentations about PIER's work, visited the PIER Website (http://www.preventmentalillness.org), and are familiar with the early warning symptoms that suggest the onset of a psychotic illness, according to the report in Behavioral Healthcare.




Mental Illness According to PIER


In a fact sheet posted to "Dispel the Myths," the PIER website claims that, "Mental disorders are as easy to diagnose as asthma, diabetes, and cancer."


"Treatments are effective 60%-80% of the time, success rates that meet or exceed success rates for cutting edge treatment for heart disease," the sheet states.


"In many cases, PIER does use medications," the Websites says. "We believe that some of the newer medications effectively improve thinking and combat early symptoms."


"Research suggests these medications may have a protective effect against changes in the brain that cause mental illness," it reports.


Under costs, it reads: "For now, services provided by PIER staff are supported by grants. However, if certain medications, medical tests, or neurological assessments are ordered, there will be a charge."


The PIER program was founded in 2000, by Dr William McFarlane, and after 10 years in operation, on May 28, 2010, the ChangeMyMind website listed only two "case studies and impact stories that illustrate the effectiveness of the Early Detection and Intervention for the Prevention of Psychosis Program."



Medicated for Life


Virtually every person entering the PIER program is prescribed antipsychotics, such as Risperdal or Invega, marketed by Johnson & Johnson, the parent company of the Robert Wood Johnson Foundation. These prescriptions are off-label because antipsychotics are not FDA approved to "prevent" mental illness in any age group.


An August 2008 article, by Charles Schmidt in Discover Magazine, highlighted the PIER program with a byline that stated: "A new mix of therapy and medication may stave off psychosis among teens at risk."


Schmidt discussed the case of Camila (not her real name), who entered the program in September 2001, when she was 14. "Camila and her family stuck with PIER for the four-year treatment program, which ended formally in 2005, and still keep in touch with counselors there," he reports.


However, "Camila’s health still hinges on antipsychotic medication," Schmidt says. "In the summer of 2007 she went off the drugs for a spell and her strange feelings returned."


He notes that her reliance on antipsychotics raises issues. "On the one hand, it shows that the threat of psychosis hasn’t really been removed, it’s just been held in check."


"What we hope is that the benefits of treatment will be lifelong," McFarlane says in the article. "We don’t have any empirical evidence to support that yet, but what we’ve seen is that young people who still haven’t converted to psychosis after about three years of our treatment don’t seem to be at much risk."


While he suggests that over time, some patients may be able to go off medications, McFarlane acknowledges that PIER hasn’t developed a plan for managing that process, Schmidt reports.


"As to when or if they can go off medication, that’s hard to say," he told Schmidt. "I think many of our patients don’t feel a need to stop; they certainly don’t feel oppressed by it. At a certain point it becomes a personal choice."


A fortune can be made from these life-long antipsychotic customers. In April 2010, the price for one box of Invega, at a middle dose, was $1,373 at DrugStore.com. Risperdal went for $788 per 90 pills. The cost was $1,395 for 100 tablets of Abilify. Seroquel cost $997 per 100. One-hundred capsules of Geodon sold for $918 and Zyprexa cost $1,523 for a hundred 10mg pills.


In 2003, McFarlane told Mental Health Weekly that with about 3% of the population at risk for a serious mental illness, Greater Portland could expect about 75 young people to develop a disorder each year.



RWJF Front Group


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. RWJF's board of trustees has always been stacked with the drug company's executives. For instance, current and past trustees have held positions at J&J such as President, CEO, Vice President, Chairman of the Board, and Treasurer, and have served along side another family heir on the board, Robert Wood Johnson IV.


RWJF is listed in a Medicaid fraud lawsuit, filed against J&J by whistleblower, Allen Jones, a former federal fraud investigator, and joined by the Texas attorney general, as providing funding for illegal marketing schemes to increase the off-label sales of Risperdal, including funding the development of the "Texas Medication Algorithm Project (TMAP)," which required doctors to prescribe the newest, most expensive antipsychotics, antidepressants, anticonvulsants, and ADHD drugs to patients covered by public programs, like Medicaid and Medicare, who were diagnosed with mental disorders, and a nearly identical set of child drugging guidelines known as the "Texas Children's Medication Algorithm Project (CMAP)."


In addition to Risperdal and Invega, J&J also markets the ADHD drug Concerta, and Topamax, an anticonvulsant.


A May 11, 2005, report by RWJF on the results of the funding of TMAP grants totaling $2,389,581 to the University of Texas Southwestern Medical Center at Dallas and a grant of $353,747 to the Texas Department of Mental Health and Mental Retardation, describes the supposed "Problem," that led to the creation of the TMAP drugging guidelines as:


"In the 1980's and 1990's, as pharmaceutical companies began producing new and more efficacious medications to treat people with serious mental disorders such as depression, bipolar disorder, and schizophrenia, the question arose of how to choose the most appropriate treatment options. Concerns about wide variation in prescribing practices by physicians and complaints from consumer advocates about the negative consequences of this variation spurred the creation of evidence-based guidelines and medication treatment algorithms."


The "Contacts" for the grants listed in the report, were Dr A John Rush, for the University, and Dr Steven Shon for the state of Texas. Shon was fired in October 2006, after the Texas attorney general determined that J&J had improperly influenced him to make Risperdal a preferred drug on TMAP. In 2008, Rush was added to a list of psychiatric academics who failed to disclose all the payments they received from drug companies, by Senator Charles Grassley, as part of an investigation conducted on behalf of the US Senate Finance Committee, which oversees Medicaid and Medicare spending.


As a main component of the off-label marketing schemes, the lawsuits against the antipsychotic makers allege that the drug companies “seeded” the medical literature with reports and papers purporting to be written by "experts" when they were actually ghostwritten with the names of experts attached after the fact.


In its report on the TMAP grant results, RWJF boasts that: "More than 50 articles on the Texas Medication Algorithm Project have appeared in the Journal of Clinical Psychiatry, Psychiatry Research, Managed Care, Health Services Research, Journal of the American Academy of Child and Adolescent Psychiatry and other peer-reviewed journals."


"Over the next two years, Project Directors Rush and Shon and their colleagues plan to publish additional articles on other areas of interest," the report said.


On August 18, 2008, a Dallas Morning News headline read: "Conflict of interest fears halt children's mental health project," in reference to the Children's Medication Algorithm Project. "A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list," the News wrote.


To date, four of the five atypical makers have settled fraud charges involving the illegal off-label marketing of antipsychotics, including for use with children. Eli Lilly paid $1.4 billion for Zyprexa, Bristol-Myers Squibb's fine was $515 million for Abilify, Pfizer paid $301 for Geodon, and AstraZeneca just forked out $520 million for Seroquel.


But the fines are merely chocked up to the cost of doing business. For instance, although AstraZeneca paid a whopping $520 million fine, Seroquel had sales of $4.9 billion in 2009, with more than half coming from the US. Overall, antipsychotics were the top-earning class of drugs in the US, in both 2008 and 2009, with sales of $14.6 billion in 2009, according to IMS Health.


J&J is the only atypical maker that has not settled the off-label marketing charges against it - yet. However, two units of J&J "will pay more than $81 million to resolve criminal and civil claims over illegal promotion of the epilepsy drug Topamax," according to Bloomberg news on April 29, 2010.


Also, over the past 2 months, J&J's McNeil division has recalled over 40 varieties of child and baby medications after the FDA found massive safety and manufacturing violations at a plant in Fort Washington, Pennsylvania, including formulations of Tylenol, Motrin, Zyrtec and Benadryl. The FDA also found problems with "strength, quality and purity."


The FDA's inspection report notes that J&J received about 46 consumer complaints “regarding foreign materials, black or dark specks [in their drugs] from June 2009 to April 2010.” J&J had knowledge of problems since May 2009, which means it was allowing children and infants to ingest potentially poisonous drugs for a year before the product recall took place.


Time Magazine as Promoter


On June 22, 2009, the RWJF website posted a link to download the full text of an article in Time Magazine, by John Cloud titled, "Staying Sane May Be Easier Than You Think," who reported: "The most exciting research in mental health today involves not how to treat mental illness but how to prevent it in the first place."


"In fact," Cloud said, "many mental illnesses — even those like schizophrenia that have demonstrable genetic origins — can be stopped or at least contained before they start."


"This isn't wishful thinking but hard science," he claimed.


The article discussed a report by the National Academics, "an organization of experts who investigate science for the Federal Government," nearly two years in the making, "on how to prevent mental, emotional and behavioral disorders." A quick check found one of the sponsors of the National Academies to be RWJF.


"The report concludes that pre-empting such disorders requires two kinds of interventions," Cloud said, "first, because genes play so important a role in mental illness, we need to ensure that close relatives (particularly children) of those with mental disorders have access to rigorous screening programs."


"Second," he noted, "we must offer treatment to people who have already shown symptoms of illness (say, a tendency to brood and see the world without optimism) but don't meet the diagnostic criteria for a full-scale mental illness (in this case, depression)."


"Some prevention programs even prescribe psychiatric medications, including antipsychotics and antidepressants, to people who aren't technically psychotic or depressed," Time reported.


"This is a big concern," Joseph Rogers, founder of the Philadelphia-based National Mental Health Consumers' Self-Help Clearinghouse told Cloud. "Because, gee, if you miss, you can really do more harm with some of these drugs than good."


"But those who contributed to the National Academies report say preventing the suffering of people with mental illness is worth the risk of some false positives, partly because of the enormous cost of treating mental illness after it's struck," Cloud reported.


The article profiled PIER and McFarlane, who was described as "one of the world's top authorities on preventing mental illness."


According to Time, the "National Institute of Mental Health is funding a trial of McFarlane's work, and while he is still writing up his data for publication, his anecdotal results are promising: most of the kids are so far avoiding a first psychotic episode."



Preemptive Drugging Unsupported


In a 2008 paper titled, Atypical Antipsychotic Agents For the Schizophrenia Prodrome: Not a Clear First Choice," published in the "International Journal of Risk & Safety in Medicine," Dr Stefan Kruszewski, a psychiatrist, and Dr Richard Paczynski, a neurologist, both from Harrisburg, Pennsylvania, explain that, "Pharmacologic intervention at the earliest stages of suspected psychotic illness is an intuitively appealing concept and a logical extension of the current approach to many other diseases of the central nervous system."


"However," they report, "a critical analysis of the results of structured clinical investigations which have explored the use of ATAPs for new-onset psychotic symptoms raises safety concerns and does not support pre-medication in this setting as a preventive strategy."


"Over the past several years," the paper states, "a voice has emerged in the international psychiatric community recommending early prescription of the atypical antipsychotic agents (ATAPs) for adolescents and young adults who appear to show signs consistent with a schizophrenia prodrome. Early use is predicated on the possibility that ATAPs may prevent progression to full-blown psychotic illness in this high-risk population. "


"This trend has been encouraged despite a paucity of data which clearly support the effectiveness of these agents for this indication, and despite evidence of adverse side effects including," the authors note.


These circumstances prompted their literature review, "focusing on the five published studies that have explicitly addressed the preventative efficacy of the most widely prescribed ATAPs in structured (i.e., non-anecdotal) clinical settings."


In the summary and conclusion section of the paper, the authors report that the results from the available controlled trials reviewed are in line with several of the conclusions of the naturalistic study by Cornblatt et al. "That is, early prescription of ATAPs to adolescents and young adults seeking medical attention for prodromal psychotic symptoms is associated with high rates of medication non-adherence."


"Additionally," they say, "the introduction of ATAPs was not associated with reduction in the rate of conversion to formal psychosis beyond that explainable by chance and/or the introduction of bias secondary to baseline imbalances, inadequate blinding or even differential psychosocial supports."


"We suggest caution in making any assumptions that justify changes in prescription-writing behavior when it involves patients who are at high risk for developing long-term psychotic illnesses but have never demonstrated sustained psychosis (psychotic illness by DSM-IV criteria)," Kruszewski and Paczynski advise.


"This would include but is not limited to persons with suspected schizophrenia prodrome," they add.


"Even in the hands of experienced investigators using detailed screening protocols in controlled settings, only one-quarter to one-third of high-risk patients converted to full-blown psychosis," they report.


"Consequently," they warn, "if early use of ATAPs continues as a quasi-standard of care for new-onset psychotic symptoms, a large majority of these often young individuals will be exposed unnecessarily to poorly defined but likely substantial risks, including but not limited to obesity, hyperlipidemia, metabolic syndrome, increased rates of type II diabetes mellitus and extrapyramidal syndromes, both acute and chronic."


"Considerations of safety must come first when the preventative efficacy of these agents remains so poorly defined," they conclude.


(Part III of this series will highlight the Psychiatric Industrial Complex as the driving force behind the American Epidemic of Mental Illness)


Evelyn Pringle


This series is sponsored by the International Center for the Study of Psychiatry and Psychology

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Tracking the American Epidemic of Mental Illness - Part I by Evelyn Pringle

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This article is Part I of a 5 Part Series.

Investigated and written by Evelyn Pringle.

Reproduced with kind permission from the author, Evelyn Pringle



Tracking the American Epidemic of Mental Illness - Part I




Over a twenty year span, starting when Prozac came on the market in 1987, the number of people on government disability due to mental illness went from 1.25 million to more than 4 million today. There has been a 35-fold increase in the number of children disabled by mental illness who receive federal disability payments, rising from 16,200 in 1987, to 561,569 in 2007.


These statistics come from a new book titled, "Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness, in America," by award winning journalist, Robert Whitaker, who also authored "Mad in America."


For the book, Whitaker reviewed 50 years of outcomes in the medical literature, for adults with schizophrenia, anxiety, depression, and bipolar illness, and the childhood disorders of ADHD, depression and juvenile bipolar disorder, to see whether medications had altered the long-term course of the disorders and whether drugs could bring on new or more severe psychiatric symptoms.


His intent was to assess whether this paradigm of care increased the risk that a person would become chronically ill, or ill with disabling symptoms, he reports in his "Mad in America" blog, on the Psychology Today website.


"Although we, as a society, believe that psychiatric medications have "revolutionized" the treatment of mental illness, the disability numbers suggest a very different possibility," he wrote in the April 28, 2010, Huffington Post.


On April 29, 2010, Alternet published an interview with Whitaker by Dr Bruce Levine, with the headline question of, "Are Prozac and Other Psychiatric Drugs Causing the Astonishing Rise of Mental Illness in America?"


The "literature is remarkably consistent in the story it tells," Whitaker told Levine. "Although psychiatric medications may be effective over the short term, they increase the likelihood that a person will become chronically ill over the long term."


"In addition, the scientific literature shows that many patients treated for a milder problem will worsen in response to a drug-- say have a manic episode after taking an antidepressant -- and that can lead to a new and more severe diagnosis like bipolar disorder," he said. "That is a well-documented iatrogenic pathway that is helping to fuel the increase in the disability numbers."


During the interview, Whitaker discusses his research on the increase of juvenile bipolar disorder in the US, as an example of how prescribing psychiatric drugs to children can actually cause mental illness.


"When you research the rise of juvenile bipolar illness in this country, you see that it appears in lockstep with the prescribing of stimulants for ADHD and antidepressants for depression," he reports.


"Prior to the use of those medications, you find that researchers reported that manic-depressive illness, which is what bipolar illness was called at the time, virtually never occurred in prepubertal children," he explains.


"But once psychiatrists started putting “hyperactive” children on Ritalin, they started to see prepubertal children with manic symptoms," he reports.


"Same thing happened when psychiatrists started prescribing antidepressants to children and teenagers," Whitaker says. "A significant percentage had manic or hypomanic reactions to the antidepressants. "


"Thus, we see these two iatrogenic pathways to a juvenile bipolar diagnosis documented in the medical literature," he states.


The bipolar kids often end up on cocktails of heavy-duty drugs, including antipsychotics such as Zyprexa, Risperdal, Invega, Seroquel, Abilify and Geodon, which cause a host of physical problems and possible cognitive decline over the long term, he told Levine.


"When you add up all this information, you end up documenting a story of how the lives of hundreds of thousands of children in the United States have been destroyed in this way," Whitaker says.


In fact, he thinks that "the number of children and teenagers that have ended up “bipolar” after being treated with a stimulant or an antidepressant is now well over one million."


"This is a story of harm done on an unimaginable scale," he told Levine.


Levine, an author himself of "Surviving America's Depression Epidemic," describes "Anatomy of an Epidemic," as the "most important book on psychiatric treatment in a generation."




Role of American Psychiatric Association


In 2006, the 38,000 member strong, American Psychiatric Association, received 30% of their funding, or more than $20 million, from the pharmaceutical industry.


This year's attendees at the group's annual meeting last month in New Orleans "had to brave 200 protestors chanting "no drugging kids for money" and "no conflicts of interest" to get into the convention hall," according to Martha Rosenberg's May 30, 2010 report in OpEd News.


"If there were a take home message at the APA meeting about the blizzard of ADHD, bipolar and personality disorders threatening adults and children, it was don't wait," Rosenberg says. "These dangerous conditions, likened to cancer and diabetes, won't go away."


"Thanks to genetic advancements, psychiatric disease risks can now be detected and treated before symptoms surface, said presenters, fostering early treatment paradigms that are pretty Brave New World: People being told they have a disease they can't feel that needs immediate and lifelong treatment at hundreds of dollars a month or their health will suffer," she reports.


"Preemptive psychiatric drugging is likely the most dangerous idea that has come along since lobotomy," warns the prolific anti-drugging activist, Vince Boehm.


As far as drugs, there was no star of the show, Rosenberg says. "The Next Big Thing was not a new drug at all but adjunctive therapy also known as adding existing drugs to existing drugs because they don't work right."


"Throwing good drugs after bad, popularized with the antipsychotic Abilify," she explains, "has only been enhanced by a study in the January JAMA that found antidepressants don't work for mild depression at all."


"Antipsychotics are also being "enhanced" by adding drugs to offset weight gain and lethargic side effects," she reports.


"The pharmaco-fraudulence which has taken over psychiatry today is absolutely breathtaking," says Dr Nathaniel Lehrman, former Clinical Director of Kingsboro Psychiatric Center, Brooklyn NY.


"There is absolutely no rationale for adding antipsychotics to antidepressants in the treatment of depression other than the hope that somehow the patient will feel better when new medication is added when the old is not enough," he reports.


Lehrman can think of no medication "which is really specific for anything in psychiatry."


"The effect of all these medications is largely happenstance," he says. "If something happens to make the patient feel better while taking a particular medication, the latter will be credited."



Catalog of Mental Disorders


In January 2010, the APA released a draft for the 5th edition of the Diagnostic and Statistical Manual, or DSM-V, also known as the Billing Bible of psychiatry, with the official definitions of normal and abnormal. Criticisms of the revisions and the task force have been non-stop.


In a March, 2010, analysis in Psychiatric Times, Lisa Cosgrove and Harold Bursztajn reported that approximately 68% of the members of the DSM5 task force had financial ties to the pharmaceutical industry, a 2% increase over the task force members of the DSM4 with such ties.


The draft criteria for "Temper Dysregulation Disorder with Dysphoria," has specifically come under attack as "one of the most dangerous and poorly conceived suggestions for DSM5," by Dr Allen Frances, who was chairman of the DSM-IV Task Force, in his "DSM5 in Distress" blog on the Psychology Today Website.


"Apparently, the Work Group was trying to correct excessive diagnosis of childhood bipolar disorder—but its suggestion is so poorly written that it could not possibly accomplish this goal and instead would it would create a new monster," he advises.


"The “diagnosis” would be very common at every age in the general population and would promote a large expansion in the use of antipsychotic medications, with all of the serious attendant risks," he warns.


"While trying to rescue kids who are now misdiagnosed as bipolar," Frances says, "it will undoubtedly open the door to the misdiagnosis of normal kids who happen to be temperamental or in difficult family circumstances."


The syndrome was first called "severe mood dysregulation (SMD)," but the Childhood Disorders Work Group decided to rename it "temper dysregulation with dysphoria (TDD)," because (a) the new name is more descriptive; and (b) the name of DSM diagnoses does not typically include a denotation of severity, according to the group's report.


In any event, the prescribing of psychiatric drug cocktails will continue no matter what they end up calling the new disorder. If TDD is a form of BD, "first-line treatment would consist of atypical antipsychotic medication and/or mood stabilizers," the group states in the report. "On the other hand, if TDD is on a continuum with unipolar depressive disorders, anxiety disorders, and ADHD, first-line treatment would consist of serotonergic reuptake inhibitor antidepressants (SSRI’s) and stimulants."


In a March 8, 2010 article in Skeptic Magazine, Dr John Sorboro warned that the "folks writing the new DSM-V are even considering a new classification of “prodromal” disorders, which means you may qualify for diagnosis of a mental disorder just based on the hunch of your psychiatrist. "


"Psychiatrists get paid for treating mental illness," he says. "There is a strong motivation for them to look at things they used to attribute to chronic personality, or just life, and see them as psychiatric illness. "


"These changes have nothing to do with any real definitive science or specific tests that can effectively demonstrate who has a disorder," Sorbora notes. "It’s little more than psychiatry repackaging people with different labels."


"Who gets what label has a lot more to do with politics and the economics of psychiatry than it does with any true understanding of the developmental or biologic underpinnings of specific behavior let alone whether we choose to see "different" as "disordered," he points out.


Sorboro says following the money has led many people to seriously question "the motivations of some of psychiatry’s most prolific researchers who shape how people get diagnosed, what disorder label they are given, and what drugs they are prescribed."


He notes Senator Charles Grassley's ongoing investigation to determine the full extent of industry fees paid to psychiatric researchers, and that "some of the biggest names in the business have been accused of misconduct."


The "biggest names in the business," identified by Grassley thus far, include Harvard University's Joseph Biederman, Thomas Spencer and Timothy Wilens; Charles Nemeroff and Zachery Stowe from Emory University; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, the president of the American Psychiatric Association from Stanford University; Martin Keller at Brown University; Karen Wagner and A John Rush from the University of Texas; and Fredrick Goodwin, the former host of a radio show called "Infinite Minds," broadcast for years by National Pubic Radio.


"Among all the problematic suggestions for DSM5, the proposal for a " Psychosis Risk Syndrome" stands out as the most ill conceived and potentially harmful," according to Dr Frances, in his "DSM5 in Distress" blog on the Psychology Today Website.


"This is a clearly the prescription for an iatrogenic public health disaster," he warns.


"The whole concept of early intervention rests on three fundamental pillars- being able to diagnose the right people and then providing them with a treatment that is effective and safe," he explains. "Psychosis Risk Syndrome" fails badly on all three counts, he warns.


"The false positive rate would be alarming," he says, "70% to 75% in the most careful studies and likely to be much higher once the diagnosis is official, in general use, and becomes a target for drug companies."


"Hundreds of thousands of teenagers and young adults (especially, it turns out, those on Medicaid) would receive the unnecessary prescription of atypical antipsychotic drugs," he warns.


"There is no proof that the atypical antipsychotics prevent psychotic episodes," he says, "but they do most certainly cause large and rapid weight gains (see the recent FDA warning) and are associated with reduced life expectancy—to say nothing about their high cost, other side effects, and stigma."


"Imagine the human tragedies that follow the mislabeling of 70% of children as severely mentally ill, who are then exposed to extremely toxic drugs that induce diabetes, cardiovascular disease, and a host of other severe adverse effects," warned Vera Hassner Sharav, founder and president of the Alliance for Human Research Protection, in a February 10, 2010 Infomail.




Unnecessary Drugging


"We are going to have an epidemic of young adults with yet-to-be-determined neurological problems due to the long term use of psychotropic drugs," warns Washington DC psychiatrist Dr Joseph Tarantolo, Board Chairperson of the International Center for the Study of Psychiatry and Psychology.


An epidemic is defined as 1% of the population and there will be far more than 1% injured by these drugs, he says.


Every human being is at risk of becoming "psychotic," he states. "It has been said that in the Nazi Germany concentration camps psychosis was 100%."


"Once one agrees that something is universal, one is simply trying to describe the human condition, not make a medical diagnosis," Tarantolo advises.


Dr Stefan Kruszewski, a graduate of Princeton University and Harvard Medical School, has seen many patients who experienced one or more episodes of psychosis from medications, illicit drug withdrawal, acute stress, metabolic conditions, PTSD or other psychiatric diagnoses, "who recovered and did not re-experience problems later in life."


In his extensive clinical experience with psychotic individuals, "recovery after psychosis has been the "norm," not the exception," he says


"More significantly, and somewhat contrary to the prevailing psychiatric professional view," he notes, "the overwhelming majority of my clients in who I observed this ‘norm’ did NOT require psychiatric medicines to sustain them."


"And, many of them who were prescribed antipsychotic medications to ‘thwart’ another psychotic episode fared somewhat worse than those who were not prescribed any combination of antipsychotics and mood stabilizers," he adds.


Dr Thomas Edward Bratter is president and founder of the John Dewey Academy in Massachusetts, a residential, voluntary, educational-treatment school for gifted but self-destructive adolescents. This drug and medicine-free facility uses compassionate psychotherapy.


Most students arrive at the Academy with multi DSM-IV labels to justify prescribing psychotropic poisons and receiving third party payments, Bratter says, and have been "raped by the pejorative psychiatric cartel."


He calls the "Psychosis Risk Syndrome" criminal because "such a diagnosis ignores the awesome toxic power of a negative self-fulfilling prophesy which maximizes failure by perpetrating the unproven myth of mental illness."


"There needs to be a class action against those who would endorse this movement," he says, and Bratter would gladly testify on behalf of children and adolescents who need to be protected from such a toxic and damaging conspiracy.


Toxicology expert, Dr Lawrence Plumlee, is president of the Chemical Sensitivities Disorders Association, and editor of, "The Environmental Physician of the American Academy of Environmental Medicine."


The Chemical Sensitivity Disorders Association was established to provide information and support to chemically sensitive people; to disseminate information to physicians, scientists and other interested persons; and to encourage research on chemical sensitivity disorders and minimizing hazards to human health.


Plumlee is concerned about the DSM5 proposal by the Somatic Symptom Disorders Work Group, to change the name of the category "Somatic Symptom Disorders," to "Complex Somatic Symptom Disorder."


"The new draft DSM manual proposes that chronic fatigue syndrome, fibromyalgia, and multiple chemical sensitivity are "somatiform" disorders requiring psychiatric consultation," he says. "It's the same old story of Psychiatry trying to extend its diagnostic labels and drug treatments to new populations."


This is "an effort by psychiatry to psychiatrize physical illnesses and to try to suppress the complaints of these patients by prescribing psychiatric drugs," Plumlee says.


"But experience is showing that the psychiatric procedures and drugs are making patients worse," he advises.


Using psychiatric diagnoses and drugs on diseases of neurotoxicity helps the chemical companies in two ways, he reports. "It fools some people into thinking that poisoned people are crazy, thus getting the poisoners (chemical companies) off the hook," and two, "it sells more chemicals (psychiatric drugs) to treat those who really need detoxification, not more chemicals in their bodies. "



(Part II of this series with show how tax dollars are being used to fuel the American Epidemic of Mental Illness)




Evelyn Pringle



This series is sponsored by the International Center for the Study of Psychiatry and Psychology



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Targeting Pregnant Women

Evelyn Pringle has wrote a fascinating article about the problems with Reglan, a drug used to treat heartburn caused by gastric reflux.

Once again, her investigative journalism tells it like it is. No sugar-coated nonsense from the pen of one of the great writer's out there.

You can access Evie's article HERE

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June 4, 2007 - The FDA, GlaxoSmithKline and the Avandia Disaster

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Following on from today's announcement on Bloomberg regarding GlaxoSmithKline making out of court settlements re their drug, Avandia.

Here is an article written by investigative journalist, Evelyn Pringle.

Evie penned this in 2007.

I think it's about high time that this suppression and obvious denial, stops, right here, right now.

If there is one thing in life I must do, it is to meet Evelyn Pringle so I can kneel down before her uttering, "We are not worthy" - This woman deserves a Pulitzer for uncovering the dodgy goings-on within the pharmaceutical industry and the supposed drug regulators.

Evie, this blog salutes you.

June 4, 2007

Partners in Crime

The FDA, GlaxoSmithKline and the Avandia Disaster

By EVELYN PRINGLE

On May 21, 2007, the New England Journal of Medicine reported a study that found GlaxoSmithKline's diabetes drug Avandia is associated with a 43% increase in heart attacks and possibly a 64% increase in cardiovascular death. The NEJM said it posted the article online ahead of its June 6, 2007 print edition because of its medical importance.

Experts point out that the studies analyzed for the NEJM report were not designed to look for heart risks, many were only 24 weeks long, and it may be that higher risks will appear after a longer term of use. Dr David Nathan, chief of diabetes care at Massachusetts General Hospital, who reviewed the paper for the NEJM, told the Associated Press, "This analysis is just scratching the surface of what may be there."

Avandia (rosiglitazone) was FDA approved in 1999 for the treatment of type 2 diabetes, a disease that affects between 18 to 20 million Americans.

When approved, Glaxo promoted Avandia as being safer than Rezulin, a diabetes drug removed from the market in 2000 after serious cases of liver damage developed in patients taking the drug.

Avandia is currently the top selling diabetes drug with total US sales of $2.2 billion in 2006, according to IMS Health, a healthcare tracking information firm. A one-month supply sells for between $90 and $170, the Associated Press reported on May 23, 2007.

"More than 6 million people worldwide," the Associated Press reports, "have taken the drug to control blood sugar since it came on the market eight years ago, and about 1 million Americans use it now."

The FDA is going to have an extremely tough time wiggling out from under the rug of blame for this regulatory failure. The situation "reflects very badly on the FDA and on Glaxo," Dr Nathan said. "It's the FDA's responsibility to be monitoring this stuff."

In an editorial that accompanied the study in the NEJM, Dr Bruce Psaty of the University of Washington and Dr Furberg of Wake Forest University wrote: The drug "represents a major failure of the drug-use and drug-approval processes in the United States."

They also state that "the rationale for prescribing rosiglitazone at this time is unclear," because when the drug was approved its benefits were "at best mixed."

Documents dating back 7 years show the FDA knew about the risks associated with Avandia and did nothing to protect consumers. The day after the new study appeared online, on May 23, 2007, Dr Sidney Wolfe, director of Public Citizen, a non-profit health research group, sent a letter to FDA Commissioner Andrew von Eschenbach, which described a July 16, 2002 FDA memo that showed FDA scientists had recommended that the label for Avandia be amended to include post-marketing reports of heart failure among patients taking the drug.

"The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough," Dr Wolfe said in a press release.

"As a result," he stated further, "millions of people -- to the detriment of their health -- are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs."

According to the memo, in July 2002, the FDA had 25 adverse reaction reports in which the use of Avandia resulted in hospitalization for heart failure. By the fall of 2006, the number of cases had increased to 415, Public Citizen reports.

Another memo dated May 22, 2002, submitted to the FDA by Dr. Wolfe and Larry Sasich for an FDA Hearing on Risk Management of Prescription Drugs informed the panel that a Glaxo-employed physician had contacted Public Citizen to report that the company was concealing reports of serious problems found with the drug.

"This week," they informed the FDA, "we received an anonymous call from a GlaxoSmithKline physician who was alarmed at the failure of his company to require a black box warning concerning heart failure caused by Avandia."

"He maintained that the company currently has 450 reports of heart failure associated with the use of the drug and over 1200 reports of edema," the statement said.

Nearly two years earlier, on March 15, 2000, Dr. John Buse, an Associate Professor of Medicine and Director of a Diabetes Care Center in Durham, North Carolina, sent a letter to then FDA Commissioner, Dr Jane Henney, warning the FDA about the risks of Avandia and describing the abuse of clinical trial data by Glaxo.

"I remain concerned about the safety of rosiglitazone," Dr Buse wrote, "in light of its consistent negative impact on lipids documented in the FDA registration data as well as a worrisome trend in cardiovascular deaths and severe adverse events in the subjects exposed to rosiglitazone versus active comparators."

Dr Buse warned, "I think the FDA has to act forcefully to prevent the rampant abuse of clinical trial data by SmithKline Beecham."

He warned Dr Henney that Glaxo was overstating the safety of Avandia with respect to cardiovascular issues. "I have been shown glossy materials claiming that rosiglitazone has been uniquely studied in patients with preexisting cardiac disease," he wrote, "including patients with a number of associated conditions (such as unstable angina)."

"I know for a fact," he noted, "that such patients are excluded in clinical trials as I am a PI [Principal Investigator] in one of their trials."

Lawmakers in both Houses of Congress reacted to the news of another FDA regulatory failure immediately. On May 21, 2007 the US House of Representatives Committee on Oversight and Government Reform announced that a hearing would be held on June 6, 2007, at 10:00 am in Room 2154, Rayburn House Office Building, to assess the FDA's role in the evaluation of the safety of Avandia.

Committee chairman, Rep Henry Waxman (D-CA) extended an invitation to the author of the NEJM article, cardiologist, Dr Steven Nissen of the Cleveland Clinic, to testify at the hearing and discuss his article.

Dr Nissen and statistician Kathy Wolski, MPH, evaluated 42 studies involving nearly 28,000 patients and compared the 15,560 patients who were using Avandia to the patients who were not using the drug. The study found there were 86 myocardial infarctions in the Avandia group and 72 in the control group and there were 39 deaths from cardiovascular causes in Avandia patients compared to 22 in the control group.

Rep Waxman also sent a letter to FDA Commissioner Andrew von Eschenbach requesting his testimony at the hearing. In addition, he instructed the Commissioner to provide the Committee with specific information from August 1, 2005, to the present to include: (1) A chronology of actions taken by FDA in relation to the cardiovascular safety of rosiglitazone; (2) All communications between GlaxoSmithKline and the FDA relating to cardiovascular safety of rosiglitazone; and (3) All internal FDA analyses, slide presentations, and memoranda relating to the cardiovascular safety of rosiglitazone.

"In complying with this request," Rep Waxman advised the Commissioner, "you should produce all responsive documents in your possession, custody, or control."

Rep Waxman also told the Commissioner, "you should submit a written certification, signed by you or your counsel, stating that: (1) a diligent search has been completed of all documents in your possession, custody, or control which reasonably could contain responsive documents: and (2) all documents located during the search that are responsive have been produced to the Committee or identified in a privilege log."

And last but not least, Rep Waxman sent a letter to Glaxo CEO, Dr Jean-Pierre Garnier, asking him to appear. "We request that you come prepared to discuss your company's actions with regard to the cardiovascular safety of Avandia," the letter states.

Over in the US Senate, Senators Max Baucus and Chuck Grassley, Chairman and Ranking Member of the Senate Committee on Finance, which has jurisdiction over the Medicare and Medicaid programs, issued a public statement and sent letters to the FDA and Glaxo demanding they provide specific documents and other information to the Committee.

"What we are learning about the handling of Avandia," Sen Baucus said in the statement, "by both GlaxoSmithKline and the FDA is appalling and unacceptable."

"Both the drug company and the FDA," he said, "have some major explaining to do about what they knew about Avandia, when they knew it, and why they didn't take immediate action to protect patients."

"We need to know if this is another Vioxx," Senator Grassley stated, "where the FDA sat on its hands and endangered lives."

"The FDA," he continued, "has talked a good game about how it's beefed up post-market
surveillance over the last two years, but a case like this undermines that claim."

Experts say the new study findings are alarming because two-thirds of the people with type 2 diabetes die of heart problems. In a May 21, 2007 letter to Christopher Viehbacher, President, US Pharmaceuticals, GlaxoSmithKline, Senators Baucus and Grassley wrote, "It is troubling, to say the least, that by taking Avandia, diabetics may be increasing their risk of the very adverse event that they hope to prevent by controlling their blood sugar."

"To make matters worse," they advised, "American taxpayers have spent hundreds of millions of dollars on this drug through the Medicare and Medicaid programs."

"One of the most immediate concerns to us," they told Mr Viehbacher, "are reports that GSK employees silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia."

"This allegation is very serious and warrants further investigation," the Senators wrote.

According to plaintiffs attorney, Karen Barth Menzies of Baum Hedlund, a law firm that has been litigating drug related cases against Glaxo since 2001, "The relationship between FDA and the drug industry is disturbing. We've seen internal correspondence between GSK and the FDA that would cause anyone to question the objectivity and regulatory effectiveness of the FDA. Apparently the FDA has failed yet again to protect the public - to the benefit of pharmaceutical industry profits. This failure, and FDA's derogatory attitude towards Dr. Nissen's study, should sound an alarm to all healthcare providers, patients and legislators that the problem is systemic. Patient safety commands serious change in the agency and the industry."

Already, legal conferences are being scheduled to discuss the legal implications of this latest drug safety scandal. Karen Barth Menzies is an invited speaker at an upcoming legal conference regarding Avandia. The conference will include Avandia's background, the science behind the drug, its side effects as well as the FDA's role in regulating Avandia.

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Interview with Investigative Journalist, Evelyn Pringle

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The following is an interview with Evelyn Pringle from the Progressive Radio Network. The interview was conducted by Gary Null.

It's a fascinating interview and Pringle comes across really well as she talks about the drugging of children in America, Teen Screen and pregnant mothers.

My favourite quote in this 17 minute piece is:

"People are disabled, not by mental illness, but by the drugs they are taking."

How true.

Gary Null is an American talk radio host and author on alternative and complementary medicine and nutrition. He is also a critic of the medical and psychiatric communities.

Evelyn Pringle is an award winning investigative journalist focused on exposing corruption in government and corporate America.



To listen to the interview hit the play button on the player.






The full 1 hour show can be downloaded here from the Progressive Radio Network website.

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Psychiatric Drugging of Infants and Toddlers in the US - Part II

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Part One HERE

Special Thanks to Evelyn Pringle for allowing me to republish her article in its entirety.

Psychiatric Drugging of Infants and Toddlers in the US - Part II

Of all the harmful actions of modern psychiatry, "the mass diagnosing and drugging of children is the most appalling with the most serious consequences for the future of individual lives and for society," warns the world-renowned expert, Dr Peter Breggin, often referred to as the "Conscience of Psychiatry."

Peter Lehman, author of the book, "Coming off Psychiatric Drugs: Successful Withdrawal from Neuroleptics, Antidepressants, Lithium, Carbamazepine and Tranquilizers," believes that giving infants and toddlers "powerful, brain-effecting psychiatric medication is close to criminal activity."

"Giving them these drugs," he says, "has no rationale, and ignores the basic fact that youngsters are very sensitive to their environments, both social and chemical, with the juvenile brain easily damaged by the latter."


Inventing Disorders

During an interview on ABC Radio National in August 2007, Dr David Healy (right), the noted British pharmacology expert, and author of the book, "Mania: A Short History of Bipolar Disorder," told reporter Jane Shields: "Just to give you a feel for how crazy things have actually got recently, it would appear that clinicians in the US are happy to look at the ultrasounds of children in the womb, and based on the fact that they appear to be more overactive at times, and then possibly less active later, they're prepared to actually consider the possibility that these children could be bipolar."

On April 9, 2009, Christopher Lane, author of the book, "Shyness: How Normal Behavior Became a Sickness," published an interview on his Psychology Today blog with Dr Healy. In the interview, Healy explained the history behind the drastic rise in the sale of anticonvulsants and antipsychotics as "mood stabilizers," and the diagnosis of bipolar disorder.

"The key event in the mid-1990s that led to the change in perspective was the marketing of Depakote by Abbott as a mood stabilizer," Healy tells Lane, and further explains:

"Mood stabilization didn't exist before the mid-1990s. It can't be found in any of the earlier reference books and journals. Since then, however, we now have sections for mood stabilizers in all the books on psychotropic drugs, and over a hundred articles per year featuring mood stabilization in their titles.

"In the same way, Abbott and other companies such as Lilly marketing Zyprexa for bipolar disorder have re-engineered manic-depressive illness. While the term bipolar disorder was there since 1980, manic-depression was the term that was still more commonly used until the mid-1990s when it vanishes and is replaced by bipolar disorder. Nowadays, over 500 articles per year feature bipolar disorder in their titles."

"As of 2008, upwards of a million children in the United States--in many cases preschoolers--are on "mood-stabilizers" for bipolar disorder, even though the condition remains unrecognized in the rest of the world," Healy points out.

"But there is no evidence that the drugs stabilize moods," he says. "In fact, it is not even clear that it makes sense to talk about a mood center in the brain."

"A further piece of mythology aimed at keeping people on the drugs," he reports, "is that these are supposedly neuroprotective--but there's no evidence that this is the case and in fact these drugs can lead to brain damage."

Healy says the FDA's decision to add a black-box warning about suicide to SSRIs likely had little to do with the switch to prescribing antipsychotics as safer for children. What "was quite striking was how quickly companies were able to use the views of the few bipolar-ologists who argued that when children become suicidal on antidepressants it's not the fault of the drug," he points out.

"The problem, they said, stems from a mistaken diagnosis and if we could just get the diagnosis right and put the child on mood stabilizers then there wouldn't be a problem," he explains.

"There is no evidence for this viewpoint, but it was interesting to see how company support could put wind in the sails of such a perspective," he says.

Because having just one label was very limiting, Healy says, child psychiatry "needed another disorder--and for this reason bipolar disorder was welcome."

He reports that the same thing is happening to children labeled with ADHD. "Not all children find stimulants suitable," he advises, "and just as with the SSRIs and bipolar disorder it has become very convenient to say that the stimulants weren't causing the problem the child was experiencing; the child in fact had a different disorder and if we could just get the diagnosis correct, then everything else would fall into place."

A report titled, "Adverse Events Associated with Drug Treatment of ADHD: Review of Postmarketing Safety Data," presented at the FDA's March 22, 2006, Pediatric Advisory Committee meeting bears witness to Healy's explanation by stating in part: "The most important finding of this review is that signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors, at usual doses of any of the drugs currently used to treat ADHD."

Between January 2000, and June 30, 2005, the FDA identified nearly 1,000 cases of psychosis or mania linked to the drugs in its own database and those from the drug makers themselves.

The antipsychotics are just as dangerous as the SSRI antidepressants, Healy says. "Long before the antidepressants were linked with akathisia, the antipsychotics were universally recognized as causing this problem," he explains in the Lane interview. "It was also universally accepted that the akathisia they induce risked precipitating the patient into suicidality or violence."

"They also cause a physical dependence," Healy states. "Zyprexa is among the drugs most likely to cause people to become physically dependent on it."

"In addition," he points out, "these drugs are known to cause a range of neurological syndromes, diabetes, cardiovascular problems, and other problems."

"It's hard to understand how blind clinicians can get to problems like these, especially in youngsters who grow obese and become diabetic right before their eyes," Healy tells Lane.

As for what he calls the "medicalization of childhood," in the radio interview, Healy points out that "children always have been unhappy, they always have been nervous, but that's actually part and parcel of being a child."

"You have to go through these things," he said. "This is how we learn to cope with the problems of life."

Children can best be helped in the safest way, he says, "if they're just seen and if they actually have the opportunity to talk about their problems, and if they get basic and sensible input about how to perhaps help them cope with these problems."

Healy said it's important to remember that severe mental illness is rare in children and that most children with a mental health problem do not need medication. Children are being picked up and put on pills "who really don't need to be on these pills and who are going to be injured by them," he warned.

"I think possibly 10 to 15 years up the road," he told Shields, "we're going to be looking at a generation of children who will have been seriously injured by the treatments that they appear ever-increasingly likely to be put on now."

But the administration of multiple drugs at once complicates the situation so that it may be impossible to determine which drugs are most responsible for the adverse reactions children experience, according to Dr Breggin.

"Because so many doctors and so many drug companies will share the blame for mistreating these children, they will be unable to seek redress against individual perpetrators through the courts when they grow up," he explains.

(Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America)

(This report is one of a series of articles focused on the rising rates of psychiatric drugging in the US and is sponsored by the International Center for the Study of Psychiatry and Psychology)

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Psychiatric Drugging of Infants and Toddlers in the US - Part I By Evie Pringle

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Following on from the excellent Louis Theroux documentary, America's Medicated Kids, here's an article from investigative journalist, Evie Pringle. Part two will be here shortly.

I have had a lot of hits on this blog in the last 24 hours or so, due, in the main to adding videos from the Louis Theroux documentary. Sadly, the videos have now been taken down by YouTube for apparent copyright infringement. It's a shame because this really was an excellent documentary... as is the article from Evie you are about to read.

Psychiatric Drugging of Infants and Toddlers in the US - Part I

The United States has become the psychiatric drugging capital of the world for kids with children being medicated at a younger and younger age. Medicaid records in some states show infants less than a year old on drugs for mental disorders.

The use of powerful antipsychotics with privately insured children, aged 2 through 5 in the US, doubled between 1999 and 2007, according to a study of data on more than one million children with private health insurance in the January, 2010, "Journal of the American Academy of Child & Adolescent Psychiatry."

The number of children in this age group diagnosed with bipolar disorder also doubled over the last decade, Reuters reported.

Of antipsychotic-treated children in the 2007 study sample, the most common diagnoses were pervasive developmental disorder or mental retardation (28.2%), ADHD (23.7%), and disruptive behavior disorder (12.9%).

The study reported that fewer than half of drug treated children received a mental health assessment (40.8%), a psychotherapy visit (41.4%), or a visit with a psychiatrist (42.6%) during the year of antipsychotic use.

"Antipsychotics, which are being widely and irresponsibly prescribed for American children--mostly as chemical restraints--are shown to be causing irreparable harm," warned Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a February 26, 2010 InfoMail.

"These drugs have measurable severe hazardous effects on vital biological systems, including: cardiovascular adverse effects that result in shortening lives; metabolic adverse effects that induce diabetes and the metabolic syndrome," she wrote. "Long-term use of antipsychotics has been shown to result in metabolic syndrome in 40% to 50% of patients."

The lead researcher on the study above, Columbia University psychiatry professor Mark Olfson, told Reuters that about 1.5% of all privately insured children between the ages of 2 and 5, or one in 70, received some type of psychiatric drug in 2007, be it an antipsychotic, a mood stabilizer, a stimulant or an antidepressant.

Psychiatric drugs bathe the brains of growing children with agents that threaten the normal development of the brain, according to Dr Peter Breggin, founder of the International Center for the Study of Psychiatry and Psychology (ICSPP), and author of about 20 books, including "Medication Madness."

The drugs themselves are causing severe disorders in millions of children in the US, he warns. "Substances like antidepressants, stimulants, mood stabilizers, and antipsychotic drugs cause severe, and potentially permanent, biochemical imbalances."

American Phenomenon

A number of presentations at the annual meeting of the American Psychiatric Association in May 2009, addressed the diagnosis of bipolar disorder, including one titled, "Pediatric Bipolar Disorder: A Critical Look at an American Phenomenon," at which Dr Peter Parry, a consultant child & adolescent psychiatrist, and senior lecturer at Flinders University in Australia, presented a survey on, "Australian and New Zealand's Child and Adolescent Psychiatrists' Views on Bipolar Disorder Prevalence and on Rates of Pediatric Bipolar Disorder in the USA."

Dr Parry and his colleagues conducted a survey of child and adolescent psychiatrists in Australia and New Zealand. Of the 199 psychiatrists who responded to the survey, 90.5% thought pediatric bipolar disorder was overdiagnosed in the US.

In an October 1, 2009 article titled, "Medicating Our Children," Dr Parry reports that since "the mid-1990s in the USA, some researchers have claimed that Paediatric Bipolar Disorder (PBD) frequently starts prior to puberty."

One of PBD's main proponents, Harvard University's Professor Joseph Biederman, stating onset "is squarely in the preschooler age group," he notes.

Parry explains that "PBD has been created by moving the diagnostic goalposts away from traditional concepts of bipolar disorder."

"In children," he says, "episodes were redefined to last hours instead of days or weeks and, instead of manic elation, severe anger in children sufficed as mania."

"Unlike diagnoses like ADHD or depression, or simply accepting a child has serious emotional and behavioural problems in reaction to various stressors, PBD implies a lifelong severe mental illness requiring of strong psychiatric medication," Parry warns.

"In the USA," he says, "the public is furthermore exposed to direct pharmaceutical advertising that can feed the natural desire parents of distressed and aggressive children have for a quick solution by suggesting a simple medication fix."

"The medicating of America's children has become intensely controversial, highlighted by the tragic case of Rebecca Riley, a four-year-old Boston girl diagnosed at 28 months old with ADHD and PBD," he points out.

On April 7, 2009, the author of the book, "Shyness: How Normal Behavior Became a Sickness," Christopher Lane, featured an interview on his Psychology Today blog, "Side Effects," with journalist, Philip Dawdy, the creator of the popular website, Furious Seasons, and discussed the rising number of children being diagnosed with bipolar disorder.

"As for bipolar disorder in kids (meaning pre-teens and younger), it's simply not an issue in the rest of the world," Dawdy told Lane. "The bipolar child is a purely American phenomenon."

"The pharma companies and the Harvard crew worked hand-in-hand to bring America a generation of ADHD kids and bipolar children, and their profound influence can be seen in the millions of children and teens who now carry lifetime diagnoses and take gobs of psychotropic drugs each day, often to their detriment," he advised. Lane asked for Dawdy's opinion on a recent report in the St Petersburg Times that found 23 infants less than one-year-old had been prescribed antipsychotics in Florida in 2007, as well as the drug overdose death of 4-year-old Rebecca Riley in Massachusetts. "How is it possible for psychiatrists to continue prescribing to infants in such numbers without more oversight?" Lane asked.

"What's gone on with antipsychotics prescribed to infants and toddlers is simply inexplicable to me," Dawdy said. "The drugs are known to cause huge problems in adults, so why the heck would a doctor give them to little kids, especially infants? It boggles my small mind."

"I'm no fan of bans or restrictions," he told Lane, "but this does strike me as a situation where there needs to be a serious rethinking of what we are doing—and maybe there should be a ban on the use of these drugs in kids under, say, 6 years of age."

An October 2007 report by the University of South Florida found the most common diagnosis for antipsychotic use with children in Florida’s Medicaid program, between July and December 2005, was ADHD. Roughly 54%, or 1,372 cases, involved prescriptions for children five and under and the total number of antipsychotic users in this young age group was 2,549, with all disorders combined, according to the report.

Increased Prescribing to Poor Children

Federally funded research published online in December, 2009, revealed that children covered by Medicaid were prescribed antipsychotics at a rate four time higher than children with private insurance. The data showed that more than 4% of children in Medicaid fee-for-service programs received antipsychotics, compared to less than 1% of privately insured youth. The study found Medicaid kids were more likely to receive antipsychotics for unapproved uses such as ADHD and conduct disorders than privately insured children.

The researchers examined records for children in seven states for the years 2001 and 2004, chosen as representative of the US Medicaid population. But more recent data through 2007 indicates that the disparity has remained, said Stephen Crystal, a Rutgers professor who led the study, according to the December 11, 2009, New York Times.

Antipsychotics were the top selling class of drugs in both 2008 and 2009. With sales of $14.6 billion in 2009, they brought in more than the $13.6 billion earned by both heart burn and cholesterol medications. Antidepressants ranked fourth with sales of $9.9 billion, according to data by IMS Health. In 2008, the drug makers took in $11.3 billion from antiseizure drugs and $4.8 billion from ADHD drugs.

In a new book titled, "Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America," Robert Whitaker reports that the number of children on government disability rolls due to severe mental illness has increased more than 35-fold since 1987.

The book explores the question of whether the epidemic rise in people disabled by mental illness, among all age groups in the US over the past 20 years, could have been fueled by a drug-based paradigm of care.

It also explores what is happening to children over the long-term who are placed on psychiatric drugs. "Once again, science tells a very clear story, and, as you might imagine, it is one that — when you think of the millions of children so affected — makes you want to weep," Whitaker stated in a March 26, 2010, notice for the book's release on the Beyond Meds Website.

Evelyn Pringle
(Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America)

(This report is one of a series of articles focused on the rising rates of psychiatric drugging in the US and is sponsored by the International Center for the Study of Psychiatry and Psychology)

PART TWO COMING SOON

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PAXIL BIRTH DEFECTS - THE PDF

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I have put together all of Evie Pringle's excellent 'Paxil Birth Defects' articles into one PDF file.

The PDF can be downloaded HERE and is 54 pages long.

If you haven't read any of Evie's 6 articles yet then do yourself a favour and download the PDF file.

Evie is an investigative journalist and has been writing about GlaxoSmithKline and Paxil [Known in the UK as Seroxat] for many years.

She is up there with Shelley Jofre. Outstanding journalism and a great contribution regarding the tainted history of Glaxo, Paxil and all those on the payroll of the second largest pharmaceutical company in the world.

Fantastic work Evie.

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Over Six Hundred and Counting - Paxil Birth Defect Cases

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"GlaxoSmithKline did not want to study the drug," Tracey told the jury. "The FDA made them study Paxil."

Part 6 [Final installment] of Evie Pringle's exposé on GlaxoSmithKline, Paxil and birth defects.

Take a bow Evie - these series of articles have been jaw-dropping and I would like to thank you personally for raising awareness on an issue that GSK would, no doubt, like to bury.

Other parts in this series:

Paxil Birth Defect Litigation - First Trial A Bust For Glaxo

Paxil Birth Defect Trial - Battle of the Experts

Glaxo Birth Defect Litigation Reveals Paxil Promoters on Speed Dial

Cold Case Files - Paxil Birth Defects

Ghostbusting in Paxil Birth Defect Litigation


Over Six Hundred and Counting - Paxil Birth Defect Cases

Since Paxil came on the market in 1992, there have been three separate types of failure to warn lawsuits filed against GlaxoSmithKline over Paxil; birth defects, suicide, and addiction.



Roughly 150 suicide cases were settled for an average of about $2 million, and about 300 cases involving suicide attempts were settled for an average of $300,000, according to a December 14, 2009 report by Bloomberg News. Glaxo paid an average of about $50,000 each to resolve about 3,200 cases linking Paxil to addiction problems. The drug giant has also paid about $400 million to end antitrust, fraud and design claims, Bloomberg reports.



All total, Glaxo has paid out close to $1 billion to resolve Paxil lawsuits since the drug came on the market in 1992. The company's provision for all legal matters and other non-tax disputes as of the end of 2008 was listed as $3.09 billion in its annual report.



The first birth defect trial, in over 600 cases filed, resulted in a verdict for the plaintiffs on October 13, 2009, and an award of $2.5 million in compensatory damages for the the family of Lyam Kilker, who was born with three cardiac birth defects after his mother took Paxil while pregnant.



In the Kilker trial, Glaxo's lead attorney was King & Spalding partner, Chilton Varner, and Sean Tracey, from Houston, led the family's legal team.


Andy Vickery, of the Houston firm of Vickery, Waldner and Mallia, is the lead attorney in several Paxil birth defect cases. The first case set for trial is unique in that it involves, Delaney Novak, an infant born with heart defects on April 4, 2002, to Laura and Derek Novak, after Laura was prescribed Paxil off label for migraine headaches.


The Novak case is also unique among the Paxil birth defect cases because Delaney's parents had their insurance with United Healthcare, and Laura was part of the study that Glaxo contracted for, which resulted in the initial warning letter about birth defects in September 2005.

According to Vickery, Glaxo conducted a study on Wellbutrin (bupropion), another antidepressant, after discovering a possible link to birth defects. "The review found no problems with Wellbutrin, but discovered that a significant number of mothers who had been prescribed Paxil (nearly twice as many as those who had not taken the drug) had children born with heart defects," he says.

Doctors Ra-id Abdulla, David Healy, Shira Kramer and Suzanne Parisian testified as the experts for the plaintiffs in the first trial. All told the jury they believed Paxil caused Lyam's heart defects. Doctors Abdulla, Healy and Kramer are also expert witnesses in the Novak case.

Ingenix Study in First Trial

The Ingenix study, with lead researcher, J Alexander Cole, was conducted using data from the Ingenix Research Data Mart, containing insurance information from United Healthcare. The study was not supposed to look at Paxil.

During the testimony of several witnesses in the first trial, the jury was shown a February 7, 2003 email in which Glaxo employee, Graham Cottam, stated that he had informed Anne Bell, the project leader for Paxil, about plans to do the Ingenix pregnancy study on Wellbutrin, and "Anne wanted to be sure that we will not be looking specifically SSRIs or Paxil."

Doctor Suzanne Parisian, a former FDA scientist, testified that the initial 2002 proposal was "to do a large database study for Bupropion in pregnancy."

There was "nothing that addresses Paxil," she told the jury. The "procedure had never been designed to specifically look at Paxil."

But when the data was broken out for Paxil in the original study, it "showed the increased risk and the pregnancy was changed to Category D," she explained.

The FDA later requested that Paxil be studied, according to the testimony of Glaxo employees and documentation, she said.

The famous neuropyschopharmacologist and professor of psychiatry from Cardiff University in Wales, Dr David Healy, explained that Glaxo had hopes that the study would show Wellbutrin as an antidepressant that did not cause birth defects and the company could apply to the FDA to have it classified as a pregnancy category B drug instead of a C.

"It would give the message," he said, "that this of the drugs we have available to use for women of childbearing years, this would be one of the safer ones."

Healy told the jury that there was "no reason from the scientific point of view why they would not want to also look at Paxil."

"And this appeared to be the FDA's view," he said, "because FDA said, well, you looked at Bupropion, why don't you look at Paxil, also," a couple years later.

When asked whether by the year 2003, he could think of any scientific reason not to do a pregnancy study with Paxil, Healy replied, "No, I can't."

In fact, Tracey showed the jury an internal company email written by a Glaxo employee two years later in August 2005, around the time that the results on Paxil from the Ingenix study came out, who asked the question: "Why hasn't the company gathered data on this until now, 13, I think, years after the product was approved?"

In the case of the study on Wellbutrin, there were only 16 reports of birth defects that indicated there was a signal to do the study, Parisian told the jury. While an internal analysis conducted by Glaxo on Paxil in 2000, showed 79 cases of birth defects.

In September 2005, the conclusions of the Ingenix study were: "The use of paroxetine in the first trimester of pregnancy was associated with an increased risk of congenital malformations compared with other drugs."

"To your knowledge, prior to 2005 did GSK ever do a single epidemiological study to determine whether or not Paxil caused birth defects?" attorney, Adam Peavey, asked Parisian.

"Not that I have seen," she said.

Ingenix Downside

During the testimony of Dr Shira Kramer, an epidemiologist, Tracey put up a slide on the Cole paper that was published in 2007.

The paper was on a study conducted by epidemiologists who were employed by Glaxo to do the research, Kramer explained. It was a continuation of the Ingenix study that looked at Wellbutrin and then Paxil. One of the co- authors was Sara Ephross, an employee of Glaxo.

Kramer was asked to explain the importance of the Cole study. "First of all," she said, "it was a cohort study comparing ... people exposed to Paxil ... to people who were exposed to other SSRIs."

"So one very key thing for you to remember is that here the ... unexposed group is not people who were not exposed to SSRIs, they were exposed to SSRIs," she told the jury.

"That's a very important point," she said, "because if SSRIs are a risk factor for cardiac defects, birth defects, then the relative risk that will be generated in this study is going to be lower than it normally would if truly people were unexposed to SSRIs."

"The other thing that is important to keep in mind," she told the jury, "is that the information was obtained from an administrative claims database called the Ingenix Research Data Mart."

"There was no individual, either examination or interviewing of anyone," she explained. "The information was extracted from administrative claims data that was available."

"The other thing that's important," she said, "is that initially the population that was studied covered the years 1995 to 2002, and then after the fact an additional two years were added to the study."

"The published results, based on all of the years that were eventually included in this study, were an odds ratio for all cardiovascular malformations related to Paxil exposure of 1.46, which means that individuals who took Paxil were at 46 percent increased risk of their child having a cardiovascular malformation diagnosed at birth compared to individuals who took other, other SSRIs," Kramer explained.

"In the second odds ratio of 1.68," she said, "showing a 68 percent increased risk, now we are comparing women who took Paxil either alone or in combination with another SSRI, compared to the other SSRI group, either alone or in combination with other SSRIs, mono- or polytherapy."

The published study contained an asterisk that said: "An interim analysis performed by Cole, et al, using births occurring between '95 and 2002 found an odds ratio of 2.0 for the association between first trimester Paxil use and cardiac birth defects."

Kramer was asked to explain what that statement was referring to. "Initially, the study was designed to include the years 1995 through 2002 with a sampling ratio of controls to cases of 7 to 1," she said. "That was the protocol."

"And when that analysis was done, the odds ratio, instead of being 1.46, which ultimately is what was published, was actually higher, it was 2," she told the jury.

"That means that the exposed group had a risk of a child with a cardiac malformation two times that of the group not exposed to Paxil," she added.

The odds ration got smaller when the Glaxo researchers, the authors of the study, "added in two additional years of data with a different sampling ratio," Kramer explained.

It is not appropriate for an epidemiologist to do that, she said, because "you are changing the rules after you look at the data."

It "really raises the questions as to, are you trying to influence the data," she noted.

"I can say very clearly," she told the jury, "that that is not considered to be appropriate conduct, scientific conduct. "

"What you are supposed to do is set up a study protocol in advance and follow it, and not change it after you have looked at the results," Kramer explained.

It is not appropriate to find out the results and change it in the middle, she said, "for obvious reasons, it looks like you are manipulating the data to make it come out looking a certain way."

"And if you want to do an unbiased, fair study," she told the jury, "the only appropriate plan of action is to develop a study protocol ahead of time, to follow it, and to analyze the results and not to fool with it, not to fiddle with it and not to change it."

While testifying, Kramer explained the meaning of "underpowering" a study. You need to have "a sufficient number of people in a study in order to test a certain research question," she said.

"And if you are going to apply statistical tests to the data that you generate," she told the jury, "you need to have enough people in that study to have generated enough cases of the outcome and you need to have enough people who are exposed."

"Now, this case," she said, "we have got a relatively rare exposure to Paxil, we have a relatively rare outcome, which is congenital cardiac birth defects, so you need to study very, very large populations in order to achieve statistical significance at these levels that we have been discussing."

She said the "investigators, the research team," dictates the size of the study.

Kramer went over the reasons why the odds ratio in the Cole study might be attenuated, or lower. It's "very clear that there are certain characteristics of this study that are making this odds ratio probably lower than it really would be given certain characteristics of the study design," she told the jury.

"One of the them is that the controls are really not unexposed to the SSRIs," she said. "They are exposed to drugs in the same class."

We have "observed in epidemiological literature that other SSRIs are associated with an increased risk of cardiac malformations," she told the jury. "Therefore, it is likely that since that's the comparison group, we have got an odds ratio in this study that's lower than it probably would be."

The second reason was that the analysis only included live births. "So you are missing fetuses who were miscarried," she said. "And then there are many miscarriages that are due to birth defects."

"You are missing fetuses that are aborted, electively aborted, because of known cardiac or other congenital malformations," she told the jury. "You are missing stillbirths."

And with a follow up for only nine months, she said, "you are missing congenital cardiac defects that aren't detected until later."

"So you have got a fairly substantial population that is not really being captured in this study of exposed fetuses," she pointed out.

Closing Recap

During closing arguments, Tracey reminded the jury about the email with Anne Bell's statement to make sure Paxil was not included in the Ingenix study, and said: "This document ... two years before this child is born, they are affirmatively saying: We do not want to look at Paxil in pregnancy."

In her closing argument, Varner told the jury: "Now, Mr. Tracey has talked to you about Anne Bell this morning."

"He has said that GSK would have done anything to avoid looking at the risk for Paxil," she pointed out.

"Well, ladies and gentlemen," Varner said, "GSK funded the study that did look at Paxil for the risk and published preliminary findings in August of 2005."

As soon "as even a possible link emerged in all of 2005, GSK reacted promptly and proactively to notify both FDA and doctors," she told the jury.

"It went immediately to FDA. It immediately changed its label," she said. "And it immediately sent out letters to doctors telling them about the changes."

In his final summation, Tracey told the jury, "I want to talk to you about the Ingenix study because Ms. Varner said something that is very, very important."

"She said when they found out what she says is August of 2005, within 21 days, they changed the label. Within 21 days, the doctors got the news," he recounted.

What "she forgets to tell you is that two years prior to this, Anne Bell said, Don't study the drug," Tracey told the jury.

"Had they not listened to Anne Bell," he said, "had they studied the drug in 2003, Michelle David wouldn't be sitting here because the warning would have gone out like that."

"We would have been two years ahead of the game," he pointed out.

"GlaxoSmithKline did not want to study the drug," Tracey told the jury. "The FDA made them study Paxil."

"It was not some sort of voluntary we're just a good drug company trying to get along," he said. "It was we don't want to study it and they're forcing us to study it."

Paxil Off-Label Promotion

Paxil is not FDA approved for use by pregnant women, so all mothers who gave birth to infants with heart defects received the drug off label. In Andy Vickery's first case set for trial, Delaney Novak was born with heart defects after his mother, Laura, was prescribed Paxil for migraine headaches, another unapproved use.

Dr Dee Mangin is an expert witness in the Novak case. Her research and published work has focused on rational prescribing, and the influence of drug company promotion both to physicians and direct to consumers. She submitted a report on October 13, 2009, which outlines Glaxo's off label promotion of Paxil around the time of Laura's pregnancy.

In her report, Mangin defines off-label use as the "practice of prescribing drugs for a purpose outside the scope of a drug's approved label - often an unproven use or one that has not been widely tested."

"While it is legal to prescribe off label in the United States, it is illegal for companies to promote off label use," she notes.

"The risks of off label promotion," she says, "are that it could lead to exposure of patients to the risks of a medicine for no benefit, and furthermore they maybe denied other more effective treatment."

"GlaxoSmithKline from 2000," Mangin says, "mounted a multifaceted and targeted national promotional campaign that employed explicit strategies designed to promote sales of Paxil in pregnant women and women of reproductive age."

An exhibit cited in the report from a "Paxil Tactical Marketing Plan in 2000," states: "New Paxil data with high media interest, hot flash, postpartum, depression, pregnancy, and lactation will position Paxil as the drug of choice for women."

"One of the known reasons that physicians change their prescribing behavior is as a response to the volume of evidence containing the same message that the physician is exposed to," she wrote. "The so-called "Carpet Bombing" technique used in the Paxil campaign feeds directly into this."

"There are a number of strategies companies can use to highlight use for off label conditions including distribution of individual scientific articles discussing the off label indication and use of the drug as well as mentions of off label use by key opinion leaders in continuing medical education," the report explains.

"In relation to the off label prescribing for migraine," Mangin says, "there is no evidence of any effectiveness over placebo for SSRIs in migraine prevention."

Yet a paper titled, "Paroxetine in the Treatment of Chronic Daily Headache," by Carol Foster, MD, and Jacklyn Bafaloukos, RN, that was distributed to doctors, specifically states: "The dramatic improvement in the patients in our study suggests that paroxetine appears to be a safe and effective drug for the treatment of chronic daily headache."

"The strategies outlined where reprints about treatment of migraine with paroxetine, large numbers of form letters containing summaries of studies of use in headache were sent to physicians and detailing and providing free samples to physicians likely to treat women with migraine were therefore encouraging use of Paxil and exposure to its risks when in reality it is no more effective in this situation than a sugar pill," Mangin reports.

Encouragement "of unapproved use for migraine further attempted to expand the market beyond that which was medically justified and likely to lead to unnecessary exposure to the risks of Paxil," she advises.

In an August 11, 2009 deposition, Laura's doctor testified that Glaxo sales representatives would commonly leave reprints of articles on off label uses and salespeople did discuss the literature on the off label use of Paxil for migraines with him. One of the sales representatives visiting the doctor at the time stated in a deposition that it was his habit to distribute all such articles.

But most importantly, the doctor said he would not have prescribed Paxil to Laura had Glaxo told him back in 2000, or early 2001, that there was an association between Paxil and birth defects. He further noted that there was no benefit from Paxil that would outweigh the risks of birth defects and that he had not used Paxil in his practice since the Dear Doctor letter warned about birth defects.

Delaney suffers from a septal heart defect. "None of the information from the medical records of the family or their statements on potential genetic, environmental and pharmaceutical causes of heart defects indicates any other factor more likely to have caused her condition than the Paxil exposure," Mangin points out.

"It is clear that if the prescribing doctor had been informed of the risk of heart defects, Laura Novak would not have been exposed to Paxil," she notes.

In the report's conclusion, Mangin states: "It is my opinion that this promotional campaign for Paxil was inappropriate given the scientific knowledge and what was known by the company at the time."

"The degree of comfort with the use of this medication in the reproductive years and pregnancy is likely to be influenced by GSK's misleading promotional campaign where concerns were minimized, efficacy was overstated, the idea of off label prescribing was seeded for migraine, and lastly the marketing specifically targeted a group at higher risk in terms of safety concerns - pregnant women and women in the reproductive age group," she reports.

"This Paxil promotional campaign was irresponsible, and potentially disastrous from a public health perspective as it was likely to expose a much greater proportion of the population to these potential harms," she concludes.

Glaxo's Phone Book

During closing arguments on October 8, 2009, Tracey told the jury regarding Glaxo: "They have a telephone book full of doctors."

Referring to an exhibit introduced during the trial, he said: "This is all the doctors that they pay to give speeches on their behalf to push their drug, to sell it, to convince other doctors to prescribe their drug."

While Healy was testifying, Tracey had him go over some of names of doctors in the book that included Lori Altshuler, Vivian Burt, Lee Cohen, Charles Nemeroff, Jeffrey Newport, Zachary Stowe, Katherine Wisner and Kimberly Yonkers. None of these doctors appeared to testify on Glaxo's behalf in the trial.

What "they did was aggressively market this drug to women," Tracey told the jury.

All "these names of people that they ghost-wrote articles for to get the doctors ... to sell the drug," he noted.

Doctor Healy told you that "they altered the prescribing practices in this country," he recounted. "What they set out to do, they succeeded in doing. They got doctors to prescribe the drug to women."

"And they did it," Tracey said, "by having seminars where they would put these doctors, experts in the field, on their payroll, that the doctors would go and listen to, unwittingly knowing what they are really hearing is a marketing campaign."

In reference to another exhibit viewed during the trial, Tracy said: "This document describes that it worked. When the doctors came out, these are the comments they made after attending these seminars: Will prescribe Paxil to pregnant women. My comfort in treating depression in pregnancy has increased. Treating pregnant patients with confidence. Will feel more comfortable giving Paxil to pregnant women."

In citing $765 million in the US alone, between 1997 and 2005, Tracey told the jury: "This is the number for over a nine-year period this company spent to convince doctors to sell their drug, to prescribe their drug to women of childbearing years."

"And they got a heck of a return on it," he said. "Net. After expenses. Almost 14 billion dollars for a nine-year period."

"Out of the 700 million dollars they spent trying to sell this drug to people," Tracey stated, "there is not one shred of evidence in the record about how much money they spent to try to figure out whether it was going to induce birth defects."

"And as far as I can tell in the record," he said, "after they bought it, they did one animal study and they didn't spend another penny."

Evelyn Pringle

(The Paxil Birth Defect Litigation Update Series is sponsored by the
Houston law firm of Vickery, Waldner and Mallia at www.justiceseekers.com )

(Evelyn Pringle is an investigative Journalist and Researcher focused on
exposing corruption in government and corporate America)


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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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