The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

ADHD and Internet Addiction SCAM!

Inventor of ADHD confesses “ADHD is a prime example of a ficticious disease”. The APA turns the hoax Ïnternet Addiction Disorder” into a DSM billing bible diagnosis!

Filed under: 'ADHD', addiction, antipsychotics, APA, big pharma, child endangerment, disease mongering, drugging children, DSM, Fraud, patient deaths, pharma payments to doctors, Ritalin, schizophrenia, screening, SSRI, , , , ,

Suicide Prevention Drug Pushing Racket – Part I

Evelyn Pringle August 6, 2010

Nearly every year, as part of the suicide prevention drug pushing racket, drug company shills publish a bogus study with claims that more people are dying from suicide due to a black box warning of an increased risk of suicide in young people on the labels of SSRI and SNRI antidepressants.

Although the FDA did announce that the black box warnings, for children under 18, would be added to antidepressants in October 2004, the warnings were not on the labels until the spring of 2005. The extended warnings, to include young persons through age 24, were not added until mid-2007.

This year’s bogus study was announced on June 2, 2009, with a WebMD headline asking: “Are Antidepressant Warnings Causing Harm?” The study titled, “Persisting Decline in Depression Treatment After FDA Warnings,” was published in the “Archives of General Psychiatry,” with claims that there has been a drastic drop in the diagnosis of depression in both children and adults.

“Policy actions are required to counter the unintended consequences of reduced depression treatment,” the authors wrote in the study.

Prescriptions written for antidepressants also have dropped significantly, and these “unintended” consequences of the FDA’s warnings are continuing, the junk science co-author of the study, Robert Valuck, PhD, of the University of Colorado Denver’s School of Medicine, told WebMD.

On June 16, 2009, Science Daily ran the headline: “FDA Warnings Led To Unintended Changes In Depression Diagnosis,” and noted that the researchers report “unrestricted investigator-initiated research grants from Eli Lilly and Company, Forest Pharmaceuticals, Lundbeck and the American Foundation for Suicide Prevention.”

According to his online CV, Robert Valuck has been a consultant to Eli Lilly, maker of the antidepressants, Prozac, Cymbalta, and Sybyax, since 2005, and has done “Medical-legal consulting” for various firms since 2004.

The CV lists a grant to Valuck from Eli Lilly for $249,417 in 2006, to study the, “Effect of the FDA Black Box Warning (Antidepressants and Suicidality) on Patterns of Depression Care in the U.S. Managed Care Population.”

The disclosure section for a study titled, “Spillover Effects on Treatment of Adult Depression in Primary Care After FDA Advisory on Risk of Pediatric Suicidality With SSRIs,” in the August, 2007, “American Journal of Psychiatry,” reported that the lead author, “Dr. Valuck also is an advisory board member for Eli Lilly.”

The study was supported by an “investigator-initiated grant from Eli Lilly and Company to fund the access fees to the independent PharMetrics database and salary support for the investigators,” the disclosure section states.

“The purpose of this study is to evaluate the impact of the FDA advisories on patterns of care for adults with depression,” the authors noted in the study.

“Time-series analyses of patterns of treatment of adult depression in the community showed statistically and clinically significant spillover effects associated with the 2003 FDA public health advisory and related warnings about a risk of suicidality in pediatric patients treated with antidepressants,” they reported in the discussion section.

“After these pediatric warnings were issued, diagnoses of adult depression declined, and among adults diagnosed with depression, antidepressant use declined, with no other treatment modalities increasing to compensate,” the authors claimed.

“The present findings underscore the need for careful consideration of unintended consequences of warnings about drug safety concerns by regulatory agencies and pose challenges for protecting patients while offering efficacious treatments,” the researchers concluded, with the standard talking point of “unintended consequences.”

Valuck’s CV also shows another grant proposal was submitted to Lilly with a proposed budget of $413,154, for the funding period of January 2008 through December 2008, to study: “Antidepressant Drug Exposure and Risk of Suicide Attempt: A Focus on Newer Agents.”

In 2007, Valuck received a “Distinguished Investigator Award,” from the “American Foundation for Suicide Prevention,” the Big Pharma front group that serves as a funnel for drug company money in the suicide prevention drug pushing racket.

On the AFSP ‘s website, under “Projects Currently Underway,” Valuck is listed as receiving a $100,000 grant to study the “Impact of Antidepressant Discontinuation on Risk of Suicide Attempt.”

In late 2007, Emory University announced that Dr Charles Nemeroff was elected president of the Foundation and would start serving a 3-year term in January 2008.
Emory’s press release reported that Nemeroff had served on the national board of directors of the AFSP since 1999 and had “been a member of the Foundation’s Scientific Council for more than 10 years and was named chair of the Council in 2007.”

In roughly the same time period, an investigation led by Senator Charles Grassley, for the US Senate Finance Committee, found that Nemeroff had earned more than $2.8 million from drug companies between 2000 and 2007, but had failed to report at least $1.2 million on disclosure forms with Emory.

In 2008, the AFSP merged with the Suicide Prevention Action Network USA (SPAN), according to a November 6, 2008 press release by the groups.

Eli Lilly’s grant report for 2008, shows the AFSP received three grants worth $78,000, and SPAN received one $10,000 grant and another for $70,000. Pfizer gave the AFSP $3,000 in 2008.

Lilly’s grant report for 2007, shows the AFSP got $25,000, and SPAN received $10,000 in one quarter, and $70,000 in another.

Back in 2004, the spring issue of SPAN’s Network News reports that: “Network News is funded by a grant from the Eli Lilly and Company Foundation.”

The Newsletter also announced further funding from the Lilly Foundation. “SPAN USA’s efforts to develop and expand its suicide survivor network received a major boost with a recent grant from Eli Lilly and Company Foundation,” it said. “The foundation generously provided funding to support training, education and collaborative opportunities for SPAN USA’s existing network and enable further expansion into all 50 states.”

The 2006 Spring Network News announced the “Friend for Life” fundraiser sponsors. The industry’s trade group, PhRMA and Forest Pharmaceuticals donated over $15,000. Pfizer gave between $10,000 and $14,999. Solvay Pharmaceuticals was listed as giving between $6,000 and $9,999, and companies that gave between $2,000 and $5,999, were AstraZeneca Pharmaceuticals and Bristol-Myers Squibb. Johnson & Johnson, Eli Lilly and Novartis each donated between $500 and $1,999.

At the end of the donor list, the newsletter stated: “Our continued gratitude goes to those who renewed their commitment from previous Friend for Life fundraisers (as indicated above by an asterisk).” Those companies included Pfizer, Bristol-Myers, Eli Lilly and Novartis.

A September 9, 2006 press release ran the headline: “SPAN USA Kicks Off National Suicide Prevention Week With Memorial March for Suicide Prevention”
Among the sponsors who offered “generous support” for this event were Eli Lilly and Forest Pharmaceuticals.

Three months later, the headline for a December 13, 2006, SPAN press release stated: “Leading Suicide Prevention Researcher Testifies against “Black Box” Notice for Antidepressants at FDA Hearing”

“Warns of Potential Tragedy for Those Discouraged from Treatment Option,” the byline read.

The AFSP’s 2008 Annual Report shows a grant of $100,000 from the Lilly Foundation. It also lists grants of between $50,000 and $99,999, from antidepressant makers, Lilly, Pfizer and Weyth, between $25,000 and $49,999 from Forest Labs, and between $10,000 and $24,000 from Solvay.

Lilly’s first quarter grant report for 2009, shows the AFSP received $69,250, and another $25,000 went to SPAN.

No drop in antidepressant prescribing

There was no drop in antidepressant prescribing in the US over the past five years. In 2008, there were 164.2 million prescriptions dispensed, compared to 143 million in 2004, according to a March, 2009, report by IMS Health, a healthcare information company.

The number of prescriptions dispensed has risen every year since 2004, with 143.9 million in 2005, 153.5 million in 2006, and 160.2 million dispensed in 2007, according to IMS.

For the year 2007, on June 20, 2008, CNN Money reported that, “for the sixth year in a row, anti-depressants ranked as the No. 1 class of dispensed prescriptions in the United States.”

The revenues from antidepressants have declined from $11.2 billion in 2004, to $9.6 billion in 2008, but only because competing generic versions are marketed at much lower prices.

Due to the loss in profitability of marketing the off-patent antidepressants, the extremely expensive atypical antipsychotics are now heavily marketed to treat depression. In 2008, they replaced antidepressants as the number one revenue producers in the US.

In fact, there was no decline in the prescribing of any psychiatric drugs in the US over the past five years. In 2004, overall sales of psychiatric drugs in the US totaled $26.7 billion, according to NDC Health Corp, a health information firm.

Four years later, the makers of psychiatric drugs had overall US sales of $40.3 billion in 2008, with $14.6 billion from antipsychotics, $9.6 billion in antidepressants, $11.3 billion from antiseizure drugs and $4.8 billion in sales of ADHD drugs, according to IMS Health.

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

Written for Natural News

Filed under: 'ADHD', 2009, AFSP, anticonvulsants, antipsychotics, APA, FDA, front groups, KOL, Natural News, SPAN, SSRIs, suicide

Sex and Psych Drugs – Young Couples Beware

Evelyn Pringle June 2, 2009

Although the adverse effects of women taking psychiatric drugs while pregnant related to birth defects and infant withdrawal syndrome are often discussed or reported, the serious adverse effects on the sex lives and reproductive systems of millions of young couples are rarely mentioned.

Whatever the reason, due to the ever widening marketing campaigns by the psycho-pharmaceutical industry, young people need to be warned before they get conned into taking psychiatric drugs.

Sexual dysfunction, including lack of libido, orgasmic dysfunction and delayed ejaculation, are common side effects of using SSRI antidepressants, according to the May 2005 report, “The Marketing of Depression: The Prescribing of SSRI Antidepressants to Women,” by Dr Janet Currie. The report warns:

“There are concerns that not all sexual dysfunction may fully resolve after termination of treatment. Since SSRIs are prescribed more often for women, women are more frequently affected by SSRI-induced sexual dysfunction. Because SSRIs can also lead to a worsening of depression, paradoxical effects, emotional blunting or detachment, reduced emotional activity, memory loss and confusion, these effects, in conjunction with sexual dysfunction, can negatively affect intimate relationships.”

In 2006, Dr Antonei Csoka, from the Department of Obstetrics, Gynecology and Reproductive Sciences, at the University of Pittsburgh, and Dr Stuart Shipko, in private practice, in Pasadena, California published a paper titled, “Persistent Sexual Side Effects after SSRI Discontinuation,” in Psychotherapy & Psychosomatics.

The paper documented three cases of fairly severe and permanent sexual dysfunction resulting from prior use of SSRIs in two men and one women.

“These case studies have important clinical implications,” the authors note. “They suggest that when patients develop sexual dysfunction as a side effect of SSRIs, clinicians should be alert to the possibility that restoration of sexual function may not correlate temporally with medication cessation.”

In recent studies, “doctors have specifically asked about sexual difficulties, and found that they are present in up to 83% of patients,” the authors report.

“Patients are often willing to continue taking SSRIs despite sexual side effects, but the possibility of increasing the probability of dysfunction remaining after discontinuance should be taken into consideration,” they state. “Such persistent side effects could even worsen the long-term prognosis of depression.”

“I suspect that these three cases are just the tip of the iceberg and that possibly thousands of people are similarly affected,” Dr Csoka told this author in an email.

In July 2005, WebMD noted that sexual side effects can cause significant problems of their own. “For both men and women, this means being unable to initiate, participate fully in, or enjoy sex, and that can lead to a crippling loss of self-confidence that can, in turn, undermine depression recovery,” the article pointed out.

On the website, Prozac.com, under possible side effects of Prozac, “decreased sex drive” and “impotence” are listed. It also states Prozac “can cause changes in sexual desire and satisfaction.”

After five years of tracking Big Pharma’s disease mongering and off-label marketing schemes, I can say without a doubt that the sickest plot ever devised is the legislation moving through the US Senate right now referred to as the “Mothers Act,” for short.

This is the sickest of all marketing schemes because it is aimed at young couples in child bearing years and reaches into the cradle where the brains and bodies of the most vulnerable victims will be forcibly drugged through pregnant and nursing mothers without any voice of their own in the matter.

Although the language in the Act says postpartum conditions refers to “postpartum depression” and “postpartum psychosis,” the campaigns run through websites like Postpartum Support International, Postpartum Progress and PerinatalPro, are using the bill as a vehicle to diagnose pregnant and nursing mothers with a whole list of pregnancy related “mood” and “anxiety” disorders to further a new cottage industry in the works for treating these women.

For instance, one website is run by Karen Kleiman, who happens to have her own counseling agency called the “Postpartum Stress Center,” and quite a few books to sell. On this website you can even buy some books directly with paypal and bypass Amazon.

“The Postpartum Stress Center specializes in the diagnosis and treatment of prenatal and postpartum depression and anxiety disorders,” the homepage says.
Services offered at the Center include, “Screening for prenatal and postpartum depression and anxiety,” and “Psychiatric evaluation and follow-up.”

The postpartum websites continuously argue that the Act does not promote screening women, but the bill they tried to slip through Congress last year specifically called for screening women and referring them for services. The language in the 2008 bill stated: “To ensure that new mothers and their families are educated about postpartum depression, screened for symptoms, and provided with essential services, and to increase research at the National Institutes of Health on postpartum depression.”

The truth is, universal screening has always been the goal of this blatant off-label marketing scheme because no psychiatric drug has been FDA approved as safe for use by pregnant women and screening opens the door for drug treatment. The screening language was removed only after strong objections were raised about the prospect of requiring all women to be screened and referred to treatment.

The history of the attempts to pass this legislation clearly shows screening was the plan. For instance, Dr Katherine Wisner is professor of psychiatry, obstetrics, gynecology and reproductive sciences and epidemiology at the University of Pittsburgh School of Medicine, and her work in promoting screening as well as drug use by pregnant and nursing mothers is constantly cited on the postpartum websites.

In an editorial in the December 2006, Journal of the American Medical Association, Dr Wisner recommended “that the United States take steps to implement a universal screening program, in which all women are screened between two- and 12-weeks postpartum,” the University reported in a December 5, 2006 news release with the heading, “JAMA Editorial Notes Childbearing Presents Unique Vulnerability for Psychiatric Illness, Making Effective Screening, Education and Treatment Essential.”

“Those presenting with symptoms of a psychiatric disorder should be treated immediately after diagnosis,” Dr Wisner said in the University news release.

The Mothers Act is said to be modeled after a New Jersey law in the home state of the bill’s main sponsor, Senator Robert Menendez. “The State of New Jersey has been the first to address the problem on the governmental level by legislating that all women receive screening and education for postpartum depression; the law went into effect in October (2006),” the University pointed out.

Six months prior to the JAMA editorial calling for “universal screening” and “treating immediately,” on August 5, 2006, Medical News Today ran the headline: “Commonly Used Anti-depressants Safe And Effective For Treating Postpartum Depression,” for a study led by Dr Wisner published in the Journal of Clinical Psychopharmacology.

The researchers compared the tricyclic, nortriptyline, and Pfizer’s Zoloft, but there was no placebo group to see if the drugs worked any better than a sugar pill, which countless studies have shown they rarely if ever do.

“We’ve been treating postpartum depression based on the assumption that drugs that work for a woman with depression under usual circumstances will work for a woman who experiences depression after giving birth, but there have not been studies that provide scientific proof that this was an effective and safe course of treatment,” Dr Wisner told Medical News.

“Treating these women based on that assumption was simply not good enough, and we felt compelled to provide scientific evidence to guide postpartum depression treatment decisions,” she stated.

The disclosure by Medical News said Pfizer provided the Zoloft for the study but did not provide any direct financial support for the conduct of the study. It was noted that Dr Wisner is a member of Pfizer’s speaker’s bureau and has a grant from Pfizer for a study of ziprasidone (antipsychotic Geodon) pharmacokinetics during pregnancy, and is also a member of the speaker’s bureau for GlaxoSmithKline.

A 2005 paper in JAMA reported that Dr Wisner had received grant funding from Pfizer and “is a member of the speaker’s bureau for Pfizer, GlaxoSmithKline, and Shire.”
Dr Wisner is also “a distinguished fellow of the American Psychiatric Association,” the University website notes.

In a running list of Mothers Act supporters, the PerinatalPro website, which is actually another site run by the owner of a treatment center, Susan Stone, with a book for sale, lists the APA as endorsing the bill. This Big Pharma front group will probably go down in history as the most notorious disease mongering association of all time.

A prime example of disease mongering at its worst can be found in a May 21, 2008 headline by US News and World Reports stating: “Postpartum Depression Strikes New Fathers, Too,” with a story based on research presented at the APA’s annual meeting.

Ten percent of new fathers and 14% of new mothers are affected by depression, psychologist James Paulson, assistant professor of pediatrics at Eastern Virginia Medical School in Norfolk, told US News.

“If untreated, a father’s postpartum depression can be harmful to the child as well as to both parents,” the article noted.

On May 8, 2008 WebMD reported that then APA President, Dr Nada Stotland, said first-time new dads are at greatest risk for postpartum depression and apparently the causes of this newly discovered mental disorder are as follows:

“The life changes for a new dad are enormous. Just thinking about the costs of raising the kid to 21, maybe for life, can be terrifying. And all the unspoken fears: Will my wife still be as interested in me? Will my baby be as cute as my brother’s baby?”, Stotland explained to WebMD.

Stotland has served on the speakers’ bureaus of Glaxo and Pfizer, according to Slate Magazine. In 2006, the pharmaceutical industry accounted for about 30% of the APA’s $62.5 million in financing, the July 12, 2008 New York Times reported.

Pfizer’s 2008 grant report shows donations of more than $700,000 to this “non-profit.” Lilly gave grants totaling more than $600,000 in both the first and second quarter of 2008. In 2007, the APA received over $400,000 from Lilly and another $450,000 went to the American Psychiatric Foundation.

Last summer, an investigation by the Senate Finance Committee, led by Iowa Senator Charles Grassley Senator accused the now president of the APA, Dr Alan Schatzberg of Stanford, of failing to disclose payments of over $70,000 from Johnson & Johnson and Lilly in filings with the University. The Senator also revealed Schatzberg’s stock ownership of millions of dollars in a company seeking to commercialize a depression drug. Schatzberg has since stepped down as chair of the psychiatry department at Emory.

On May 29, 2009, Katherine Stone wrote on the Postpartum Progress website: “The MOTHERS Act is not sponsored by the pharmaceutical industry.”

“Its only sponsors,” she said, “are the Senators (Menendez) and Representatives (Rush) who created it and brought it to a vote, thanks to the unending insistence of Carol Blocker, the mother of Melanie Blocker Stokes, who committed suicide while suffering from postpartum psychosis.”

“Its endorsers, I might point out, include the American College of Obstetricians & Gynecologists, the March of Dime, the National Healthy Mothers Healthy Babies Coalition, the Children’s Defense Fund and NOW,” she says, and also mentions a new one, the National Perinatal Foundation.

However, Katherine did not mention the main supporters listed on PerinatalPro, including the Depression and Bipolar Support Alliance, Mental Health America (MHA), National Alliance for the Mentally Ill (NAMI), National Council for Community Behavioral Healthcare, and the Suicide Prevention Action Network USA and the APA.

This sudden omission might have something to do with an article I wrote titled, “Just Say No to the Mothers Act,” in which I showed all the drug company money directly flowing to these front groups in great detail.

On June 2, 2009, Amy Philo, the leader of “Unite For Life,” a coalition of 50 groups against the Mothers Act, posted the dollar amounts funneled to these main supporters of the Act on her website, based on estimates from specific excerpts from the “Just Say No,” article, also posted on the site. The total she came up with was between $13,095,010 and $16,487,497.

The variation in the total amount resulted from the fact that front groups will often list how much companies give by wide margins For instance, the 2007 Annual Report for the Depression and Bipolar Alliance says the group received between $150,000 and $499,000 from AstraZeneca, Pfizer, and Wyeth. Abbott, Cyberonics, Lilly, Forest, Glaxo, Organon, and Otsuka American Pharmaceuticals gave between $10,000 and $149,999.

The 2006 annual report for Mental Health America shows the group received over $1 million from Lilly, Bristol-Myers, and Wyeth in 2006. Pfizer and Janssen gave between $500,000 and $1,000,000, and AstraZeneca and Forest Labs donated between $100,000 and $499,000. Glaxo gave the group between $50,000 and $100,000.

As I have previously pointed out, Pfizer’s 2008 grant report shows a $20,000 grant to a Mental Health America group in Georgia to sponsor: “Project Healthy Moms: Education for Prevention/Treatment for Perinatal Depression Disorders.”

Next, I found a June 8, 2008 newsletter put out by the Georgia group that advertised Katherine Stone as the speaker for the lectures paid for by Pfizer. However, the Georgia group called the program: “Project Healthy Moms: What You Need To Know About Perinatal Mood Disorders.”

E-news said attendees of her presentation would learn in part: “One size does NOT fit all: Why postpartum depression is just part of a spectrum of mood disorders women may experience & what to look for.”

Without disclosing the large amount, e-news stated: “This special hour of learning is made possible by a grant from Pfizer.”

But in checking the Georgia group’s website yesterday, the ad there contained no mention of the fact that Pfizer paid the tab.

Pfizer markets drugs now commonly called “mood stablizers,” such as the anticonvulsants Lyrica and Neurontin, and the antipsychotic Geodon, 3 antidepressants including Zoloft, and Viagra, a big seller, likely due in part, to all the sexual side effects caused by psych drugs.

After Senator Grassley demanded an accounting, the National Alliance for the Mentally Ill, the executive director, Michael Fitzpatrick, admitted that “pharmaceutical companies contributed an average of 56% of national NAMI’s budget annually for the period 2005 to 2009,” in an April 28, 2009 letter to NAMI leaders and members.

Amy’s total does not include money to the National Healthy Mothers Healthy Babies Coalition, which receives money from Wyeth, Glaxo, J&J, Merck, and Sanofi Pasteur.

The total amount funneled through the Suicide Prevention Action Network USA is not available because it recently merged with the American Foundation for Suicide Prevention and Pfizer and Lilly were the only drug companies with public disclosures of their grants to both groups.

Dr Charles Nemeroff, another disgraced shrink who recently stepped down as the chair of the department of psychiatry at Emory University after 17 years, took over the presidency of the Foundation for Suicide Prevention for a 3-year term in 2008. Nemeroff’s resignation came after Senator Grassley revealed that he had earned more than $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million to Emory. Amy included this amount in the estimated total.

The list of members on councils and committees on the Foundation’s website includes Alan Lipschitz, MD, from Glaxo, Steven Romano, MD, of Pfizer, David Norton from Johnson & Johnson, and Cathryn Clary, MD of Pfizer, along with APA president, Alan Schatzberg, and Dr Frederick Goodwin, who had his radio show thrown off the air last fall after Senator Grassley revealed that he failed to tell listeners that he was receiving millions of dollars from drug companies.

The “Directors” of the Foundation include Pfizer’s Cathryn Clary, and Philip Ninan, MD of Wyeth Pharmaceuticals.

Katherine has herself listed online for hire on LinkedIn with a lead-off pitch that reads: “Talented, award-winning marketing and PR professional returning to the workforce after brief sabbatical as full-time mom.”

“Skills include experiential marketing concept development, brand positioning, marketing strategy, social networking, and public relations campaign development and execution,” she writes.

“Used break from full-time employment to become an expert at social media, creating most widely-read blog in the U.S. in her niche,” the summary says in obvious refererence to the Postpartum Progress site.

At the end, Katerine includes a paragraph on her days as an agent for the the public relations firm Cohn & Wolfe. This firm’s clients have included Lilly, Merck, Novartis, Pfizer and the American Foundation for Suicide Prevention.

Another website with links to all the others, is run by Lauren Hale, the Postpartum Support International Georgia coordinator. Her site seems dedicated to minimizing any negative information that comes out about taking psych drugs while pregnant or harm to the fetus. Once a commentary or article is posted on her site, the other gals usually put up a link to it on theirs to get maximum exposure on the internet.

For instance, on April 29, Hale used her site to discount some of the top experts in the field quoted in the May 2009 Vogue article, “Pregnant Pause,” by Alexis Jetter, which stated: “With a flurry of recent reports challenging the safety of antidepressant drugs for unborn babies, doctors and concerned mothers-to-be are rethinking the guidelines.”

“What alarms doctors is the sheer number of pregnant women who use SSRI antidepressants – perhaps as many as 250,000 in the U.S. each year – when we still know so little about how the drugs effect babies,” Jetter reported.

“SSRI usage dramatically increases the chances that a baby may be miscarried, born prematurely or too small, suffer erratic heartbeats, and have trouble breathing,” she noted.

The rise to 250,000 appears to be quite a jump considering that back in the May 2005 Journal of the American Medical Association, researchers estimated that in any given year about 80,000 pregnant women in US were prescribed SSRIs.

In the article, Jetter quotes Dr Adam Urato as saying, “these antidepressants are portrayed almost like prenatal vitamins that will level out their mood and lead to a healthier baby. But antidepressants have not been shown to decrease rates of miscarriage or birth defects or low birth weight. On the contrary, they’ve been shown to increase those problems.”

Hale’s commentary was titled, “Thoughts on exploring a “Pregnancy Pause,” and she also sent it to Vogue. “I methodically refuted and balanced the article’s bias against medicating with anti-depressants during pregnancy,” she writes on her site.

On May 6, Karen Kleiman provided a link to “Thoughts” on her website and told readers, “Please take the time to read her very thoughtful and well-researched post.” The same day, Katherine also posted a link on Postpartum Progress with the headline, “Hale Responds to Vogue Piece on Antidepressants in Pregnancy.”

Not surprisingly, Hale specifically singled out the comments made by Dr Urato in the Vogue article. In 2006, Urato was responsible for exposing the fact that the financial ties of the authors to SSRI makers were not disclosed in a paper titled, “Relapse of Major Depression During Pregnancy in Women Who Maintain or Discontinue Antidepressant Treatment,” published in the Journal of the American Medical Association, which led to major media coverage and a public admonition by the editor of JAMA reporting that seven authors had failed to reveal their financial ties to drug makers.

A letter from Urato was also published in JAMA, stating that being the study dealt in part with the question of stopping antidepressants during pregnancy, the readers should be aware of the potential for pro-drug bias.

The Wall Street Journal reported that, “the study and resulting television and newspaper reports of the research failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants,” and “the authors failed to disclose more than 60 different financial relationships with drug companies.”

Most of the authors, the Journal noted, were leading psychiatrists at Harvard’s Massachusetts General Hospital, Emory University, and the University of California Los Angeles.

The American Psychiatric Associations’s pumping up SSRI sales at their annual meeting via a new male diagnosis of PPD may cause problems for couples who want more children for more reasons than lack of interest in sex by one or both partners. On October 24, 2006, the Guardian reported that a study by doctors at the Cornell Medical Center found that two patients who had normal sperm counts and mobility before taking SSRIs had a severe deterioration of both when they began taking the antidepressants.

The doctors, who were treating the two men for infertility, found that when the men stopped taking the SSRIs, their fertility problems disappeared only to resume again when they went back on SSRIs.

The problem is believed to be caused by an adverse effect of SSRIs on both the concentration and swimming ability of sperm. The men were tested over a 2-year period and Dr Peter Schlegel, who presented the research at the American Society for Reproductive Medicine conference, in New Orleans, explained that:

“The patients had normal sperm counts and motility before medication. On the medication they have severe deterioration of both. The same patients going on and off medication had the same pattern. It shows a strong association.”

Impotence and delayed ejaculation are well-known side-effects of SSRIs but now Dr Schlegel says he believes the drugs may be preventing sperm from getting into semen.

“These were men with normal sperm counts that went to nearly zero when they were on these antidepressants but returned to normal when they were off them. It’s a dramatic effect and it’s never been described before,” he advised in the Guardian article.

“We believe that while it’s had a profound effect on these two men,” he said, “it could be having a significant but more subtle effect on many more men.”

Two years later, on September 24, 2008, Bloomberg News reported another study from Cornell University that found Paxil may impair fertility by damaging DNA in sperm.

The study of 35 healthy men who were given the antidepressant “found that the amount of damaged DNA in the men’s sperm rose to 30.3 percent after four weeks, from 13.8 percent,” the report noted.

“We suspect the other SSRIs would have similar effects,” Dr Schlegel told Bloomberg.

The treatment for all these “mood” and “anxiety” disorders women will be screened for as a result of the Mothers Act, includes not only antidepressants, but also drugs used as “mood stabilizers,” such as the antipsychotics Zyprexa, Seroquel, Risperdal, Invega, Geodon and Abilify, and antiseizure medications, along with benzodiazepines like Ativan and Xanax and sleeping pills such as Ambien or Lunesta.

In most cases patients are given combinations of different types of drugs at the same time. In fact, two different drug classes, Zyprexa and Prozac, are combined in Lilly’s Symbyax, and prescribed for “treatment resistant” depression. This one is a real money maker, selling at $1,564 for ninety 12-25mg capsules on DrugStore.com in May 2009.

For a simple diagnosis of “postpartum obsessive-compulsive disorder,” after her first pregnancy, Katherine Stone took “Effexor, Celexa, Seroquel, Risperdal, Wellbutrin, Luvox, Cymbalta, and etc.,” according to a line in a story about the treatment she received on her website, which was removed after I wrote about it.

In a blog describing her treatment during her next pregnancy, where she admits she took Cymbalta throughout, Katherine identifies her shrink. “I saw my fabulous psychiatrist at Emory every month (Hi Dr. Newport!),” she writes.

That would be the Dr Jeffrey Newport at Emory University who has received research support from Lilly, Glaxo, Janssen, and Wyeth, and has served on speaker’s bureaus and/or received honoraria from AstraZeneca, Lilly, Glaxo, Pfizer, and Wyeth, according disclosures in the August 2007 study titled, “Atypical Antipsychotic Administration During Late Pregnancy: Placental Passage and Obstetrical Outcomes.”

Another author listed on this antipsychotic study is Charles Nemeroff.

On April 29, 2009, Philip Dawdy’s headline on the popular website Furious Seasons, read: “10 Percent Of Depressed Patients Now Take Antipsychotics,” based on statements made during a conference call by executives of Abilify maker Bristol-Myers Squibb.

“Forget about Prozac Nation, this is Atypical Nation,” he said. “Antipsychotics are now the top revenue producing class of drugs, topping even statins.

The labeling on Risperdal says Risperdal “can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use.”

“Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection,” the label notes.

A Patient Fact Sheet by the American Society for Reproductive Medicine, explains that, “Hyperprolactinemia is a condition in which too much prolactin is present in the blood of women who are not pregnant and in men.”

“In women, this results in a decline in the body’s production of progesterone after ovulation which, in turn, can lead to irregular ovulation and infrequent menstruation, cause you to stop menstruating altogether, or cause your breasts to start producing milk, a condition called galactorrhea,” it states.

“Men also can experience galactorrhea,” the Society says. “High prolactin levels in men can also lead to impotence, reduced libido, and infertility.”

A 2005 paper titled, “Medication-Induced Hyperprolactinemia,” from the Mayo Clinic reports that other classes of medications that cause hyperprolactinemia include antidepressants.

“The clinical consequences of hyperprolactinemia include galactorrhea and hypogonadotropic hypogonadism, the latter manifesting as oligomenorrhea or amenorrhea in women, erectile dysfunction in men, and loss of libido and infertility in both sexes,” the paper states.

A July 1, 2000 paper in the American Family Physician, by Dr Nancy Phillips, lists psychoactive medications that cause “disorders of desire” as antipsychotics, barbiturates, benzodiazepines, SSRIs, Lithium and Tricyclic antidepressants.

The list of drugs that cause “disorders of arousal” also includes benzodriazepines, SSRIs and Tricyclic antidepressants. These drugs, as well as antipsychotics and amphetamines (ADHD drugs) are reported to cause “orgasmic dysfunction” in the paper.

Purely to increase profits, people are encouraged to take psychiatric drugs for life and in some cases can never get off because the withdrawal syndrome is so severe.

It would be interesting see how many patients would be willing to begin a life-long treatment regimen if doctors were required to warn that it could mean the end of a normal sex life.

It would also be interesting to know how many patients are given the opportunity to check with their partners to see how long they will remain in a sexless relationship.

Correction: The article above mistakenly says that Alan Schatzberg stepped down as chair of the psychiatry department at Emory. He is at Stanford and he has not stepped down as chair of the psychiatry department. The statement should have been that Schatzberg of Stanford has “resigned his position as principal investigator on a federal research grant in response to the committee’s scrutiny,” the Stanford Daily reported.

Filed under: 'ADHD', 2009, AFSP, anticonvulsants, antipsychotics, APA, front groups, MHA, mothers act, NAMI, PPD, pregnant, sex, SSRIs

Mothers Act Fuels Multibillion Dollar Industry

Evelyn Pringle April 7, 2009

Motherhood has fallen prey to the psycho-pharmaceutical complex. If new legislation known as the Mother’s Act becomes law, the drugging of infants through pregnant and nursing mothers will no doubt increase.

Congress has rightfully refused to pass this bill for eight years. The official title is currently the “Melanie Blocker Stokes Mom’s Opportunity to Access Health, Education, Research, and Support for Postpartum Depression Act of 2009.”

The legislation was introduced in the House during the 110th Congress on January 4, 2007, by Illinois Democrat Bobby Rush and later reintroduced into both bodies of the new Congress in January 2009, after the bill died in the Senate last year.

Democratic Senator Robert Menendez from New Jersey, home to a large number of drug companies, and Richard Durbin (D-IL) are the main sponsors of the bill in the Senate.

In a March 30, 2009 speech on the House floor, Congressman Rush identified the target of this piece of legislation when he claimed that, “60 to 80 percent of new mothers experience symptoms of postpartum depression while the more serious condition, postpartum psychosis, affects up to 20 percent of women who have recently given birth.”

After the House voted to pass the legislation on that day, the Congressman stated: “H. R. 20 will finally put significant money and attention into research, screening, treatment and education for mothers suffering from this disease.”

However, he only mentions screening and treatment for postpartum depression. The true goal of the promoters of this Act is to transform women of child bearing age into life-long consumers of psychiatric treatment by screening women for a whole list of “mood” and “anxiety” disorders and not simply postpartum depression.

Enough cannot be said about the ability of anyone with a white coat and a medical title to convince vulnerable pregnant women and new mothers that the thoughts and feelings they experience on any given day might be abnormal.

The constant watching and barrage of questions such as are you depressed, are you anxious, are you moody, are you fearful of motherhood, are you sleeping well, are there changes in your eating habits, will predictably have the net effect of convincing many women that normal thoughts and emotions are a sign of mental disorders.

In the March 13, 2008 NewsWithViews article, “Branding Pregnancy as a Mental Illness,” Byron Richards writes:

“The Mothers Act has the net affect of reclassifying the natural process of pregnancy and birth as a mental disorder that requires the use of unproven and extremely dangerous psychotropic medications (which can also easily harm the child). The bill was obviously written by the Big Pharma lobby and its passage into law would be considered laughable except that it is actually happening.”

While mania, psychosis, agitation, hostility, anxiety, confusion, depression and suicidality are often cited as “symptoms” of mental illness, many of the same exact “symptoms” are listed as side effects on the warning labels for antidepressants, antipsychotics and anticonvulsants.

All of these drugs are now being prescribed to treat the “mood” and “anxiety” disorders that women will be screened for if the Act becomes law. In the case of pregnant women, no psychiatric drug has been FDA approved as safe for use.

The newly recruited customers will be stigmatized for life with labels of the most serious forms of mental illness simply because they are unlucky enough to become pregnant in the United States, where serious disorders lead to major profits from the prescribing of multiple classes of psychotropic drugs.

On September 1, 2008, Medical News Today ran a headline for a study that stated: “Americans Show Little Tolerance For Mental Illness Despite Growing Belief In Genetic Cause.” The study by University of Pennsylvania sociology professor Jason Schnittker showed that while more Americans believe that mental illness has genetic causes, the country is no more tolerant of the mentally ill than it was 10 years ago.

The study explored tolerance in terms of: unwillingness to live next door to a mentally ill person, having a group home for the mentally ill in the neighborhood, spending an evening socializing with a mentally ill person, working closely with such a person on the job, making friends with someone with a mental illness or having a mentally ill person marry into the family.

Multi-billion dollar industry

In an article for AlterNet on June 18, 2008, Dr Bruce Levine, author of the book, “Surviving America’s Depression Epidemic,” explains how the psycho-pharmaceutical cartel works. “Mental health treatment in the United States is now a multibillion-dollar industry,” he reports, “and all the rules of industrial complexes apply.”

“Not only does Big Pharma have influential psychiatrists… in their pocket, virtually every mental health institution from which doctors, the press, and the general public receive their mental health information is financially interconnected with Big Pharma.”

“The American Psychiatric Association, psychiatry’s professional organization, is hugely dependent on drug company grants, and this is also true for the National Alliance for the Mentally Ill and other so-called consumer organizations.”

“Harvard and other prestigious university psychiatry departments take millions of dollars from drug companies, and the National Institute of Mental Health funds researchers who are financially connected with drug companies.”

More Democrats than Republicans are supporting the Mother’s Act. The increased campaign funding to Democrats may well explain this turn of events. For the last eight election cycles the pharmaceutical industry has contributed far more to Republicans than Democrats. In the 2006 cycle the percentage was 28% to Democrats and 70% to Republicans, according to the Center for Responsive Politics, a nonprofit group that tracks political funding.

But the Democrats were close to matching the Republicans for the 2008 cycle with $5,099,942 to Democrats compared to $5,680,871 to Republicans, which is probably why the Democrats would allow such an obvious drug marketing scheme to be implemented.

“The Mothers Act, while appearing like an Act of benevolence, is a dangerous and unnecessary measure that will result in the further over-prescription of drugs that are already grotesquely over-prescribed,” says Kate Gillespie, one of the lead attorneys handling SSRI birth defect lawsuits and Paxil suicide cases at the Los Angeles based Baum, Hedlund, Aristei & Goldman law firm.

“The Act is a slippery slope,” she warns, “toward the forced drugging of women of childbearing years with drugs of questionable efficacy and serious safety issues effecting mothers and their innocent children – drugs that can cause horrific side effects, including, suicidal behavior, violence and devastating birth defects.”

“Of course, mothers who truly cannot cope should be helped,” Ms Gillespie says, “but do we really need legislation requiring mothers to be screened and drugged?”

“Take out politics and Big Pharma and the push for this legislation just doesn’t make sense,” she states.

“For politicians, a much safer issue than pushing drugs for pregnant mothers is promoting the expansion of medical treatment for postpartum depression,” according to Dr Levine.

He says the Mother’s Act “omits relevant truths” about Melanie Blocker-Stokes, the woman the bill is named after, and the following information about her suicide should be made known:

“Blocker-Stokes… did in fact receive extensive psychiatric treatment. She was hospitalized three times in seven weeks, given four combinations of anti-psychotic, anti-anxiety, and antidepressant medications, and underwent electroconvulsive therapy (electroshock). But despite her psychiatric treatment — or because of it — Melanie Blocker-Stokes jumped to her death from the twelfth floor of a Chicago hotel.”

“There is no evidence that antidepressant use by depressed mothers lowers their likelihood of suicide,” Dr Levine says, “and there is a great deal of evidence that antidepressant use can make some people manic, agitated, and violent.”

Money-making promoters behind the Act

Katherine Stone runs an internet website called “Postpartum Progress” and posts a daily blog. She also serves on the board of Postpartum Support International as the public relations outreach chairwoman. Her Bio says she “is a nationally-recognized, award-winning advocate for women with perinatal mood and anxiety disorders.”

“In 2001,” Katherine reports on her website, that “she suffered postpartum obsessive compulsive disorder after the birth of her first child. The feeling of isolation and shame she suffered inspired her to create Postpartum Progress, which has become the most widely-read blog in the United States on postpartum depression, postpartum OCD, antepartum depression, postpartum PTSD and postpartum psychosis.”

On another page titled, “The Art of Psychiatric Medication,” Katherine tells women to hang in there if a medication does not work because for her diagnosis of OCD, she states:

“I’ve taken many medications, including Effexor, Celexa, Seroquel, Risperdal, Wellbutrin, Luvox, Cymbalta, etc. Throughout all of them, I was on the road to recovery. Some just worked better than others at treating my symptoms.”

She ends the commentary by telling women: “You will find the right medication for you, and you will get better.”

The prescribing of seven drugs, including two antipsychotics and five antidepressants, to treat OCD is a typical example of the profit-driven drugging that women snagged by the Mother’s Act will face, but it’s a far cry from the description Katherine wrote about regarding the comparatively minor treatment she received, when she stated in the June 7, 2004 issue of Newsweek, “in my case, that meant taking an antidepressant and going for weekly therapy sessions.”

Aside from all the serious health risks now known to be associated with these drugs, most women could not afford the 7-drug “cure” that Katherine ingested. According to DrugStore.com in December 2008, from first to last, at a middle dose for a 30-day supply, the drugs would cost: Effexor $197.86, Celexa $279.92, Seroquel $388.38, Risperdal $652.07, Wellbutrin XI $202.08, Luvox CR $135.99, and Cymbalta $366.62. The cost of “etc” is impossible to calculate without knowing how many more drugs she took.

In a March 11, 2009 Postpartum Progress blog, Katherine plugs herself for speaking jobs, along with a study that concluded “the Internet is a viable and feasible tool to screen for PPD.”

“I’ll be adding this study to the speech I give on how women with perinatal mood and anxiety disorders use the Internet,” she reports, and then adds:

“If you’re interested in having me speak at your event, let me know!”

On March 10, 2009, Katherine’s headline read: “It’s Petition Signing Time! Get Out Your Virtual Pen & Support Women with PPD”, and reported “that Susan Stone over at Perinatal Pro is alerting everyone to the new petition created by the Depression and Bipolar Support Alliance to support the Melanie Blocker Stokes MOTHERS Act. She states that last year’s petition generated more than 24,000 signatures. The petition has been reintroduced this year to try and get this legislation passed once again.”

The blog carried a live link to a page where “you can scroll down, enter your zip code and generate letters of support in a matter of seconds for the Melanie Blocker Stokes MOTHERS Act that will be sent to your local Congresspeople and Senators.”

Katherine further told readers: “I know you’re thinking ‘but I already did that last year.’ Well that was then and this is now. Do it again.”

The 2007 Annual Report for the Depression and Bipolar Support Alliance shows this Big Pharma front group received between $150,000 and $499,000 from AstraZeneca, Pfizer, and Wyeth. Abbott Labs, Cyberonics, Eli Lilly, Forest Labs, GlaxoSmithKline, Organon, and Otsuka American Pharmaceuticals each gave between $10,000 and $149,999.

The 2006 Annual Report shows that AstraZeneca gave the group more than $500,000. Abbott Labs, Bristol-Myers Squibb and Wyeth gave between $150,000 and $499,000, and Forest Labs, Glaxo, Janssen, Pfizer, and Shire Pharmaceuticals each gave between $10,000 and $149,000. The Depression and Bipolar Support Alliance in Baltimore also received $5,000 from Eli Lilly in the first quarter of 2008, according to Lilly’s grant report.

In the section of the 2007 Annual report “at a Glance: How We Met Our Mission,” among the things accomplished by the group, it states:

“Promoted Melanie Blocker-Stokes Postpartum Depression Research & Care Act at invitation of Rep. Bobby Rush (D-Ill.)

“Promoted MOTHER’s Act at invitation of Sen. Dick Durbin (D-Ill.)”

After writing letters to Congress through the link established by the industry funded Alliance, those visiting Postpartum Progress will hopefully click on the link to Amazon and buy the book “Perinatal and Postpartum Mood Disorders: Perspectives and Treatment Guide for the Health Care Practitioner” by none other than the Perinatal Pro “expert,” Susan (Dowd) Stone, and Alexis Menkin, at a special price of $43.20, for a savings of $10.80.

Katherine also provides a link to the PerinatalPro website, where women can find treatment for all the “mood” and “anxiety” disorders diagnosed with internet screenings at “Blue Skye Consulting,” where Susan is listed as the Managing Director and Owner.

She also served as president of Postpartum Support International from 2006 – 2008, as vice-president and Conference Chair in 2005 – 2006, and will chair the group’s President’s Advisory Council through 2010. This group brags of being the leading proponent of the Mother’s Act. On March 2, 2009, Susan’s PerinatalPro Blog announced: “The Melanie Blocker Stokes MOTHERS Act moves forward!” and stated:

“Thank you to Congressman Bobby L. Rush, U.S. Senator Robert Menendez and Senator Richard Durbin for your unceasing efforts on behalf of America’s mothers!”

She should have thanked these members of Congress for boosting her career status and yearly income from her treatment center, speaking fees and book sales.

On PerinatalPro, Susan posts a running list of supporters for the Mother’s Act. On March 27, 2009, the list included many drug company funded groups. For instance, the American Psychiatric Association is listed as a supporter. In 2006, the pharmaceutical industry provided close to 30% of the Association’s $62.5 million in financing, according to the July 12, 2008 New York Times.

In the first quarter of 2007, Eli Lilly gave the Association grants worth more than $412,000, according to Lilly’s grant report. The group also received $623,190 from Lilly in the first quarter of 2008.

In her PerinatalPro blogs, Susan has nothing but praise for Katherine’s website and directs visitors back to Postpartum Progress with a live link. On March 16, 2009, Katherine posted a “Quick Survey on Postpartum Anxiety,” and wrote:

“The fabulous Karen Kleiman has asked me to ask you to participate in a short, five-question online survey on anxiety. She says ANYONE can answer it, regardless of the age of their baby(s) and regardless of diagnosis or lack thereof. ANY mother should answer the questions. It’s super quick — I know because I took it myself.”

Kleiman must be fabulous because she has three books for sale on Postpartum Progress with links to purchase them on Amazon. In fact, there are a total of fourteen books for sale on Katherine’s site from which she most likely gets a kick-back with every sale.

Kleiman’s survey is an excellent example of the methods used to con women into suspecting they are mentally ill via the “expert” blogs. The preface states: “The questions on this survey can be answered by a new mother of an infant or an empty-nester with good recall of the early days with her baby. Please answer as honestly as you can.”

The question, capital letters and all, reads: “When you were carrying your baby down a flight of stairs, did you EVER, at ANY time, have ANY thought, image or concern that you could accidentally drop your baby?” The survey further tells women:

If you answered YES to the first question, please describe the type of worry you had: Scary thoughts about dropping the baby, Scary images about dropping the baby, Both thoughts and images, Other.

How much distress did this cause you? A Great deal of distress, Some distress but I quickly got over it, Some distress that seemed to linger, Not much stress

Did this thought or image occur once or did it recur? Only once, It recurred frequently, It recurred persistently, It occurred off and on, Did you ever tell anyone about the fear of dropping the baby? (Please describe why you chose to tell someone or why you chose not to)

As a mother with good recall, the “honest” answer is yes, with two babies born 4 years apart, every single night as I stumbled out of bed half asleep for a nightly feeding, my normal fear instinct kicked in and warned me to be careful not to trip and fall down the stairs or drop the baby.

Women who take the survey are told nothing about what the results mean; but clearly the seed is planted that something is wrong if you “EVER, at ANY time, have ANY thought, image or concern that you could accidentally drop your baby”.

Katherine’s website also provides links to the “Top Women’s PPMD Treatment Programs & Specialists.” The first link on the list takes women to the “Emory Women’s Mental Health Program” that primarily focuses on “the evaluation and treatment of emotional disorders during pregnancy and the postpartum period,” according to Emory University’s website. Lilly’s 2008 first quarter grant report shows Emory’s Department of Psychiatry received $25,000.

The “experts” at Emory include some top pharmaceutical industry shills. For example, a link to “Articles” brings up roughly 90 studies and papers that include the co-author Dr Charles Nemeroff. Nemeroff is on an ever-growing list of academic researchers in the field of psychiatry under investigation by the US Senate Finance Committee for not disclosing millions of dollars of income from the makers of psychotropic drugs.

Emory’s investigation found he was paid more than $960,000 by Paxil maker, GlaxoSmithKline, from 2000 through 2006, but listed less than $35,000 on his Emory disclosure forms. All totaled, Nemeroff had earnings of $2.8 million from speaking and consulting arrangements with drug companies between 2000 and 2007, but only disclosed a fraction of that amount, according to the Senate Finance Committee reports.

On July 23, 2008, Medscape Psychiatry & Mental Health posted an article by Nemeroff titled: “Weighing Risk and Benefit for Treatment of Depression in Pregnancy and Post Partum”. On March 17, 2009, the Medscape website stated: “This article is temporarily unavailable.”

Maybe that’s because the “top expert,” Dr Nemeroff, recently stepped down as chairman of Emory’s psychiatry department.

(Article sponsored by the Baum, Hedlund, Aristei & Goldman law firm http://www.baumhedlundlaw.com)

Filed under: 2009, antipsychotics, APA, Baum, DBSA, front groups, MHA, mothers act, NAMI, PPD, pregnant, SSRIs

Tracking the American Epidemic of Mental Illness – Part III

Evelyn Pringle June 9, 2010

The Psychopharmaceutical Industrial Complex

For the past two decades, the Psychopharmaceutical Industrial Complex has been the driving force behind the epidemic of mental illness in the United States with the promotion of biological psychiatry and a bogus “chemical imbalance” in the brain theory.

The Psychopharmaceutical Industrial Complex (PPIC) is a symbiotic system composed of the American Psychiatric Association, the pharmaceutical industry, public relations and advertising firms, patient support organizations, the National Institute of Mental Health, managed care organizations, and the flow of resources and money among these groups, according to an October 1, 2009 paper in the Journal of Mental Health Counseling, by Dr Thomas Murray, director of Counseling and Disability Services at the University of North Caroline School of Art.

Murray’s paper draws parallels between cult indoctrination and PPIC techniques and notes the similarities between cult members and mental health consumers who are vulnerable to losing their identities to the PPIC.

The PPIC and “its adherence to the disease model pervades mainstream culture and greatly impacts psychotherapy,” he says. “Consequently, the effects of the PPIC may have resulted in some psychiatric consumers adopting disease-model messages in ways similar to cult indoctrination.”

“Consumer adoption of the disease model can create obstacles to treatment when hope is fundamental,” he advises.

Murray says his most difficult cases “involve clients who have in essence been drawn into the PPIC and have become resigned to the disease model with little sense of empowerment to overcome their emotional problems.”

“These are the consumers who have little self-efficacy and little hope that they have options other than to suffer,” he reports.

“Insurance companies rely on pharmaceuticals to contain costs (and limit psychotherapy sessions), and reimbursement depends on a diagnosis of a diseased brain,” Murray notes.

For psychiatrists, insurance “companies typically encourage short medication visits by paying nearly as much for a 20-minute medication visit as for 50 minutes of therapy,” according to the April 19, 2010, New York Times article, “Mind Over Meds,” by Dr Daniel Carlat, author of the Carlat Psychiatry Blog, and the new book, “Unhinged: the Trouble With Psychiatry.”

Psychiatrists have become enthralled with diagnosis and medication and have given up the essence of their profession – “understanding the mind,” Carlat reports in his book.

“We have become obsessed with psychopharmacology and its endless process of tinkering with medications, adjusting dosages, and piling on more medications to treat the side effects of the drugs we started with,” he says. “We have convinced ourselves that we have developed cures for mental illnesses … when in fact we know so little about the underlying neurobiology of their causes that our treatments are often a series of trials and errors.”

Back in December 2003, a study in Psychiatric Services on “financial disincentives” for psychotherapy noted that psychiatrists could earn about $263 an hour doing three 15-minute “medication management” sessions, verses about $156 for a 45 to 50-minute therapy session, representing a pay cut of close to 41% per hour for doing therapy only.

The most common excuse given for the high rate of prescribing psychiatric drugs is that talk, behavioral, cognitive or other forms of non-drug treatment cost too much. However, in 2008, more than $24 billion worth of antidepressants and antipsychotics were dispensed. “Such expenditure would employ 240,000 psychotherapists earning an annual income of $100,000 to provide 6 million hours of psychotherapy averaging 25 client-hours a week,” Murray estimates.

These figures do not include what would be possible using the additional revenue generated by the sales of antianxiety, hypnotic, and psychostimulant drugs, he says.

Drug Makers Pay Prescribing Shrinks Top Dollar

Vermont is one of the few states that requires pharmaceutical companies to disclose the money spent on marketing drugs to prescribers each year. In 2009, the report by the state’s Attorney General, showed that during the period July 1, 2007, through June 30, 2008, pharmaceutical companies spent approximately $2.9 million, in a state with a population of less than 609,000, on consulting and speaker fees, travel expenses, gifts, and other payments to or for physicians, hospitals, universities and others authorized to prescribe or dispense pharmaceutical products.

“The greatest amount of expenditures went to psychiatrists as a group, totaling nearly half a million dollars; one psychiatrist received over $112,000, the greatest amount of pharmaceutical marketing dollars spent on any single person,” the report states.

Eleven psychiatrists made the top 100 recipients list with an average payment total of $43,473. Shrinks also received the highest pay in 2007, when 11 earned a total of $626,379, or about 20% of the total payments made that year.

The top five spenders in last year’s report were Eli Lilly, Pfizer, Novartis, Merck and Forest Pharmaceuticals, with $242,730 listed for the promotion of depression medications and $217,983 for ADHD drugs.

Lilly was the top spender in Vermont for 3 years in a row. The company’s psychiatric drug portfolio includes Zyprexa, Prozac, Cymbalta, Strattera, and Symbyax, a combination of Prozac and Zyprexa. A list of drugs in the report shows the most marketing dollars went for Lilly’s ADHD drug Strattera and spending on its antidepressant Cymbalta was second. Forest’s Lexapro ranked fifth and Pfizer’s atypical antipsychotic Geodon was in the thirteenth position.

The drug makers now even have general practitioners wildly writing prescriptions for psych drugs. A study in the September 2009 journal, Psychiatric Services, reported that 59% of prescriptions for mental health drugs in the US are written by family doctors, not psychiatrists.

Drug Peddling in the Military

In a joint project with Northwestern University’s Medill School of Journalism, the Center for Public Integrity reviewed travel disclosure forms filed by Department of Defense personnel from 1998 through 2007, and found the medical industry was the largest sponsor of free travel, accounting for about 40% of all trips.

According to their June 2009 report, “Pentagon Travel,” there were 8,700 trips by DOD personnel paid for by the healthcare industry, at a price tag of more than $10 million, with sponsors that included drug and device makers as well as health foundations and trade groups often funded by those companies.

“Drug companies and device manufacturers spent about $1.7 million for more than 1,400 trips taken by DOD doctors, medical researchers, pharmacists, and other health care employees over the decade, creating relationships that pose serious conflict of interest issues, according to medical ethics experts,” the Center said in a study summary titled, “Medical Industry Showers DOD with Free Travel.”

“Of special interest to the industry were DOD employees who prescribe, purchase, or recommend the use of drugs or medical equipment,” the Center notes.

DOD’s pharmacy system employees, who can influence which drugs are selected at base pharmacies, took more than 400 trips, worth over $400,000, from medical industry sources, according to the Center’s analysis.

The review found drug companies paid more than $115,000 for trips to destinations that included Orlando, Las Vegas, San Diego, New York City, New Orleans, Paris, and Rome.

Shahram Ahari worked as a sales rep for Eli Lilly in 1999 and 2000, and described how he used free meals, trips, and unrestricted grants to subtly seduce civilian physicians into prescribing Lilly’s drugs. The strategy was to make friends with doctors and pharmacists to get them talking about the drugs and then reward them with additional perks for prescribing the drugs.

“The return on dividends is phenomenal,” Ahari says in the summary. “If it costs them a thousand dollars for a dinner, that’s a [patient’s drug] payment for one month.”

“If they fly you on the Concord to Paris for five grand, even if they get one patient out of it, it’s a lifetime of cash,” he pointed out.

From fiscal year 2000 to fiscal year 2006, the Pentagon’s prescription drug spending more than tripled from $1.6 billion to $6.2 billion, according to an April, 2008 Government Accountability Office report.

The head of the DOD’s pharmaceutical program, Rear Admiral Thomas McGinnis, banned his own staff from going on company-paid trips, but other military pharmacy staff took about 400 trips, the Center points out.

Drug spending hit $6.8 billion in 2008, said McGinnis, and “the GAO expects DOD pharmaceutical spending to reach $15 billion by 2015,” according to the summary.

In a May 19, 2009, report for MSNBC titled, “U.S. military: Heavily armed and medicated, Melody Petersen pointed out that military physicians “can be swayed by the aggressive promotional efforts of the pharmaceutical industry just like civilian doctors often are.”

Military rules limit the handouts doctors can take from drug companies, she says. “A doctor can go to a dinner paid for by a drug company, but the meal’s value can’t be more than $20, and the value of all gifts received from a company over the course of a year can’t exceed $50. “

However, drug companies find ways to work around the limits. For instance, Petersen reports that when “thousands of military and federal health-care professionals met in November (2008) for the annual meeting of the Association of Military Surgeons of the United States (AMSUS), more than 80 pharmaceutical companies and other health-care firms were on hand.”

“The companies helped pay for that San Antonio event in exchange for the opportunity to set up booths in the convention hall, where sales reps pressed doctors to prescribe their products or to use their medical equipment and devices,” she notes.

The 6-day meeting also included a celebration, she reports, “15 military and federal doctors and other health professionals received awards that included cash prizes provided by various drug companies.”

On March 17, 2010, Navy Times ran the headline, “Medicating the Military,” to report a Military Times investigation that found 1 in 6 service members is on some form of psychiatric drug.

“And many troops are taking more than one kind, mixing several pills in daily “cocktails” — for example, an antidepressant with an antipsychotic to prevent nightmares, plus an anti-epileptic to reduce headaches — despite minimal clinical research testing such combinations,” the Times noted.

The investigation also found that drugs originally developed to treat bipolar disorder and schizophrenia are now commonly used to treat symptoms of post-traumatic stress disorder, such as headaches, nightmares, nervousness and fits of anger.

“It’s really a large-scale experiment. We are experimenting with changing people’s cognition and behavior,” says Dr Grace Jackson, a former Navy psychiatrist and author of the book, “Drug-Induced Dementia: A Perfect Crime,” in the article.

Troops and military health care providers told Military Times that these drugs are also being prescribed, consumed, shared and traded in combat zones, despite some restrictions on the deployment of troops using those drugs.

The Times investigation of records obtained from the Defense Logistics Agency showed $1.1 billion was spent on common psychiatric and pain medications from 2001 to 2009, and the use of psychiatric drugs had increased 76% overall, since the start of the current wars.

Orders for antipsychotics rose by more than 200%, and annual spending more than quadrupled, from $4 million in 2001, to $16 million in 2009. Orders for anti-anxiety drugs and sedatives increased 170%, and spending rose from $6 million to about $17 million. Annual orders of anticonvulsants had a 70% increase, with spending more than doubled, from $16 million to $35 million.

Antidepressants orders had a 40% gain, but an overall decrease in spending, from $49 million in 2001 to $41 million in 2009, due to the arrival in recent years of cheaper generic versions of the drugs.

Collateral Damage

During the same time frame, from 2001 to 2009, the Army’s suicide rate increased more than 150%, from 9 per 100,000 soldiers to 23 per 100,000, and the Marine suicide rate increased about 50%, from 16.7 per 100,000 in 2001, to 24 per 100,000 marines in 2009.

In a June 20, 2009, commentary for Huffington Post titled, “Antidepressants Cause Suicide and Violence in Soldiers,” Dr Peter Breggin, author of “Medication Madness: The Role of Psychiatric Drugs in Violence, Suicide, and Murder,” dismisses the theory that the increased use of prescription of drugs in the military is a response to increased depression among the soldiers.

“In reality,” he says, “the use of psychiatric drugs escalates when, and only when, drug companies and their minions target new markets.”

“In this case, the armed services have been pushing drugs as a cheap alternative to taking genuine care of the young men and women in our military,” he states. “Instead of shortening tours of duty, instead of temporarily removing stressed-out soldiers from combat zones, and instead of providing counseling – the new army policy is to drug the troops.”

“During Vietnam, a mere 1% our troops were taking prescribed psychiatric drugs,” he reports. “By contrast, in the past year one-third of marines in combat zones were taking psychiatric drugs.”

In Medication Madness, Breggin evaluated more than fifty cases of suicide, violence, mania and crime induced by psychiatric medications, especially the new antidepressants.

Atypical antipsychotics produce a potentially disastrous “metabolic syndrome” that includes elevated blood sugar, elevated cholesterol, elevated blood pressure, and severe obesity, according to Breggin in a 2009 Psychiatric Drug Facts Newsletter.

“They can also cause direct harm to the function of the heart,” he says. “Overall, it’s a prescription for cardiac disease and premature death.”

As far as claiming the increase in suicides is due to increased horrors in the current wars, California neurologist, Dr Fred Baughman points out: “Who can claim that one war is any more horrible, evil or effecting than another?”

“What jumps out as different about these wars,” he says, “are veterans and soldiers saturated with psychiatric drugs, and kept on the front lines or sent back to the front lines time after time.”

“These frequent, sudden deaths occurring in the military are due to its policy of reckless, anti-scientific, psychiatric drugging,” he warns.

Veterans Dying

“Official figures regarding military “suicides” also have to be taken with a grain of salt,” Baughman says.

In 2008, after reading an article in the Charleston Gazette, titled “Vets Taking Post Traumatic Stress Disorder Drugs Die in Sleep,” Baughman began to investigate veterans dying in their sleep because the deaths did not make sense. “Young men in their twenties do not suddenly die for no reason,” he points out.

He specifically investigated the deaths of four West Virginia veterans who died unexpectedly in their sleep in 2008, including Andrew White, Eric Layne, Nicholas Endicott and Derek Johnson. At the time, Stan White, Andrew’s father, knew of eight such cases in Kentucky, Ohio and West Virginia.

Baughman learned that all four veterans had been diagnosed with PTSD and all were taking the same three-drug cocktail consisting of Seroquel, an atypical antipsychotic, Paxil, an antidepressant, and the anti-anxiety drug, Klonopin.

His investigation determined they did not commit suicide or go into a coma, as a result of an accidental mixed drug overdose, as suggested by the military. “None of the veterans who died in their sleep were drunk, drugged, or overdosed when they went to bed, they all appeared normal,” Baughman says.

Within a year, he had learned of between 70 and 80 more similar cases. “These are undoubtedly sudden cardiac deaths,” he reports, “due to the prescription of antipsychotics and antidepressants.”

“Although antipsychotics and antidepressants have been proven to increase the risk of sudden cardiac death, they are routinely prescribed together, as if no such risk is known,” Baughman warns.

He points to the January 2009 study, Ray et al, which reported that antipsychotics double the risk of sudden cardiac death, and that on March 17, 2009, Whang et al reported antidepressants, as well, increase the rate of sudden cardiac deaths.

Sudden cardiac death has been defined as the “unexpected natural death” from a cardiac cause. Some studies suggest that 85 to 90% of these deaths result from ventricular tachyarrhythmias and medications may contribute to the risk of these underlying arrhythmias. Ray et al found atypical antipsychotics increased the risk for arrhythmias.

As of May 24, 2010, by conducting Google searches on the internet, veteran’s wife, Diane VandeBurgt, of Charleston, found 128 deaths of veterans using terms such as “dead in barracks,” “in bed,” “at work station.” Diane’s husband quit taking Seroquel, prescribed as sleep aid as part of his PTSD treatment, after experiencing many terrible side effects.

Andrew White joined the Marines because he wanted to follow in the footsteps of his older brothers. One brother served in the army and the other in the Navy.

Andrew returned from Iraq in September of 2005 and less than two weeks later his brother was killed in Afghanistan. “Andrew had not even emptied his bags when we all had to deal with this loss,” his mother Shirley recalls. Shirley and her husband, Stan, have been on a non-stop mission to find answers for Andrew’s death and the deaths of other veterans.

The soldiers, veterans, and their families deserve the truth about this epidemic of antipsychotic-antidepressant sudden cardiac deaths in the military, Baughman states.

“Most importantly,” he says, “they cannot be allowed to continue to cover up these deaths and dole out psychiatric drug cocktails as they are doing to the exclusion of psychotherapy.”

“The number of Americans on government disability due to mental illness skyrocketing from 1.25 million in 1987 to over 4 million today is an iatrogenic, physician induced epidemic that will only mount in the future,” Dr Baughman says. “The utter, complete fraud based on the fiction of psychiatric diseases has got to stop.”

Invented Diseases

Unlike a medical diagnose that indicates a probable cause, treatment and prognosis, mental disorders are voted into existence by committees representing the American Psychiatric Association, a roughly 38,000 member professional group, that gets to decide what is normal, and what is not, for the more than 300 million other people in the US.

The APA’s “Diagnostic and Statistical Manual for Mental Disorders IV (DSM IV),” contains all the billable mental disorders and amounts to nothing much more than a bunch of checklists of symptoms. The original 1952 version contained just over 100 disorders. By the fourth edition the number had more than tripled to over 350. The DSM5 is due for publication in May 2013.

The DSM is immensely important to drug makers because the FDA will not approve a medication to treat a disorder unless the condition is listed in the manual. For the DSM IV, fifty-six percent of of the 170 panel members, and one-hundred percent of the experts involved in writing diagnostic criteria for “mood disorders” and “schizophrenia and other psychotic disorders,” for which medication is standard treatment, had financial ties to the drug companies, according to a 2006 study titled, “Financial Ties Between DSM-IV Panel Members and Pharmaceutical Industry,” in the “Psychotherapy and Psychosomatics” journal.

The leading categories of financial interest for panel members were research funding (42%), consultancies (22%) and speakers bureau (16%).

The authors of the DSM5 have agreed to limit their industry income to $10,000 or less per year until the completion of their work. But as Dr J Wesley Boyd, an academic psyhiatrist, pointed out in an April 11, 2009 editorial in the Boston Globe:

“Even if these individuals adhere to the stated income limits, how much pharmaceutical funding is being funneled into the authors’ respective departments by way of lectureships, endowed chairs, or sponsored research? And if the authors are free to resume their usual heavier ties to industry after 2012, how can the promise of big payouts later not influence their current work?”

In 2003, a group of psychiatric survivors went on a hunger strike in California with the goal of forcing the APA and the National Alliance on Mental Illness to acknowledge that there was no scientific proof for the claim that mental illness was biological in nature. Three weeks into the strike, the APA issued a statement admitting that “brain science has not advanced to the point where scientists or clinicians can point to readily discernible pathologic lesions or genetic abnormalities that in and of themselves serve as reliable or predictive bio-markers of a given mental disorder or mental disorders as a group.”

The marketing strategy in psychiatry is to invent diagnoses out of thin air and call them diseases as a means to prescribe drugs, says Dr Baughman.

“They take entirely normal people and create patients by diagnosing them with fictional diseases,” Baughman says. “It’s a total fraud.”

To validate this point, he tells how he helped a father in Canada, whose son had been diagnosed with multiple disorders, write a letter to Health Canada, an agency similar to the FDA, asking for information on ways to validate a diagnosis of mental illness.

In a November 10, 2008 response letter, Health Canada stated: “For mental/psychiatric disorders in general, including depression, anxiety, schizophrenia and ADHD, there are no confirmatory gross, microscopic or chemical abnormalities that have been validated for objective physical diagnosis. Rather, diagnoses of possible mental conditions are described strictly in terms of patterns of symptoms that tend to cluster together.”

Baughman then wrote a similar inquiry to the FDA Commissioner, and forwarded a copy of Health Canada’s letter. Donald Dobbs, from the Center for Drug Evaluation and Research, consulted with the FDA’s new drug review division, and responded to Baughman’s inquiry by stating: “…they concurred with the response you enclosed from Health Canada. Psychiatric disorders are diagnosed based on a patient’s presentation of symptoms that the larger psychiatric community has come to accept as real and responsive to treatment. We have nothing more to add to Health Canada’s response.”

“The entirely bogus stigmatizing labels are a barcode on the forehead of a child, and once a label gets in a record, it sticks,” Baughman warns. “These children are going to have problems getting health insurance and trouble finding employment.”.

As a neurologist, “I would say that a third to a half of all the patients I saw had no organic disease,” he says. “Now contrast that with a 2002 survey of child psychiatrists, where 91% of the kids were given a drug.”

“It’s not just psychiatry, it’s pediatrics, neurologists, family practitioners, and psychologists all across the country,” he states. “They have all become members of the child drugging establishment.”

An alarming study by researchers from Thomson Reuters and the US Substance Abuse and Mental Health Services Administration reviewed 472 million prescriptions for psychiatric drugs from August 2006 and July 2007, and found general practitioners wrote more than half of prescriptions in two main classes of drugs, 62% of antidepressants and 52% of stimulants. Family doctors also wrote 37% of prescriptions for antipsychotics, and 22% of anti-mania drugs, the study showed.

The researchers were especially concerned over antipsychotics being prescribed by general practitioners. The fact that antipsychotics may be more complex to prescribe, have some potentially serious side-effects, “emphasizes the need to understand the adequacy of care being provided by a GP,” said Tami Mark, director of analytic strategies for the healthcare and science business of Thomson Reuters.

Attack on Child Drugging

The massive drugging of America’s children, particularly poor, disadvantaged children and youth through Medicaid and in foster care, is an unfolding public health catastrophe of massive proportions, according to Alaskan attorney, Jim Gottstein, the leader the Law Project for Psychiatric Rights. Gottstein and PsychRights have made attacking this problem a priority.

In letters to several federal lawmakers in May 2009, Gottstein reported the massive Medicaid Fraud involved in the prescribing of psychiatric drugs to children covered by Medicaid. Copies of the letters were also sent to Kathleen Sebelius, Secretary of Health & Human Services, Kerry Weems, Acting Administrator, CMS, and Joyce Branda, Director of the Department of Justice Commercial Litigation Branch (Frauds).

“The fraudulent activities of drug companies in promoting off-label pediatric use of psychiatric drugs … has begun to be exposed, but the psychiatric drugging of America’s children and youth goes on unabated,” Gottstein advises in the letters.

While preparing the filing of a lawsuit to prohibit the State of Alaska from paying for psychiatric drugs prescribed off-label to children covered by Medicaid in Alaska, Gottstein led an investigation that determined the vast majority of psychiatric drugs prescribed to kids on Medicaid constitute fraud. A tremendous percentage of the prescriptions did not qualify for reimbursement the letters point out:

“For example, no anti-convulsants masquerading as “mood stabilizers,” such as Depakote or Tegretol, have been approved for pediatric psychiatric use or supported by any of the compendia. However, these drugs, especially Depakote, are routinely paid for by Medicaid without any apparent consideration that the practice has been prohibited by Congress.

“With respect to the second generation neuroleptics, no pediatric use of Seroquel, Zyprexa or Geodon is approved by the FDA or supported by any of the designated compendia. Risperdal is approved for very narrow uses, as is Abilify, but even when prescribed for these indications, they are almost always prescribed concurrently with another drug(s), which is not FDA approved or supported by any of the designated compendia.”

In 2007, through a state FOI request, PsychRights found Alaska Medicaid was paying approximately $123,000 per month for anticonvulsants prescribed to kids and $288,000 for second generation neuroleptics for a “total averaging approximately $411,000 per month in improper Medicaid payments in Alaska alone.”

“Extrapolating this to the entire country,” the letters state, “there is over $2 Billion in Medicaid payments for psychiatric drugs to children and youth that Congress has explicitly prohibited.”

“In truth,” Gottstein says, “this is the smallest amount because typically two or more of these drugs are administered concurrently, in what is called polypharmacy, none of which has been approved by the FDA for pediatric use or supported by any of the designated compendia.”

“It is hard to come up with an adjective that adequately conveys the horror this is inflicting on America’s children and youth,” he states. “Suffice it to say that when the country wakes up to the carnage this has caused, it will be recognized as the largest iatrogenic (doctor caused) public health disaster in history.”

In January 2010, PsychRights announced the unsealing of a major Medicaid Fraud lawsuit against psychiatrists, their employers, pharmacies, state officials, and a medical education and publishing company for their roles in submitting fraudulent claims to Medicaid. The complaint was filed on April 27, 2009, under the federal False Claims Act which allows private parties to bring fraud actions on behalf of the Government, but was kept under seal until January 2010. The defendants include more than a dozen child psychiatrists, Alaska officials, health care agencies, and pharmacies.

PsychRights has also developed a streamlined model Qui Tam Complaint for use by interested attorneys around the country. The complaint is drafted for former foster children to bring the lawsuits and receive the whistleblower’s share of the recovery, but anyone with knowledge of specific offending prescriptions, such as parents and mental health workers, can bring suit.

Last fall, Gottstein gave presentations on how to file and conduct these types of cases at the national conventions of the National Association for Rights Protection and Advocacy (NARPA), and the Internation Center for the Study of Psychiatry and Psychology.

While PsychRights is not bringing these cases for the money, such lawsuits represent a tremendous financial opportunity for attorneys to do well by doing good. “These are about as open and shut as cases can get,” Gottstein says, “it is Medicaid fraud to cause or submit prescriptions to Medicaid for reimbursement if they are not for a medically accepted indication. End of story.”

(This series is sponsored by the International Center for the Study of Psychiatry and Psychology http://icspponline.org/index.html)

Filed under: 'ADHD', 2010, antipsychotics, APA, drugging children, DSM, front groups, http://schemas.google.com/blogger/2008/kind#post, ICSPP, military, SSRIs, veterans

Tracking the American Epidemic of Mental Illness – Part IV

Evelyn Pringle June 22, 2010

Non-Profit Advocacy Groups

As a main component of the Psychopharmaceutical Industrial Complex, the so-called “patient advocacy” organizations have become the leading force behind the American epidemic of mental illness over the past two decades.

Drug makers, and their foundations, funnel millions of dollars to these non-profits every year. In return, the leaders recruit their members as foot soldiers to carry out the latest marketing campaigns and to provide a fire-wall so that no money trail can be tracked back to the drug companies.

Gigantic Pyramid

The psychiatric front groups form a gigantic pyramid and once pharmaceutical money enters the system through a major organization, it gets channeled into a huge spider-web that weaves through many groups, making it nearly impossible to keep track of where it came from or where it all went. Often, when the grant reports of the drug companies list a large donation to one organization, the annual reports of the other groups will show smaller gifts from that same organization.

The “charity” groups are exempt from income tax and the “contributions” funneled through them are tax deductible. The money is used for disease mongering campaigns to both market disorders and pressure public health care programs and private insurers to pay for expensive treatments.

“Presenting themselves as patient advocacy groups is highly disingenuous not only to their membership, many of which may have a sincere desire to help a loved one or a family member with mental problems, but to legislators, the press and the American public — for they have consistently lobbied for legislation that benefits the mental health and pharmaceutical industries which fund them, and not patients they claim to represent,” according to Citizens Commission on Human Rights International, a mental health watchdog group.

In a June 2, 2010, commentary titled, “Psychiatric Fads and Overdiagnosis,” on the Psychology Today website, Dr Allen Frances points out that it “is too bad that there is no advocacy group for normality that could effectively push back against all the forces aligned to expand the reach of mental disorders.”

The leaders of the supposedly “non-profits” earn outrageously high salaries, along with excellent benefit packages, while many of the patients they claim to represent are encouraged to seek federal disability payments of under $700 a month, and apply for public housing, food stamps, and Medicaid, to make ends meet. The top officials will often move from a leadership role in one organization to a higher position in another.

The drug makers rely on the front groups to do their bidding any time profits are threatened. For instance, if the FDA is considering adding a black box warning about a deadly side effect to a drug’s label, which may result in a drop in sales, representatives of front groups will show up at the FDA advisory panel hearings to testify against adding the warning.

They will also lobby FDA panels whenever there is a chance to increase profits, such as enlarging the drug customer base. In June 2009, the Psychopharmacologic Drugs Advisory Committee was set to meet to evaluate AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa for use with 13 to 17 year-olds diagnosed with schizophrenia, and 10 to 17 year-olds diagnosed with pediatric bipolar disorder.

On June 8, 2009, nine front groups issued a joint statement urging the panel to vote to approve all three drugs for kids. The groups signing the letter included the American Academy of Child and Adolescent Psychiatry, American Foundation for Suicide Prevention, American Psychiatric Association, Child and Adolescent Bipolar Foundation, Children and Adults with Attention-Deficit/Hyperactivity Disorder, Families for Depression Awareness, Mental Health America, National Alliance on Mental Illness, and the National Council for Community Behavioral Healthcare.

“As advocates for people living with mental illnesses, we strongly urge the FDA to carefully consider the importance of viable treatment options for bipolar disorder and schizophrenia in pediatric and adolescent populations,” they wrote. “Access to safe and effective treatments, including more information about all treatment options, is crucial to treating these serious and complex conditions in children and adolescents.”

In an obvious attempt to downplay the serious side effects of the antipsychotics, the groups stated: “Other treatments for grave childhood illnesses such as cancer can cause hair loss, nausea, compromised immune systems and even death. However, few people question the necessity of these aggressive forms of treatment.”

“Like cancer,” they wrote, “aggressive treatment may be needed for some patients with bipolar disorder and schizophrenia, diseases with a higher risk of death than some forms of cancer.”

The National Council for Community Behavioral Healthcare only recently began showing up in public pharma campaigns with the other front groups. Last year it was listed as a supporter of one of the most evil customer recruitment schemes ever devised, targeting the roughly four million pregnant women who give birth in the US each year, through passage of federal legislation known as the “Mothers Act.”

On its website, the Council is described as “a non-profit association representing 1,300 mental health and addictions treatment and rehabilitation organizations.” But a review of the few grant reports available on drug companies found this non-profit received over a half a million dollars since 2008, from Eli Lilly and Wyeth alone.

Lilly’s grant reports shows a $440,000 donation in 2008, and another $25,000 grant in 2009. The Council also received $20,000 in 2008, and $10,000 in 2009, from Wyeth (now owned by Pfizer). For the first quarter of 2010, Lilly’s lists two grants to the Council totaling $90,000.

The front groups all have “experts” serving on advisory or scientific boards and committees from major universities and government agencies, who have financial relationships with drug makers of one kind or another. Some organizations even have drug company officials, often from marketing and sales departments, sitting on boards and committees. Many of the same people will serve in multiple groups within the pyramid.

For example, Dr Herbert Pardes, a former director of the NIMH, is president of the scientific board of the National Alliance for Research on Schizophrenia and Depression (NARSAD). He is also a past president of the American Psychiatric Association, and served as chairman of the APA’s Council on Research for several years. A bio on the internet says he is a regular advisor to the National Alliance for the Mentally Ill (NAMI), the Anxiety Disorders Association of American, and Mental Health America. He has also served on the board of TeenScreen and is a charter associate member of the Depression and Bipolar Support Alliance.

Collapse of the Pyramid?

For several years, with Iowa’s Republican Senator, Charles Grassley, leading the charge, the US Senate Finance Committee has been investigating pharmaceutical industry funding, as it relates to marketing practices, involving Continuing Medical Education, consulting arrangements, publications in medical journals, the non-profit professional and patient advocacy organizations, and the conflicts of interest among academics who receive federal funding from the National Institutes of Health through research grants to major universities.

The Committee oversees spending in public health care programs, such as Medicaid and Medicare, for coverage of more than 100 million Americans, including mental health treatment and prescription drugs.

The “drug industry’s most powerful means of boosting the bottom line is funding research, which allows companies to control, or at least influence, a great deal of what gets published in the medical journals, effectively turning supposedly objective science into a marketing tool,” Shannon Brownlee explained in an April, 2004, Washington Monthly report titled, “Doctors Without Borders.”

“By penetrating the wall that once existed around academic researchers,” she says, “drug companies have gained access to the “thought leaders” in medicine, the big names whose good opinion of an idea or a product carries enormous weight with other physicians.”

“Companies target academic KOLs, or Key Opinion Leaders, in the lexicon of marketing, and woo them with invitations to sit on scientific advisory committees, or to serve as members of speakers’ bureaus, which offer hefty fees for lending their prestige to a company and touting its products at scientific meetings and continuing medical education conferences,” she reports.

Grassley’s investigations at major universities turned up more conflicted academics in the field of psychiatry than in any other specialty. His chief investigator, Paul Thacker, developed a system where he would request conflict-of-interest records on psychiatrists from their universities and simultaneously ask drug companies to provide reports on what they paid the same researchers.

Some of the biggest names in the field appear on the list of psychiatrists who failed to disclose all their financial benefits from drug companies, which thus far includes three from Harvard, Joseph Biederman, Thomas Spencer and Timothy Wilens; Charles Nemeroff and Zachery Stowe from Emory; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, outgoing president of the American Psychiatric Association, and chair of psychiatry at Stanford; Martin Keller, a former chair of psychiatry at Brown; Karen Wagner and Augustus John Rush from the University of Texas; and Fredrick Goodwin, of George Washington University, and also the host of a radio show called “Infinite Minds,” that was broadcast for years by National Pubic Radio.

All of the above “KOLs” have served as officials, or on boards and committees, of major front groups, and many have received awards, consulting and speakers fees, and research funding from various organizations.

Ensuing Outrage

The revelation that millions of dollars have been flowing from drug makers to academics in psychiatry, undetected for a decade, has drawn outrage and demands for more accountability in the entire field. “Financial transparency and full disclosure is not just an advocacy position anymore,” says anti-drugging proponent, Vince Boehm. “This is rapidly becoming the order of the day.”

“While the efforts of advocates were crucial in precipitating this amazing shift in public policy,” he says, “our efforts were unwittingly helped by the massive greed of our opponents and the public furor that ensued.”

“Events such as the Biederman scandal at Harvard and other equally disgusting problems of the same proportions have provoked public outrage,” he points out.

Back on June 18, 2008, Dr Bruce Levine, author of, “Surviving America’s Depression Epidemic,” issued a warning in an Alternet commentary. “If those physicians who are not drug-company shills want to save their profession they might want to start taking aggressive actions against their colleagues who are on the take,” he said.

“Perhaps it will help motivate clean physicians to be reminded that history shows that any institution — no matter how large and powerful — can arrogantly cross those lines leading to its demise,” he advised.

On the Health Care Renewal website, Dr Bernard Carroll, former head of Duke’s psychiatry department, says the leaders of the major professional and scientific organizations, like the American Psychiatric Association, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the Society of Biological Psychiatry, may not be stepping up to the plate publicly because “perhaps they are confounded by the awkward fact” that some of the exposed individuals “are current and past presidents of these very organizations.”

They may also be confounded by the “awkward fact,” that all the medical journals, textbooks and other literature put out by the so-called “professional” groups in the field of psychiatry are filled with ghostwritten infomercials, fraudulently crediting the shills on Grassley’s list as authors, with major universities following their names, and nothing short of a mass book burning event will erase all the false advertising.

About a year ago, Grassley asked eight leading medical journals to describe their policies and practices regarding ghostwriting as part of a “broader effort to establish transparency with regard to financial relationships between the pharmaceutical industry and medical professionals,” according to his July 2, 2009 press release.

In a June 16, 2010, letter to the editor of the Miami Herald, Dr John Nardo, a former faculty member in Emory’s Department of Psychiatry, alluded to this problem while complaining about the fact that the University of Miami has “hired a a chairman for the Department of Psychiatry, Dr. Charles Nemeroff, who has become the poster child for what’s wrong with academic medicine in our country.”

“Nemeroff was relieved of his chairmanship at Emory University in Atlanta for failing to disclose conflicts of interest in his publications and presentations,” he said. “That means that he was a well-paid frontman for a number of drug manufacturers.”

“Now it has been revealed that many of his articles were ghost-written by the drug companies and that he recommended a drug, Paxil, as safe for pregnant women when, in fact, it can cause congenital heart defects in newborns,” Nardo wrote.

“One has to wonder what the people at UM are thinking?” he said. “Or if they’re thinking at all?”

Nardo’s letter is related to the latest scandal, in the seemingly never-ending Charles Nemeroff saga, which now involves the Director of the National Institute of Mental Health, Thomas Insel, who apparently worked behind the scenes to help Nemeroff get hired at the University of Miami, after he was kicked off the chair of psychiatry thrown at Emory, according to a June 6, 2010, article by Paul Basken in the “Chronicle of Higher Education.”

Bernard Carroll, who was Nemeroff’s boss for over 6 years while Nemeroff was a professor at Duke, says Nemeroff probably called in some markers. Because back in 1994, Nemeroff found Insel a position at Emory when Insel was facing nonrenewal of a research job at NIMH. And, in addition to being Insel’s boss at Emory, Nemeroff also lobbied for Insel’s appointment as NIMH director, and soon after Insel moved to the NIMH, he appointed Nemeroff as an advisor, Carroll says.

In a November 5, 2009, press release, UM announced Nemeroff’s hiring and described him as “one of the world’s leading experts in the field of psychiatry.”

Although not a peep was said about his fall from grace or the problems Nemeroff caused at Emory, the release stated: “He moved to Emory in 1991 as chairman of psychiatry. There he took an average department to become one of the top ten in the country.”

On January 4, 2010, Ed Silverman posted a Pharmalot blog under the title, “Charles Nemeroff and the House That Glaxo Built,” with a link to a December 30, 2009, headline for a story by BlockShopper, in South Florida, that read: “Psychiatrist spends $1.91M on Miami 6BD.”

“Dr. Charles B. Nemeroff and Gayle Nemeroff bought a six-bedroom, seven-bath home at 1780 Espanola Dr. in Miami from David and Carolyn Shulevitz for $1.91 million on Dec. 4, ” BlockShopper reported.

In addition to pointing out that Nemeroff had taken a new job at UM, Silverman wrote, “the new home appears big enough to house plenty of consulting materials.”

The next day, he informed readers that the first house that Glaxo built for Nemeroff in Atlanta was up for sale at a price of $1.25 million. “This one sports just five bedrooms, but still plenty of room for storing consulting materials,” he wrote.

The Emory investigation found Nemeroff was paid more than $960,000 by Glaxo, from 2000 through 2006, but he listed less than $35,000 on disclosure forms. All totaled, he had earnings of $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million, according to Grassley’s reports.

The real outrage toward Insel stems from the reporting that Pascal Goldschmidt, dean of the UM’s medical school, told Baskin that Insel guaranteed him Nemeroff would be allowed to apply for NIH research grants, even though Emory had suspended Nemeroff’s work on an NIH grant, and in December 2008, placed a 2-year ban on Nemeroff applying for NIH funding. Goldschmidt claimed Emory’s ban “was an immediate reaction to the political pressure that the university was under.”

Further fanning the flames, was the Chronicle’s revelations that Nemeroff is serving on the NIH expert panels that help decide “which grant applications win federal financing,” at a time when there is still an ongoing investigation into the NIH’s lack of oversight of Emory and conflicts of interest involving Nemeroff, by the Department of Health and Human Services Office of Inspector General.

After reading Baskin’s article, Grassley fired off a letter to Daniel Levinson, the Inspector General, on June 7, 2010. “I was extremely disturbed to read a story today in The Chronicle of Higher Education,” he told the IG.

“For almost a year,” he wrote, “Dr. Charles Nemeroff has been under investigation by your office for failing to fully disclose his conflicts of interest regarding his grants from the National Institute of Mental Health (NIMH).”

“During this same time, The Chronicle of Higher Education reports that the Director of the NIMH was assisting Dr. Nemeroff in obtaining a new job and made assurances that Dr. Nemeroff would be able to apply for new NIMH grants,” he said. “I ask that you look into this matter and proceed as you deem appropriate.”

On June 7, 2010, Grassley sent a letter to UM president, Donna Shalala, basically stating the same thing except he told her: “I was also troubled by Dr. Goldschmidt’s comments that a ban against Dr. Nemeroff from receiving NIH grants was ‘an immediate reaction to the political pressure that the university was under.’”

“President Shalala,” he wrote, “I hope that you would agree–contrary to Dr. Goldschmidt’s views that disciplining researchers for failing to disclose conflicts of interest is merely a political issue–that enforcing federal conflict of interest policy involves ethical and legal issues that ensure taxpayer trust.”

In response to the letter, Grassley asked her to provide “all emails and communications by Dr. Goldschmidt,” regarding Nemeroff’s conflicts of interest and Nemeroff’s work and/or grants with the NIH, and “all emails and communications by Dr. Nemeroff,” regarding the same, along with all conflict of interest forms filed by Nemeroff with UM.

Money Laundering Operation

Dr Daniel Carlat, author of the Carlat Psychiatry Blog, and the new book, “Unhinged: the Trouble With Psychiatry,” explains that “much of the continuing medical education (CME) industry in the United States is a legalized money laundering operation,” in a June 10, 2008 blog.

“Rather than paying doctors directly to give accredited CME courses (which is illegal), drug companies pay third party companies to create the courses,” he says. “The checks are actually written by the education company, but the ultimate source is clearly the sponsoring pharmaceutical company.”

The Harvard scandal represents the “perfect storm” of the CME industry money laundering operation, Carlat reported on his blog.

It’s clear that “the majority of money received by these doctors did not come directly from drug companies, but indirectly from various third party companies,” he says. “And this is likely the key to the mystery of why the doctors assumed they could ethically hide these payments.”

After going through the list of payments posted in the Congressional Record, Carlat found it appeared that “the vast majority of the money eventually reported by the Harvard Trio, a combined $4.2 million over 7 years, was drug company money that was laundered and processed to seem like it wasn’t drug company money.”

“The most glaring example,” he says, “comes from Dr. Wilens disclosures.”

Grassley posted slightly more than a third of Wilens’ payments ($612,303 out of a total of $1.6 million). Only $69,915 of this (11%) came directly from drug companies. Most of the money ($542,388) came from various third party companies, many, possibly all of which, are CME companies, Carlat reports.

“The biggest tool the industry has for off-label promotion is continuing education,” says Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center, involved with a program called PharmedOut, created to educate doctors about the prescribing influences of big drug companies, in the Star-Ledger on June 6, 2010.

“Physicians have freedom of speech and aren’t under the same constraints as industry employees,” she explained.

When drugs are prescribed for off-label or unnecessary uses, public health care programs not only have to pay for the drugs, they must also pay the prescribing doctors’ fees and the cost of medical care for any injuries caused by the drugs.

Government spending tied to psychiatric drugs has gone through the roof in the past two decades due to the bilking of public programs. And no doubt as a result, pharma CEOs are earning over the top pay packages. In 2008, the head of J&J pulled in $29.1 million, Abbott Labs’ CEO took home $28.3 million, the top dog at Bristol-Myers earned over $23 million, Lilly’s CEO pulled down close to $13 million, Pfizer’s took home over $15.5 million, Wyeth’s CEO earned nearly $26 million, and Forest Labs’ top official was paid more than $6.5 million, according to the AFL-CIO’s “Executive Pay Watch” website.

American Psychiatric Association

Early on in his investigation, Grassley asked the “American Psychiatric Association,” for an accounting of money received from drug companies and foundations created by drug companies. In 2006, the industry accounted for about 30% of the Association’s $62.5 million in financing, or about $18.75 million, according to the New York Times.

The 38,000 member APA describes itself as “a national medical specialty society whose physician members specialize in the diagnosis, treatment, prevention and research of mental illnesses.”

The outgoing president of the APA is Alan Schatzberg, the same guy whose name appears on the Grassley list.

The “American Psychiatric Foundation,” is the charitable and public educational arm of the APA, according to its website. In 2009, the Foundation’s 15 member board of directors included four Vice Presidents from the drug companies Pfizer, Eli Lilly, and J&J’s Janssen Pharmaceutica division.

On its website, the Foundation identifies drug companies that donate but does not give the exact amount. For example, AstraZeneca, Bristol-Myers, Lilly, Forest, Janssen, and Wyeth are listed as giving “$40,000 and above.” However, the few grant reports publicly available show drug companies may be giving more than ten times that amount. Lilly donated $450,000 to the Foundation in 2007, in addition to the $400,000 given to the American Psychiatric Association.

The Foundation also received one grant from Lilly for $241,915 in 2009, and another $20,000 donation to fund the Foundation’s Newsletter. The Foundation received $102,961 from Pfizer, and $205,400 from Wyeth, in 2009, as well.

In the first quarter of 2010, the Foundation received grants from Lilly of $36,000, $10,000 and $18,000. Pfizer gave the Foundation $20,000 in the first quarter of 2010.

Pfizer’s 2008 grant report shows donations of more than $700,000 to the American Psychiatric Association. Lilly gave the APA grants totaling more than $600,000 in both the first and second quarter of 2008. Wyeth donated $43,831 in 2008.

Lilly’s 2009 report shows the APA received four grants of $154,575, $142,575, $142,575, and $154,575. Pfizer gave the group $250,000 in 2009.

The American Psychiatric Institute for Research and Education (APIRE), is another philanthropic arm of the APA, established in 1998 “to establish the leadership role of the APA in contributing to the scientific base of psychiatric practice and policy,” with a stated mission to “improve the quality of psychiatric care through research, education, health policy analysis, and dissemination.”

For the March 6, 2010, paper, “Pharmaceutical Philanthropic Shell Games,” in Psychiatric Times, Lisa Cosgrove, PhD and Harold J. Bursztajn, MD, investigated the financial relationships of the APIRE board members with pharmaceutical companies that manufacture psychiatric drugs and found 9 of the 16 board members have industry ties.

“The fact that over half of APIRE’s board has financial ties to industry is problematic, and it is noteworthy that this percentage is a highly conservative estimate,” they wrote.

“Current disclosure policies do not require reporting of pooled industry monies (eg, when companies give large sums of money to academic departments, units, hospitals, and medical schools)—even when direct benefit, such as salary, may be derived from pooled funds,” they point out.

In addition, one board member who reported “no disclosure” in an APA publication “was found to be on the speakers’ bureau of multiple pharmaceutical companies,” they note.

The APA is currently revising psychiatry’s billing bible, the DSM-V. “Approximately 68% of the members of the DSM-V task force reported having industry ties, which represents a relative increase of 20% over the proportion of DSM-IV task force members with such ties,” Cosgrove and Bursztajn report.

“Also, of the 137 DSM-V panel members who have posted disclosure statements, 77 (56%) have reported having industry ties, such as holding stock in pharmaceutical companies, serving as consultants to industry, or serving on company boards—no improvement over the 56% of DSM-IV members who were found to have such industry relationships,” they point out.

The APA also issues “Clinical Practice Guidelines,” with recommendations for the use of specific drugs for mental disorders. “Ninety percent of the authors of 3 major clinical practice guidelines in psychiatry had financial ties to companies that manufacture drugs explicitly or implicitly identified in the guidelines as recommended therapies for the respective mental illnesses,” according Cosgrove and Bursztain.

They also found the corporate advisory council of the Foundation “is made up of pharmaceutical companies that contribute significant funding to APF and that manufacture medications recommended in the APA’s CPG.”

On June 11, 2010, the Wall Street Journal reported that the APA “has seen a $7.5 million decrease in pharmaceutical industry dollars over the past year – a more than 10% cut in revenue, which funds its research and education activities.”

“The biggest changes at the APA have come at its money making annual meeting,” the Journal said. “Over the past three years it has been phasing out industry sponsored symposia – dinners and talks.” This translated to a loss of $1.8 million to $1.9 million in industry funding between 2008 and 2009, an APA official told the Journal.

However, according to Martha Rosenberg’s coverage of the group’s annual meeting in a May 31, 2010, Scoop article, although 200 protestors were chanting “no drugging kids for money,” and “no conflicts of interest,” at the convention hall, “polarizing figures” were still present at this year’s event.

For instance, she writes: “Sitting next to outgoing APA president Alan F. Schatzberg, MD, even as protestors chanted outside, was Charles Nemeroff, MD, former psychiatry chairman at Emory University who was investigated by Congress.”

“And a paper presented about attention deficit hyperactivity disorder (ADHD) was co-written by Harvard’s Joseph Biederman, MD, also investigated by Congress for pharma financial links and considered the father of the pediatric bipolar disorder craze,” she reports.

“Nemeroff was signing the Textbook of Psychopharmacology which he co-edited with Schatzberg, also investigated by Congress. Schatzberg, psychiatry chairman at Stanford, consults to seven drug companies, owns stock and patents with others and is on Sanofi-Aventis’ Speakers Bureau according to the meeting’s Daily Bulletin,” she wrote.

National Alliance on Mental Illness

Last year, the National Alliance on Mental Illness became the first patient advocacy group to come under investigation by Grassley’s Committee. In a letter to Michael Fitzpatrick, Executive Director of NAMI, in April 2009, Grassley asked for “an accounting of industry funding that pharmaceutical companies or foundations established by these companies have provided,” to NAMI since January 2005.

“Based upon reporting in the New York Times,” Grassley said, “I have come to understand that money from the pharmaceutical industry shapes the practices of non-profit organizations which purport to be independent in their viewpoints and actions.”

“Specifically, it is alleged that pharmaceutical companies give money to non-profits in an attempt to garner favor in ways that increase sales of their products,” he explained.

The disclosures provided to Grassley revealed that the National NAMI group receives nearly two-thirds of its funding from the pharmaceutical industry. Between 2006 and 2008, drug companies, and their foundations, gave the group almost $23 million.

After receiving Grassley’s letter, NAMI’s executive director sent out an email to many NAMI supporters and stated in part: “NAMI does not engage in product promotion, endorsement, licensure or certification of any product, service or program owned by a corporate sponsor.”

However, Philip Dawdy pointed out the falsity of that claim on his Furious Seasons website. “Fitzpatrick has certainly engaged in product pimpery for J&J/Janssen,” he wrote in his daily blog. To substantiate the “pimpery” charge, Dawdy provided a link to a blog he wrote on December 21, 2006, in response to a J&J press release put out to promote its Risperdal’s me-too drug, Invega, with Fitzpatrick praising the drug using his official title of “Executive Director, National Alliance on Mental Illness.”

“New and efficacious treatment options, like INVEGA, provide significant opportunities for more people with schizophrenia to manage their disease as they work with their treatment teams to live more fulfilling and productive lives,” Fitzpatrick stated in the press release.

In her book, Side Effects, Alison Bass tells a story of how James McNulty, NAMI president from 2002 to 2004, failed to disclose that he was being paid thousands of dollars by drug companies to promote their products to NAMI members, and others, at speaking engagements. “In a particularly intriguing twist,” she notes on her website, “McNulty laundered this drug company money through a state chapter of NAMI.” Bass further explains how the scheme worked for funneling the cash to McNulty:

“He would be paid thousands of dollars to speak about the benefits of various antidepressants — McNulty himself suffered from depression — and rather than pay him directly, companies such as Eli Lilly, the maker of Prozac, Pfizer, the maker of Zoloft, and GlaxoSmithKline, which made Paxil, would give his speaking fees to the Rhode Island chapter of NAMI, which would then cut McNulty a check.”

On May 8, 2008, when the APA announced the members of the work groups who would develop the DSM5, James McNulty was listed as a task force member with an expert qualification of “President Emeritus,” of NAMI.

Each year, NAMI gives awards to “Exemplary Psychiatrists,” at its annual banquet. In 2008, a May 5, press release reported that “support for the awards” is provided by Eli Lilly and Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

NAMI was named as a defendant, right along with Pfizer, in a Medicaid fraud lawsuit filed by whistleblower, Mark Westlock, involving the illegal promotion of Geodon. Pfizer “conspired” with NAMI to act as a front organization in the off-label promotion of Geodon, the complaint says. Pfizer turned “NAMI into a Trojan Horse for the illegal marketing scheme to promote Geodon,” for use with children on the NAMI website.

Laurie Flynn, the former executive director of NAMI, and current leader of Columbia University’s TeenScreen, even went so far as to claim that with the advent of atypical antipsychotic medicines “the long-term disability of schizophrenia can come to an end,” the complaint alleges.

In addition to Geodon, the drugs currently marketed by Pfizer, through NAMI and the pyramid of front groups, include the antidepressants Zoloft, Nardil, Sinequan, Effexor and Pristiq, Xanax for anxiety, the anticonvulsants, Neurontin and Lyrica, and the anti-smoking drug, Chantix, and the ED drug, Viagra.

In September 2009, the US Department of Justice announced that Pfizer would pay the largest single criminal fine, and largest combined federal and state health care fraud settlement in the history of the DOJ. The company agreed to pay $2.3 billion, with $1.3 billion in criminal fines, “to resolve criminal and civil health care liability relating to fraudulent marketing and the payment of kickbacks,” according to the government’s “Stop Medicare Fraud Website.”

The charges included paying kickbacks to health care providers to “induce them to prescribe,” or “in connection with marketing,” for a list of thirteen drugs that included Geodon, Zoloft, Lyrica and Viagra. The six whistleblowers received a combined total of roughly $100 million for helping the government.

Brian Kenney and Tavy Deming of the Pennsylvania firm of Kenney Egan McCafferty & Young, represented the Geodon whistleblowers. The off-label marketing allegations were first made in a lawsuit filed on behalf of Harrisburg psychiatrist, Dr Stefan Kruszewski.

The antipsychotic was approved only for adults with schizophrenia or acute manic or mixed episodes of bipolar disorder, but Pfizer illegally promoted it for off-label conditions that included depression, bipolar maintenance, mood disorder, anxiety, aggression, dementia, ADHD, obsessive compulsive disorder, autism, PSTD, and for pediatric, adolescent and geriatric patients, according to the complaint.

Less than “5% of the United States population is diagnosed with schizophrenia or bipolar disorder, yet in 2008 Geodon surpassed the blockbuster benchmark of $1 billion in sales,” Attorney Deming reported in a September 2, 2009 press release.

As part of its marketing campaign, Pfizer claimed that Geodon had a safe metabolic profile when compared to other antipsychotics, such as Zyprexa, Seroquel and Risperdal, and urged doctors to switch patients to Geodon. The switching campaign “endangered patients by ignoring or materially understating Geodon’s serious, and even life threatening, side effects,” Attorney Kenney said in the press release.

On September 3, 2009, Kruszewski told the Philidelphia Inquirer that Pfizer sales representatives pushed him to prescribe Geodon to children for such symptoms as anxiety and agitation.

“Pfizer targeted pediatrics and adolescents to expand off-label use and maintained on its payroll an army of more than 250 child psychiatrists nationwide,” Kenney reported in the press release.

“Pfizer regularly paid generous speaking fees to these child psychiatrists to give what were basically promotional lectures about the benefits of Geodon to their peers, who were naturally also child psychiatrists,” he said.

Apparently, NAMI will continue on with business as usual, except now it will disclose the amounts of Pharma gifts. In 2009, NAMI received 84 payments over $5,000 from different sources, according to an April 2010, analysis by John Mack, on his popular Pharma Marketing Blog. Of payments totaling $4,737,610, Mack found $3,836,750, or 81%, came from major drug companies, with the largest amounts coming from antipsychotic makers, including $1,255,000 from AstraZeneca, followed by Lilly with $750,500, and Bristol-Myers giving 506,250. Wyeth’s 2009 grant report shows donations to all NAMI groups totaling $268,000.

In October 2009, Grassley sent letters to all fifty state NAMI chapters asking them to disclose income from pharmaceutical companies and their foundations. On April 26, 2010, Grassley sent a letter to the leaders of NAMI National and included a chart showing the top 10 state chapters receiving the most money from January 2005 to October 2009, totaling $3.84 million.

Also in October 2009, NAMI CEO Fitzpatrick told the New York Times: “For at least the years of ’07, ’08 and ’09, the percentage of money from pharma has been higher than we have wanted it to be,” and promised the industry’s share of NAMI fund raising would drop “significantly” in 2010.

However, NAMI’s grant report for the first quarter of 2010, shows the group received $1,247,128 from drug companies and foundations, or only $2,212 less than the $1,249,340 it received in the first quarter of 2009. So far this year, Lilly gave NAMI groups over $84,000, and Pfizer’s report shows $78,000 went to NAMI groups.

Conspicuously missing from NAMI’s 2010 first quarter report is AstraZeneca, being the Seroquel maker gave the National group $905,000 in the last quarter of 2009. It may be that Astra was too busy rounding up the more than $520 million it agreed to pay the Federal government and State Medicaid programs in April 2010, to resolve fraud allegations related to the off-label marketing of Seroquel.

“Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets,” said Attorney General, Eric Holder, in an April 27, 2010, DOJ press release.

But Astra can’t be hurting financially because in 2008, even though it makes up only about 5% of the world population, the US accounted for over $3 billion of the roughly $4.45 billion in world-wide Seroquel sales. It was Astra’s second-best selling drug that year, behind the heartburn drug Nexium, and the fifth top selling drug in sales overall in the US. The price of Seroquel at DrugStore.com that year was $839 for hundred middle dose tablets in December 2008. By August 23, 2009, the price had increased by $50 to $890 for the same number of pills.

“A half a billion dollar one-time settlement is just a small cost of doing business for a company that sold $17 billion worth of the offending drug in the last five years,” Dr Roy Poses points out on the Health Care Renewal website.

“This was a well thought out marketing campaign that operated on many levels,” said Brian Kenney, one of the attorneys who again represented, Dr Kruszewski, one of two whistleblowers in this case as well, in an April 28, 2010 press release.

“AstraZeneca orchestrated scientific studies, ghost written articles, and the payment of large fees to academic psychiatrists to act as ‘thought leaders’ to promote the drug off label,” he noted.

“The success can be seen in the huge numbers the campaign generated with 4.9 billion in sales in 2009,” Kenney pointed out.

“It’s particularly disconcerting that AstraZeneca successfully co-opted large portions of psychiatric academic community,” he added.

“The manipulation and misuse of Seroquel scientific data to support AstraZeneca’s off-label marketing campaign was the most disturbing aspect of the case to me,” Kruszewski said in the press release. “There were strong indications from AstraZeneca’s earliest clinical trials that Seroquel increased the risk of diabetes and induced profound sedation out of proportion to its weak antipsychotic effects.”

“In the elderly population, they basically marketed Seroquel as an expensive sleeping pill and put hundreds of thousands of patients at risk for serious medical complications, premature cardiovascular disease, pneumonias, and premature death,” he reported.

In addition to paying $520 million, Astra had to enter into a 5-year corporate integrity agreement that requires the company to post information about payments to doctors on its website, which no doubt will include payments funneled through front groups like NAMI, for Continuing Medical Education programs, speaker fees, research grants, and the various awards given out each years.

Because according to the DOJ press release, the government contends that Astra “promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored Continuing Medical Education programs.”

“The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel,” it says. “In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.”

According to a recent report by Jim Edwards on BNET, former NAMI policy director and board member, Jim Dailey, was a paid consultant for Astra’s Seroquel marketing team, and was paid $600, plus airfare and limousine service, to attend one Seroquel consultant meeting in December 2003.

A picture taken at the meeting shows Daily, along with current NAMI CEO, Fitzpatrick, and Chuck Harmon, NAMI director of corporate relations, meeting with several Astra sales executives. The agenda for the meeting was: Seroquel vision, Role of Advocacy Groups, Increasing role of State/Medicaid with MH issues and MAP initiatives, and Ensuring access for patients.

Edwards explains that “MAP” sometimes stands for “Medication Algorithm Project.” NAMI, along with J&J’s Robert Wood Johnson Foundation, is identified in a Medicaid fraud lawsuit filed against J&J by former federal fraud investigator, Allen Jones, and joined by the Texas attorney general, as participating in off-label marketing schemes to increase the sales of Risperdal, including the “Texas Medication Algorithm Project,” and “Texas Children’s Medication Algorithm Project.”

Latest Plan of Attack

On June 17, 2010, under the headline, “Psychotropic Drug Abuse in Foster Care Costs Government Billions,” Politics Daily reported that the Senate Subcommittee on Federal Financial Management, has asked the Government Accountability Office to look into the drugging of foster care children, who are typically concurrently enrolled in Medicaid.

“The investigators will attempt to account for estimates in the hundreds of millions of dollars of possible fraud arising from prescriptions for drugs explicitly barred from Medicaid coverage,” according to the report.

“Often young patients under state supervision are also prescribed three or four high-risk drugs at a time — all paid for by Medicaid,” it pointed out.

“The GAO is collecting data from Oregon, Massachusetts, Florida, Maryland, Minnesota and Texas, to search for patterns of abuse,” Politics said. “This effort marks the first time suspicion of Medicaid fraud related to psychotropic drugs has been examined at the federal level.”

Alaska attorney, and founder of the Law Project for Psychiatric Rights, Jim Gottstein, told Politics that the increase of antipsychotic use in foster care amounts to “drug companies sacrificing children’s lives on the altar of corporate profits.”

In attempt to put a stop to the rampant off-label psychiatric drugging of foster kids, and other children on Medicaid, in Alaska, Gottstein and PsychRights have filed a Medicaid fraud lawsuit against a number of prescribing doctors, drug companies, pharmacies, and insurance companies in that state.

After learning NAMI was pulling in two-thirds of its funding from Pharma, Grassley sent disclosure requests to over 30 more non-profits. The final part in this series will cover the psychiatric front groups contacted including the Depression and Bipolar Support Alliance, Mental Health America, the National Alliance for Research on Schizophrenia and Depression, Screening for Mental Health, Children and Adults with Attention Deficit/Hyperactivity Disorder, and the National Center for Mental Checkups at Columbia University, or better known as TeenScreen.

(This series is sponsored by the International Center for the Study of Psychiatry and Psychology http://icspponline.org/index.html)

Filed under: 'ADHD', 2010, AFSP, antipsychotics, APA, CHADD, DSM, FDA, front groups, ICSPP, Insel, KOL, MEDICAID, MHA, NAMI, NIMH, Paxil, TeenScreen, TMAP

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