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!
Evelyn Pringle December 27, 2006
One-hundred percent of the experts involved in writing diagnostic criteria for mood disorders and schizophrenia for the, “Diagnostic and Statistical Manual for Mental Disorders (DSM),” have undisclosed financial ties to the pharmaceutical companies whose drugs are used to treat those conditions.
The April 2006 study in the journal, Psychotherapy and Psychosomatics, also determined that more than 80% of the members on the panels involved in decisions related to “anxiety disorders,” “eating disorders,” “medication-induced movement disorders” and “premenstrual dysphonic disorder” have financial ties to the pharmaceutical industry.
Experts say the importance of the manual, also referred to as the “Psychiatric Billing Bible,” cannot be understated, especially for the Big Pharma. The FDA will not approve a drug to treat a disorder that is not included in the DSM and public and private health insurance programs will not pay to treat a disorder that is not listed in the manual.
Medications for the treatment of schizophrenia and mood disorders are the top sellers of all psychiatric drugs in the US. In 2004, antidepressants and antipsychotics became the third and fourth-biggest selling classes of drugs, following cholesterol and heartburn medications, with combined sales of $20.7 billion.
The April study, led by Dr Lisa Cosgrove, a clinical psychologist from the University of Massachusetts, is the first of its kind, and was conducted in part, by sifting through legal files, conflict of interest databases, patent records, journal articles, and other records.
Dr Cosgrove told the Washington Post that she began the research after learning that 5 of six panel members deciding whether certain premenstrual problems should be considered a psychiatric disorder had ties to Eli Lilly, a company that was at the time seeking approval to market Prozac to treat those problems.
“I don’t think the public is aware of how egregious the financial ties are in the field of psychiatry,” she told the Post.
“The very vocabulary of psychiatry is now defined at all levels by the pharmaceutical industry,” according to Dr Irwin Savodnik, assistant clinical professor of psychiatry at the University of California, in a statement to the Chicago Tribune.
A co-author of the study, Sheldon Krimsky, a science policy specialist at Tufts University and author of, “Science in the Private Interest,” told the Washington Post, “When someone is establishing a clinical guideline for the bible of psychiatric diagnosis, I would argue they should have no affiliation with the drug companies in those areas where the companies could benefit from those decisions.”
Critics say the pill-promoting list of bogus “mental disorders” in the DSM apparently has no end and kids appear to be the most sought after customers. For instance, in the DMS, a child’s behavior become an “oppositional defiant disorder,” if a child exhibits at least four of eight behavior patterns, four of which are “often argues with adults,” “often loses temper,” “often touchy or easily annoyed by others” and “often spiteful or vindictive.”
And to treat these alleged “disorders” the drug companies have doctors prescribing the strongest, most expensive psych drugs on the market. On November 11, 2006, the New York Times reported that 13-year-old Paul Williams “has had almost as many psychiatric diagnoses as birthdays.”
“The first psychiatrist he saw, at age 7,” the Times said, “decided after a 20-minute visit that the boy was suffering from depression.”
A string of office visits with psychologists, social workers and psychiatrists led to labels with disorders such as “compulsive tendencies,” “oppositional defiant disorder,” and “pervasive developmental disorder,” or some combination of the others.
Each diagnosis was accompanied by a different regimen of drugs. By the time Paul was 11, his mother said, it was bipolar “with it a whole new set of drug prescriptions.”
In June 2006, a study in the Archives of General Psychiatry, said the use of antipsychotics to treat children for problems with aggression and mood swings had increased more than 5-fold between 1993 to 2002, even though none of the drugs are approved for children.
The study found that about a third of the kids who received antipsychotics were diagnosed with behavior disorders, such as attention deficit; another third listed psychotic symptoms or developmental problems; and the others were for mood disorders.
In addition to antipsychotics, the study found that more than 40% of the children were also taking one or more other psychiatric drugs.
Experts say the rise in prescribing antipsychotics to children corresponds with the introduction and heavy promotion of the new generation of antipsychotics known as “atypical” antipsychotics which include Risperdal, Zyprexa and Seroquel, promoted as superior to older and much cheaper antipsychotics like Haldol.
Atypicals are FDA approved for very limited uses in the treatment of adults with schizophrenia, psychosis, and bipolar disorder.
Over the past several years, these new antipsychotics have been shown to cause extremely serious side effects. According to Dr Stefan Kruszewski, MD, a Harvard trained psychiatrist from Harrisburg, Pennsylvania, they increase the risk of obesity, diabetes type II, hypertension, cardiovascular complications, heart attacks and stroke.
He says the atypicals were marketed as being safer and easier to tolerate than the older, cheaper antipsychotics because the drug companies said that they would cause fewer neurological injuries like tardive dyskinesia and akathesia.
Those claims have turned out to be totally false Dr Kruszewski says, and “at the same time they continue to cause neurological side-effects like the older antipsychotics.”
In addition, the new drugs have been shown to be less effective with children than the old. An August 2006 study by the New York Psychiatric Institute, found that the average response rate in children enrolled in 8 studies taking the new antipsychotics was only 55.7%, compared to 72.3% with children in 13 studies who were taking the older drugs.
The over-prescribing of the atypical drugs to children is found to be most rampant when the cost of the drugs is covered by government health care programs. For instance, a study in the August 3, 2004, Archives of Pediatric Adolescent Medicine, found the number of children in Tennessee covered by the state’s Medicaid program, who were prescribed antipsychotics nearly doubled in six years.
The age group with largest increase was children aged 13 to 18 at 116%, followed by a 93% increase in children aged 6 to 12, and perhaps the most alarming was a 61% increase in the use of antipsychotics with preschool children.
In the wake of budget busting costs, the state of Texas hired ACS-Heritage, a medical consulting firm, to investigate the prevalence of psychotropic drugs prescribed to children and billed to the state, and learned that during the months of July and August, 2004, more than 19,400 teens were prescribed antipsychotics, with nearly 98% prescribed for conditions not approved.
In fact, ACS said that almost half of the children did not appear to have a valid diagnosis warranting the use of the drug, and that one-third of the children were on 2 or more drugs.
The drug companies promote the life-long use of antipsychotics. For instance, a Relapse Prevention Booklet (2004), by the Manic-Depression Fellowship, sponsored by Eli Lilly, for Zyprexa states that “bipolar disorder is often a lifelong illness needing lifelong treatment; symptoms come and go, but the illness stays; people feel better because the medication is working; almost everyone who stops taking the medication will get ill again and the more episodes you have, the more difficult they are to treat.”
Some states have filed lawsuits against the drug makers to recoup the costs incurred by the over-prescribing of the atypicals for conditions not approved by the FDA, as well as the cost of medical care for citizens injured by the drugs.
A West Virginia lawsuit alleges that Eli Lilly promoted Zyprexa for “off label” conditions including anxiety, sleep disruption, mood swings, attention deficit hyperactivity and dementia. As a result of these actions, the complaint states, Lilly sold more Zyprexa than it would have sold if it had disclosed the risk of diabetes and other diseases.
The lawsuit also alleges that Lilly concealed the dangers of Zyprexa, such as an increased risk of diabetes, resulting in further cost to the state to treat Medicaid recipients who became ill from using the drug.
In June 2005, Lilly paid $690 million to settle claims by an estimated 8,000 people who claimed that before September 2003, the information on Zyprexa labels regarding the risk of hyperglycemia and diabetes was not adequate.
But on an up-note, according to the company’s SEC filings, Zyprexa’s sales are booming, with $4.2 billion in 2005, or 29% of Lilly’s corporate revenue.
All this money for a new drug that has been proven to be no better than the old antipsychotics which cost pennies a day. Referring to a study published in the New England Journal of Medicine, on September 21, 2005, The Age.com, reported that a “US Government-financed study of drugs used to treat schizophrenia has confirmed what many psychiatrists long suspected: newer drugs that are highly promoted and widely prescribed offer few — if any — benefits over older medicines that sell for a fraction of the cost.”
As for pushing pills for the mood disorders, with the help of President George Bush’s New Freedom Commission on Mental Health, put in place by an executive order as a gift to the drug companies in return for the millions of dollars in contributions, Big Pharma is zeroing in on children, even infants, as customers for Paxil, Zoloft, Prozac, Lexapro, Effexor, and Celexa, by setting up mental health screening programs in schools and daycare centers.
In a 2003 speech, the director of the Substance Abuse and Mental Health Services Administration, Kathryn Power, reported that mental health assessments are increasingly being conducted in “non-mental health settings,” and she praised one community for “placing mental health consultants in child care settings.”
She also bragged about the federal “Prevention and Early Intervention Grant Program,” and noted that the program’s goal is to reach children, and babies, before they have a diagnosable problem. At that time, Ms Power said that more than half of the administration’s programs were focused on infants and preschoolers.
Mental health screening programs for kids as young as age 0, are being implemented in states all across the country. For instance, in Minnesota an early childhood program is being integrated to ensure all children ages 0 to 5 are screened “early and continuously” and to link children and their families to mental health services.
In Florida, the Florida Strategic Plan for Infant Mental Health Plan is to develop a system to prevent children from 0 to age five from developing emotional and behavioral disorders.
In Illinois, “all children” are to receive social and emotional screens and the schools are to incorporate social and emotional standards as part of the state’s learning standards.
Its not as if infant recruitment schemes are necessary considering the record breaking sales of these drugs. According to SEC filings, Pfizer’s Zoloft, pulled in $2.5 billion in the first three quarters of 2005, and worldwide, Wyeth’s Effexor totaled $3.5 billion in 2005.
But then, Big Pharma would be out of the psych drug business in no time if not for the cooperation of the doctors writing the prescriptions. On August 17, 2005, the Wall Street Journal said, “If the icon of American psychiatry was for years a couch, it is now arguably a pill.”
“And that change in focus,” the Journal reports, “has brought to prominence a new type of psychiatrist: the psychopharmacologist.”
According to the Journal, “these doctors frequently prescribe complex cocktails of drugs for patients with multiple diagnoses of mental illnesses and sometimes prescribe other drugs to counterbalance side effects from the primary drugs.”
A 2003 study by the American Psychiatric Association, on “financial disincentives” for psychotherapy found doctors could earn about $263 an hour for holding three 15-minute medication management sessions per hour, compared to about $156 for a single therapy session, which boils down to an hourly pay cut of 41% for doctors doing therapy.
According to Dr Juan Riestra, associate director of medicine in the department of psychiatry at Mountainside Hospital in Montclair, NJ, a psychopharmacologist is often someone “using a trendy word as a marketing device.”
When a psychopharmacologist sees 30 or 40 patients a day, as some do, Dr Riestra told the Journal, “it becomes like a factory.”
Evelyn Pringle December 6, 2006
In the run-up to the December 13, 2006, meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee, to review the suicidality data from adult SSRI studies, a host of newly identified disorders have been popping up in the media, all treatable with SSRIs.
The committee is expected to vote on whether the association between the selective serotonin reuptake inhibitor antidepressants and suicide in adults should be included in a Black Box warning label on all SSRIs, including Paxil, Prozac, Zoloft, Lexapro, and Celexa.
In light of all these new SSRI treatable disorders in the news, advocates who have been campaigning for the Black Box warning are wondering whether the SSRI makers have received some kind of inside information from the FDA, or the advisory committee members, that is not known to the public.
In fact, its quite possible that the public will have no access to any information that will be discussed at the hearing until the last minute, because the FDA announcement says: “The background material will become available no later than the day before the meeting and will be posted on FDA’s Web site.”
Critics say it seems odd that drug makers would be pouring money into studies to increase the use of SSRIs by finding new “disorders” to add to the DSM, at the very same time that stronger warnings to doctors and consumers on the use of the drugs are being considered.
The ever-expanding Diagnostic and Statistical Manual for Mental Disorders, was released in 1952, and had about 106 different mental disorders. It has since gone through 5 revisions and now has about 375.
The next version of what is referred to as the “Psychiatric Billing Bible,” is not due out until 2011, but there are definite sightings of new “disorders” already on the horizon.
For instance, to the “untrained eye,” a person afflicted with one of the newly identified ailments would probably be viewed as a typical and harmless everyday slob; but GlaxoSmithKline is apparently getting ready market Paxil as a cure for what a new study estimates to be 2 million everyday slobs in the US.
On November 10, 2006, HealthDay News discussed the study, published in the Journal of Psychiatric Research, that said Paxil is effective in treating people with a condition called “compulsive hoarding syndrome.”
The researchers claim it has 3 main features: (1) severe anxiety prevents patients from throwing out seemingly worthless items; (2) patients are prone to acquiring things, sometimes leading to buying sprees; and (3) there is excessive clutter in the patient’s home and work spaces.
Indecisiveness, procrastination and disorganization are also listed as other symptoms. Although the syndrome is found in patients with other diseases, such as dementia, Alzheimer’s, schizophrenia and anorexia, the researches note, it is most often seen in patients with obsessive-compulsive disorder (OCD).
According to Healthday, the research team is not yet certain whether compulsive hoarding is a subtype of OCD, or a separate disorder. The study included 79 patients with OCD, and 32 were found to have “compulsive hoarding syndrome.”
The good news is that the researchers say that both the hoarding and non-hoarding patients showed significant improvement in their symptoms when treated with Paxil.
Moving on to the next earth-shaking discovery, a study from Stanford University, in the October 2006, American Journal of Psychiatry, measured the prevalence of the dreaded, “compulsive buying disorder,” and found that more than 1 in 20 adults in the US suffers from this ailment.
On October 3, 2006, the New York Times reported that compulsive buying is not a recognized psychiatric diagnosis, “but it is now being considered for inclusion in the next edition of the Diagnostic and Statistical Manual of Mental Disorders.”
Lorrin Koran, a professor at Stanford, and senior author of the study, told the San Francisco Chronicle on October 13, 2006, that the results were a surprise. “It was thought previously that this was a disorder that primarily affects women,” he said. “It turns out that it afflicts almost as many men.”
The study found that about 6% of women and 5.5% of men show symptoms of “compulsive buying disorder,” which is characterized by “an irresistible, intrusive and often senseless impulse to buy.”
A finding that doubles the number of “compulsive buying” patients had to be good news for Forest Laboratories, the company that not only paid for the study, but believes its top money making SSRI drugs, Lexapro and Celexa, can be used to treat the disorder.
“My hope,” Dr Koran told the Times, “is that people who think they have this disorder will seek help because available studies suggest that psychotherapy or medications help many compulsive buyers to stop.”
Critics say from an economic stand point, the amount of money that could be saved by seeking treatment would depend on the shopaholic. If weekly therapy sessions cost $200 and the prescription for Lexapro runs $250 a month, a patient might end up in the hole.
Then there is the little-known disorder called “night-eating syndrome,” discussed in an article titled, “Midnight munchies can signal big problems,” in the October 26, 2006 Courier-Journal.
“Those who skip breakfast, eat more than half the day’s calories after dinner and sometimes wake up and snack likely have this condition,” the Courier reported.
“It’s characterized by hormonal imbalances,” the article says, “that lead to disturbed patterns of sleep and eating.”
But help can be found in the old reliable SSRIs here as well. “Research at the University of Pennsylvania has found the antidepressant Zoloft helped,” the Courier reports, “along with therapy to change eating and exercise patterns.”
Considering the recent estimates that more than a third of all Americans are considered obese, with a good PR firm, Zoloft sales could go through the roof if the “night-eating syndrome,” gets enough publicity because according to the Courier, “some research has found that up to 28 percent of obese people have it.”
Zoloft is on a roll. In the October 2006, Journal of Clinical Psychiatry, researchers reported that low doses of Zoloft taken for 2 weeks before the menstrual period may be an effective treatment for moderate-to-severe premenstrual syndrome, or PMS.
Pfizer already managed to get Zoloft approved for the treatment of premenstrual dysphoric disorder (PMDD), referred to as a severe form of premenstrual syndrome.
Apparently, this study is meant to snag customers among the gals whose suffering is less severe. By the way, Pfizer paid for the study that found its drug helpful for PMS.
As for recruitment efforts aimed at the other gender, according to Health Day News on September 9, 2006, “SSRIs, which are used to treat depression and other psychiatric disorders, are now also used “off-label” as a treatment for premature ejaculation.”
However, the article reports that experts say continued use of SSRIs can have negative side effects, such as psychiatric problems, skin reactions, weight gain, and loss of libido.
But not to be discouraged, researchers have gone ahead and developed a new SSRI, dapoxetine, just for premature ejaculation. “This is the first drug specifically developed for premature ejaculation,” lead researcher Dr Jon Pryor, a professor and chairman of urologic surgery at the University of Minnesota, told Health Day News.
In a study, after 12 weeks, men taking a 30-milligram dose of the drug increased their time to ejaculation to 2.78 minutes, and men receiving a 60-milligram dose went for 3.32 minutes. For men taking a placebo, the time to ejaculation averaged 1.75 minutes.
Dr Pryor thinks this study will get people talking about the problem. “I hope this paper brings premature ejaculation out of the closet,” he told Health Day News.
Moving on to the next SSRI miracle, in what is sure to be an extremely successful widening of the customer base for Paxil and Effexor, doctors at the University of Rochester Medical Center, now claim that nearly half of all Parkinson’s patients suffer from depression, but they assume that depression is something they just have to live with.
Not so, say the doctors who announced a nationwide study to test the effectiveness of Paxil and Effexor with Parkinson’s patients, in a September 19, 2006 Press Release.
The doctors say the study is funded by the “National Institute of Neurological Disorders and Stroke,” which can mean one of two things. One, that tax payers are funding the research to find new uses for these drugs, or two, the drug makes are funneling money by way of contributions to the Institute, which the government Web site says it accepts.
The benefit that results from the funneling scheme is that when the doctors find the drugs effective, which they no doubt will, instead of saying the research was paid for by the drug’s makers, it lists the government as the funding source.
Either way, no tax dollars should be spent on this type of study. If there is funding available for research on Parkinson’s disease, it should be spent on finding a cure.
If GlaxoSmithKline and Wyeth want to go on a wild-goose chase looking for new uses for Paxil and Effexor, let them do it on their own dime and time. And after that, they need to apply for approval of any new use with the FDA, instead of using a trumped up study as justification for prescribing the drugs off-label.
In a completely different field of medicine, on October 30, 2006, Reuters reported that researchers at Jerusalem’s Hebrew University discovered what surely must be described as another scientific wonder. Their study found that depression can lead to brittle bones and the Israeli scientists suggest that SSRIs can be used to treat osteoporosis.
They reached this conclusion after they found that mice that were given drugs to induce human-like depression suffered a loss of bone mass, but after receiving SSRIs, their bone density increased, along with their level of activity and social interaction.
According to Reuters, an earlier study at the Forsyth Institute in Boston also found that Prozac increased bone mass – in mice.
When mulling over all the new “disorders” being considered for the DSM, it should be recognized that according to a study in the April 2006, Psychotherapy and Psychosomatics journal, 80% of the members on the expert panels, involved in approving most of the off-the-wall disorders for the DSM in recent years, had undisclosed financial ties to the drug companies whose drugs would be used to treat the disorders approved.
In fact, the review found that 100% of the experts involved in writing diagnostic criteria for depression and schizophrenia had undisclosed financial relationships with the drug companies who market drugs to treat those conditions.
Evelyn Pringle August 2, 2006
Despite years of public outcry, based on recommendations by President Bush’s New Freedom Commission to screen all school children for mental illness, TeenScreen is now being administered in the nation’s public school system and children are being regularly diagnosed with one, or more, disorders chosen from the close to 400 listed in the “Diagnostic and Statistical Manual of Mental Disorders IV” (DSM), also known as the psychiatric “Billing Bible.”
The list of mental disorders to chose from when diagnosing children mentally ill with TeenScreen, are “voted” into the Billing Bible by members of the American Psychiatric Association, and include, among others, conduct disorder, avoidant personality disorder, mathematics disorder, reading disorder, disorder of written expression, general anxiety disorder, nightmare disorder, oppositional defiant disorder, and factious disorder.
A mental illness that drew a lot of ridicule recently, is called the “intermittent explosive disorder,” for people who fly into occasional but unwarranted fits of rage.
Critics view TeenScreen is a main components in an overall pharmaceutical industry-backed marketing scheme pushed along by the NFC, aimed at recruiting new customers for psychiatric drugs. The NFC’s report specifically identifies the target population Big Pharma is after when it states:
“Schools are in a key position to identify mental health problems early and to provide a link to appropriate services. Every day more than 52 million students attend over 114,000 schools in the U.S. When combined with the six million adults working at those schools, almost one-fifth of the population passes through the Nation’s schools on any given weekday.”
The TeenScreen survey is billed as a suicide prevention tool, but according to former government investigator, Allen Jones, “Teen Screen is a nefarious effort to recruit our children into the quagmire of biological psychiatry.”
“The program employs dubious screening tools administered by non-professionals,” he states. “It is based on misleading science and diagnostic criteria that would be downright laughable if the stakes were not so high,” he adds.
“While the idea of screening kids for mental problems seems like a good idea, it ends up being nothing more than a Drugging Dragnet,” says Jim Gottstein, an attorney who represents clients harmed by the psychiatric industrial complex.
“The high rate at which we are drugging America’s children with psychotropics,” he says, “is a national disgrace.”
“This is junk science at it’s worst,” says Dr Jan Johnson, MD, “follow the money, the trail leads right back to the drug companies.”
Activist groups against TeenScreen have posted an online petition and plan to send it to federal, state and local lawmakers. The petition can also be used to educate people about TeenScreen because it conveys many of the facts about mental health screening and can be printed off and presented to school board members or legislators. Persons interested in signing the petition can click on the following link: http://www.petitiononline.com/TScreen/petition.html
As an additional bonus to Big Pharma, Bush set it up the overall scheme so that tax payers will foot the bill for the implementation of the TeenScreen program. On October 21, 2004, he signed a bill into law that authorized $82 million to be spent over 3 years for programs like TeenScreen.
From there, the way the scheme is set up, if a child is diagnosed with a mental illness and the family can not afford the expensive regiment of psychiatric drugs, tax payers will fund the purchase of the drugs as well through public health care programs like Medicaid.
The fact is, Bush and most of his Republican puppets in Congress, would not be in office today if not for the financial support of Big Pharma. Drug companies spend hundreds of millions of dollars a year sending lobbyists to Washington to call in their markers by getting industry-friendly legislation passed.
According to a 2004, report by the consumer group, Public Citizen, drug companies, HMOs, their trade associations and industry-backed advocacy groups spent nearly $141 million on lobbying in 2003, and deployed over 950 lobbyists to do their bidding on Capitol Hill and at the White House.
In 2003, the top 10 drug makers and trade associations spent $55.8 million on lobbying, accounting for 60% of the industry’s total lobbying expenditures. A record 24 companies and trade groups each spent $1 million, or more, on lobbying in 2002.
However, spending on lobbying is a drop in the bucket when compared with the $35.9 billion in profits recorded in 2003, by the 10 top companies. The industry soared past all other sectors, with profits five-and-a-half times greater than the median for industries represented in the Fortune 500.
And, the efforts to influence lawmakers have not been limited to lobbying. Since 1997, the top 25 drug companies with the highest lobbying expenditures, also gave $48.6 million in campaign contributions, with 80% going to Republicans.
According to concerned citizen Barbara Becker, “TeenScreen and similar projects are nothing more than a stealth trolling of the general population for drug consumers.”
“The roots of these projects,” she says, “grow straight from the drooling over additional excessive profiteering by the pharmaceutical industry, with the blessings of too many ever-grateful politicians who also profit from it through enormous pharmaceutical political contributions.”
In all fairness, it should be noted that Big Pharma has managed to cozy up with a few Democrats as well. For instance, Senator Joe Lieberman has been known to pal around with lobbyists representing drug companies that provides large contributions to his campaign.
In fact, according to Joe Conason in the July 17, 2006, New York Observer, Mr Liberman, “has literally been sleeping with one of their Washington representatives ever since his wife Hadassah joined Hill & Knowlton last year.”
“The legendary lobbying and P.R. firm,” Mr Conason explains, “hired her as a ‘senior counselor’ in its ‘health and pharmaceuticals practice.’
One of the firm’s clients is GlaxoSmithKline, the manufacturer of flu vaccines, as well as many other drugs, and Mrs Lieberman joined the firm in March 2006.
“In April 2005,” according to Mr Conason, “Mr. Lieberman introduced a bill that would award an array of new government ‘incentives’ to companies like GSK to produce more vaccines’notably patent extensions on other products, at a cost of billions to governments and consumers.”
Mr Conason noted that the bill drew a critical commentary from by Mr Lieberman’s hometown newspaper, the New Haven Register, titled, ‘Lieberman Crafts Drug Company Perk.’
The newspaper described the bill as being even more generous to the industry than a similar proposal by Republicans. ‘The government can offer incentives and guarantees for needed public health measures,’ the Register said. ‘But it should not write a blank check, as these bills do,” it read, “to the pharmaceutical industry that has such a large cost to the public with what may be an uncertain or dubious return.’
In return for industry support, lawmakers have been very generous when doling out tax dollars to fund marketing schemes like TeenScreen. On September 21, 2005, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced grants of over $9.7 million in funding for the implementation of the TeenScreen Program.
“The Columbia University TeenScreen Program,” the press release said, “provides early identification of mental health problems, such as depression, that can lead to suicide.”
TeenScreen uses a voice computer version of the Diagnostic Interview Schedule for Children (DISC ), and claims it can show signs of 30 disorders, according to an article by Reuters on October 13, 2003.
On March 2, 2004, TeenScreen’s Executive Director, Laurie Flynn, testified at a congressional hearing and said that in the screening process, “youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and drug abuse, and suicidality.”
The goal mentioned by Dr Paul, is obviously being reached because kids are “flunking” TeenScreen all over the country. According to Anne Yates, from Colorado, when the program was piloted at two sites in that state, at the high school, ‘a whopping 50% were found to be at risk of suicide.’
‘Figures from a homeless shelter,’ she reports, ‘were even more outrageous: 71% of the youth screened were found to have “mental disorders.”
‘You can bet psychiatric drugs were pushed at these kids,’ Ms Yates says, ‘TeenScreen is a feeder line to the drug companies.’
During an interview with award-winning investigative journalist, Kelly O’Meara, officials from the highly respected Association of American Physicians & Surgeons (AAPS), described suicide screening in schools as “a dangerous scheme that will heap even more coercive pressure on parents to medicate children with potentially dangerous side effects.”
Further, they told Ms O’Meara, “even the government’s own task force has concluded that mental health screening does little to prevent suicide.”
Critics say, TeenScreen asks teens about normal thoughts, feelings and emotions in a way that turns them into symptoms of mental illness. Concerned parent, Dennis McLoth says, “it looks like a way to make more young people dependent on prescription drugs earlier in life when all they really need is to deal with growing up, just like we all did before there was a drug for every ailment and new ailment to justify even more new drugs.”
Human rights groups contend children are being diagnosed with disorders based on nothing more than a list of behaviors. Kevin Hall, New England Director of the Citizens Commission on Human Rights, notes that ‘unlike medical illnesses that are found through scientific research and discovery, mental disorders are merely groups of symptoms that are voted into existence by American Psychiatric Association committees.’
A May 20, 2006, article on TeenScreen in the National Journal, includes a admission by Steven Sharfstein, President of the American Psychiatric Association, that states: “medical science has no biological or chemical tests that can determine whether a person is depressed, suicidal, schizophrenic, or afflicted with another mental problem. There is no laboratory test that establishes a specific diagnosis.”
Psychiatrist, Dr Nathaniel Lehrman says the claim that TeenScreen can reduce suicides is unsupported by any data. “It is impossible,” he explains, “on cursory examination, or on the basis of the Program’s brief written screening test, to detect suicidality or “mental illness,” however we define it.”
Another complaint heard often from activists is the fact that TeenScreen labels children mentally ill without testing for possible underlying health problems such as nutritional deficiencies, allergies, or other physical illnesses, before initiating drug treatment.
And, the medications the children end up taking as a result of the screening are the most high-priced and dangerous psychotropic drugs on the market, and include selective serotonin re-uptake inhibitor antidepressants (SSRIs), like Paxil, Prozac, Zoloft, and Effexor, and atypical antipsychotics, such as Zyprexa, Risperdal, Geodon, Seroquel, Clozaril, and Abilify, and ADHD stimulant drugs such as Adderall, Dexedrine and Ritalin.
In recent years, the use of these drugs with children has escalated. An examination of prescriptions by Medco Health Solutions in 2004, for 300,000 children ages 19 and younger, concluded that for the first time in history, spending on drugs for behavior problems with kids exceeded expenditures for any other medication category, including antibiotics.
According to Dr Barry Duncan, author of the book, “What’s Right With You,” more than 150 million prescriptions were written for antidepressants in 2003, with sales worth more than $14 billion. And he goes on to note that the “rates of depression have not changed for thirty years,” and “suicide rates, despite the millions taking antidepressants, have not reduced.”
In June 2005, the Washington Post reported that despite “a dramatic increase in treatment of psychiatric disorders during the past 10 years, there has been no decrease in the rate of suicidal thoughts and behavior among adults,” citing a study by researchers from Harvard Medical school and elsewhere, primarily funded by the National Institute of Mental Health.
The study found that although people who attempt suicide were far more likely to be treated with antidepressants in 2001-03, compared to 1990-92, the rates of suicidal ideation, gestures and attempts remained basically unchanged, the Post said.
TeenScreen is being used as a vehicle to get kids on SSRIs, even though there has been a steady stream of warnings against treating kids with SSRIs for years, and even though the drugs are not approved for use with children. Back on June 10, 2003, British pubic health authorities issued a warning of a two-to three-fold increased risk of suicide in pediatric clinical trials during testing of SSRIs.
A week or so later, on June 18, 2003, Glaxo issued a warning to British physicians against the use of Paxil in children, acknowledging failure of clinical trials “to demonstrate efficacy in major depressive disorders and doubling the rate of reported adverse events – including suicidal thoughts and suicide attempts – compared to placebo.”
On August 22, 2003, Wyeth sent warnings to UK and US healthcare professionals stating: “In pediatric clinical trials, there were increased reports of hostility and especially in Major Depressive Disorder, suicide-related adverse events such as suicidal ideation and self-harm.”
On December 18, 2003, Eli Lilly issued two letters to British healthcare professionals, indicating that Prozac was not recommended for children – for any use.
During FDA hearings on SSRIs back in February 2004, researchers presented evidence showing SSRIs to be little or no more effective than placebos. Psychologist, David Antonuccio, from the University of Nevada Medical School, was part of a team that analyzed 12 studies and told the committee, ‘Our conclusions were that the advantages of the antidepressants in children were so small and so trivial as to be clinically insignificant.’
‘In order to evaluate the cost effectiveness of antidepressant use in children, the committee must consider the benefits, as well as the risks,’ Dr Antonuccio testified.
‘Clinically meaningful benefits have not been adequately demonstrated in depressed children,” he said, “therefore, no extra risk is warranted.’
‘An increased risk of suicidal behavior is certainly not justified by these minimal benefits,’ he warned. ‘Neither are the established increased risks of other commonly reported side effects, which include agitation, insomnia, and gastrointestinal problems,’ he added.
On July 21, 2004, the Journal of the American Medical Association, also reported that there was a significantly higher risk of suicide and suicidal thoughts during the first 9 days of treatment with SSRIs, and that children who were first starting treatment were 4 times more likely to think about suicide, and 38 times more likely to commit suicide and that children as young as five had committed suicide while taking these drugs.
In the fall of 2004, the FDA ordered drug makers to post a black box warning on SSRIs, the most serious warning a drug can carry. The problem is black box warnings do not stop doctors from prescribing SSRIs to children.
“Unfortunately,” said Senator Charles Grassley, who had been conducting oversight of the FDA from his position as chairman of the Senate Finance Committee, in response to the news of a black box warning on SSRIs, “the poor performance data for these drugs has been coupled with the very compelling and heart-wrenching testimony from parents and other public witnesses who identify the medications themselves as triggering tragic and unexpected suicides and suicidal behavior among users.”
“I understand,” he continued, “that the testimony yesterday even included discussions about patients who had not been suffering from depression, yet were prescribed these powerful drugs by physicians who may perhaps have been all too ready to medicate their patients.”
When reviewing studies that had previously been suppressed, the FDA found one trial on the SSRI, Paxil, with a “possibly suicide-related” risk of 6.5 percent, and a 5.4% risk of suicide attempts, compared to a 1.1% and zero, respectively in patients taking a placebo.
In fact, in 2004, Paxil maker, Glaxo, was sued by New York State Attorney General, Eliot Spitzer, for committing fraud by hiding studies that “not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo.”
In September 2005, British public health officials instructed doctors to never prescribe SSRIs to children without providing psychotherapy as well. Physicians were also told to never prescribe the drugs without trying other alternative drugs first, and to not prescribe Effexor or Paxil to children under any condition.
In addition to all the other problems with SSRIs, previously suppressed studies also show the drugs are addictive. In June 2003, Glaxo, removed labels that said Paxil was not habit-forming after thousands of patients claimed they had become addicted to the drug.
Experts warn that SSRIs can also cause children to become violent as well as suicidal. According to Dr Julian Whitaker, SSRIs cause akathisia, a mental and physical agitation that sparks self-destructive, violent behavior, and induce disassociative reactions that make patients who take the drugs insensitive to the consequences of their behavior. This is the type of drug, he says, that Eric Harris was taking when he killed his fellow students at Columbine.
Kip Kinkel was on Prozac, Dr Whitaker says, when he killed his parents and then went to his high school in Oregon, and killed two students and wounded 22 others, and says Joseph Wesbecker was also taking Prozac when he killed 7 people at a printing plant in Kentucky, before taking his own life.
In 2003, seventeen-year-old, Julie Woodward, took a test at North Penn High School, in North Wales, Pennsylvania, that said she was suffering from depression and two doctors convinced her parents, Tom and Kathy Woodward, to put her on Zoloft.
Julie’s parents say they watched as her behaviors got steadily worse as soon as she began taking the drug. On the third day, Julie was arguing with her mother, and all of a sudden pushed her mother down to the floor.
Everyone in the family was shocked because Julie had never been violent before. ‘It was an out-of-character act,’ Tom Woodward notes.
Over the next few days, the usually calm Julie, became extremely irritable, could not sit still, and began pacing incessantly. She also became reclusive, her parents recall.
Six days after she began taking Zoloft, Julie hanged herself in the family’s garage. Since their daughter’s suicide, Tom and Kathy have become activists and have work diligently in attempt to educate others parents about the dangers of SSRIs.
Sue Weibert, is an ardent activist against TeenScreen, and has been investigating the program for well over a year. She recently found that when a school enters into a contract to administer the TeenScreen survey, it must agree to screen a minimum of 200 children per season.
According to Ms Weibert, a recent study showed 33% of the kids screened test positive, and quoting a figure provided by Dr Shafer seven years ago in 1999, the study said the cost was about $37 per child per screening.
So all total, 200 times a rounded off fee of $35 would amount to $7,000 in tax dollars just for the screening. After that, the 33% who screen positive are sent for a “further assessment” at an average cost of $250 to parents.
Screening promoters claim that currently, only one out of every 3 children who are mentally ill receives treatment. “That being the case,” says Jan Eastgate, the International President of the Citizen’s Commission on Human Rights, “with mass screening already in play, if we do not act to prevent this, we can very shortly expect to have 30 million American children prescribed mind-altering drugs.”
Parents are beginning to strike back against schools when their children are screened without their consent. Last year, an Indiana high school was sued for subjecting 15-year-old student to mental health testing with TeenScreen and diagnosing the teen with two mental illnesses, without her parents’ knowledge or consent.
A Massachusetts department of education investigation recently determined that a counselor at the Thomas Hamilton Primary School violated federal law in April 2005, when a student, who was enrolled in a special education class due to a speech delay, was screened for ADHD, without parental consent.
The investigation followed complaints by the mother that the counselor had pressured her to put her daughter on drugs for 3 years. The mother said she did not give consent for a mental evaluation and pulled her children out of the school because of the incident.
Wilmette, Illinois, attorney, S Randolph Kretchmar, defends patients who are violated by the psychiatric industry, and says he is dead against drugging and labeling children with mental health disorders. ‘The great crime of psychiatry and the pushers of psychiatric drugs,’ he advises, ‘is that they have purposely confused us to sell their products.’
‘What the drugs do is disable people,’ he says, ‘it’s just that simple.’
‘They may disable people from behaving badly,’ he explains, ‘but they also disable people in other ways, generally, neurologically.’
He points out that a slow reader or difficult middle-schooler is no threat to public safety. ‘When it becomes popular,’ he says, ‘to neurologically disable children from being disagreeable to their teachers and their parents, we descend into some horrific barbarism, and sacrifice the future of the human race.’
This month, the CCHR issued a report titled, “The Side Effects of Common Psychiatric Drugs,” that explains the various adverse effects of psychiatric drugs and defines the complex medical terms that often makes it hard for readers to understand the side effects. The report also includes the recent FDA warnings about specific drugs, as well as information, they say drug makers have kept hidden for years. Copies of the report can be obtained from their web site.
Evelyn Pringle June 2, 2010
Over a twenty year span, starting when Prozac came on the market in 1987, the number of people on government disability due to mental illness went from 1.25 million to more than 4 million today. There has been a 35-fold increase in the number of children disabled by mental illness who receive federal disability payments, rising from 16,200 in 1987, to 561,569 in 2007.
These statistics come from a new book titled, “Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness, in America,” by award winning journalist, Robert Whitaker, who also authored “Mad in America.”
For the book, Whitaker reviewed 50 years of outcomes in the medical literature, for adults with schizophrenia, anxiety, depression, and bipolar illness, and the childhood disorders of ADHD, depression and juvenile bipolar disorder, to see whether medications had altered the long-term course of the disorders and whether drugs could bring on new or more severe psychiatric symptoms.
His intent was to assess whether this paradigm of care increased the risk that a person would become chronically ill, or ill with disabling symptoms, he reports in his “Mad in America” blog, on the Psychology Today website.
“Although we, as a society, believe that psychiatric medications have “revolutionized” the treatment of mental illness, the disability numbers suggest a very different possibility,” he wrote in the April 28, 2010, Huffington Post.
On April 29, 2010, Alternet published an interview with Whitaker by Dr Bruce Levine, with the headline question of, “Are Prozac and Other Psychiatric Drugs Causing the Astonishing Rise of Mental Illness in America?”
The “literature is remarkably consistent in the story it tells,” Whitaker told Levine. “Although psychiatric medications may be effective over the short term, they increase the likelihood that a person will become chronically ill over the long term.”
“In addition, the scientific literature shows that many patients treated for a milder problem will worsen in response to a drug– say have a manic episode after taking an antidepressant — and that can lead to a new and more severe diagnosis like bipolar disorder,” he said. “That is a well-documented iatrogenic pathway that is helping to fuel the increase in the disability numbers.”
During the interview, Whitaker discusses his research on the increase of juvenile bipolar disorder in the US, as an example of how prescribing psychiatric drugs to children can actually cause mental illness.
“When you research the rise of juvenile bipolar illness in this country, you see that it appears in lockstep with the prescribing of stimulants for ADHD and antidepressants for depression,” he reports.
“Prior to the use of those medications, you find that researchers reported that manic-depressive illness, which is what bipolar illness was called at the time, virtually never occurred in prepubertal children,” he explains.
“But once psychiatrists started putting “hyperactive” children on Ritalin, they started to see prepubertal children with manic symptoms,” he reports.
“Same thing happened when psychiatrists started prescribing antidepressants to children and teenagers,” Whitaker says. “A significant percentage had manic or hypomanic reactions to the antidepressants. “
“Thus, we see these two iatrogenic pathways to a juvenile bipolar diagnosis documented in the medical literature,” he states.
The bipolar kids often end up on cocktails of heavy-duty drugs, including antipsychotics such as Zyprexa, Risperdal, Invega, Seroquel, Abilify and Geodon, which cause a host of physical problems and possible cognitive decline over the long term, he told Levine.
“When you add up all this information, you end up documenting a story of how the lives of hundreds of thousands of children in the United States have been destroyed in this way,” Whitaker says.
In fact, he thinks that “the number of children and teenagers that have ended up “bipolar” after being treated with a stimulant or an antidepressant is now well over one million.”
“This is a story of harm done on an unimaginable scale,” he told Levine.
Levine, an author himself of “Surviving America’s Depression Epidemic,” describes “Anatomy of an Epidemic,” as the “most important book on psychiatric treatment in a generation.”
Role of American Psychiatric Association
In 2006, the 38,000 member strong, American Psychiatric Association, received 30% of their funding, or more than $20 million, from the pharmaceutical industry.
This year’s attendees at the group’s annual meeting last month in New Orleans “had to brave 200 protestors chanting “no drugging kids for money” and “no conflicts of interest” to get into the convention hall,” according to Martha Rosenberg’s May 30, 2010 report in OpEd News.
“If there were a take home message at the APA meeting about the blizzard of ADHD, bipolar and personality disorders threatening adults and children, it was don’t wait,” Rosenberg says. “These dangerous conditions, likened to cancer and diabetes, won’t go away.”
“Thanks to genetic advancements, psychiatric disease risks can now be detected and treated before symptoms surface, said presenters, fostering early treatment paradigms that are pretty Brave New World: People being told they have a disease they can’t feel that needs immediate and lifelong treatment at hundreds of dollars a month or their health will suffer,” she reports.
“Preemptive psychiatric drugging is likely the most dangerous idea that has come along since lobotomy,” warns the prolific anti-drugging activist, Vince Boehm.
As far as drugs, there was no star of the show, Rosenberg says. “The Next Big Thing was not a new drug at all but adjunctive therapy also known as adding existing drugs to existing drugs because they don’t work right.”
“Throwing good drugs after bad, popularized with the antipsychotic Abilify,” she explains, “has only been enhanced by a study in the January JAMA that found antidepressants don’t work for mild depression at all.”
“Antipsychotics are also being “enhanced” by adding drugs to offset weight gain and lethargic side effects,” she reports.
“The pharmaco-fraudulence which has taken over psychiatry today is absolutely breathtaking,” says Dr Nathaniel Lehrman, former Clinical Director of Kingsboro Psychiatric Center, Brooklyn NY.
“There is absolutely no rationale for adding antipsychotics to antidepressants in the treatment of depression other than the hope that somehow the patient will feel better when new medication is added when the old is not enough,” he reports.
Lehrman can think of no medication “which is really specific for anything in psychiatry.”
“The effect of all these medications is largely happenstance,” he says. “If something happens to make the patient feel better while taking a particular medication, the latter will be credited.”
Catalog of Mental Disorders
In January 2010, the APA released a draft for the 5th edition of the Diagnostic and Statistical Manual, or DSM-V, also known as the Billing Bible of psychiatry, with the official definitions of normal and abnormal. Criticisms of the revisions and the task force have been non-stop.
In a March, 2010, analysis in Psychiatric Times, Lisa Cosgrove and Harold Bursztajn reported that approximately 68% of the members of the DSM5 task force had financial ties to the pharmaceutical industry, a 2% increase over the task force members of the DSM4 with such ties.
The draft criteria for “Temper Dysregulation Disorder with Dysphoria,” has specifically come under attack as “one of the most dangerous and poorly conceived suggestions for DSM5,” by Dr Allen Frances, who was chairman of the DSM-IV Task Force, in his “DSM5 in Distress” blog on the Psychology Today Website.
“Apparently, the Work Group was trying to correct excessive diagnosis of childhood bipolar disorder—but its suggestion is so poorly written that it could not possibly accomplish this goal and instead would it would create a new monster,” he advises.
“The “diagnosis” would be very common at every age in the general population and would promote a large expansion in the use of antipsychotic medications, with all of the serious attendant risks,” he warns.
“While trying to rescue kids who are now misdiagnosed as bipolar,” Frances says, “it will undoubtedly open the door to the misdiagnosis of normal kids who happen to be temperamental or in difficult family circumstances.”
The syndrome was first called “severe mood dysregulation (SMD),” but the Childhood Disorders Work Group decided to rename it “temper dysregulation with dysphoria (TDD),” because (a) the new name is more descriptive; and (b) the name of DSM diagnoses does not typically include a denotation of severity, according to the group’s report.
In any event, the prescribing of psychiatric drug cocktails will continue no matter what they end up calling the new disorder. If TDD is a form of BD, “first-line treatment would consist of atypical antipsychotic medication and/or mood stabilizers,” the group states in the report. “On the other hand, if TDD is on a continuum with unipolar depressive disorders, anxiety disorders, and ADHD, first-line treatment would consist of serotonergic reuptake inhibitor antidepressants (SSRI’s) and stimulants.”
In a March 8, 2010 article in Skeptic Magazine, Dr John Sorboro warned that the “folks writing the new DSM-V are even considering a new classification of “prodromal” disorders, which means you may qualify for diagnosis of a mental disorder just based on the hunch of your psychiatrist. “
“Psychiatrists get paid for treating mental illness,” he says. “There is a strong motivation for them to look at things they used to attribute to chronic personality, or just life, and see them as psychiatric illness. “
“These changes have nothing to do with any real definitive science or specific tests that can effectively demonstrate who has a disorder,” Sorbora notes. “It’s little more than psychiatry repackaging people with different labels.”
“Who gets what label has a lot more to do with politics and the economics of psychiatry than it does with any true understanding of the developmental or biologic underpinnings of specific behavior let alone whether we choose to see “different” as “disordered,” he points out.
Sorboro says following the money has led many people to seriously question “the motivations of some of psychiatry’s most prolific researchers who shape how people get diagnosed, what disorder label they are given, and what drugs they are prescribed.”
He notes Senator Charles Grassley’s ongoing investigation to determine the full extent of industry fees paid to psychiatric researchers, and that “some of the biggest names in the business have been accused of misconduct.”
The “biggest names in the business,” identified by Grassley thus far, include Harvard University’s Joseph Biederman, Thomas Spencer and Timothy Wilens; Charles Nemeroff and Zachery Stowe from Emory University; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, the president of the American Psychiatric Association from Stanford University; Martin Keller at Brown University; Karen Wagner and A John Rush from the University of Texas; and Fredrick Goodwin, the former host of a radio show called “Infinite Minds,” broadcast for years by National Pubic Radio.
“Among all the problematic suggestions for DSM5, the proposal for a ” Psychosis Risk Syndrome” stands out as the most ill conceived and potentially harmful,” according to Dr Frances, in his “DSM5 in Distress” blog on the Psychology Today Website.
“This is a clearly the prescription for an iatrogenic public health disaster,” he warns.
“The whole concept of early intervention rests on three fundamental pillars- being able to diagnose the right people and then providing them with a treatment that is effective and safe,” he explains. “Psychosis Risk Syndrome” fails badly on all three counts, he warns.
“The false positive rate would be alarming,” he says, “70% to 75% in the most careful studies and likely to be much higher once the diagnosis is official, in general use, and becomes a target for drug companies.”
“Hundreds of thousands of teenagers and young adults (especially, it turns out, those on Medicaid) would receive the unnecessary prescription of atypical antipsychotic drugs,” he warns.
“There is no proof that the atypical antipsychotics prevent psychotic episodes,” he says, “but they do most certainly cause large and rapid weight gains (see the recent FDA warning) and are associated with reduced life expectancy—to say nothing about their high cost, other side effects, and stigma.”
“Imagine the human tragedies that follow the mislabeling of 70% of children as severely mentally ill, who are then exposed to extremely toxic drugs that induce diabetes, cardiovascular disease, and a host of other severe adverse effects,” warned Vera Hassner Sharav, founder and president of the Alliance for Human Research Protection, in a February 10, 2010 Infomail.
“We are going to have an epidemic of young adults with yet-to-be-determined neurological problems due to the long term use of psychotropic drugs,” warns Washington DC psychiatrist Dr Joseph Tarantolo, Board Chairperson of the International Center for the Study of Psychiatry and Psychology.
An epidemic is defined as 1% of the population and there will be far more than 1% injured by these drugs, he says.
Every human being is at risk of becoming “psychotic,” he states. “It has been said that in the Nazi Germany concentration camps psychosis was 100%.”
“Once one agrees that something is universal, one is simply trying to describe the human condition, not make a medical diagnosis,” Tarantolo advises.
Dr Stefan Kruszewski, a graduate of Princeton University and Harvard Medical School, has seen many patients who experienced one or more episodes of psychosis from medications, illicit drug withdrawal, acute stress, metabolic conditions, PTSD or other psychiatric diagnoses, “who recovered and did not re-experience problems later in life.”
In his extensive clinical experience with psychotic individuals, “recovery after psychosis has been the “norm,” not the exception,” he says
“More significantly, and somewhat contrary to the prevailing psychiatric professional view,” he notes, “the overwhelming majority of my clients in who I observed this ‘norm’ did NOT require psychiatric medicines to sustain them.”
“And, many of them who were prescribed antipsychotic medications to ‘thwart’ another psychotic episode fared somewhat worse than those who were not prescribed any combination of antipsychotics and mood stabilizers,” he adds.
Dr Thomas Edward Bratter is president and founder of the John Dewey Academy in Massachusetts, a residential, voluntary, educational-treatment school for gifted but self-destructive adolescents. This drug and medicine-free facility uses compassionate psychotherapy.
Most students arrive at the Academy with multi DSM-IV labels to justify prescribing psychotropic poisons and receiving third party payments, Bratter says, and have been “raped by the pejorative psychiatric cartel.”
He calls the “Psychosis Risk Syndrome” criminal because “such a diagnosis ignores the awesome toxic power of a negative self-fulfilling prophesy which maximizes failure by perpetrating the unproven myth of mental illness.”
“There needs to be a class action against those who would endorse this movement,” he says, and Bratter would gladly testify on behalf of children and adolescents who need to be protected from such a toxic and damaging conspiracy.
Toxicology expert, Dr Lawrence Plumlee, is president of the Chemical Sensitivities Disorders Association, and editor of, “The Environmental Physician of the American Academy of Environmental Medicine.”
The Chemical Sensitivity Disorders Association was established to provide information and support to chemically sensitive people; to disseminate information to physicians, scientists and other interested persons; and to encourage research on chemical sensitivity disorders and minimizing hazards to human health.
Plumlee is concerned about the DSM5 proposal by the Somatic Symptom Disorders Work Group, to change the name of the category “Somatic Symptom Disorders,” to “Complex Somatic Symptom Disorder.”
“The new draft DSM manual proposes that chronic fatigue syndrome, fibromyalgia, and multiple chemical sensitivity are “somatiform” disorders requiring psychiatric consultation,” he says. “It’s the same old story of Psychiatry trying to extend its diagnostic labels and drug treatments to new populations.”
This is “an effort by psychiatry to psychiatrize physical illnesses and to try to suppress the complaints of these patients by prescribing psychiatric drugs,” Plumlee says.
“But experience is showing that the psychiatric procedures and drugs are making patients worse,” he advises.
Using psychiatric diagnoses and drugs on diseases of neurotoxicity helps the chemical companies in two ways, he reports. “It fools some people into thinking that poisoned people are crazy, thus getting the poisoners (chemical companies) off the hook,” and two, “it sells more chemicals (psychiatric drugs) to treat those who really need detoxification, not more chemicals in their bodies. “
(Part II of this series with show how tax dollars are being used to fuel the American Epidemic of Mental Illness)
(This series is sponsored by the International Center for the Study of Psychiatry and Psychology http://icspponline.org/index.html)
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.
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.
“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.”
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)
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.
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.
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)