Drug industry corruption, scientifically unreliable diagnoses and pseudoscientific research have compromised the values of the psychiatric profession.

Alternet
By Bruce E. Levine
January 6, 2012

Why do some of us become dissident mental health professionals?

The majority of psychiatrists, psychologists and other mental health professionals “go along to get along” and maintain a status quo that includes drug company corruption, pseudoscientific research and a “standard of care” that is routinely damaging and occasionally kills young children. If that sounds hyperbolic, then you probably have not heard of Rebecca Riley, and how the highest levels of psychiatry described her treatment as “appropriate and within responsible professional standards.”

When Rebecca Riley was 28 months old, based primarily on the complaints of her mother that she was “hyper” and had difficulty sleeping, psychiatrist Kayoko Kifuji, at the Tufts-New England Medical Center in Boston, Massachusetts, diagnosed Rebecca with attention deficit hyperactivity disorder (ADHD). Kifuji prescribed clonidine, a hypertensive drug with significant sedating properties, a drug Kifuji also prescribed to Rebecca’s older sister and brother. The goal of the Riley parents—obvious to many in their community and later to juries—was to attain psychiatric diagnoses for their children that would qualify them for disability payments and to sedate their children making them easy to manage.

By the time Rebecca was three years old, again based mainly on parental complaints, Kifuji had given Rebecca an additional diagnosis of bipolar disorder and prescribed two additional heavily sedating drugs, the antipsychotic Seroquel and the anticonvulsant Depakote.

At the age of four, Rebecca was dead.

At the time of her death, Rebecca had a life-threatening amount of clonidine—enough to kill her—in her body, according to the former director of the Massachusetts toxicology lab and the medical director of a regional poison control center. The medical examiner who performed the autopsy concluded that Rebecca died from intoxication of clonidine, Depakote and two over-the-counter cold and cough medicines that led to heart failure, lungs filled with bloody fluid, coma, and then death. Rebecca’s abusive parents went to prison for the over-drugging that led to their daughter’s death.

Kifuji’s fate? The psychiatric establishment rallied around Kifuji, enabling her to return to Tufts Medical Center practicing child psychiatry without any restrictions, penalties or supervision. After Rebecca’s death, Tufts-New England Medical Center defended Kifuji. A Tufts spokesperson told “60 Minutes” in 2009, “The care we provided was appropriate and within responsible professional standards.”

Apparently, psychiatric care that is considered appropriate and within responsible professional standards includes diagnoses of ADHD for a two-year-old and bipolar disorder for a three-year-old when the symptoms of those disorders are normal behaviors for those ages; prescribing three heavily sedating drugs that have not been approved by the FDA for child psychiatric treatment; ignoring the warnings from a school nurse about over-dosages for Rebecca; and making diagnoses based almost entirely on the reports of Rebecca’s mother, who herself was diagnosed with mental illness and heavily medicated to the point of falling asleep in Kifuji’s office.

Long before the Rebecca Riley tragedy hit the headlines, I was embarrassed by the mental health profession for seven major reasons:

1. Corruption by Big Pharma

How did it become within responsible professional standards for a two-year-old to get an ADHD diagnosis, for a three-year-old to get a bipolar diagnosis, and for toddlers to be prescribed multiple heavily sedating drugs? The short answer is drug company corruption of the mental health profession.

Congressional hearings in 2008 revealed that psychiatry’s “thought leaders” and major institutions are on the take from drug companies.

On June 8, 2008, the New York Times reported about psychiatrist Joseph Biederman: “A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007.”

Due in large part to Biederman’s influence, the number of American children and adolescents treated for bipolar disorder increased 40-fold from 1994 to 2003. Pediatrician and author Lawrence Diller notes about Biederman, “He single-handedly put pediatric bipolar disorder on the map.” In addition to his popularization of bipolar disorder for children, Biederman is one of the most significant forces behind the expanding numbers diagnosed with ADHD; and congressional investigators also discovered that Biederman conducted studies of Eli Lilly’s ADHD drug Strattera that were funded by National Institute of Health at the same time he was receiving money from Lilly.

Not only does the drug industry have influential psychiatrists such as Biederman in their pocket, virtually every major mental health institution is financially interconnected with Big Pharma. Congressional hearings also exposed the American Psychiatric Association psychiatry’s premier professional organization, as being on the take from drug companies. In 2006, the drug industry accounted for about 30 percent of the APA’s $62.5 million in financing. Most relevant here, the APA is the publisher of the psychiatric diagnostic bible, the Diagnostic and Statistical Manual of Mental Disorders (DSM), and thus the APA is the institution responsible for creating mental illnesses and disorders.

2. Invalid Illnesses and Disorders

Psychiatry’s first DSM (1952) and its DSM-II (1968) listed homosexuality as a mental illness. Only because of a fierce political fight waged in the 1970s by gay activists did the APA abolish homosexuality as an illness and eliminate it from its DSM-III (1980). Gay activists’ fight was not only a victory for themselves but a service for everyone else, as it made public the important scientific problem of psychiatric disorder invalidity. Specifically, are psychiatric disorders scientifically valid illnesses, or are they simply behaviors that create discomfort for some authorities at a given moment in time?

While psychiatry lost homosexuality as a mental illness in the 1980 DSM-III, the APA found other groups it could pathologize, groups that could not mobilize and resist, most notably children, who are now routinely given psychiatric diagnoses for behaviors that many of us view as normal for their ages.

Psychiatry sees it as within responsible professional standards to diagnose three-year-olds such as Rebecca Riley with bipolar disorder. The symptoms of bipolar disorder include irritable and rapidly changing moods, severe temper tantrums, defiance of authority, agitation and distractibility, sleeping too little or too much, poor judgment, impulsivity and grandiose beliefs.

Psychiatry also sees it as within responsible professional standards for Rebecca Riley to have been diagnosed at 28 months old with ADHD. The symptoms of ADHD are inattention (easily distracted and bored, difficulty organizing and completing tasks, losing things, not seeming to listen, not following instructions); hyperactivity (fidgeting, talking nonstop, having trouble sitting still, difficulty with quiet tasks), and impulsivity (impatience, blurting out inappropriate comments, interrupting conversations).

Today, children and teens are also diagnosed with oppositional defiant disorder (ODD), the symptoms of which include “often actively defies or refuses to comply with adult requests or rules,” and “often argues with adults.”

The standard for a medical disorder should not be whether or not an individual causes friction.

3. Scientifically Unreliable Diagnoses

Even if you believe that bipolar disorder for three-year-olds, ADHD for two-year-olds, ODD for teenagers, and all the other DSM diagnoses are valid disorders, there is still the scientific issue of diagnostic unreliability—the lack of diagnostic agreement among professionals examining the same person.

A generation ago, psychiatrists admitted that their diagnoses were unreliable and agreed that this was a major scientific problem. So in 1980, in an attempt to eliminate this embarrassment, they created the DSM-III with concrete behavioral checklists and formal decision-making rules, but they failed to correct the problem. Psychiatric diagnoses remain unreliable, but now psychiatry no longer talks about the unreliability problem.

If a measurement is a reliable one, then clinicians trained with it should be in high agreement on the diagnosis. A major 1992 study, conducted at six sites with 600 prospective patients, was done to examine the reliability of psychiatric diagnoses. Experienced mental health professionals were given extensive training in how to make accurate DSM diagnoses. Because of the extensive training, one would expect that diagnostic agreement would be much higher than in typical clinical settings. Herb Kutchins and Stuart Kirk summarize the study in Making Us Crazy (1997):

What this study demonstrated was that even when experienced clinicians with special training and supervision are asked to use DSM and make a diagnosis, they frequently disagree, even though the standards for defining agreement are very generous. . . . [For example,] if one of the two therapists made a diagnosis of Schizoid Personality Disorder and the other therapist selected Avoidant Personality Disorder, the therapists were judged to be in complete agreement of the diagnosis because they both found a personality disorder—even though they disagreed completely on which one! So even with this liberal definition of agreement, reliability using DSM is not very good.

Kutchins and Kirk conclude: “Mental health clinicians independently interviewing the same person in the community are as likely to agree as disagree that the person has a mental disorder and are as likely to agree as disagree on which of the over 300 DSM disorders is present.”

4. Biochemical Imbalance Mumbo Jumbo

Just as nothing was more important in selling the Iraq war in 2003 than the Bush administration’s certainty that Iraq possessed weapons of mass destruction, nothing has been more important in selling psychiatric drugs than psychiatry’s certainty of biochemical brain imbalances as the cause for mental illnesses.

Prior to psychiatry’s proclamation that depression was caused by too little of the neurotransmitter serotonin, few Americans were taking antidepressants. But by declaring that depression was caused by a serotonin imbalance analogous to diabetes and an insulin imbalance, depressed Americans became far more receptive to serotonin-enhancing drugs such as the “selective-serotonin-reuptake inhibitors” (SSRIs) Prozac, Paxil, and Zoloft.

SSRIs can make some depressed people feel better; however, alcohol makes some shy people less shy, but that’s not enough evidence to say that shyness is caused by an alcohol imbalance. The truth is—and scientists have known this for quite some time—that serotonin levels are not associated with depression.

Researchers have used a variety of methods to test the serotonin imbalance theory of depression, including comparing serotonin metabolites in depressed and nondepressed people, and depleting serotonin levels through a variety of means and then observing whether this resulted in depression. Elliot Valenstein, professor emeritus of psychology and neuroscience at the University of Michigan, reviewed the research in his book Blaming the Brain (1998) and reported that it is just as likely for people with normal serotonin levels to feel depressed as it is for people with abnormal serotonin levels, and that it is just as likely for people with abnormally high serotonin levels to feel depressed as it is for people with abnormally low serotonin levels. Valenstein concluded, “Furthermore, there is no convincing evidence that depressed people have a serotonin or norepinephrine deficiency.”

In 2002, the New York Times reported: “Researchers knew that antidepressants seemed to raise the brain’s levels of messenger chemicals called neurotransmitters, so they theorized that depression must result from a deficiency of these chemicals. Yet a multitude of studies failed to prove this precept.”

Yet even now, many psychiatrists and other mental health professionals continue to promulgate the serotonin imbalance theory of depression, and polls show that the majority of Americans continue to believe it.

5. Pseudoscientific Drug Effectiveness Research

There are multiple tricks that psychiatric drug manufacturers and their researcher psychiatrists and psychologists use to make their drugs look more effective than they really are. One of the most common depression measurements used by researchers paid by drug companies is the Hamilton Rating Scale for Depression. In the HRSD, researchers rate subjects, and the higher the point total, the more one is deemed to be suffering from depression. On the HRSD, there are three separate items about insomnia (early, middle and late) and one can receive up to six points for difficulty either falling or remaining asleep; however, there is only one suicide item, in which one is awarded only two points for wishing to be dead. The HRSD is heavily loaded with items that are most affected by drugs, and it is therefore especially damning for antidepressants that even with such measurement dice-loading, these drugs routinely fail to outperform placebos—even dice-loaded placebos.

Proper drug research requires that neither subject nor experimenter knows who is getting the drug and who is getting the placebo (a true double-blind control). Drug company antidepressant researchers use inactive placebos such as sugar pills (which don’t create side effects). Independent research on inactive placebos show that many subjects in antidepressant and other studies can guess if they are getting the actual drug or not, which changes their expectations and subverts the double-blind control. In order to make it more difficult to guess correctly, an active placebo (which creates side effects) should be used. In 2000, a Psychiatric Times article concluded: “In fact, when antidepressants are compared with active placebos, there appear to be no differences in clinical effectiveness.”

Dice-loading depression measurements and placebos are just two of many techniques drug company researchers use to make antidepressants look more effective than they really are. But even with such dice-loading, antidepressants have not fared well, at least when one examines all the studies.

Drug companies try to ensure that those studies showing antidepressants to be no more effective than placebos are not published; however, all studies must be submitted to the FDA. So independent researcher Irving Kirsch and his research team at the University of Connecticut used the Freedom of Information Act to gain access to all data, and analyzed 47 studies that had been sponsored by drug companies on Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone. Kirsch discovered that in the majority of the trials, the antidepressant failed to outperform a sugar pill placebo (and in the trials where the antidepressant did outperform the placebo, the advantage was slight).

6. Psychotropic Drug Hypocrisy

Chemists consider psychiatric prescription drugs and illegal mood-altering drugs all to be psychotropic or psychoactive drugs. Cocaine and ADHD drugs such as Adderall and other amphetamines affect the neurotransmitters dopamine, serotonin, and norepinephrine; and antidepressants used in combination also affect the same neurotransmitters. Not only are prescription psychotropics and illegal psychotropics chemically similar, they are used by people for similar reasons, including taking the edge off their discomfort so they can function. The hypocrisy surrounding illegal and prescription psychotropic drugs is harmful to society in at least two ways.

At one level, because people are being misinformed about the realities of prescription psychotropic drugs, they are more likely to gulp them down and to give them to their children. This has helped create a tragic phenomenon detailed by investigative reporter Robert Whitaker in his book Anatomy of an Epidemic (2010). Psychiatric drug use turning mild and episodic conditions into severe and chronic ones has helped create a huge increase of Americans with severe mental illness, especially among children.

At a second level, this psychiatric-illegal psychotropic drug hypocrisy allows for unfair criminalizing and incarceration of people using illegal psychotropics.

7. Diversion from Societal, Cultural and Political Sources of Misery

When we hear the words disorder, disease or illness, we think of an individual in need of treatment, not of a troubled society in need of transformation. Mental illness expansionism diverts us from examining a dehumanizing society.

In addition to pathologizing normal behavior, the mental health profession also diverts us from examining a society that creates the ingredients—helplessness, hopelessness, passivity, boredom, fear, and isolation—that cause emotional difficulties. We are diverted from the reality that many emotional problems are natural human reactions to loss in our society of autonomy and community. Thus, the mental health profession not only has financial value for drug companies but it has political value for those at the top of societal hierarchies who want to retain the status quo.

Today, a handful of dissident mental health professionals do challenge and resist their profession’s dehumanizing standard practices. I know several of these dissidents, and they are the only psychiatrists, psychologists and mental health professionals that I have any respect for.

Read article here:  http://www.alternet.org/story/153634/7_reasons_america%27s_mental_health_industry_is_a_threat_to_our_sanity/

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The Brisbane Times, Australia – Spetember 9, 2011
by Lisa Appignanesi

"Over the last 40 years the Diagnostic and Statistical Manual of Mental Disorders - the bible of the psychiatric professions - has spawned more and more diagnostic categories, "inventing" disorders along the way and radically reducing the range of what can be construed as normal or sane. Meanwhile Big Pharma, feeding its appetite for profits and ours for drugs, has gained an ever greater hold over our mental and emotional lives, medicalising normality."

In 2000 the World Health Organisation named depression as the fourth leading contributor to the global burden of disease and predicted that by 2020 it would rise to second place. I suppose WHO didn’t mean it to sound like a target to be aimed for, but we seem to be rising to the challenge in any case.

A new survey from the European College of Psychopharmacology, a meta-analysis of a mass of research, reports that a staggering 164.8 million Europeans – 38.2 per cent of the population – suffer from a mental disorder in any year.

As well as depression, this includes neural disorders such as dementia and Parkinson’s; childhood problems from ADHD to “conduct disorder”; and the leading anxiety disorders – everything from panic attacks to obsessive-compulsive disorder to shyness. The latest figures for Australia, from 2007, indicate that more than one in five people – 3.2 million – had suffered from anxiety, a mood disorder or substance abuse in the preceding 12 months; 2-3 per cent more were estimated to have been affected by other mental illnesses.

Depression and anxiety, they tell us, are disproportionately women’s ailments. Men, it seems, become alcoholics (another illness category) rather than depressives, particularly in eastern Europe.

Such reports are worrying. They may draw attention to a rising toll of human suffering, but they pinpoint the imperialising tendency of the mental health sector. Our ills and unhappiness are squeezed into a package labelled “disorder” and an ever-proliferating assortment of supposedly objective diagnostic categories. A cure is somehow promised, though it rarely seems to come, certainly not for everyone or for ever. In talking to the press or drafting press releases, researchers often extrapolate from their material in order to create good copy.

The notion that women are somehow more prone to mental illness often emerges. According to Hans-Ulrich Wittchen, one of the report’s authors, the reason women suffer nearly twice as much depression and anxiety disorders as men lies in the changing social pattern in which women take on work on top of marriage and children.

So stay home, ladies, and you’ll be as happy as apple pie; though in the 50s when we stayed home to bake it, the doctors gave us Miltown and Valium to help us take pain-free care of hubby and the young ones.

On the subject of women’s greater susceptibility, it’s just as well to remember that women go to doctors far more than men, for all kinds of ills: indeed, women’s greater incidence of mental ills just about equals their greater number of visits to the doctors. If men went to doctors as often as they go to the pub, it’s a fair guess that their unhappiness would be represented as depression or anxiety as well.

One of the many things that became clear to me as I was working on my book on the rise and rise of the mind-doctoring professions over the last 200 years, is that classifications of mental disorder are hardly absolutes. They are far more often constructs that mirror their time’s aspirations and ways of understanding. They may reflect subjective experience, but only insofar as we can prod and organise our inchoate inner lives to fit pre-existing psychiatric tick lists.

Useful tools for statisticians, the classifications are also useful to public health administrators, insurance companies, lobbying bodies, or pharmaceutical companies who need “homogeneous populations” on whom to carry out drug trials. But I remain to be convinced that these proliferating classifications help individuals find relief – except, of course, that momentary relief from giving an expert name to what may feel like an intractable set of problems.

Over the last 40 years the Diagnostic and Statistical Manual of Mental Disorders – the bible of the psychiatric professions – has spawned more and more diagnostic categories, “inventing” disorders along the way and radically reducing the range of what can be construed as normal or sane. Meanwhile Big Pharma, feeding its appetite for profits and ours for drugs, has gained an ever greater hold over our mental and emotional lives, medicalising normality.

The more studies that come along to tell us about the rise in mental illness, the more we fit our problems and unhappiness into a category of mental disorder, developing symptoms to take to the doctor in search of a cure. Humans are suggestible creatures. And doctors like to help: they provide the pills Big Pharma recommends, though many must now know that research has shown placebos can work just as well and with fewer side effects.

If doctors – rather than politicians or teachers or priests or friends and family – are to be the guardians of our wellbeing, then doctors really should be provided with new kinds of “treatments”. Psycho- and group therapy could, of course, be rolled out, and not just of the 10-week variety: anything that builds up the individual’s inner resources and allows emotions to be reflected on can’t be bad.

But doctors could recommend group running for depression, proved to have far better effects than SSRIs. Reading groups, too, offer a definite lift. As for women, more free childcare, after-school clubs and husbands who take days off to go to the doctor with the kids (or sort out that drinking problem) would lift a depressed mood wonderfully. Then there’s poverty, terrible schools … could health systems take those on as well?

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Violence as a drug side effect seems preposterous to patients, pharmacists, physicians and even juries. Trying to use the “Prozac defense” to justify killing or hurting someone is often met with scorn.

Although drug-induced hostility or aggression has not been well-studied, a surprising number of medications come with precautions about violent acts.

Antidepressant prescribing information, for example, warns physicians that, “All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior.” Drugs such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil) and sertraline (Zoloft) carry warnings about aggressiveness, agitation, hostility, impulsivity and irritability.

The stop-smoking medication varenicline (Chantix) also comes with warnings about agitation, hostility, depressed mood and changes in behavior. The trouble with such warnings is that people don’t imagine that these bad things could happen to them. But many readers have shared scary stories about Chantix and violence. Here is one:

“I started taking Chantix early in January 2011 because I promised my son I’d quit. After about two weeks on the drug, my husband and I got into a disagreement, and I ended up giving him a black eye and busting out his tooth. Rage and panic attacks were occurring every day, so I quit taking Chantix.

“I figured it was just the stress of having to live with my in-laws, so I stayed off it until I left my husband and got my own place with my son. I’ve now been taking Chantix for about two weeks, and I’m having emotional outbursts and extreme rage again. I have no stress in my life right now, so it can’t be anything else but the drug.

“I’ve researched this, and apparently Chantix is at the top of a list of drugs that cause violent behavior. Chantix worked very well for a friend of mine to help her stop smoking, but now I wonder if it contributed to her breakup with her fiance.”

Other readers have shared stories of people who had no history of aggressiveness, violence or mental-health problems going berserk while taking Chantix. One man beat his wife and called police but had no recollection of the incident.

A recent article in the European Journal of Clinical Pharmacology (online, June 7, 2011) “confirms the risk of violence associated with benzodiazepines and related drugs (zopiclone and zolpidem). … Physical aggressiveness, rapes, impulsive decision making and violence have been reported, as have autoaggressiveness and suicide.”

Benzodiazepines are anti-anxiety agents such as alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium) and lorazepam (Ativan). Eszopiclone and zolpidem are popular prescription sleep aids. Americans need to know how prescribed drugs might affect their behavior. Only then can they take responsibility for their actions.

http://www.tuscaloosanews.com/article/20110721/NEWS/110719697/1005/sitemaps04?p=2&tc=pg

(Note from CCHR:  Our psychiatric drug database, comprised of international drug regulatory agency warnings and clinical studies,  contains 19 warnings of psychiatric drugs causing violence, aggression and hostility -  type in aggression in the red search box – or suicide which has 66 warnings)  http://www.cchrint.org/psychdrugdangers/drug_warnings.php )

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The One Click Group – June 16, 2011

By Dr. Marc-André Gagnon
and Dr. Sergio Sismondo
Expert Advisors – EvidenceNetwork.ca

The medical research world has been concerned about the problem of ghostwriting for more than a decade.

The issue has been repeatedly raised in the mainstream media over the past few years, with most of the commentary focused on the ethics of academics serving as authors on papers they did not write and on some of the most egregious actions by pharmaceutical companies.

But these efforts miss the ways in which Big Pharma has developed new forms of medical research to serve its own interests.

How ghostwriting feeds Big Pharma profits

Big Pharma firms spend twice as much on promotion as on research and development (R&D). But it is worse than that: more and more medical R&D is organized as promotional campaigns to make physicians aware of products. The bulk of the industry’s external funding for research now goes to contract research organizations to produce studies that feed into large numbers of articles submitted to medical journals.

Internal documents from Pfizer, made public in litigation, showed that 85 scientific articles on its antidepressant Zoloft were produced and coordinated by a public relations company. Pfizer itself thus produced a critical mass of the favourable articles placed among the 211 scientific papers on Zoloft in the same period. Internal documents tell similar stories for Merck’s Vioxx, GlaxoSmithKline’s Paxil, Astra-Zeneca’s Seroquel, and Wyeth’s hormone-replacement drugs.

To promote the now-notorious Vioxx, Merck organized a ghostwriting campaign that involved some 96 scientific articles. Key ones did not mention the death of some patients during clinical trials. Through a class action lawsuit against Vioxx in Australia, it was discovered that Elsevier had created a fake medical journal for Merck – the AustralasSian Journal of Joint and Bone Medicine – and perhaps 10 other fake journals for Merck and other Big Pharma companies.

In another example, GlaxoSmithKline organized a ghostwriting program to promote its antidepressant Paxil. According to internal documents made public in 2009, the program was called “Case Study Publication for Peer-Review”, or CASPPER, a playful reference to the “friendly ghost”. Such strategies are not exceptions; they are now the norm in the industry. Most new drugs with blockbuster potential are introduced accompanied by 50, 60, or even 100 medical journal articles. Any firm that refused to play this game in the name of ethics would likely lose market share. Profits in the pharmaceutical industry depend on companies’ capacity to influence medical knowledge and create market share and market niches for their products.

A call for Evidence-Based medicine

In 2008, research showed that pharmaceutical companies systematically failed to publish negative studies on their SSRIs, the Prozac generation of antidepressants. Of 74 clinical trials, 38 produced positive results and 36 did not: 94 per cent of the positive studies were published, but only 23 per cent of the negative ones were, and two-thirds of those were spun to make them look more positive.

Physicians reading the scientific literature got a biased view of the benefits of SSRIs. This helps to explain the huge number of antidepressant prescriptions, in spite of the fact that, according to a meta-analysis in JAMA in January 2010, for 70 per cent of people taking SSRIs, the drug did not bring more benefits than a placebo. Compared to placebo, however, SSRI antidepressants can result in serious adverse drug reactions.

There we see one of the problems with the ghost management of medical research and publication. Pharmaceutical companies want upbeat reports on their drugs. They design, write, and publish studies that are likely to show their drugs in positive lights – and there are myriad ways to do so. Ghosts sometimes bend the truth, and sometimes even commit fraud, with grave results.

Why do academics serve as authors on scientific articles they did not write, using research they did not perform? Because they are rewarded, both by their universities and by their colleagues for how much they publish and for its prominence. Pharmaceutical companies and their agents are very good at placing articles in prestigious journals, and then make them even more prominent by having their armies of sales reps circulate them and talk them up.

Researchers who serve as authors on studies and analyses (perhaps scientifically correct) that are favourable to the industry can expect to see these articles increase their prestige and influence, and possibly even funding.

What happens, however, when a researcher produces studies and analyses (also scientifically correct) showing that some products are dangerous or inefficient, as some did about Vioxx before the scandal broke? Reading Merck’s internal e-mails, revealed during the class lawsuit, it was exposed that the company drew up a hit list of “rogue” researchers who needed to be “discredited” or “neutralized” – “seek them out and destroy them where they live,” reads one e-mail. Eight Stanford researchers say they received threats from Merck after publishing unfavourable results.

Corporate science

In the ghost management of research and publication by drug companies we have a new model of science. This is corporate science, done by many unseen workers, performed for marketing purposes, and drawing its authority from traditional academic science. The high commercial stakes mean that all of the parties connected with this new corporate science can find reasons or be induced to participate, support, and steadily normalize it. It also biases the available science by pushing favourable results and downplaying negative ones – and sometimes through outright fraud.

As long as pharmaceutical companies hold the purse strings of medical research, medical knowledge will serve to market drugs, not to promote health. And as long as universities grovel for more partnerships with these companies, the door will remain wide open to proceed with the corruption of scientific research.

http://www.theoneclickgroup.co.uk/news.php?id=6349#newspost

Dr. Marc-André Gagnon is assistant professor with the School of Public Policy and Administration at Carleton University. He is also an expert advisor with EvidenceNetwork.ca, a comprehensive and non-partisan online resource designed to help journalists covering health policy issues in Canada. Dr. Sergio Sismondo is professor of Philosophy and Sociology at Queen’s University. His current research is on the pharmaceutical industry’s relationships with academic medicine and practicing physicians.

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The effect of antidepressants on arteries was separate and independent from any diagnoses of 'depression'

Note from CCHR: One of the most common tricks of the psychiatric/pharmaceutical industry is whenever a valid study shows psychiatric drugs as the cause of medical damage to patients,  such as heart attack, stroke, sudden death, diabetes etc, they will quickly spit out press releases  saying their studies show ‘depression’ or ‘bipolar’ or some ‘psychiatric disorder’ is the actual cause.   You’ll start seeing  headlines such as Depressed patients more likely to have heart attacks or Patients with Bipolar at risk for stroke,  or Patients with Schizophrenia Prone to Develop Diabetes….  Now that’s a nifty little trick that psycho/pharma does,  but the fact is  those studies are bogus.   And here’s how you can tell;  Psychiatrists have never proven that people diagnosed “schizophrenic” or “bipolar” or “depressed”   were more prone to develop any medical or life threatening condition – that weren’t already on drugs, or who had been on drugs. Period.   They  just omit that one key fact from all their propaganda studies.  What we found significant about this latest study is that the authors actually address this very point in preemptively stating their findings were separate and independent from any diagnoses of ‘depression.’  — CCHR

NaturalNews – April 6, 2011

by Sherry Baker, Health Sciences Editor

Millions of Americans take antidepressant drugs — most are Prozac and related antidepressant medications in the class known as selective serotonin reuptake inhibitors (SSRIs). A gigantic money maker for the drug giants, the SSRIs bring in billions to Big Pharma a year. They are promoted and prescribed as safe treatments for depression, anxiety and even premenstrual tension — despite a long list of possible side effects ranging from sexual dysfunction and headaches to dizziness and suicide.

Now you can add another reason to think twice before agreeing to take antidepressants.  At the American College of Cardiology meeting in New Orleans, Emory University School of Medicine scientists have just announced they’ve discovered that the drugs are linked to thicker arteries.  The significance? The findings  strongly suggest Prozac and similar meds could raise the risk of heart disease and stroke.

Depression is sometimes listed as a risk for heart disease. But that was not the explanation for the Emory findings, according to Amit Shah, MD, a cardiology fellow at Emory University School of Medicine. Instead, Dr. Shah said in a press statement, the data indicates the effect of antidepressant use on arteries that was revealed by the study is separate and independent from depression.

Dr. Shah worked with Viola Vaccarino, MD, PhD, chair of the Department of Epidemiology at Emory`s Rollins School of Public Health, on the groundbreaking study which involved 513 middle-aged male twins who both served in the U.S. military during the Vietnam War. Twins are genetically the same but may be different when it comes to other risk factors such as diet, smoking and exercise, so studying them is a good way to factor out the effects of genetics.

The Emory  research team measured the thickness of the lining of the main arteries in the neck (carotid intima-media thickness, or IMT) by ultrasound. The results showed that among the 59 pairs of twins where only one brother took antidepressants, the one taking the medication had a significantly higher carotid IMT — even when heart disease risk factors such as smoking were taken into account. In fact, the thicker arteries were found in antidepressant users whether or not they had ever had a stroke or heart attack in the past.

In the new study, the scientists documented higher carotid IMT in research subjects who used SSRIs (60 percent of those who took antidepressants) as well as those who used other kinds of antidepressants. Curiously, higher levels of depressive symptoms were associated with thicker arteries only in those taking antidepressants — so the Big Pharma meds themselves seem to be the key to this disturbing change in the cardiovascular system.

“One of the strongest and best-studied factors that thickens someone`s arteries is age, and that happens at around 10 microns per year,” Dr. Shah stated. “In our study, users of antidepressants see an average 40 micron increase in IMT, so their carotid arteries are in effect four years older.”

How could antidepressants have an effect on blood vessels? The Emory scientists think it may result from changes in serotonin. The SSRIs are the most commonly prescribed antidepressants and they are known to increase the level of serotonin in the brain. Other kinds of antidepressant drugs also impact serotonin levels. And, although serotonin is a chemical that helps some brain cells communicate, what is often ignored in the hyping of SSRIs is that serotonin functions outside the brain, too.

Actually, most of the body`s serotonin is found outside the brain, especially in the intestines, Dr. Shah stated in a media release. What`s more, serotonin is stored by platelets, the cells that promote blood clotting; the chemical is released when platelets bind to a clot. The chemical can, in fact, act in a variety of ways and either constrict or relax blood vessels, depending on whether the vessels are damaged or not.

“I think we have to keep an open mind about the effects of antidepressants on neurochemicals like serotonin in places outside the brain, such as the vasculature. The body often compensates over time for drugs` immediate effects,” Dr. Shah said.

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By Bob Fiddaman and Shelia Matthews
March 10, 2011

For some time now, Sheila Matthews has been suspicious about her home state of Connecticut’s treatment of its most vulnerable children. As a mother of two children and co-founder of Ablechild, her instincts led her to scrutinize the dubious relationships among Connecticut’s Department of Children and Family Services [DCF], the pharmaceutical industry and a billion dollar law firm who has defended the likes of Pfizer Inc and Merck & Co., among others.

Sheila’s investigation has led her on a journey that links a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF – an $865 million bureaucracy, as described by the Connecticut Mirror.

The Connecticut DCF serves approximately 36,000 children and 16,000 families across its four Mandate Areas:

1. Child welfare;
2. Children’s behavioral health;
3. Juvenile Services; and
4. Prevention.

Sheila’s Ablechild has been questioning the Connecticut DCF since 2003, when Ablechild demanded that the Connecticut DCF immediately ban the use of the antidepressant Paxil in its treatment of mental disorders after multiple studies confirmed Paxil increased the risk of suicide in children and adolescents. This was more than a year prior to America’s Food & Drug Association (FDA) announcement that all antidepressants, including Paxil, should bear a black box warning regarding this suicide risk. Ablechild was disturbed that children in state custody were being prescribed this dangerous psychotropic medication. Ablechild’s public pressure paid off, and the Connecticut DCF deemed Paxil unsafe for children and adolescents, and according to the DCF drug approval list, Paxil has not been approved for use in over eight (8) years.

In August 2003, less than one month later, Ablechild reported that the commissioner of the Connecticut DCF held a ‘behind closed doors‘ meeting with Glaxo officials. This meeting was reported by the Associated Press, who wrote:

The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the State stopped using the drug to treat young people in its care.

GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families. [Source]

Despite repeated requests from Ablechild, the Connecticut DCF refused to inform the public what was discussed at this secret meeting.

Eight years later, Sheila and Ablechild continue to raise concerns and investigate potential wrongdoings and conflicts within the Connecticut DCF. Last month, in February 2011, Sheila attended a meeting sponsored by the Connecticut Behavioral Health Partnership [CBHP], where its medical director, Dr Steven Kant, presented the Husky Behavioral Pharmacy Data. The CBHP is a state vendor that provides mental health services to DCF children. These services are paid, in part, by the State-run insurance program, HUSKY. Incredibly the pharmacy data presentation showed that dangerous psychotropic drugs, like Paxil, are still being prescribed to thousands of children and adolescents. In fact, the Pharmacy Data presentation showed that the HUSKY program, financed by taxpayer dollars, paid drug companies over $60 million for psychotropic drugs for Connecticut’s children and adolescents in 2009 alone – many of which are not approved by the FDA for use in the pediatric population and all of which carry the most serious warning possible regarding the risk of suicide.

According to the pharmacy data presentation: [Which can be downloaded as a Powerpoint presentation HERE]

More than 50% of HUSKY Youth Behavioral med utilizers are on stimulants.
Close to 30% of HUSKY Youth Behavioral med utilizers are on antipsychotics.

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth

Medications for ADHD

Ritalin (10%)
Adderall (5%)
Vyvanse (4%)
Strattera (3%)

Atypical Antipsychotics

Abilify (11%)
Risperdol (10%)
Seroquel (8%)

Anti-anxiety

Hydroxyzine (2.5%)

Antidepressants

Prozac (4.5%)
Zoloft (4%)
Zyban (3%)
Desyrel (2.5%)
Celexa (2%)

Mood Stabilizers

Lithum (3%)
Depakote (3%)
Lamictal (2.5%)

Curiously, none of the above medications are on the Connecticut DCF list of approved/unapproved drugs listed in its DCF PMAC document.

With this in mind, Sheila Matthews contacted Dr Steven Kant and inquired as to whether any of the above drugs were approved by the Connecticut DCF for use in children.

Dr Kant replied:

… the answer to your question is not that straight forward.. . . Medications may be indicated by age and/or by specific treatment needs so it is not either a simply “yes” or “no”. Also, some medications may have the age indication but for a totally different condition, such as anti epileptic condition. . .Also FDA indications are static, they do not change over time though medical practice is constantly evolving…

Contradicting the very document that lists Connecticut’s approved and unapproved drugs, a “check-off” list that verifies the status of medications, Dr Kant replied, “I don’t think a “check off” for each medication would work in terms of verifying their status.”

With such an ambiguous response from Dr. Kant, we found the DCF Approved Medication List on the Internet. This particular version was revised in 2009.

It appears that the DCF has approved drugs in children that have not been approved for children by the FDA. In fact, the FDA has issued multiple advisories and alerts since 2004 about the increased risk of suicide in children, adolescents and young adults up to age 25 who are treated with psychotropic medications.

And while Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older, it still carries a black box warning regarding the risk of suicide.

In contrast, the DCF seems to be ignoring the conclusions of the FDA. Its list of approved medication in children and adolescents include every single antidepressant except paroxetine [Paxil] and venlafaxine [Effexor].

Forest Lab’s citalopram [Celexa] – APPROVED

Forest Lab’s escitalopram [Lexapro] – APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] – APPROVED

Pfizer’s sertraline [Zoloft] – APPROVED

GlaxoSmithKline’s bupropion [Wellbutrin -also marketed as an anti-smoking cessation drug under the name of Zyban] – APPROVED [1]

Alarmingly, the DCF has produced a guide entitled, “MEDICATIONS USED FOR BEHAVIORAL & EMOTIONAL DISORDERS – A GUIDE FOR PARENTS, FOSTER PARENTS, FAMILIES, YOUTH, CAREGIVERS, GUARDIANS, AND SOCIAL WORKERS” where it writes, “Most of the side effects from the medications are mild and will lessen or go away after the first few weeks of treatment.” The guide also points out possible side effects of SSRI’s/SNRI’s:

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

One of the most dangerous side effects of these medications, suicidal thoughts/ideation, doesn’t even make the 5 bullet-pointed list. The Guide does, however, add the following: “Watch for worsening of depression and thoughts about suicide.”

The DCF Approved Medication List writes:

“The DCF Approved Medication List is a list of psychotropic medications that has been carefully established by the Psychotropic Medication Advisory Committee, a group of DCF and community professionals.”

Sheila has since investigated other advocacy groups that were concerned about the off-label prescribing of psychiatric medications to youths in state custody. This is where she stumbled upon Children’s Rights, a non-profit charity based in New York City.

In 2005, Children’s Rights employed ten (10) attorneys and a staff of 31. It claims to use its expertise to change child welfare red tape and scrutinize failing systems. If the child welfare system fails to respond, Children’s Rights files a lawsuit. If successful, it enforces reform and then monitors its implementation.

In 1989, Children’s Rights had in fact filed a suit against William O’Neill and the Connecticut state Department of Children and Youth Services [DCYS].

The suit charged that an overworked and underfunded DCYS failed to provide services including abuse and neglect investigations, adoption, foster care, mental health care, caseloads and staffing. The case has been pending for over twenty (20) years, and while there have been numerous arguments that DCYS should be more inclusive or has failed to provide certain services, the issue of massive off-label prescription of psychotropic medications has never been brought to the court’s attention.

Children’s Rights is chaired by Alan C Myers, a partner at Skadden, Arps, Slate, Meagher and Flom, a billion dollar law firm which represents the pharmaceutical industry in mass torts and class actions. Myers is also co-head of the firm’s REIT Group [Real Estate Investment Trust].

Also, listed on the Children’s Rights website are individuals and law firms that have served as co-counsel on Children’s Rights’ legal campaigns to reform America’s failing child welfare systems, including:

Missouri - Shook Hardy & Bacon – Eli Lilly Co. and Forest Labs, defended the original Wesbeker Prozac trial in Kentucky and still defend Prozac, Celexa and Lexapro.

New Jersey – Drinker Biddle & Reath – GlaxoSmithKline attorneys – defended Paxil as local counsel in Philadelphia cases.

Oklahoma – Kaye Scholer LLP – provides work in Pharmaceutical Products Liability defense and employs an attorney who was former General Counsel of Pfizer, Inc.

A particular success for Skadden Arps occurred in 2010 when it secured a summary judgement ruling for Pfizer Inc. in a suit filed by two insurance companies who sought $200 million in damages for Pfizer’s predecessors alleged “off-label” marketing of its epilepsy drug, Neurontin.

Furthermore, in February 2011, Skadden Arps secured the dismissal of over 200 cases in a multi-district litigation pending against their client, Pfizer Inc. The plaintiffs had alleged injuries related to the use of Pfizer’s anti-epilepsy drug, Neurontin.

Neurontin, the generic version is called gabapentin, is prescribed by psychiatrists for a variety of “off-label” indications. It is often tried as an alternative treatment, when patients are unable to tolerate the side effect of more proven mood stabilizers such as lithium. [2]

Gabapentin has also been associated with an increased risk of suicidal acts or violent deaths.

This is a drug that has been known to cause behavioral problems, which include unstable emotions, hostility, aggression, hyperactivity or lack of concentration.

Children dependent on child welfare systems have rights and, according to its web page, Children’s Rights is dedicated to protecting them.

It should come as no surprise that the site fails to discuss the off-label prescription of non-approved psychotropic medications to children and adolescents, unless this falls under the ‘abuse and neglect’ category?

If Children’s Rights’ motive was to accomplish fixing the child welfare system then why hasn’t it investigated why thousands of children under state care are prescribed “off-label” psychiatric drugs? With a partner in a billion dollar pro-pharmaceutical law firm as its Chair, and supporters who also defend pharmaceutical products, is it safe to assume that its stance on the drugging of children is one that is being ignored?

Children’s Rights push to remove abused and neglected children into safety.

The basic question always comes down to trust. When power, money and a good cause is mixed, it is imperative to check motives. We would be less of a society if we didn’t check out all the facts. Abuse and neglect exist, always has and always will, but society is obligated to ensure those victims are not transformed into “good cause victims” and expensed out. There is no doubt we have a right to question the system and those who claim to promote change for the good of the children within it.

Children’s Rights Chairman, Alan C. Myers, Medical Director of Connecticut Behavioral Health Partnership, Steven Kant and the Connecticut Department of Children and Families may get their knickers in a twist with regard to an advocate of Ablechild and a blogger from Birmingham, UK questioning their motives but hey, what’s the downside of shinning a light on all these players, be they good or bad players?

Sheila’s concern is that Children’s Rights with its multi-million dollar budget and with the help of its billion dollar law firms, will continue to ignore the risks of these unapproved and dangerous medications, under the guise of helping our nation’s most vulnerable children. The question remains: how can the lawyers who defend psychotropic drugs also be the same lawyers who advocate for abused and neglected children to get into state welfare programs which place these children on the same drugs? The conflict is clear and obvious – and it poses an unmistakable danger to children who truly need our help.

[1] Bupropion [also known as Wellbutrin, Zyban] is a non-tricyclic antidepressant.
[2] Gabapentin

Bob Fiddaman is the author of the Seroxat Sufferers blog and the book, “The evidence, however, is clear… the Seroxat scandal.” Chipmunka Publishing.

Sheila Matthews is the co-founder of Ablechild and a mother of two children.

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The Daily Mail, December 13, 2010

by John Nash

As new research reveals antidepressants raise the danger of heart attacks, the disturbing cost of this modern addiction

Just as David Cameron launches his campaign to boost national happiness, along comes grim news for the 12 million Britons taking happy pills. London-based researchers have just announced that antidepressants raise the risk of fatal heart attacks.

This research is only the latest wake-up call for a nation hooked on happy pills. Might we finally heed the warnings and shake ­ourselves out of our pharmaceutical stupor?

It is high time we did: a small mountain of studies shows that antidepressant drugs are largely ineffective. But more than that, they can ruin lives by creating chronic dependency and a grinding ­hopelessness that ­sometimes leads to self-neglect and death.

The latest study, by Dr Mark Hamer, a ­public health researcher at University ­College ­London, shows that people on the older drugs — tricyclic antidepressants — are at far higher risk of cardiovascular disease than those ­taking the newer class of pills, selective ­serotonin reuptake inhibitors (SSRIs).

But if I were taking SSRIs, I would not be cheered by the findings. Tricyclics were ­discovered in the Forties and it is only now we have identified these dangerous effects.

Moreover, some SSRI drugs are known to cause serious problems such as stomach bleeding. In addition, the withdrawal ­symptoms can be so severe that patients may become dependent on them.

Dr Hamer says his findings do not only affect people with depression, because antidepressants are also prescribed to people with back pain, headache, anxiety and sleeping problems.

Last year, according to Dr ­Hamer’s ­figures, about 33 million antidepressant prescriptions were dispensed in England.

At some point, surely, there will be no one left to prescribe for. In my view, it’s fast becoming one of the greatest medical scandals of our age.

The most worrying thing about these drugs is not their side-effects, but their widespread non-effect: they just don’t work for most ­people with mild to moderate depression.

Two years ago, researchers at Hull ­University concluded that the pills only benefit ­people who are most seriously, clinically depressed. In these extreme cases, there is often a physical problem in their brain, a result of genetics or accident. But what of the rest?

There is a growing view that many people are being needlessly drugged because the natural state of feeling unhappy is viewed as an illness, rather than a ­normal part of life that we should experience and learn from.

An American study of 8,000 ­people who had been treated for depression found that a quarter of them were not clinically sick, but had just undergone a normal life event such as bereavement.

Their symptoms, it said, should be left to pass naturally (that, of course, would be a blow to the drug manufacturers, who profit so handsomely from the mass ­consumption of their mind-numbing chemicals).  For most of us, the healthiest option is to face our problems, rather than disappear down a black hole of antidepressant dependency.

One leading expert, Randolph Nesse, a psychiatry professor at Michigan University, argues that this mild form of depression is ­beneficial, often ­interjecting in life to tell us to stop what we are doing and reconsider.

This can help, he says, when something awful happens to us, such as a job loss or relationship break-up, when it makes sense to slow down to grieve, reassess and make changes.

But instead, we live in a world that tells us that when we feel out of sorts we need a pill to recover.

It is this belief that ­creates queues of patients at the doors of hard-pressed GPs, who often feel they have no option but to hand out happy pills as though they were sweeties.

Many patients later claim they couldn’t have coped without them. They will swear that ‘the drugs make me feel better, so they must be working’. But often the drugs do not actually work as chemicals. Instead, they merely reassure us — the so-called placebo effect.

In 2008, Professor Irving Kirsch at Hull University found something strange when he took a close look at some figures from drug manufacturers’ own trials of four common antidepressants.

The drugs improved patients’ sense of wellbeing. So far, so ­unremarkable.

But many of those involved in the trials were given sugar pills instead of antidepressants.

And their depression scores improved just as much as those on the real pharmaceuticals. In other words, the placebo patients put so much store by the magical (and much-promoted) power of antidepressants that they lifted their own morale without any genuine chemical intervention. Such is the life-enhancing power of human belief.

Everybody hurts: Sadness is a part of life and shouldn’t always be treated as an illness

But this phenomenon also has a dark side: the opposite of placebo, which is called the ‘nocebo’ effect.

This occurs when you convince someone that a particular thing will do them harm, and they begin to feel sick.

Talk to someone about food poisoning while they are tucking into a hearty meal and you will see the nocebo effect at work.

Sadness is a part of life and shouldn't always be treated as an illness

Something similar is happening in our pill-obsessed world. When we are convinced that we need drugs to get us out of an ­emotional crisis, we stop doing things to help ourselves.

This was clear from the latest research. Dr Hamer found that tricyclic drugs raise a person’s heart attack risk.

But that risk was dwarfed by another danger: the people ­taking the drugs often lost the will to look after themselves properly. They were more likely to smoke, be overweight and not exercise.

Dr Hamer says that if they started living more healthily they would cut their heart attack risk by three times. Exercise and weight loss would also help alleviate their depression and anxiety.

But people stuck in the role of helpless drug-munchers often ­cannot make that change for themselves.

They simply sit waiting for their questionable pills to work. And when the pills fail, they become even more demoralised. It’s a vicious cycle, and one that’s ­sucking in more and more vulnerable people.

Read more: http://www.dailymail.co.uk/health/article-1338340/Will-wake-deadly-risks-happy-pills.html#ixzz186xwdATE

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Since direct-to-consumer drug advertising was legalized 13 years ago, Americans have become a nation of pill poppers — choosing the type of drug they desire like a new toothpaste, sometimes whether or not they need it.

But if patients want the drugs, doctors and pharma executives want them to have the drugs and media gets full page ads and huge TV flights (when many advertisers have dried up), is the national pillathon really a problem?

Yes, when you consider the cost of private and government insurance and the health of patients who take potentially dangerous drugs like these.

Seroquel, Zyprexa, Geodon, atypical antipsychotics

Even though the antipsychotic Seroquel surpasses 71 drugs on the FDA’s January quarterly report with 1766 adverse events, even though it’s linked to eight corruption scandals, even though military parents blame Seroquel for unexplained troop deaths, it is the fifth biggest-selling drug in the world and netted AstraZeneca almost $5 billion last year.

Atypicals were originally promoted to replace side-effect prone drugs like Thorazine but soon became pharmaceutical Swiss Army Knives for depression, anxiety, insomnia, bipolar and conduct disorders and other off label uses — and betrayed the same side effects as older antipsychotics. (Especially tardive dyskinesia-linked Abilify.)

Foisted disproportionately on the young, poor and disadvantaged, atypicals cause such weight gain and metabolic derangement — 16 percent of Zyprexa patients gain 66 pounds and some gain over 100 — manufacturer Lilly Eli Lilly agreed to pay the state of Alaska $15 million in 2008 for the Medicaid costs of Zyprexa patients who developed diabetes.

Atypicals carry warnings of death in demented patients but are widely used in nursing homes. And even though Risperdal maker Johnson & Johnson, Geodon maker Pfizer, Abilify maker Bristol-Myers Squibb, Lilly and AstraZeneca have all entered into government settlements that acknowledge fraudulent or wrongful atypical marketing, FDA rewarded atypical makers by approving Zyprexa and Seroquel for children last year. And approved a new atypical antipsychotic, Latuda, in October. Maybe the FDA is bipolar.

Ritalin, Concerta, Strattera, Adderall and ADHD drugs

When it comes to the epidemic of 5.3 million US children between 3 and 17 diagnosed with ADHD, suspicions of pharma pushing the disorder are exceeded only by pharma’s admissions thereof.

During an August conference call with financial analysts, Shire specialty pharmaceuticals president Mike Cola credited the “very dynamic ADHD market” to Shire’s globalization efforts and “investments we have made in new uses for our existing products.”

Those uses, a.k.a. diagnoses, for Shire products like stimulants Adderall, Vyvanse and Intuniv include adult ADHD, cognitive impairment, depression and excessive daytime sleepiness.

Still, Cola says despite the 10 percent ADHD “new starts” that are helping Shire “grow the market,” and the “co-administration market” of add-on prescription drug$, the ADHD franchise suffers from patients who drop out when they quit seeing their pediatrician. “We don’t see those patients show up again until their mid-to-late 20s,” laments Cola.

ADHD drugs, in addition to “robbing kids of their right to be kids, their right to grow, their right to experience their full range of emotions, and their right to experience the world in its full hue of colors,” as Anatomy of an Epidemic author Robert Whitaker puts it, can also be deadly.

A 2009 article in the American Journal of Psychiatry called Sudden Death and Use of Stimulant Medications in Youths found 1.8 percent of youthful stimulant users died sudden deaths from cardiac dysrhythmia or unexplained causes versus 0.4 percent who were not on stimulants. Though it helped fund the study, the FDA said the results proved no “real risk” and kids should keep taking their meds.

Meanwhile, says Robert Whitaker, kids on ADHD meds “are told they are going to be on these drugs for life. And next thing they know, they’re on two or three or four drugs,” a phenomenon also known as the co-administration market.

Selective serotonin reuptake inhibitor (SSRIs) antidepressants like Prozac, Paxil, Zoloft and Lexapro probably did more to inflate pharma profits in the last decade than direct-to-consumer advertising and Viagra put together, no pun intended: over 60 million prescriptions were filled in the US in 2007 with many patients reporting their depression lifted.

But some critics say for mild depression, SSRIs don’t work at all and are no better than placebo.

And others say they can add aggression, bizarre behavior, self-harm and suicidal thoughts to depression. In fact, there are 4,200 published reports of SSRI-related violence, aggression, bizarre behavior, self-harm and suicide since the drugs were introduced in 1988 including the well known gun massacres at Columbine (1999), Red Lake (2005), NIU and likely, Virginia Tech (2007).

SSRIs have non-behavioral perks both sides agree on: life-threatening serotonin syndrome when taken with migraine drugs, gastrointestinal bleeding when taken with aspirin, Aleve or Advil and the bone condition, osteoporosis.

Paxil can reduce or abolish the effect of tamoxifen in breast cancer patients and increase deaths says British Medical Journal. It’s linked to a two-fold increased risk of cardiac birth defects in infants according to its own manufacturer, GSK.

And sex? SSRIs are so linked to dysfunction even the pharma-identified web site WebMD admits many will experience impotence, delayed ejaculation or no orgasm. But there is a solution (besides going off SSRIs) says WebMD: Add another antidepressant that’s not an SSRI, like Wellbutrin!

Effexor, Cymbalta, Pristiq, SNRIs

Selective norepinephrine reuptake inhibitors (SNRIs) are like their SSRIs chemical cousins except their norepinephrine effects can modulate pain, which has ushered in your-depression-is-really-pain, your-pain-is-really-depression and other crossover marketing. But the problem with giving a psychoactive drug for pain is that you’re giving a psychoactive drug for pain. “After three months of taking Savella [another SNRI], I started self-destructing and cutting myself,” writes a 40 year old woman on askapatient.com. “I don’t know why or anything, but it does similar to Prozac where it makes you think and do weird things.”

And Cymbalta, approved this fall for chronic back pain and osteoarthritis?

Cymbalta was the drug healthy 19-year-old volunteer Traci Johnson was testing when she hung herself in an Eli Lilly dorm in 2005. It was the drug Carol Anne Gotbaum killed herself on at Phoenix’s Sky Harbor airport in 2007.

SNRI’s are also harder to quit than SSRIs, especially Effexor. 25-year-old Chicagoan David F. told AlterNet he stood at the top of an 8-story parking lot contemplating jumping every day for weeks after quitting. It’s also the drug Andrea Yates was on when she drowned her five children in 2001.

But not all SNRI side effects are behavioral. The FDA would not approve Pristiq, a newer version of Effexor, when Wyeth/Pfizer tried to market it for vasomotor symptoms, because it caused heart attacks, coronary artery obstruction and hypertension in clinical trials. That’s similar to another SNRI, the diet pill Meridia, which was just withdrawn from the market for causing heart problems. Pristiq is still available.

Read the rest of the article here: http://www.alternet.org/story/149078/nation_of_pill_poppers_19_dangerous_drugs_shamelessly_pushed_by_big_pharma?page=entire

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LawyersandSettlements, November 13, 2010

by Gordon Gibb

Swedish research on maternal use of antidepressants in pregnancy continues to bolster existing concerns about SSRI birth defects, according to a recent issue of Obesity, Fitness & Wellness Week (OFWW). “Concerns have been expressed about possible adverse effects of the use of antidepressant medication during pregnancy, including risk for neonatal pathology and the presence of congenital malformations,” according to the authors of the study.

According to the September 18th issue of OFWW, the researchers used data from the Swedish Medical Birth Register from July 1995 through 2007. Women who reported the use of antidepressants in early pregnancy, or were prescribed antidepressants during pregnancy by antenatal care, were identified for the study.

The end number for study purposes was 14,821 women with 15,017 infants.

“Maternal characteristics, maternal delivery diagnoses, infant neonatal diagnoses and the presence of congenital malformations were compared with all other women who gave birth, using the Mantel-Haenszel technique and with adjustments for certain characteristics,” the authors noted.

“There was an association between antidepressant treatment and pre-existing diabetes and chronic hypertension, but also with many pregnancy complications. Rates of induced delivery and caesarean section were increased.”

The study authors noted that neonatal complications were common, especially with regard to the use of tricyclic (TCA) antidepressant use. “An increased risk of persistent pulmonary hypertension of the newborn (PPHN) was verified. The congenital malformation rate was increased after TCAs,” wrote M. Reis and colleagues.

The conclusion?

“Use of TCAs was found to carry a higher risk than other antidepressants, and paroxetine (Aropax, Paxil, Seroxat) seems to be associated with a specific teratogenic property.”

Paxil, one of the antidepressants mentioned, is a drug belonging to the SSRI class (selective serotonin reuptake inhibitor) and includes a host of SSRI side effects. One of the most grievous adverse reactions is PPHN, or persistent pulmonary hypertension of the newborn. The latter is considered a serious birth defect.

M. Reis is affiliated with the National Board of Forensic Medicine, Department of Forensic Genetics and Forensic Toxicology, Linkoping, Sweden. The study authored by Reis and colleagues updates a previous study and was published in the Journal of Psychological Medicine, published out of New York.

http://www.lawyersandsettlements.com/articles/15389/ssri-birth-defects-side-effects-pphn-swedish.html

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Despite evidence suggesting that Paxil could cause birth defects, Glaxo deliberately chose not to conduct studies that would have uncovered the true dangers of the drug.

The law firm of Hissey Kientz, LLP is pleased to announce the launch of its new website, Paxil Birth Defects Lawyers (http://www.paxilbirthdefectslawyers.com/). The site will serve as an information resource for the parents and families of children born with birth defects linked to their mothers’ use of Paxil during pregnancy. Multiple studies have found that the children of mothers who take Paxil while pregnant are at an increased risk of severe birth defects.

September 27, 2010

The law firm of Hissey Kientz, LLP is pleased to announce the launch of its new website, Paxil Birth Defects Lawyers (http://www.paxilbirthdefectslawyers.com/). The site will serve as an information resource for the parents and families of children born with birth defects linked to their mothers’ use of Paxil during pregnancy.

Paxil is part of a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). After it first went on the market in December 1992, Paxil has gone on to become one of the most widely prescribed drugs in the United States, with annual sales of $3.2 billion by 2002.

Multiple studies have found that the children of mothers who take Paxil while pregnant are at an increased risk of severe birth defects. In December 2005, the Food and Drug Administration called for stronger birth defects warnings on the drug’s labeling after two studies found that Paxil doubles the risk of birth defects when taken by women during the first trimester of pregnancy. Most of these birth defects involved cases of atrial and ventricular septal defects (holes in the walls of the chambers of the heart).

Paxil has also been linked to an increased risk of birth defects when taken later in pregnancy. A 2006 study published in the New England Journal of Medicine found that women who take Paxil or similar antidepressants after the 20th week of pregnancy are six times more likely to give birth to a child with persistent pulmonary hypertension of the newborn (PPHN), a condition which causes breathing and circulation problems that may lead to hospitalization or death.

Taking Paxil during pregnancy may also be linked to a number of other serious heart defects in newborns, including cardiomyopathy, tricuspid stenosis, cleft mitral valves, hypoplastic left heart syndrome (HLHS), hypoplastic right heart syndrome (HRHS), bicuspid aortic valves or patent ductus arteriosus (PDA).

Documents uncovered in the ongoing litigation against GSK [Paxil] products liability litigation (MDL-1574)] have revealed that GlaxoSmithKline, the drug’s manufacturer, was aware of the potential link between the antidepressant and birth defects as early as 1980, but failed to recall the drug or properly warn about its dangers until these risks were made public by researchers.

“Despite evidence suggesting that Paxil could cause birth defects, GlaxoSmithKline deliberately chose not to conduct studies that would have uncovered the true dangers of the drug,” says David Friend of Hissey Kientz, LLP. “It is impossible to say how many lives were drastically altered because of the company’s failure to heed the advice of experts and investigate the link between Paxil and birth defects.”

Read the rest of the article here: http://www.prweb.com/releases/2010/09/prweb4565144.htm

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