Patient killed by 'massive overdose' of anti-psychotic drug after nurse 'mistakenly gave him 21 times what he needed'

From a much longer report in the MIRROR.

A patient died from a massive overdose of anti-psychotic drugs after being given 21 times the medication he needed by a nurse, a court has heard.

Joshua Gafney was handed 4,200mg of clozapine instead of just 200mg by Amanda Young after the nurse visited him at his home.

Mr Gafney, 22, was handed a glass containing six bottles of the drug by 40-year-old Young when he needed just under a teaspoon-worth, just hours before he died on February 8 2012.

Bristol Crown Court heard how the nurse claimed she "did not see" crucial labels on Mr Gafney's medication, causing her to confuse the dosage.

She mistakenly believed each 14 ml bottle contained 50 mg of the powerful drug - when in fact this figure was per millilitre meaning there were actually 700 mg in the bottle.

His mother immediately raised concerns, which Young, from Summerlands Hospital, Somerset, attempted to resolve by putting some water in the solution.

Just two hours after the nurse left the family home in Yeovil, Somerset, Joshua was found unresponsive in bed by his mother, Tina Marren.

In spite of desperate attempts by his sister, Jasmine Gafney, and paramedics, to save Joshua, he was declared dead that evening.

A postmortem examination found Mr Gafney had died as a result of acute clozapine toxicity - an overdose.

GAO Finds Major Overuse of Antipsychotic Drugs by the Elderly

From the Illinois Nursing Home Abuse Blog

In late 2014 we blogged about the accusations levied against Dr. Michael J. Reinstein about his improper use of antipsychotic drugs prescribed to patients in abundance, as well as taking kickbacks from the drug maker to prescribe it, and making 140,000 or more false billing claims submitted to Medicare and Medicaid for those treatments. This activity landed him in both civil and criminal hot water, and in more recent news he pled guilty to criminal charges as well as settled civil claims with the Illinois and federal governments.

The companies accused of providing those kickbacks and receiving Medicare and Medicaid dollars from the business Reinstein generated by prescribing their antipsychotic drugs. Reinstein exemplifies a holdover of a slowly diminishing practice of using antipsychotic medications, which now is viewed more as the easy way out and a method of chemical restraint when there are other methods that could more humanely calm and care for a patient, particularly dementia and Alzheimer’s patients who have historically been the recipients of antipsychotic medications. Nursing homes historically used these especially when they kept low staffing levels and did not have the manpower to aid patients. Yet antipsychotic drugs can create a cycle of drug dependency, and can even lead to death.

Changing Tides?

While the movement to eliminate the use of antipsychotic medications has gained steam in recent years, the federal government reports that elderly Americans have been overusing psychiatric drugs such as clozapine (Dr. Reinstein’s apparent drug of choice), Abilify, and others. Such drugs are meant to calm down and sedate patients that are prone to violence or outbursts, which those suffering from dementia or psychosis may be particularly prone to exhibiting. The Government Accountability Office (GAO) has released a report stating that elderly adults who live outside of nursing homes and long-term care facilities overuse antipsychotic drugs which are prescribed to them by doctors, though residents in nursing homes also fell into such dependency and overuse, and efforts to curb over-prescription and overuse must continue there as well.

Notably, according to the report, about 86% of Medicare enrollees who suffer from dementia and live outside of nursing homes are prescribed antipsychotic medications, which is a staggering statistic. It is even more remarkable when considering that only approximately 6% of total Medicare enrollees living outside of nursing homes suffer from dementia. Thus the choice of treatment has predominantly been geared toward chemical intervention. For those in nursing homes, of the elderly dementia patients living in nursing homes for over 100 days in the year 2012, approximately a third of those patients were prescribed antipsychotic drugs (and 14% of those outside of nursing homes during 2012).

Part of the problem, according to the GAO report, is the lack of oversight by the government. Medicare and Medicaid specifically take responsibility for such oversight on behalf of the federal government, and states typically have Medicaid fraud units that look into not only financial fraud related to health care, but also investigate when issues include abuse or misuse of medications (which can result in unnecessary and excessive, and thus fraudulent, payments to providers and pharmaceuticals with federal dollars). Those agencies and offices, as well as the U.S. Department of Health and Human Services as the report notes, should be vital in promoting awareness of the dangers of antipsychotic drugs and reducing that use far more than the government has in the past.

"They said if I kept making noise, they would drag me into the mental-health ward and diagnose me as having mental illness."

As reported by the CBC, with much more including a video report and documentation at the link

You can also see the video here

Another case of a person being diagnosed as mentally ill for the convenience of the doctors, not to help the patient. Apparently they wanted to put here on anti-psychotics to shut her up.

Alice Zhang says she's being denied a life-saving kidney transplant because doctors at Vancouver General Hospital have decided she is mentally ill.

The 45-year-old mother of two, who speaks only Cantonese, and her family say she has no history of mental illness, and that she was only removed from the transplant list for complaining about her treatment in the hemodialysis unit.

"That's what started this whole situation" Zhang, speaking through an interpreter, told CBC Investigates.

She said doctors threatened to admit her involuntarily under the Mental Health Act.

"They said if I kept making noise, they would drag me into the mental-health ward and diagnose me as having mental illness."

Zhang said that is where she ended up on two occasions.

Polycystic kidney disease

Zhang has polycystic kidney disease. She shares custody of her boys, aged nine and 11 years old.

She needs hemodialysis three times a week, and has been on the kidney transplant list since 2009.

She said a sudden diagnosis of delusional disorder came right after she filed written complaints that nurses were too rough on her injection site.

"They said, 'Right now, we are going to temporarily stop the transplant process,'" said Zhang. Hospital documents confirm that the process was halted.

"Because I complained about them, they said that to me."

According to a psychiatrist’s handwritten notes, Zhang was paranoid.

Difficult but not delusional, says family

Zhang's husband, from whom she is separated, believes doctors are misinterpreting her actions.

"If they don't even understand what she's saying, how can they say she has a mental illness?" said Lea Kwong Chow.

"This person doesn't really have great social skills. Just because of that, you can't say they have a mental illness."

Chow said that in the nearly 20 years he has known Zhang, she has never shown any signs of paranoia.

While a translator attends most appointments, Chow and Zhang said there are many informal interactions without one.

In October, the psychiatrist's handwritten note to Zhang raised concern that she was following a nurse.

"You were asking about her last name. This was interpreted as concerning behaviour," the note said.

The notes show Zhang tried to explain she had been asked to find out the nurse's last name by her lawyer, something he confirmed in a letter to Vancouver Coastal Health.

The same psychiatrist wrote, "The fact that you believe that the nurses are trying to harm you tells me that you have a mental illness ... the nurses are starting to feel threatened by you. Some of this has to do with your complaints about them."

But Zhang — who refused to take prescribed anti-psychotic drugs — said she has never said anyone tried to hurt her on purpose.

"I have never been the suspicious type," she said. "I believe they have violated my human rights."

Chicago psychiatrist pleads guilty to taking drug kickbacks

As reported by ABC channel 7 in Chicago

A long-time Chicago psychiatrist pleaded guilty Friday to receiving illegal kickbacks and benefits totaling nearly $600,000 from pharmaceutical companies in exchange for prescribing an anti-psychotic drug to his patients.

Dr. Michael J. Reinstein, 71, of Skokie, has also agreed to pay $3.79 million to settle a civil lawsuit alleging that he caused the submission of at least 140,000 false Medicare and Medicaid claims for the thousands of patients he prescribed Clozapine to in nursing homes and other facilities in exchange for kickbacks.

"The defendant put his patients at great risk of serious health problems to benefit his personal interests at taxpayer expense," said Attorney General Lisa Madigan, whose office handled the civil litigation.

Reinstein's plea agreement calls for the government to recommend a sentence of 18.5 months in prison when he is sentenced.

The U.S. Attorney for the Northern District of Illinois filed a single felony charge against Dr. Michael Reinstein, a Chicago psychiatrist took kickbacks for prescribing an antipsychotic drug

As reported on ProPublica

Be sure to the original for many extar links related to the story

A former Chicago psychiatrist who was the nation's top prescriber of the most powerful and riskiest antipsychotic drug intends to plead guilty to a federal felony charge of taking kickbacks from its manufacturer in exchange for prescriptions, court records show.

The U.S. Attorney for the Northern District of Illinois filed a single felony charge against Dr. Michael Reinstein this week for taking $2,000 in November 2009 from drugmaker Teva "in return for Reinstein's referrals of patients" for clozapine prescriptions.

Clozapine, also known as Clozaril and FazaClo, is approved to treat schizophrenia patients who don't respond to other medications. But it can have dangerous side effects, including seizures, inflammation of the heart muscle, and a drop in white blood cells. The drug is considered particularly risky for elderly patients.

A note in court records says that Reinstein intends to plead guilty at his arraignment next Friday. The action was first reported by the Chicago Tribune.

Reinstein's prescribing patterns have been detailed in two ProPublica reports.

In 2009, ProPublica and the Chicago Tribune reported how in one year Reinstein prescribed more of the antipsychotic clozapine to patients in Medicaid's Illinois program than all doctors in the Medicaid programs of Texas, Florida and North Carolina combined. Autopsy and court records showed that at least three patients under Reinstein's care had died of clozapine intoxication. At that time, Reinstein defended his prescription record, arguing that clozapine is effective and underprescribed.

Then, in 2013, as part of a ProPublica investigation into Medicare's failure to monitor problem prescribers, we reported that Reinstein prescribed even more clozapine in Medicare's prescription drug program for seniors and the disabled. Medicare continued to let him prescribe in the program even after the U.S. Department of Justice accused him of fraud and Illinois' Medicaid program suspended payments to him.

The U.S. Attorney's office declined to discuss Reinstein's upcoming plea. Reinstein's attorney, Terence Campbell, did not immediately return a phone call from ProPublica seeking comment. He told the Tribune on Thursday that Reinstein was "working toward resolving the issues raised by the government and hopes to put this episode behind him soon."

The Tribune reached Reinstein, as well, yesterday. He would not discuss the criminal case but denied any payments from Teva, clozapine's manufacturer, were for prescribing the drug. The doctor instead said the money was for lectures he gave.

In November 2012, the federal government filed a civil fraud lawsuit against Reinstein, saying he "received illegal kickbacks from pharmaceutical companies and submitted at least 140,000 false claims to Medicare and Medicaid for antipsychotic medications he prescribed for thousands of mentally ill patients in area nursing homes."

Last August, Illinois medical regulators indefinitely suspended Reinstein's medical license after determining that Reinstein received " illegal direct and indirect remuneration" from the maker of generic clozapine, did not consider alternative treatments for his patients, and disregarded patients' well-being. In response to the medical board's accusations, Reinstein's lawyers invoked his right against self-incrimination.

Early last year, Teva Pharmaceutical Industries Ltd., the maker of generic clozapine, agreed to pay more than $27.6 million to settle state and federal allegations that it induced Reinstein to prescribe the drug.

Reinstein's prescribing of clozapine appears to have declined after our 2009 articles about him. From 2007 to 2009, he wrote an average of 20,000 Medicare prescriptions annually for clozapine and the brand-name version, FazaClo. That figure dropped to about 8,000 in 2012, according to data obtained by ProPublica.

Choosing Wisely: Five Things Physicians, Psychiatrists, and Patients Should Question

As seen on the Choosing Wisely website

Available also as a PDF

1 Don’t prescribe antipsychotic medications to patients for any indication without appropriate initial evaluation and appropriate ongoing monitoring.

Metabolic, neuromuscular and cardiovascular side effects are common in patients receiving antipsychotic medications for any indication, so thorough initial evaluation to ensure that their use is clinically warranted, and ongoing monitoring to ensure that side effects are identified, are essential. “Appropriate initial evaluation” includes the following: (a) thorough assessment of possible underlying causes of target symptoms including general medical, psychiatric, environmental or psychosocial problems; (b) consideration of general medical conditions; and (c) assessment of family history of general medical conditions, especially of metabolic and cardiovascular disorders. “Appropriate ongoing monitoring” includes re-evaluation and documentation of dose, efficacy and adverse effects; and targeted assessment, including assessment of movement disorder or neurological symptoms; weight, waist circumference and/or BMI; blood pressure; heart rate; blood glucose level; and lipid profile at periodic intervals.

2 Don’t routinely prescribe two or more antipsychotic medications concurrently.

Research shows that use of two or more antipsychotic medications occurs in 4 to 35% of outpatients and 30 to 50% of inpatients. However, evidence for the efficacy and safety of using multiple antipsychotic medications is limited, and risk for drug interactions, noncompliance and medication errors is increased. Generally, the use of two or more antipsychotic medications concurrently should be avoided except in cases of three failed trials of monotherapy, which included one failed trial of Clozapine where possible, or where a second antipsychotic medication is added with a plan to cross-taper to monotherapy.

3 Don’t use antipsychotics as first choice to treat behavioral and psychological symptoms of dementia.

Behavioral and psychological symptoms of dementia are defined as the non-cognitive symptoms and behaviors, including agitation or aggression, anxiety, irritability, depression, apathy and psychosis. Evidence shows that risks (e.g., cerebrovascular effects, mortality, parkinsonism or extrapyramidal signs, sedation, confusion and other cognitive disturbances, and increased body weight) tend to outweigh the potential benefits of antipsychotic medications in this population. Clinicians should limit the use of antipsychotic medications to cases where non-pharmacologic measures have failed and the patients’ symptoms may create a threat to themselves or others. This item is also included in the American Geriatric Society’s list of recommendations for “Choosing Wisely.”

4 Don’t routinely prescribe antipsychotic medications as a first-line intervention for insomnia in adults.

There is inadequate evidence for the efficacy of antipsychotic medications to treat insomnia (primary or due to another psychiatric or medical condition), with the few studies that do exist showing mixed results.

5 Don’t routinely prescribe an antipsychotic medication to treat behavioral and emotional symptoms of childhood mental disorders in the absence of approved or evidence supported indications.

There are both on and off label clinical indications for antipsychotic use in children and adolescents. FDA approved and/or evidence supported indications for antipsychotic medications in children and adolescents include psychotic disorders, bipolar disorder, tic disorders, and severe irritability in children with autism spectrum disorders; there is increasing evidence that antipsychotic medication may be useful for some disruptive behavior disorders. Children and adolescents should be prescribed antipsychotic medications only after having had a careful diagnostic assessment with attention to comorbid medical conditions and a review of the patient’s prior treatments. Efforts should be made to combine both evidence-based pharmacological and psychosocial interventions and support. Limited availability of evidence based psychosocial interventions may make it difficult for every child to receive this ideal combination. Discussion of potential risks and benefits of medication treatment with the child and their guardian is critical. A short and long term treatment and monitoring plan to assess outcome, side effects, metabolic status and discontinuation, if appropriate, is also critical. The evidence base for use of atypical antipsychotics in preschool and younger children is limited and therefore further caution is warranted in prescribing in this population.

These items are provided solely for informational purposes and are not intended as a substitute for consultation with a medical professional. Patients with any specific questions about the items on this list or their individual situation should consult their physician.

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Psychiatry is Broken

A very interesting blog post slash column entitled "When Psychiatrists Distrust Their Patients, Their Patients Can Only Respond In Kind" by Rebecca Vipond Brink

She reviews the problems she has had with Psychiatrists when they become arrogant, and do not take seriously what their patients are saying. Unfortunately this is all too common.

Here are some snippets

The worst psychiatrist I had, on the other hand, seemed awesome when we started — our initial appointment was an hour long, and she probed into my family’s medical history for clues about mine. It seemed holistic. As time went on, though, appointments became sparser and shorter — she was constantly double-booked, she got to the point that she was doing five-minute refill appointments, and I was eventually on four different medications in an attempt to treat anxiety and what we thought was depression in the fallout of PTSD. When I disputed her original diagnosis at my last appointment, she responded, “That’s just not what I know about you from our work.” Our work? She had only spoken to me for a grand total of maybe two hours at that point, while I had been out in the world living my life with my emotions. I wanted to be trusted that I was the best possible source of information about my well-being, not a brief description of a few symptoms and the DSM-V.

I told her that I wanted to get off of my medications because they just weren’t working — I was still having massive, debilitating anxiety attacks, nightmares, insomnia, paranoia. I had had a full-on nervous breakdown while on medications. And I didn’t feel like anti-depressants were appropriate, because with a lot of reflection, I landed on the opinion that debilitating anxiety looks a lot like depression but is not the same thing. All of my feelings and neurotic impulses were still very intense, and yet here I was, taking more and more medications in higher and higher doses to treat them, to no effect. Instead of weaning me off of anything, she prescribed two more medications. I found out later that some of the medications she wanted me to take had unsavory interactions that she didn’t disclose to me.

[...] All of this has left me feeling more than a little suspicious about psychiatry. I felt like my psychiatrist had dismissed my opinions in her care plan, and had distrusted me and my word without me having given her any reason over the course of my treatment to do so. I felt like I had had no control over my care, and that feeling of a lack of control over what was a major part of my life was devastating — I have PTSD because of abuse and rape. Control over my body is important to me.

Much more at the the link.

Just another data point of evidence that Psychiatry is Broken

VA to look into overmedication reports at Tomah center

From an AP Report in the San Francisco Chronicle

The U.S. Department of Veterans Affairs is launching an investigation into reports of overmedication and retaliatory management practices at the VA Medical Center in Tomah, the agency said Thursday.

Veterans Health Administration specialists plan to visit the western Wisconsin facility within two weeks to review medication prescription practices, the federal agency said in a statement Thursday afternoon. They also plan to send representatives from the Office of Accountability Review to look into allegations of retaliatory behavior.

"My sense is that this isn't just unique to Tomah," U.S. Rep. Ron Kind, a Democrat whose district includes Tomah. "We have a system-wide issue that needs to be addressed when it comes to pain management with our veterans."

Kind and other Wisconsin lawmakers had sent requests to Veterans Affairs Secretary Robert McDonald this week seeking an investigation

Tomah VA spokesman Scott Farley said in a statement the medical center will fully cooperate with the investigation.

A recent story from The Center for Investigative Reporting noted the number of opiates prescribed at the Tomah VA had more than quintupled between 2004 and 2012, even as the number of veterans seeking treatment there has declined. Health care professionals have complained about the medical center's practices for several years.

Here is more info from The Center for Investigative Reporting Looks like the main culprite is, of course, another damn psychiatrist Dr. David Houlihan

Politicians from both parties and government bureaucrats are rushing to look into allegations of rampant overmedication, retaliatory management practices and preventable overdose deaths at the U.S. Department of Veterans Affairs Medical Center in Tomah, Wisconsin, that The Center for Investigative Reporting revealed last week.

In the story’s wake, the VA has begun “actively reviewing allegations of retaliatory behavior and overmedication at the Tomah VA Medical Center,” said agency spokesman James Hutton. He said the facility’s chief of staff, psychiatrist Dr. David Houlihan, has been temporarily reassigned to the VA regional office while an internal investigation takes place.

But the problems disclosed should not have surprised politicians or federal officials: Health care professionals at the hospital have complained for at least five years about Houlihan’s prescription practices and his retaliatory management style – filing numerous reports with those in charge of oversight.

“It’s about time,” said Robin Weeth, a former social worker at the hospital who wrote to the VA inspector general in 2012 with a long list of allegations, including that “veterans are overmedicated and have been driving while impaired, fallen asleep while smoking and set themselves on fire.”

Today, Weeth reports that he never heard back from the inspector general.

The CIR story reported that the number of opiates prescribed at the Tomah VA had more than quintupled between 2004 and 2012, even as the number of veterans seeking care at the hospital declined. It included details of the August death of a 35-year-old Marine Corps veteran, who overdosed while in the hospital’s inpatient psychiatric ward.

[...]

The VA inspector general had closed an investigation into the Tomah VA before Baldwin even got in touch, in March 2014. The inspector general’s report noted that Houlihan’s narcotic prescriptions were “at considerable variance compared to most opioid prescribers” and “raised potentially serious concerns” that should be brought to the attention of the federal agency’s leadership. But the report suggested no punishment.

Weeth said he believed that Jason Simcakoski, the 35-year-old former Marine who fatally overdosed in the Tomah VA psychiatric ward in August, still would be alive today if the inspector general had come down harder on Houlihan.

[...]

Much more information at the links

Life Care Of Greeneville, NC Named In Wrongful Death Lawsuit

As reported in the Greenville Sun

Many more Details are available at the link

A wrongful death civil lawsuit has been filed against a Greeneville nursing home and several other defendants alleging wrongdoing in the care the facility gave an elderly dementia patient.

In the complaint, filed Dec. 2, 2014, in Greene County Circuit Court, the plaintiff, Robin Tweed Keller, of Virginia, alleges that medical battery and negligence by Life Care Center of Greeneville resulted in the suffering and eventual death of her father, Bobby Glenn Tweed, on Nov. 19, 2013, at the age of 79.

The suit identifies Keller as Tweed's only daughter and his next-of-kin -- and the person he had designated his Tennessee Healthcare Durable Power-of-Attorney in September 2009.

She is also identified as the court-appointed representative of his estate.

Defendants named in the lawsuit are:

• Life Care Center of Greeneville, 725 Crum St.;
• Life Care Centers of America Inc., based in Cleveland, Tenn., the parent company of Life Care Center of Greeneville and more than 100 other similar centers in the nation;
• Wayne E. Tasker & Associates Inc., of Morristown, doing business as Green Tasker & Associates Inc., and Tasker Green & Associates Inc., a firm which Keller believes provides services to Life Care Centers in connection with the mental health of patients;
• Dr. William C. Diebold, a medical doctor and board-certified psychiatrist with Takoma Regional Hospital's Center for Outpatient Behavioral Health and Senior Care, who, the lawsuit states, treated Tweed at one point during the last months of his life;
• Stephen L. Haile, an advanced-practice registered nurse who the plaintiff believes to be an officer or employee of the Tasker firm; and
• Dr. Kenneth Nickle, a physician with Summit Medical Group, who, the lawsuit states, served as medical director of Life Care Center of Greeneville during the last three months of Tweed's life and, in that capacity, treated Tweed for two-and-a-half to three months.

Also cited as a defendant is an unnamed female who, the complaint states, was employed at Life Care Center of Greeneville. The lawsuit alleges that she was involved in the care and treatment of Tweed and administered certain "atypical anti-psychotic drugs" without obtaining the legally-required informed consent from Keller.

The Greeneville Sun has made attempts to seek comment from each defendant listed in the complaint. Each defendant contacted has declined comment on the pending case at this time.

WHAT LAWSUIT CLAIMS

The suit alleges that, for a few days in August 2013 at Takoma Regional Hospital and then continuing until mid-October 2013 at Life Care Center of Greeneville, Tweed was administered powerful drugs that were inappropriate for his medical condition: dementia and Alzheimer's disease (but not mental illness).

The drugs mentioned in the lawsuit -- Seroquel, Geodon and Depakote -- are described in the suit as "extremely powerful psychotropic medications" classified as "atypical anti-psychotic drugs."

Seroquel and Geodon, the suit alleges, "and other atypical anti-psychotic drugs" have been shown to increase death in elderly patients who are suffering from dementia.

Because of that increased risk of death, the U.S. Food and Drug Administration (FDA) has required the manufacturers of Seroquel and Geodon to include "black box" warnings about the danger of using those drugs with elderly patients who are suffering from dementia, the suit alleges.

The suit describes Depakote as "an anti-epileptic drug, which is used to treat a variety of epilepsy seizure types as well as acute manic symptoms in patients with bipolar disorder."

But, the suit continues, "It has not been approved by the FDA for use with Alzheimer's disease or dementia."

Many more Details are available at the link

FDA warns Pfizer's antipsychotic Geodon and generic versions of the drug could cause a fatal skin reaction

As Reported by Reuters

Pfizer Inc's antipsychotic Geodon and generic versions of the drug can trigger a potentially fatal skin reaction, the U.S. Food and Drug Administration warned on Thursday.

A new warning has been added to the drug's label to describe the condition - known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) - which may start as a rash and spread all over. (1.usa.gov/1Gh2I8p)

Other symptoms include fever, swollen lymph nodes and organ inflammation.

Geodon, known generically as ziprasidone, is used to treat schizophrenia and bipolar I disorder by reducing hallucinations, delusions and other psychotic symptoms.

While no deaths have been reported, the regulator reviewed six cases in whom the signs and symptoms of D.R.E.S.S. appeared between 11 and 30 days after ziprasidone treatment was initiated.

Last year, 2.5 million prescriptions for oral formulations of ziprasidone were dispensed, the agency said.

Patients on the drug who have a fever with a rash and/or swollen lymph glands should seek urgent care, the regulator said, advising doctors to halt treatment if they suspect D.R.E.S.S.

[BOOK] Brain Disabling Treatments in Psychiatry: Drugs, Electroshock, and the Psychopharmaceutical Complex

Renowned psychiatrist Peter Breggin documents how psychiatric drugs and electroshock (ECT) disable the brain. He presents the latest scientific information on potential brain dysfunction and dangerous behavioral abnormalities produced by the most widely used drugs including Prozac, Xanax, Halcion, Ritalin, and lithium. Even though this book was published a few years ago, it is still a highly relevant and import work

Many of Breggin's earlier findings have improved clinical practice, led to legal victories against drug companies, and resulted in FDA-mandated changes in what the manufacturers must admit about their drugs. This greatly expanded second edition, supported by the latest evidence-based research, shows that psychiatric drugs achieve their primary or essential effect by causing brain dysfunction, and they tend to do far more harm than good.

Author's website

Available through Amazon.com here.

Author's description of the book:

"For those who have been following my work or who wish an introduction to my lifetime reform efforts and scientific investigations in the field of psychiatry, the newly published second edition of Brain-Disabling Treatments in Psychiatry: Drugs, Electroshock and the Psychopharmaceutical Complex (Springer Publishing Company, 2008) has recently been published. It is a thorough and up-to-date presentation of my overall critique of modern psychiatry, including the latest medications and treatments.

"The new edition describes general principles for the safe withdrawal from psychiatric drugs with specific examples of withdrawal problems related to each type of psychiatric medication, including antidepressants, tranquilizers, stimulants, mood stabilizers and neuroleptic (antipsychotic) drugs. For interested professionals, patients and clients, it presents guidelines for how to conduct psychotherapy and counseling without resort to psychiatric drugs, even for the most emotionally distressed people.

"The new edition of the book presents evidence confirming many of the first edition’s most controversial conclusions. Research continues to demonstrate that antidepressants are ineffective in treating depression and instead increase the risk of suicidality. As another example, additional studies have shown that stimulants offer no long-term positive effects on the behavior of children and that these drugs suppress growth and make children prone to cocaine abuse as young adults. Recent reports continue to confirm that electroshock causes permanent brain damage and cognitive dysfunction.

"The scientific premise of the book is that all psychiatric treatments—drugs, electroshock and lobotomy—have their 'therapeutic' impact by disabling the brain. They do not improve brain function or correct biochemical imbalances, they cause brain dysfunction and biochemical imbalances. These brain-disabling interventions are then considered effective when the doctor, family, patient or society views impaired brain dysfunction in the target individuals as a desirable or beneficial effect. Because psychiatric drugs in reality do more harm than good, the psychopharmaceutical complex must devote billions of dollars to exerting its power and influence in the political, professional and public arenas.

"'Antipsychotic' drugs such as Risperdal, Zyprexa, Seroquel and Geodon are used literally to chemically lobotomize millions of adults and children because the resulting apathy and indifference are seen as an improvement over their previously distressed and distressing state of mind or behavior. Millions more adults take 'tranquilizers' like Xanax, Ativan, Klonopin and Valium, suppressing their overall brain function in order to reduce feelings of anxiety. A large percentage of our nation’s children have their spontaneity reduced or even crushed by stimulant drugs such as Ritalin, Concerta, Adderall and Strattera, causing them to become more docile and more obsessively attentive to rote work.

"Despite all the propaganda, antidepressants such Prozac, Paxil, Zoloft and Cymbalta have no scientifically demonstrable effectiveness and are proven to cause suicidality, as well as violence and mania. They too 'work' by causing mental disabilities such as apathy and euphoria that are misinterpreted as improvements. Meanwhile, their continued widespread use is determined in part by the fact that withdrawal produces severe psychiatric symptoms, including anxiety and depression. In short, it is too difficult and painful for people to stop taking them.

"All psychiatric drugs have the potential to cause withdrawal reactions, including the antidepressants, stimulants, tranquilizers, antipsychotic drugs and 'mood stabilizers' such lithium. When the individual’s condition grows markedly worse within days or weeks of stopping the psychiatric drug, this is almost always due to a withdrawal reaction. However, misinformed doctors and misled parents, teachers and patients think that this is evidence that the individual 'needs' the drug even more, when in fact he or she needs time to recover from withdrawal effects.

"People commonly use alcohol, marijuana and other non-prescription drugs to dull their feelings. Usually they do not fool themselves into believing they are somehow improving the function of their minds and brains. Yet when people take psychiatric drugs, they almost always do so without realizing that the drugs “work” by disrupting brain function, that the drugs cause withdrawal effects, and that they frequently result in dangerous and destructive mental reactions and behaviors.

"Most consumers of psychiatric drugs do not realize how much these chemical agents disrupt the function of the brain and mind. As a result, their treatment in effect becomes involuntary. Many other adults are physically forced to these drugs in hospitals and even under outpatient commitment that allows for enforced drugging in the home. Because children cannot control their lives, or understand the implications of taking drugs, they are always involuntary participants in these brain-disabling treatments. Our society needs to stop forcing psychoactive drugs on its citizens, young and old.

"Electroshock provides a more obvious illustration of the brain-disabling effects of psychiatric treatment. Shock treatment is simply closed-head injury caused by an overwhelming current of electricity sufficient to cause a grand mal seizure. When the patient becomes apathetic, the doctor writes in the hospital chart, 'No longer complaining.' When the patient displays the euphoria commonly associated brain damage, the doctor writes, 'mood improved.' Meanwhile, the individual’s brain and mind are so drastically injured that he or she is rendered unable to protest. They are easily led to take repeated shock treatments. In many cases, family members must intervene to stop the destructive 'treatment.'

"The brain-disabling principle of psychiatric treatment is not a speculation. It is a solid scientific theory based on hundreds of evidence-based reports, clinical experience, and common sense observations. I believe it will stand the test of time."

"The new edition of Brain-Disabling Treatments in Psychiatry introduces the concept of medication spellbinding—the capacity of psychoactive drugs to blunt the individual’s appreciation of drug-induced mental dysfunction and, at times, to encourage a misperception that they are doing better than ever when they are, in fact, doing worse than ever. In the extreme, medication spellbinding drives individuals into bizarre, out-of-character destructive actions, including suicide and violence. Medication spellbinding is an aspect of the brain-disabling principle that explains why so many individuals take drugs of all kinds, from antidepressants to alcohol, when they are causing them great harm and even destroying their lives.

"The power of the psychopharmaceutical complex, a concept that I introduced in 1991 in Toxic Psychiatry, has now received confirmation from innumerable books by disenchanted members of the medical establishment. The new edition of Brain-Disabling Treatments in Psychiatry reviews some of these other books and articles, and presents details about how the drug companies continue to rule the world of psychiatry; they control research and journal publications, dominate medical education, collaborate with insurance companies and federal agencies, and finance organized psychiatry and medicine.

"This new edition of Brain-Disabling Treatments in Psychiatry has a long history, originating in the 1983 publication of Psychiatric Drugs: Hazards to the Brain and then evolving into the initial 1997 edition of Brain-Disabling Treatments in Psychiatry. The concepts and information—contained 16 detailed chapters and 85 pages of scientific bibliography—provide a mountain of information about what’s wrong with modern psychiatry and what’s needed to correct it."

Abilify Is Top-Selling U.S. Drug -- But New Reports Question Long-Term Antipsychotic Use

Part of a much longer report seen in the Huffington Post

The author tries to play fair with both sides, but ends up making a muddle of it.

Last month, the news broke that the anti-psychotic Abilify, thanks in part to direct marketing to consumers for depression, has become the best-selling drug in the United States, raking in roughly $7 billion a year. Yet as Jay Michaelson in The Daily Beast pointed out recently, no one's sure how it may achieve its purported effects as an "augmented" treatment for depression.

The alarms about the dangerous and sometimes deadly side-effects of antipsychotics affecting children and the elderly, among others, have been mounting for years. But only very recently have mainstream health officials in the United States and in Britain started to express concerns about these medications, with limited efforts, for example, to rein in their overuse in nursing homes. At the same time, there's a rethinking underway at the National Institute of Mental Health (NIMH), U.K.'s National Health Service and the British Psychological Society (BPS) over the way clinicians diagnose schizophrenia and treat the illness over the long term with antipsychotics. In late November, for instance, the respected BPS released an updated study, "Understanding Psychosis and Schizophrenia," that offers a sweeping challenge to conventional thinking and treatments for schizophrenia.

[...]

The rest of us should be concerned about these trends, too. Nearly one in four visits to a psychiatrist for anxiety will lead to a prescription for an antipsychotic, an "off-label" use not approved by the FDA. What's happened is that the risky anti-psychotics originally intended for schizophrenia, then later approved for bipolar disorder, have seen their use extend to bipolar grade-schoolers and adult depressives with the dubious blessing of a pro-Pharma FDA, often based on shaky science. Now about 85 percent of all antipsychotic prescriptions are for "off-label" uses still unapproved by the easygoing FDA, such as anxiety and insomnia.

[...]

The commonly-hyped notion of an imbalance of chemicals -- especially serotonin -- causing depression, for instance, has largely been discredited in recent research. There is no single biological marker yet found for depression or other mental illnesses, but there are enough indicators showing that biology doubtless plays a key role -- although not yet precisely determined or quantified -- in mental illness. These include studies of identical twins; neural imaging studies highlighting malfunctioning brain activity; and research into abnormal brain development. That research has helped to spur a new federal "brain initiative."

[...]

Now, important recent reports reinforce mounting concerns about the long-term use of antipsychotics and the potential benefits of at least considering using lower dosages. Even the director of NIMH, Dr. Tom Insel, citing recent research about long-term outcomes in JAMA Psychiatry and other journals, has raised questions about these medications

Drug Shills Dispensing Pills A psychiatrist questions Big Pharma’s influence on her profession.

A recent article by Jean Kim in the magazine IN THESE TIMES

Jean Kim is a psychiatrist and writer in Washington, D.C., who is finishing her M.A. in nonfiction writing at Johns Hopkins University

In 2009, as an eager young psychiatry professor at New York-Presbyterian Hospital, I presented to faculty on the need for a moral dimension to psychiatric diagnoses. I was laughed out of the room.

One psychiatrist, a schizophrenia specialist, said he didn’t see the point. The acting medical director said he felt I’d called him immoral. A top research psychiatrist said, incredibly, “Morality and psychiatry should be kept separate.”

So a few years later, when ProPublica launched its Dollars for Docs database to track the drug company money doctors were taking, I typed in their names. The acting medical director received $12,550 in 2010 and 2011 for speaking gigs. The researcher received more than $212,489 between 2009 and 2012 for speaking gigs and consultations. The schizophrenia specialist made more than $323,300. And the database only includes disclosures from 17 of the more than 70 drug companies in the world. According to Dollars for Docs, hundreds of thousands of doctors have raked in a total of more than $4 billion since 2009, with the top earner, psychiatrist Dr. Jon Draud, netting at least $1.2 million.

As a psychiatrist who “grew up” in the last decade, I was not surprised.

I started my residency training in New York City in 2000. Lunches and dinners provided by drug company reps were astaple of my diet. For a hungry, harried resident on a paltry salary, a free pit stop at a steaming Chinese buffet was heaven. All around me in Manhattan, investment bankers and freshly minted lawyers were living it up, and I admit that I wanted a piece of the pie as well. By mid-decade, academic psychiatry had become glamorous. A resident might schmooze with a drug rep and get invited to a trendy spot—Nobu, Olives, Tao—where we could imbibe Sex and the City-style cocktails and sample the freshest sushi. Drug reps, selected for their looks and charm, were the popular, beautiful best friends we geeky docs never had.

In 2003, I won a free ride to the American Psychiatric Association annual meeting in San Francisco as part of an Aventis-sponsored fellowship for women in psychiatry. An industry-sponsored gala featured an open bar and a Brobdingnagian spread: tables loaded with huge flower displays, chocolate fountains, petit fours and gourmet hors d’oeuvres. The conference also hosted a Disney-esque exhibit hall full of brightly colored drug company displays with touchscreen computer stations. I filled my free tote bag with gifts—pens, laser pointers, candy, textbooks. My favorite was the Xanax XR clock, whose hands rested on a bed of clear turquoise fluid, to simulate the feeling of floating on a summer pool.

I graduated from residency training and became an attending psychiatrist myself. Back then, it was viewed as a symbol of academic prowess to be on a drug company’s speaker’s bureau. So when an enthusiastic new drug rep from my alma mater invited me, a lowly junior attending, to a speaker training session, I was flattered and accepted. On an all-expenses-paid two-day training trip to Chicago, I stayed at a posh hotel on Michigan Avenue and sat through lectures about the then-new antipsychotic drug Geodon. I was paid $2,500 for going, and another $1,000 for giving a “talk” for about seven minutes a few weeks later at a dinner with a handful of colleagues. Persuaded that I needed to gain experience with Geodon so that I could be a better presenter, I began prescribing it more often. Then I began to see that it was less reliable than other medications. I quit the speaker’s bureau, realizing I had been manipulated into writing more Geodon prescriptions. In fact, the drug rep’s salary depended on such performance increases. Drug companies can track all physicians’ prescriptions—a 2011 Supreme Court decision upheld their right to do so, citing data as “free commercial speech.”

In November 2007, as the economy imploded, a prominent psychiatrist, Dr. Daniel Carlat, wrote a famous essay in the New York Times Magazine about a stint as a pharma shill. He concluded, “The money was affecting my critical judgment. I was willing to dance around the truth in order to make the drug reps happy. Receiving $750 checks for chatting with some doctors during a lunch break was such easy money that it left me giddy. Like an addiction, it was very hard to give up.” I read it and realized that I had been going along with the tide—that a colossal, profit-driven advertising engine was using our own psychological tactics to manipulate us.

The next year, heads began to roll. In October 2008, Dr. Charles Nemeroff, then head of psychiatry at Emory University, made the front page of the New York Times for failing to report more than $1.2 million dollars in drug company-related income to Emory, which had strict guidelines for non-academic money. He resigned and now works for the University of Miami.

Dr. Joseph Biederman of Harvard Medical School went one step farther than Nemeroff. As the Times reported in November 2008, he not only hid from Harvard that he’d taken more than $1.4 million from drug companies; he publicly advocated for diagnosing more children with bipolar disorder and prescribing them more antipsychotic medications. The rate of prescriptions for these medications skyrocketed. Antipsychotics should only be used when absolutely necessary, given their potential for serious side effects, especially in children.

Since then, FDA regulations have gotten tighter, and in 2009, the Pharmaceutical Researchers and Manufacturers of America self-imposed a code on interactions with healthcare professions. Drug company speakers can no longer ad-lib invented uses for their medications and have to include mention of “negative studies” if available. Comped dinners must be modest by local standards and include presentations. Pens and trinkets are banned. The once-charming reps can speak to you only if spoken to, not unlike vampires who cannot enter your home unless invited.

The reforms have cut down on blatant pharma influence, but prominent psychiatrists still shill shamelessly, and much research is pharma-funded. Take the October 2014 issue of the American Journal of Psychiatry, the elite scientific publication in our field. Five of the six research articles contain disclosures that one or more of the authors worked or consulted for pharma. It remains to be seen whether more data releases from ProPublica—and now from Open Payments, a federal database mandated by the Affordable Care Act and unveiled in late September—will create enough public backlash to convince these doctors that this type of income does harm. Conflicts of interest weaken the credibility of research and hurt patients by encouraging poor prescribing practices. They also undermine the crucial trust between doctor and patient by fueling the paranoiac skepticism that all psychotropic medications are mind-altering, toxic tools of profit.

The right medications, alongside psychotherapy, can save and improve lives. I have seen people frozen in psychosis or melancholia awaken, as though from a nightmare, after getting the right treatment. I have seen soldiers back from war, riddled with flashbacks, become able to do simple things again, like go to a shopping mall. I have seen people once stuck in hospitals able to work again, to finish school, to have loving relationships. Those moments fulfill me as a doctor and as a human being. But I wish my profession would recognize that our ethics are worth more than a quick buck.

Quote: A top research psychiatrist said, incredibly, “Morality and psychiatry should be kept separate.”

Sums it up nicely, no?

Psychiatric drugs responsible for 90,000 hospital emergency room visits annually

Just can across this recent report in the Formulary Journal from a few month back

Psychiatric drugs responsible for 90,000 ED visits annually

The original study is

Emergency Department Visits by Adults for Psychiatric Medication Adverse Events

Adverse reactions to antipsychotics, antidepressants, sedatives and anxiolytics, lithium salts or stimulant drugs are responsible for almost 90,000 emergency department (ED) visits each year by US adults, according to a study in JAMA Psychiatry.

The authors estimated the number of emergency department visits for adverse drug events from the therapeutic use of antipsychotics, antidepressants, sedatives and anxiolytics, lithium salts or stimulants using active, nationally representative surveillance data from the National Electronic Injury Surveillance System – Cooperative Adverse Drug Event Surveillance (NEISS-CADES).

They also estimated the number of outpatient visits at which those drugs were prescribed using the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey. They used the estimates of ED visits for adverse drug events and of outpatient prescription visits to calculate the number of ED visits for adverse events from a particular psychiatric drug per 10,000 outpatient prescription visits at which the drug was prescribed.

Almost 1 in 5 of those ED visits (19.3%) resulted in hospitalization. Sedatives and anxiolytics, antidepressants, and antipsychotics each caused 20,000 to 30,000 ED visits annually. However, relative to how often each of these types of medications was prescribed at outpatient visits, antipsychotics and lithium salts were more likely to cause ED visits for adverse drug events than were sedatives, stimulants, and antidepressants. Antipsychotics caused 3.3 times more ED visits for adverse drug events than sedatives, 4.0 times more ED visits than stimulants, and 4.9 times more ED visits than antidepressants relative to their outpatient use.

Out of the 83 specific drugs the study looked at, 10 drugs were implicated in nearly 60% of the ED visits for adverse drug events from therapeutic use of antipsychotics, antidepressants, sedatives and anxiolytics, lithium salts or stimulants. Zolpidem was implicated in nearly 12% of all such ED visits and 21% of such ED visits involving adults aged 65 years or older, more than any other sedative or anxiolytic and more than any antipsychotic, antidepressant, lithium salt or stimulant.

“The study highlights the importance of encouraging doctors to be cautious in their prescribing of medications,” said one of the study’s leaders Lee M. Hampton, MD, of the Centers for Disease Control and Prevention's healthcare quality promotion division. “The study findings can also be used to prioritize efforts to reduce the burden of adverse events from the therapeutic outpatient use of psychiatric medications within a given managed care or healthcare system.”

[...]

Why the University of Minnesota psychiatric research scandal must be investigated

As writen by Carl Elliot, and Published on the MinnPost Website

Carl Elliott is a professor in the Center for Bioethics at the University of Minnesota.

Three former editors of the New England Journal of Medicine have called for an investigation. So has the scholar who uncovered the Guatemala syphilis studies. The former Health and Disability Commissioner of New Zealand has called the conduct of the researchers “unethical,” pointing out the need to “put in safeguards in place to prevent a similar tragedy from happening again.” A recent Medical Journal of Australia editorial compared it to the exploitation of poor black men with syphilis in Tuskegee, Ala. Yet the University of Minnesota, where the research scandal occurred, simply keeps repeating, “Nothing to see here, folks. Just move along.”

The research abuse in this case is so stunning that when I first learned about it I could scarcely imagine it happening anywhere, much less at the university where I work. In late 2003, psychiatric researchers at the University of Minnesota recruited a mentally ill young man named Dan Markingson into a profitable, industry-funded research study of antipsychotic drugs. The researchers signed him up over the objections of his mother, Mary Weiss, who did not want him in the study, and despite the fact that he could not give proper informed consent. Dan was acutely psychotic, plagued by delusions about demons, and he had repeatedly been judged incapable of making his own medical decisions. Even worse, he had been placed under an involuntary commitment order that legally compelled him to obey the recommendations of the psychiatrist who recruited him into the study.

For months, Mary tried desperately to get Dan out of the study, warning that he was getting worse and that he was in danger of committing suicide. But her warnings were ignored. On April 23, 2004, she left a voice message with the study coordinator, asking, “Do we have to wait for him to kill himself or someone else before anyone does anything?” Three weeks later, Dan committed suicide in the most violent way imaginable. His body was discovered in the shower of a halfway house, his throat slit so severely that he was nearly decapitated, along with a note that said, “I went through this experience smiling.”

Conflicts of interest, other issues

As outrageous as that sounds, there is more. The psychiatrists had financial conflicts of interest from their work with the pharmaceutical industry. The study sponsor also provided financial incentives for the researchers to keep subjects in the study as long as possible. Last fall, the state Board of Social Work found that the study coordinator had falsified the initials of doctors on study records, failed to warn Dan of new dangers of the study drugs, had been given medical responsibilities far beyond her training as a social worker, and had failed to respond to Mary’s warnings that Dan was in danger of killing himself.

After Dan’s suicide, it got even worse. When Mary’s lawsuit against the university was dismissed on technical grounds of “sovereign immunity,” the university lawyers filed a legal action against her called a “notice to assess costs,” demanding that she pay them $57,000 in legal fees. Yes, you read that correctly: The U tried to force the mother of a suicide victim to pay it $57,000.

None of this is a secret. The case has generated international outrage. Yet for three years the University of Minnesota has managed to bluster and stonewall its way through all the criticism, insisting that it has already been exonerated. Even when the state Legislature passed “Dan’s Law” in 2009, banning psychiatrists from recruiting mentally ill patients under an involuntary commitment order into drug studies, the university continued to insist it had done nothing wrong.

A petition to Gov. Dayton

Two weeks ago, as a last resort, Mary Weiss, the mother of Dan Markingson, and her friend Mike Howard started a petition to Gov. Mark Dayton. Their request is simple: Please appoint an external, impartial panel to investigate the scandal. More than 1,200 people have signed, including well over 150 academic experts. Many University of Minnesota alumni have joined as well. A typical but telling comment: “I am ashamed of my alma mater right now.”

This is not an issue from the distant past. We do not know if other research subjects have died, or if they have been injured or mistreated. We do not even know if mistreatment is still continuing today. That may well be the most compelling reason for Minnesotans to sign the petition. If a case of research abuse this brazen can be sanctioned and defended by the university, there is no way to feel confident that other research subjects are being protected. In 2004 it was Dan Markingson. But it could have been any of us.

3 Skilled Nursing Facility staff arrested for drugging deaths of patients

Report from thje Kern Valley Sun

Attorney General Jerry Brown today announced the arrests of a nurse, physician, and a pharmacist of the Kern Valley Healthcare District's Skilled Nursing Facility for “forcibly administering psychotropic medications for their own convenience, rather than for their patients’ therapeutic interests.” The Attorney General said these actions are alleged to have resulted in the deaths of three residents.

Taken into custody earlier today, Feb. 18, by California Department of Justice special agents were Gwen Hughes, the former Director of Nursing at the Skilled Nursing Facility of the Kern Valley Healthcare District in Lake Isabella, on charges of elder abuse and assault with a deadly weapon; Debbi Hayes, the former pharmacist at KVHD, on charges of elder abuse and assault with a deadly weapon; and Dr. Hoshang Pormir, a staff physician at Kern Valley Hospital, who was serving as the medical director of the Skilled Nursing Facility, on charges of elder abuse.

“These people maliciously violated the trust of their patients, by holding them down and forcibly administering psychotropic medications if they dared to question their care,” Attorney General Brown said. “This is appalling behavior, which amounts to assault with a deadly weapon.”

According to the statement issued by the Attorney General's office, Hughes, upon taking over as Director of Nursing in September 2006, ordered that Alzheimer’s and other dementia patients be given high doses of psychotropic medications to make them more tranquil and easy to control. It goes on to say, “She ordered the administration of these medications to patients who argued with her, were noisy, or who were otherwise disruptive.” Two patients who resisted were held down and forcibly given injections.

The complaint also alleges that Hughes directed Debbi Hayes, the hospital pharmacist, to fill prescriptions for these psychotropic medications. Hayes wrote and filled these prescriptions without first obtaining a doctor’s approval, the complain said.

According to complaint, Pormir approved these psychotropic medications only some time after they had been administered and without examining the patients first and determining whether these psychotropic medications were medically necessary.

Investigators allege that several of these patients had medical complications as a result of being given these psychotropic medications, including lethargy and the inability to eat or drink properly. It is believed that that three patients died and one patient suffered great bodily injury as a result.

The case came to the attention of authorities in January 2007, when an ombudsman reported to the Bakersfield office of the California Department of Public Health that a patient in the Skilled Nursing Facility had been held down and given an injection of psychotropic medication by force.

The Department of Public Health immediately sent an investigative team with a doctor, a nurse, and a doctor of pharmacology. They determined that 22 patients, including some who were suffering from Alzheimer’s at the Skilled Nursing Facility, were being given high doses of psychotropic medication not for therapeutic reasons, but to simply control and quiet them for the convenience of the staff.

The Department of Public Health issued a Certificate of Immediate Jeopardy which resulted in the immediate dismissal of the Ms. Hughes. The matter was then turned over to the California Department of Justice, Bureau of Medi-Cal Fraud and Elder Abuse.

Special Agents from the Bureau of Medi-Cal Fraud and Elder Abuse began a year-long investigation, with the co-operation and assistance of the Department of Public Health and the administration of the Kern Valley Healthcare District.

Pamela Ott, CEO at the time, left the district in May 2007. Current KVHD Board of Directors Chair Kay Knight said, “A lot of people don't understand that this happened more than two years ago and is not going on now.”

Chet Beedle, Chief Financial Officer, reported that CEO Rick Carter and Board of Directors spokesperson Victoria Alwin were unavailable. He added that he was prohibited from commenting on the arrests and that a formal statement was coming.

A search warrant was served on the facility in August 2008, resulting in the seizure of 36 patients' medical files and records.

Criminal charges were filed in Kern County Superior Court and the defendants are being held in Kern County Jail in Bakersfield. Pormir is charged with one felony count of causing harm/death of an elder of dependent adult. He is being held on $400,000 bail. Hughes and Hayes are each charged with two felony counts, one count of causing harm/death of an elder of dependent adult and another felony count of assault with a deadly weapon other than a firearm of great bodily force. The trio will be arraigned in Superior Court in Bakersfield Friday morning. If convicted, the defendants could face up to 11 years in prison.

The case is being prosecuted by the Attorney General’s Bureau of Medi-Cal Fraud and Elder Abuse, with the co-operation and assistance of the Kern County District Attorney’s Office.

More than half of all foster children in Texas above 6 are drugged, 41,3% of those who receive medication receive 3+ different classes of medicines

Who are the real child abusers here? More than half of all foster children in Texas above 6 receive psychotropic medication, 41,3% of those who receive medication receive 3+ different classes of medicines. A study published in Pediatrics, the Official Journal of the American Academy of Pediatrics

Psychotropic Medication Patterns Among Youth in Foster Care

Julie M. Zito, PhD a,b,
Daniel J. Safer, MD c,
Devadatta Sai, MS a,
James F. Gardner, ScM a,
Diane Thomas, BA d,
Phyllis Coombes, MA d,
Melissa Dubowski, BS d and
Maria Mendez-Lewis, MPA d

Departments of

a Pharmaceutical Health Services Research
b Psychiatry, University of Maryland, Baltimore, Maryland
c Department of Psychiatry and Pediatrics, Johns Hopkins Medical Institutions, Baltimore, Maryland
d Office of the Texas Comptroller of Public Accounts, Austin, Texas

---

ABSTRACT

CONTEXT. Studies have revealed that youth in foster care covered by Medicaid insurance receive psychotropic medication at a rate >3 times that of Medicaid-insured youth who qualify by low family income. Systematic data on patterns of medication treatment, particularly concomitant drugs, for youth in foster care are limited.

OBJECTIVE. The purpose of this work was to describe and quantify patterns of psychotropic monotherapy and concomitant therapy prescribed to a randomly selected, 1-month sample of youth in foster care who had been receiving psychotropic medication.

METHODS. Medicaid data were accessed for a July 2004 random sample of 472 medicated youth in foster care aged 0 through 19 years from a southwestern US state. Psychotropic medication treatment data were identified by concomitant pattern, frequency, medication class, subclass, and drug entity and were analyzed in relation to age group; gender; race or ethnicity; International Classification of Diseases, Ninth Revision, psychiatric diagnosis; and physician specialty.

RESULTS. Of the foster children who had been dispensed psychotropic medication, 41.3% received ≥3 different classes of these drugs during July 2004, and 15.9% received ≥4 different classes.

The most frequently used medications were antidepressants (56.8%), attention-deficit/hyperactivity disorder drugs (55.9%), and antipsychotic agents (53.2%).

The use of specific psychotropic medication classes varied little by diagnostic grouping.

Psychiatrists prescribed 93% of the psychotropic medication dispensed to youth in foster care. The use of ≥2 drugs within the same psychotropic medication class was noted in 22.2% of those who were given prescribed drugs concomitantly.

CONCLUSIONS. Concomitant psychotropic medication treatment is frequent for youth in foster care and lacks substantive evidence as to its effectiveness and safety.

Full Study at the Link

SSRI Pushers under Fire

We now have another excellent story by Evelyn Pringle, as seen in the Scoop Independent News, and elsewhere.

SSRI Pushers under Fire

By Evelyn Pringle

Throughout the 1990's, most doctors who attended conferences, medical seminars and other events were not aware that the so-called "key opinion leaders" encouraging them to prescribe the new generation of antidepressants for everything under the sun, including to children as young as infants, were nothing more than highly paid drug pushers for Big Pharma.

For years, the research that showed SSRI antidepressants (selective serotonin reuptake inhibitors) were dangerous and practically useless was kept hidden, while the studies published and presented to potential prescribers painted a glowing picture of success. These days, a person would be hard pressed to find someone who does not have a family member or friend labeled mentally ill and taking drugs like Prozac, Paxil, Zoloft, Lexapro and Celexa, or their chemical cousins Effexor, Cymbalta and Wellbutrin.

About once a year, a new round of headlines about all the money made by the SSRI pushers comes and goes; but nothing really ever seemed to stick, until now.

The Senate Finance Committee, with the ranking Republican, Senator Charles Grassley, leading the charge, is investigating GlaxoSmithKline regarding new revelations in a report filed in litigation showing that the company manipulated the numbers on adverse events related to suicidality in clinical trials back in 1989, to make it appear that Paxil did not increase the risk of patients experiencing suicidal behavior when, in fact, trial subjects on Paxil were eight times more likely to attempt or commit suicide than patients taking placebos.

Quite a few of the top pushers are also under investigation by the Committee due to revelations that millions of dollars has changed hands between the SSRI makers and the academics who signed off on some of the most fraudulently reported research in the history of modern medicine. A full list of names is easy to compile by scanning the literature on SSRI studies conducted on children. The same names appear repeatedly.

In alphabetical order, the Fortune 500 team of pushers, at a minimum, includes Drs Joseph Biederman, David Brent, Jeffrey Bridge, Daniel Casey, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer, and Karen Wagner.


Truth Buried in Litigation Graveyard

On February 6, 2007, the world famous historian on psycho-pharmacology, Dr David Healy, published a commentary entitled, "Why you should never trust new wonder drugs," in the UK's Daily Mail stating:

"Ten years ago, I sat faced with boxes and boxes that contained a dirty secret. Inside were thousands of confidential internal company documents about Prozac."

"The secret they revealed was that public statements about the safety of the drug were a lie; that the company knew Prozac was responsible for a raised risk of suicide and was only slightly more effective than a placebo."

Several years later, Dr Healy recounts, he was faced with the secrets of Paxil. "No one outside the two companies, and few within them," he writes, "knew what those boxes contained; I saw them because I was an expert witness in a court case."

"Documents prised out of companies by American court cases," he says, "have become the main way we have of discovering the truth about some of our best-selling drugs."

"The scientific literature, the very place doctors would look for a warning," he writes, "contained barely a hint of problems.”

"What's more, no one seems likely ever to have to answer for what appears to be fraud," he points out.

"In other organizations when evidence of disregard for public safety emerges, heads roll," Dr Healy said. "But there have been no resignations following these drug disasters - barely a flicker of embarrassment."

The UK's medicines “watchdog,” the British Medicines and Healthcare Products Regulatory Agency, he reports, "has never taken any action against the academics who make fraudulent claims in ghostwritten articles, nor doctors working for the companies who repeat such claims, even when they have been shown to be untrue."

"And no one in Britain," he points out, "has any means of finding out why their husband or child might have died."

Seven years before Dr Healy wrote this commentary, in a Prozac case for which he served as an expert witness, the plaintiff's legal team learned that Eli Lilly had withheld evidence in a jury trial when the May 7, 2007 Boston Globe reported that Lilly had agreed to pay $20 million for the rights to a patent on a new version of Prozac that would reduce "akathisia," the very side effect long believed to increase the risk of suicidal behavior, three months before the trial began.

While testifying under oath, Lilly researcher, Gary Tollefson, had told the jury, "there is absolutely no medically sound evidence of an association between any antidepressant medicine, including Prozac, and the induction of suicidal ideation or violence."

When in fact, the wording in the patent for the new formula stated "fluoxetine (Prozac) produces a state of inner restlessness (akathisia), which is one of its more significant side effects," and the "adverse effects which are decreased by administering the R(-) isomer of fluoxetine include but are not limited to headaches, nervousness, anxiety, insomnia, inner restlessness (akathisia), suicidal thoughts and self mutilation."

Patients who lived to talk about a failed suicide attempt have described the SSRI-induced akathisia, as being so unbearable that their only option for relief seemed to be death.


America’s Most Wanted

Dr Daniel Casey was a major player in the SSRI drug-push and useful in many ways to the companies promoting the drugs. He was the chairman of the very first FDA advisory committee that met in 1991, to decide whether a warning about the increased risk of suicide should be added to the label of Prozac, the first SSRI approved in the US, and voted it down. He was also the chairman of the advisory panel that voted to approve Zoloft for Pfizer later that same year.

Bob Sorenson was a sales representative for Pfizer for 21 years. He moved to Oregon shortly before Zoloft was approved. During the first week at his new location, Pfizer’s chief of marketing at the time told him he needed to start calling on a doctor by the name of Dr Daniel Casey at the V.A. in Portland because he was very important to the company.

Dr Casey worked at the V.A., but never treated patients for depression, Mr Sorenson says. "His expertise [was] psychotropic drugs and experimentation."

The chief of marketing said he was interested in finding out what Dr Casey thought of the company's new drug, Zoloft. The company tried to call on him that day, but Dr Casey was not in. Mr Sorenson called on him later in the week and learned that Dr Casey was the lead investigator on Zoloft, which was up for approval by the FDA advisory committee Dr Casey chaired.

"He said I shouldn't be there, but I did ask how it looks for the drug and he said very well," Mr Sorenson recalls.

Dr Casey ended up making a ton of money from Zoloft. "He told me personally one time that he made enough from Pfizer in one year to purchase two cars," Mr Sorenson reports.

Dr Casey became a member of Pfizer's Advisory Board for Zoloft, which meant "all expense paid trips," including honorariums, to anywhere Pfizer wanted him to advise, at any location in the world, Mr Sorenson explains.

"Many speakers were sought out that would only give lectures that put Zoloft in a positive light," he notes, "there was no room for a balanced lecture."

"Dr Casey later became one of the most sought after speakers for the Pfizer promotion of Zoloft," he says, "the reps loved him because of his positioning of Zoloft."

Mr Sorenson was often told to take information to speakers, "including Dr Casey, to have them add the information to their lectures," he reports. "I look back at it now and see how wrong it was," he states.

"As far as the suicide issue," Mr Sorenson says, "the standard company line was that parents and doctors should be monitoring these kids because after being on Zoloft they finally feel good enough that they can carry out their suicide tendencies."

"Another tactic was to blame Paxil and Effexor," he recalls, "it was those drugs that caused suicidal tendencies, not Zoloft."

"Finally," he notes, "the statement was made that if they didn't take Zoloft, they probably would have committed suicide anyway."

Sales reps would practice and rehearse these statements at sales meetings to be able to respond to concerns or objections raised by Doctors about Zoloft’s relationship to suicidality, he says. "There would be contests as to who could detail the drug the best with objections," he recalls.

Pfizer was able to get rid of employees and still keep them quiet, he says, by offering severance packages of up to a year's salary, while forcing them to sign a confidentiality agreement, in which they promised not to sue, or speak adversely about Pfizer, as part of the deal.

Many people were so surprised at being terminated that they felt forced to sign because Pfizer kept the pressure on, he explains. They feared they wouldn’t find another job before financial problems set in, but regretted signing the agreement later, he says.

Mr Sorenson did not sign an agreement when he was fired. His young son had developed cancer, but Pfizer expected him to continue to attend out-of-town meetings and refused to believe that his son was terminally ill, he recalls. After 20 years with the company, Mr Sorenson was let go when he insisted that he needed to remain near his dying son and distraught wife. The Sorenson's son passed away on April 1, 2005.


Going rate for Legal Drug Pushers

SEC filings for Cypress Bioscience provide a good source for estimating how much money legal drug pushers can make each year, from each company, because the names of several appear in these filings. According to its website, “Cypress Bioscience is committed to developing and commercializing pharmaceutical products and personalized medicine laboratory services that allow physicians to serve unmet medical needs.”

Drs Martin Keller and Charles Nemeroff, two of the most prolific depression-mongers, have served on the company’s board of directors, on its scientific advisory board and as consultants for this company. Under their 2004 Consulting Agreements, Cypress was required to pay them $50,000 per year for services rendered up to and including “two days per fiscal quarter.” In addition, the company could request additional services at a rate of $5,000 per day.

During 2003, Dr Nemeroff was paid $19,000 for additional services under his agreement, and Dr Keller was paid an extra $18,000. But they were only making $2,000 per day that year. As members of the Psychopharmacology Advisory Board, Dr Nemeroff earned $19,000 and Dr Keller $18,000 in 2003.

For their service as directors of the company in 2002, they each received $24,000. They were also offered stock options regularly. Cypress is only company. A bio on Dr Keller in a July 25, 2002 agenda for an annual meeting states that he is also a consultant to, "Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Janssen, Merck, Inc, Organon, Otsuka Pharmacia/Upjohn, Pharmastar, Pfizer, Inc. and Wyeth-Ayerst Laboratories."

It also shows he serves on the scientific advisory boards of, "Bristol-Myers Squibb, Cephalon, Cyberonics, Inc., Eli Lilly, Forest Laboratories, Merck, Inc, Mitsubishi, Organon, Pfizer, Sepracor, Scirex, SmithKline Beecham, Somerse, Vela Pharmaceuticals and Wyeth-Ayerst."

Dr David Dunner and a few more of the usual suspects appear in the Cypress SEC filings as advisory board members as well.

Dr Nemeroff's role in the prostitution of research is legendary. In April 2004, Shannon Brownlee, author of, "Overtreated," wrote an article in the Washington Monthly entitled, "Doctors Without Borders," after he was caught failing to disclose his financial ties to the companies whose treatments he promoted in a paper in Nature Neuroscience, and noted:

"With financial ties to nearly two dozen drug and biotech companies, Dr. Charles B. Nemeroff may hold some sort of record among academic clinicians for the most conflicts of interest.

"A psychiatrist, a prominent researcher, and chairman of the department of psychiatry and behavioral science at Emory University in Atlanta, Nemeroff receives funding for his academic research from Eli Lilly, AstraZeneca, Pfizer, Wyeth-Ayerst--indeed from virtually every pharmaceutical house that manufactures a drug to treat mental illness.

"He also serves as a consultant to drug and biotech companies, owns their stocks, and is a member of several speakers' bureaus, delivering talks--for a fee--to other physicians on behalf of the companies' products."

Dr Nemeroff stood to "reap as much as $1 million in stock" from just one company that manufactured one of the products in his Nature Neuroscience paper, she noted.

"But the drug industry's most powerful means of boosting the bottom line is funding research," Ms Brownlee writes, "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."

She notes how companies are able to routinely delay or prevent the publication of data and specifically how the majority of studies which found antidepressants to be no better than placebos, "never saw print in medical journals."

In conclusion, she states, "I'm struck more than anything by the apparent lack of shame among clinicians when it comes to this issue."

Two years later, on July 19, 2006, the Wall Street Journal reported that the journal, Neuropsychopharmacology, published by the American College of Neuropsychopharmacology (ACNP), planned to publish a correction of a favorable review of a new depression treatment device because it failed to list the ties of the eight academic authors to the device maker, Cyberonics, including lead author Dr Nemeroff, the editor of Neuropsychopharmacology at that time. The FDA had approved the VNS device in July 2005 over the objections of "more than 20" FDA scientists, Bloomberg reported a day earlier on July 18, 2006.

"This is about as classic an example as you'll ever find of conflict of interest and manipulation by thought leaders who are beholden to corporations," Dr Bernard Carroll, a member of the ACNP, told Bloomberg. "This article is a piece of a slick, skillfully coordinated PR campaign directed by the corporation," he said.

Ten days before the Wall Street Journal article, Cyberonics had sponsored a little noticed symposium on treatment-resistant depression at the annual Collegium Internationale Neuro-Psychopharmacologicum Meeting. The main presenters at the July 9, 2006 event were Drs Nemeroff, Dunner, and Keller (the lead author of the infamous Paxil “Study 329” on adolescents).

"In recent years, new treatment modalities have emerged, among them, the only FDA-approved treatment option specifically designed for this patient population, VNS Therapy," Dr Dunner stated in a press release for the event.

Dr Dunner was one of the authors vouching for the new device in the Neuropsychopharmacology paper. However, a “stamp of approval” from this guy should be taken with a grain of salt. Back in March 1995, he also vouched for Paxil as lead author of a study titled, "Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo," in the journal of European Neuropsychopharmacology. However, he later admitted that he never reviewed any of the actual data from that study.

Dr Nemeroff apparently learned nothing from the public embarrassment of the previous scandals. Last week, he was forced to step down as Chair of Emory’s psychiatry department. According to a December 23, 2008 posting by Ed Silverman, on the popular blog, Pharmalot:

"Under pressure from a US Senate Finance Committee investigation, renowned psychiatrist Charles Nemeroff is giving up the post he held for 17 years and must follow new restrictions on his outside activities, according to an Emory University statement.”

“Emory’s own investigation found Nemeroff received more than $800,000 from Glaxo, which paid Nemeroff more than any other drugmaker, but he never reported the fees. There were more than 250 speaking engagements between 2000 and 2006.”

"Moreover, Emory will not submit any National Institutes of Health grant or other sponsored grant or contract requests in which Nemeroff is listed as an investigator or has any other role for a period of at least two years,” Pharmalot reports.

All total, Dr Nemeroff earned more than $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million to Emory, according to the Senator.

Dr Keller’s disclosure records are under investigation as well He also appears center stage in a new book by former Boston Globe reporter, Alison Bass, called, "Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial," The book contains a treasure trove of insider revelations with specifics on Dr Keller's endless conflicts of interest, along with other academics on the take. However, Ms Bass first broke the Keller story back on October 4, 1999, in the Globe, when she reported that he was forced to forfeit "hundreds of thousands of dollars" in state grant money in 1998.

She explained how in the same year that Dr Keller authored a review article in "Biological Psychiatry," and concluded that the newer antidepressants Zoloft, Bristol-Meyer’s Serzone, and Wyeth’s Effexor were more effective, he received $77,400 in personal income and $1.2 million in research funding from Bristol-Myers, as well as $8,785 in personal income from Wyeth.

In "Side Effects," she notes that Dr Keller did not report any income to the IRS from Glaxo for 1998, but says he did receive money from the Paxil maker, and also earned $62,500 from Celexa maker Forest Labs that year.

Dr Keller published 3 studies, "with colleagues," in the Journal of the American Medical Association and the Journal of Clinical Psychiatry, touting the efficacy of Zoloft in 1998, and received $218,000 in personal income and more than $3 million in research funding from Pfizer the same year, Ms Bass reports.

The "colleagues," referred to include the all-time champion of child drugging, Dr Joseph Biederman, the main promoter of the bogus epidemic of childhood bipolar disorder. He too is under investigation for taking $1.6 million from drug companies between 2000 and 2007, and only disclosing a fraction of that amount to Harvard. On December 30, 2008, Harvard’s teaching hospital, Massachusetts General announced that Dr Biederman was no longer participating in several industry-funded trials and had agreed to “not to participate in any outside activities that are paid for or sponsored by industry, such as consulting activities or speaking engagements.”

In most of the SSRI trials conducted on children, "colleagues," will also include Dr Graham Emslie of Prozac fame, and the Zoloft Czar, Dr Karen Wagner, both from the University of Texas.

Back in April 2004, the British Medical Journal published a paper by a research team led by Dr Jon Jureidini, head of the department of psychological medicine at Women's and Children's Hospital in Australia, after a review of the clinical trial data on the safety and efficacy of antidepressant use with children. The review included the published trials, along with some unpublished data made public by the Committee on Safety of Medicines in the UK.

The Australian team was extremely critical of the published papers on the major trials of Prozac, Paxil and Zoloft, with Emslie, Wagner and Keller listed as lead authors. "In discussing their own data," the team wrote, "the authors of all of the four larger studies have exaggerated the benefits, downplayed the harms, or both."

"It is vital," they wrote, "that authors, reviewers, and editors ensure that published interpretations of data are more reasonable and balanced than is the case in the industry-dominated literature on childhood antidepressants."

Seven months later, the New York Times ran a report by Barry Meier on November 29, 2004, throwing another spotlight on the trail of corruption within the SSRI research factories, and zeroed in on Dr Wagner. He noted that, from 1998 to 2001, she was one of several researchers participating in more than a dozen industry-funded pediatric trials of antidepressants and other drugs, and that some of the results were published, but many were not.

In her Zoloft study, Dr Wagner acknowledged that she had received "research support" from several drug makers including Pfizer, which paid $80,000 to the center in connection with the test, Mr Meier reports. But she did not state that she received “sizable payments” from Pfizer for work related to the study, he says.

The same month that patients were first recruited for the Zoloft trial, in a financial filing with the school in December 1992, Dr Wagner reported that she received more than $10,000 from Pfizer, with no further details. A lawyer for the school told Meier that Dr Wagner said Pfizer had paid her $20,500 during the course of the Zoloft trial. But records for payments she received in speaking and consulting fees could not be located.

In September, Dr Wagner’s name was added to the Senator Grassley’s investigative roster, along with Dr John Rush. Between 2000 and 2005, Glaxo alone paid Dr Wagner $160,404, but only $600 was disclosed to the University, according to the Senator. She was also paid over $11,000 in 2002, by Eli Lilly, and that money was not disclosed either. Lilly paid Dr Rush $17,802 in 2001, but he only reported $3,000, Senator Grassley said.

Dr Emslie’s financial trail to the drug makers gained media attention last summer due to his prominent role in the “Texas Children's Medication Algorithm Project,” and the creation of a drug formularies for children. He was chairman of the panel that wrote guidelines instructing doctors to prescribe SSRIs off-label to kids for depression in 1998. On August 18, 2008, the Dallas Morning News ran the headline: “Conflict of interest fears halt children's mental health project.”

“A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list,” the News reported. University disclosure forms indicate that Dr Emslie “has made at least $130,000 in drug company speakers fees and consulting contracts since 2002,” the paper noted.

In discussing the investigation of Dr Wagner on the Senate floor, Dr Grassley pointed out that she was a co-author on Paxil Study 329. In 2001, when the study was published, Glaxo “reported paying her $18,255,” he said. “Study 329 was cited in a New York case where GlaxoSmithKline was charged with ‘repeated and persistent fraud,’” the Senator added.

Dr Emslie was also a co-author on the Paxil study and a check of the full list for 329, reveals that 5 of the co-authors appear with Dr Emslie on the guidelines for the “Children's Medication Algorithm Project,” including Karen Wagner, Boris Birmaher, Barbara Geller, Neil Ryan and Michael Strober. Dr Rush’s name is also on the Texas guidelines but he moved to Singapore last August.

********

Evelyn Pringle

epringle05@yahoo.com

(Written as part of the SSRI Litigation Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department at http://www.baumhedlundlaw.com)

(Evelyn Pringle is a columnist for Scoop Independent News and an investigative journalist focused on exposing corruption in government and corporate America)