Posts Tagged ‘Zyprexa’

Meet the Queen of “Preschool Depression” — and Her Drug Company Backers

Monday, August 30th, 2010

by Jim Edwards

BNET August 30, 2010

The NYT Sunday magazine crowned Dr. Joan Luby as the queen of preschool depression this weekend, but failed to mention that Luby has taken cash from Johnson & Johnson (JNJ), Shire (SHPGY) and AstraZeneca (AZN) to study using atypical antipsychotics in young children. The article is significant because of the outsize role that the Times magazine plays in creating and naming new social trends. (Remember when you suddenly figured out that carbs make you fat but fatty meat doesn’t? That was the NYT mag.)

In this case, the phenomenon is depression in children as young as three years old, and the trend is to treat it with drugs such as Risperdal, Zyprexa, Adderall and Seroquel. The article, by Pamela Paul, provides a useful roadmap into how parenting will be medicalized by Big Pharma:

“The idea is very threatening,” says Joan Luby, a professor of child psychiatry  at Washington University School of Medicine, … “In my 20 years of research, it’s been slowly eroding,” Luby says of that resistance. “But some hard-core scientists still brush the idea off as mushy or psychobabble, and laypeople think the idea is ridiculous.”

The “ridiculous” layperson who first pointed out that Luby had written medical journal articles urging the use of antipsychotics on preschool children without declaring her drug company payments was me. Luby was a paid speaker for AstraZeneca in 2003-2004 (AZ makes Seroquel); she received $2019 in a for a consultancy from Shire in 2004 (Shire makes Adderall and Vyvanse); and prior to 2006 she received grant/research support from Janssen, the unit of J&J that markets Risperdal. Luby is also a member of a group of scientists who want greater study of potential new uses for psychiatric drugs in young children. That group has ties to 16 different drug companies. Some of these drugs have dangerous side effects.

The Archives of General Psychiatry (published by the American Medical Association) said it would investigate how Luby failed to disclose her past ties when it published “Preschool Depression,” a study she did on 3- to 6-year-olds. Joseph Coyle, the editor of the AGP, did not immediately respond to an email requesting an update on its Luby probe. (The American Psychiatric Association, which publishes the American Journal of Psychiatry, has chosen to ignore the issue.)

Read the rest of this article here:  http://www.bnet.com/blog/drug-business/meet-the-queen-of-8220preschool-depression-8221-8212-and-her-drug-company-backers/5595

To read about other pharma funded psychiatrists promoting a psycho/pharma agenda  read Shrinks For Sale – The Corrupt Alliance of the Psychiatric-Pharmaceutical Industry by CCHR   http://www.cchrint.org/cchr-issues/the-corrupt-alliance-of-the-psychiatric-pharmaceutical-industry/

Also read DSM Panel Members Still Getting Pharma Funds by CCHR http://www.cchrint.org/2010/05/21/dsm-panel-members-still-getting-pharma-funds/

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Americas Mental Illness Epidemic

Thursday, August 26th, 2010

Rense.com
By Gary G. Kohls, MD
August 25, 2010

Tens of millions of innocent, unsuspecting Americans, who are mired deeply in the mental “health” system, have actually been made crazy by the use of or the withdrawal from commonly-prescribed, brain-altering, brain-disabling, indeed brain-damaging psychiatric drugs that have been, for many decades, cavalierly handed out like candy ­ often in untested and therefore unapproved combinations of drugs – to trusting and unaware patients by equally unaware but well-intentioned physicians who have been under the mesmerizing influence of slick and obscenely profitable psychopharmaceutical drug companies aka, BigPharma.

That is the conclusion of two books by investigative journalist and health science writer Robert Whitaker. His first book, entitled Mad in America: Bad Science, Bad Medicine and the Enduring Mistreatment of the Mentally Ill noted that there has been a 600% increase (since Thorazine was introduced in the US in the mid-1950s) in the total and permanent disabilities of millions of psychiatric drug-takers. This uniquely First World mental ill health epidemic has resulted in the life-long taxpayer-supported disabilities of rapidly increasing numbers of psychiatric patients who are now unable to be happy, productive, taxpaying members of society. Whitaker has done a powerful, albeit unwelcome job of presenting previously hidden, but very convincing evidence to support his thesis, that it is the drugs and not the diagnosis that is causing the epidemic of mental illness disability. Many open-minded physicians and many aware psychiatric patients are now motivated to be wary of any and all synthetic chemicals that can cross the blood/brain barrier because all of them are capable of altering the brain in ways totally unknown to medical science, especially when the patients are taking the drugs long-term..

In Whitaker’s second book Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America, he goes much further in advancing this sobering reality. He documents the history of the powerful forces behind the relatively new field of psychopharmacology and its major shaper and beneficiary, BigPharma. Psychiatric drugs, whose developers, marketers and salespersons are all in the employ of the giant drug companies, are far more dangerous than the drug and psychiatric industries are willing to admit: These drugs, it turns our, are fully capable of disabling ­ often permanently – body, brain and spirit.

More evidence to support Whitaker’s well-documented claims are laid out in two important new books written by psychiatrist and scholar Grace Jackson. Jackson did a beautiful job of researching and documenting, from the voluminous basic neuroscience research (which is uniformly ignored by the clinical sciences) the unintended and often disastrous consequences of the chronic ingestion of any of the five major classes of psychiatric drugs. Her second and most powerful book: Drug-Induced Dementia: A Perfect Crime, proves beyond a shadow of a doubt, that any of the five classes of drugs that are commonly used in psychiatric patients (antidepressants, antipsychotics, psychostimulants, tranquilizers and anti-seizure/”mood-stabilizer” drugs) have shown microscopic, macroscopic, biochemical, clinical and/or radiological evidence of brain shrinkage and other signs of brain damage, which can result in clinically-diagnosable, permanent dementia, premature death and a variety of other related brain disorders that can mimic mental illnesses. Jackson’s first book, Rethinking Psychiatric Drugs: A Guide for Informed Consent was an equally sobering book warning about the many hidden dangers of psychiatric drugs.

This sad truth is that the seemingly knee-jerk prescribing (without very much information being given to patients about the long list of serious long-term adverse effects) of potent and often addicting/dependency-inducing psychiatric drugs has become the standard of care in American psychiatry since the introduction of the so-called anti-schizophrenic “miracle” drug Thorazine in the mid-1950s. (Thorazine was the offending drug that all of Jack Nicholson’s fellow patients were coerced into taking at “medication time” in the Academy Award-winning movie “One Flew Over the Cuckoo’s Nest”.) Thorazine and all the other “me-too” early antipsychotic drugs are now universally known to have been an iatrogenic (= doctor or other treatment-caused) disaster because of their serious long-term, initially unsuspected, brain-damaging effects that resulted in a number of incurable neurological disorders such as tardive dyskinesia and Parkinson’s disease.

Thorazine and all the other knock-off drugs like Prolixin, Mellaril, Navane. etc, are synthetic “tricyclic” chemical compounds similar in molecular structure to the tricyclic “antidepressants” like imipramine and the similarly toxic, obesity-inducing, diabetogenic, “atypical” anti-schizophrenic drugs like Clozaril, Zyprexa and Seroquel.

Thorazine, incidentally, was originally developed in Europe as an industrial dye. That doesn’t sound so good although it may not be so unusual in the closely related fields of psychopharmcology and the chemical industry, especially when one considers that Depakote, a popular drug marketed initially as an anti-epilepsy drug but now is being heavily used as a so-called “mood stabilizer”. Depakote, known to be a hepatotoxin and renal toxin, was originally developed as an industrial solvent capable of dissolving fat – including, presumably, the fatty tissue in human livers and brains.

Some sympathy and understanding needs to be generated for the various victims of BigPharma’s compulsive drive to expand market share and “shareholder value” (share price, dividends and the next quarter’s financial report) by whatever means necessary. Both the prescribers and the swallowers of BigPharma’s drugs have succumbed to BigPharma’s cunning marketing campaigns, the prescribers having been seduced by attractive drug company representatives and their “pens, pizzas and post-it note” freebies in the office, and the patients being brain-washed by the inane and unbelievable (if one has intact critical thinking skills) commercials on TV that quickly gloss over the lethal adverse effects in the fine print while urging the watcher to “ask your doctor” about the latest unaffordable wannabe blockbuster drug..

For a quick overview of these issues, I recommend that everybody with an open mind read a long essay written by Whitaker that persuasively identifies the source of America’s epidemic of mental illness disability (a phenomenon that doesn’t exist in Third World nations because costly psych drugs are not prescribed so cavalierly as in the US).

Whitaker and Jackson (among a number of other ground-breaking and whistle-blowing authors who have been essentially black-listed by the mainstream media and mainstream medical journals) have proven to most critically-thinking scientists, alternative practitioners and assorted “psychiatric survivors” that it is the drugs – and not the so-called “disorders” – that are causing our nation’s epidemic of mental illness disability. The Whitaker essay, plus other pertinent information about his books can be accessed at www.madinamerica.com A recent interview on Wisconsin Public Radio can be accessed at www.wpr.org (at their radio archives link) and a long interview with Dr.Joseph Mercola can be heard at: http://articles.mercola.com/sites/articles/archive/2010/05/08/robert-whitaker-interview.aspx

After reading and studying all these inconvenient truths, mental health practitioners must consider the medicolegal implications for them, especially if the information is ignored or if the information is dismissed out of hand by practitioners who might be tempted to not take the time to study this new information. Those people who are hearing about this for the first time need to pass the word on to others, especially their prescribing healthcare practitioners who should be equally concerned. This is important because the opinion leaders in the highly influential (for good or ill) psychiatric and medical industries have been marketed into submission without hearing the all the facts (which may have been intentionally hidden from them. If that is the case, they cannot be automatically blamed for proceeding in a practice that some day might represent malpractice. It shouldn’t have to be pointed out that is the solemn duty of ethical practitioners who are in positions of authority to fully examine potential malpractice issues and then warn others, especially their patients, of the dangers.

Sadly, it must be admitted that most of the over-worked, double-booked care-givers in medical clinics have not yet heard the news that most if not all of the brain-altering synthetic chemicals known as psychotropic drugs (which are treated as hazardous waste unless they are packaged in a swallowable capsule!) have been marketed as safe and effective – but only for short-term use. The captains of the drug industry know that the psychotropic drugs that they present for the FDA-approval have only been tested in animal trials for days and in clinical trials for 6 weeks. They also know ­ indeed they hope – that patients will be taking their drugs for years (despite no long-term trials proving safety and efficacy) as the only “treatment” for mental ill health. They know that their brain-altering drugs are also dependency-inducing (aka addicting, causing withdrawal symptoms when stopped), neurotoxic and increasingly ineffective (a la “Prozac Poop-out”) as time goes by.

The truth is that the people diagnosed as “mentally ill” for life are often simply those unfortunates who find themselves in acute or chronic states of crisis or “overwhelm” due to any number of preventable, curable and treatable (without the use of drugs) bad luck accidents such as poverty, abuse, violence, torture, homelessness, discrimination, underemployment, brain malnutrition, addictions/withdrawal, brain damage from electroshock “therapy” and/or exposure to neurotoxic chemicals in their food, air, water or prescription bottles.

Those labeled as the “mentally ill” are just like us “normals” who have not yet decompensated because of some yet-to-happen, crisis-inducing, overwhelming (however temporary) life situation. And thus we have not yet been given a billable code number (accompanied by the seemingly obligatory – and unaffordable – drug prescription or two signifying we are now chronically mentally ill. Unlabeled, we are likely to remain off prescription drugs but with a label and in “the system”, it is hard to “just say no to drugs.”

The victims of hopelessness-generating situations like simple bad luck, bad circumstances, bad company, bad choices, bad government, big business, and a competitive society that generates a few winners but mostly losers. America tolerates, indeed celebrates, punitive and thus fear-inducing social systems resembling in many ways the infamous police state realities of 20th century European totalitarianism, where people who were different or just dissidents were thought to be abnormal and therefore “disappeared” into insane asylums, jails or concentration camps without just cause or competent legal defense. And many of them were and are drugged with disabling psychoactive chemicals against their will.

The truth is that most, if not all, of BigPharma’s psychotropic drugs are lethal at some dosage level (the LD50, the lethal dose that kills 50% of lab animals, is calculated before efficacy testing is done), and therefore the drugs must be regarded as dangerous. The chronic use of these drugs is a major cause of cognitive disorders, brain damage, loss of creativity, loss of spirituality, loss of empathy, loss of energy, loss of strength, fatigue and tiredness, permanent disability and a multitude of metabolic adverse effects that can readily sicken the body, brain and soul by causing insomnia or somnolence, increased depression or anxiety, delusions, psychoses, paranoia, mania, etc. So before filling the prescription, it is advisable to read the product insert labeling under WARNINGS, PRECAUTIONS, ADVERSE EFFECTS, CONTRAINDICATIONS, TOXICOLOGY, OVERDOSAGE and the ever-present BLACK BOX WARNINGS ABOUT SUICIDALITY.

Long-term, high dosage or combination psychotropic drug usage could be regarded as a chemically traumatic brain injury (TBI) or, as drugs like Thorazine were known in the 1950s and 60s, a “chemical lobotomy”. That is a useful way to conceptualize this serious issue, because such chemically brain-altered patients are often indistinguishable from those who have suffered a physically traumatic brain injuries or been subjected to ice-pick lobotomies which were popular in the 1940s and 50s – before the drugs came on the market.

America has a mental ill health epidemic on its hands that is grossly misunderstood because it is worsening, not by the supposed disease progression, but because of the neurotoxic, non-curative drugs that are somehow regarded as first-line “treatment.”
Read the rest of this article here: http://www.rense.com/general91/edi.htm

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Prescription Pill-Popping By Far a Leading Killer as Florida’s Drug Deaths Spike 20%

Thursday, July 1st, 2010

FlaglerLive.Com
July 1, 2010

Oxycodone, the addictive prescription pain-killer also known by its Purdue Pharma brand name OxyContin, directly caused more deaths in Florida in 2009 than cocaine, heroin and morphine combined. Prescription drugs as a whole are killing far more Floridians than illegal drugs, with some 8,600 deaths last year involving at least one prescription drug, according to an annual report released today by the Florida Medical Examiners Commission.

That’s 5 percent of all deaths in Florida in 2009, when 171,300 people died in the state.

The number of people killed by prescription drugs is a significant 20 percent increase over last year’s 6,200 deaths attributed to overdoses. Much of the increase is due to a spike in oxycodone addiction. The increase in prescription-drug addiction continues a trend that began in Florida 10 years ago, when prescription drugs overtook illegal drugs as leading causes of drug-related deaths.

Alcohol is also included in the examiners’ analysis, and it leads the way of all drug-related deaths, with 4,046.

The annual report is a stark look at the effects of legalized drug addiction and over-prescription of drugs, both of which affect a far larger segment of the population than recreational or illegal narcotics.

For the first time in 2009, the commission tracked deaths by region. In Flagler County’s district, which includes St. Johns and Putnam counties, 22 deaths were attributed to oxycodone (the fourth lowest number in the state’s 23 districts), with 13 of those deaths directly attributed to the drug, and nine cited as being present among other drugs that contributed to death.

Hydrocodone claimed 16 lives in the district. Cocaine contributed to 19 deaths in the Flagler district, though only four cases were directly attributed to the drug. In 15 cases, cocaine was present in the body in conjunction with other drugs that proved lethal. Overall in Florida, cocaine-related deaths (including the majority of cases where cocaine wasn’t directly the factor but was present in the body at the time of death), have fallen from a peak of 2,179 in 2007 to 1,462 in 2009. (Again, cocaine was the direct result of death in 529 cases out of those).

Ken Kramer, a researcher with the Citizens Commission on Human Rights of Florida, says the numbers underestimate the extent of the problem, because medical examiners do not track deaths attributed to antipsychotic drugs or to antidepressants, both of which carry black-box or black-label warnings. The warnings on antidepressants, required by the Food and Drug Administration, state that the drugs increase the risk of suicidal thinking and behavior in children, adolescents and young adults up to age 24. (Antidepressants include Paxil, Prozac, Zoloft, Effexor, Lexapro and Celexa.)

Anti-psychotic drugs carry a variety of black label warnings of increased mortality in elderly patients (including a death rate almost twice as high for people taking Risperdal, for example). Those drugs, prescribed and often overprescribed in nursing homes and assisted living facilities, include Abilify, Clozaril, Geodon, Risperdal, Seroquel and Zyprexa.

“Certainly, the actual number of prescription drug deaths is higher than the annual report states,” Kramer said. “It is unknown just how much higher because the Medical Examiners Commission does not track these classes of drugs.”

Two years ago Kramer got his concern heard by the commission following an email exchange with a commissioner in which he argued that antidepressants and anti-psychotic drugs’ contributions to mortality should be part of the annual report. He was rebuffed. One examiner vsaid he had not seen “more than the occasional death caused by these types of drugs,” according to the minutes of the Aug. 13, 2008 meeting of the commission.

Read entire article:  http://flaglerlive.com/7256/florida-prescription-drugs-deaths-oxycontin-oxycodone

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Senator Grassley Investigates Big Pharma’s Treatment of Drug Company Whistleblowers Who File Complaints

Thursday, July 1st, 2010

Bloomberg
By David Voreacos
July 1, 2010

U.S. Senator Charles Grassley asked 16 drugmakers, including Pfizer Inc., AstraZeneca Plc and Eli Lilly & Co., to reveal how they treat whistleblowers who file complaints under the False Claims Act.

Grassley, an Iowa Republican, sent letters June 28 that posed eight questions such as how companies notify employees of the law, how they treat whistleblowers and what changes they have made in response to a 2009 law extending anti-retaliation protections. Grassley’s office provided copies of the letters.

The False Claims Act lets private citizens sue on behalf of the government and share in any recovery. Whistleblowers were paid $2.39 billion from 1987 to 2009, or 16 percent of the $15.19 billion collected in False Claims lawsuits in which the U.S. government joined the case, according to the Justice Department.

“What measures does Pfizer have in place to ensure fair treatment to those filing complaints?” Grassley wrote to Chief Executive Officer Jeffrey Kindler. “Of employees who have filed complaints, have any complained of unfair treatment and/or retaliation after the filing of the complaint?”

The False Claims Act was passed by Congress in 1863 and strengthened three times since 1986. Citizens file so-called qui tam cases that remain sealed from public view as the Justice Department investigates the claims and decides whether to join the suit. Twenty-five U.S. states have their own versions of the law.

Large Settlements

Drugmakers have reached some of the largest settlements in recent years. Pfizer agreed to pay $2.3 billion over improper drug marketing, Lilly paid more than $1.6 billion to settle claims over its marketing of the drug Zyprexa, and AstraZeneca paid $520 million over marketing of its drug Seroquel.

Read entire article:  http://www.bloomberg.com/news/2010-06-30/grassley-seeks-data-from-pfizer-lilly-on-how-whistleblowers-are-treated.html

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Behind the Psychopharmaceutical Industrial Complex; Pharma-funded front groups masquerading as “patient advocates”

Tuesday, June 22nd, 2010

Scoop Independent News
By Evelyn Pringle
June 22, 2010

Non-Profit Advocacy Groups

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

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

Gigantic Pyramid

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

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

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

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

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

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

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

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

Read entire article:  http://www.scoop.co.nz/stories/HL1006/S00162.htm

Also see:  http://www.cchrint.org/psycho-pharmaceutical-front-groups/

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Earth Times: Neurologist Fred Baughman—Vets Sudden Deaths Due to Antidepressant & Antipsychotic Drugs

Monday, May 24th, 2010

EarthTimes.org
By Fred A. Baughman, Jr.
May 24, 2010

Fred A. Baughman Jr., MD today announced the results of his research into the “series” of veterans’ deaths acknowledged by the Surgeon General of the Army.

Upon reading the May 24, 2008, Charleston (WV) Gazette article “Vets Taking Post Traumatic Stress Disorder Drugs Die in Sleep,” Baughman began to investigate why these reported deaths were “different.”  And, why they were likely, the “tip of an iceberg.”

Andrew White, Eric Layne, Nicholas Endicott and Derek Johnson were four West Virginia veterans who died in their sleep in early 2008. Baughman’s research suggests that they did not commit suicide and did not “overdose” leading to coma as suggested by the military.  All were diagnosed with PTSD.  All seemed “normal” when they went to bed.  And, all were on Seroquel (an antipsychotic) Paxil (an antidepressant) and Klonopin (a benzodiazepine).

They were not comatose and unarousable ? with pulse and respirations or pulse intact, responsive to CPR, surviving transport to a hospital, frequently surviving.  These were sudden cardiac deaths.

At the time, Stan White, father of Andrew White knew of eight such cases in Kentucky, Ohio and West Virginia.

In a February 7, 2008 interview with the Chicago Tribune, Lt. Gen. Eric B. Schoomaker, the Army’s surgeon general, said there has been “a series, a sequence of deaths” in the new “warrior transition units.”

In April 2005, the FDA warned that Seroquel put elderly patients with dementia-related psychosis at increased risk of death.

On January 15, 2009, Ray et al, reported that antipsychotics double the risk of sudden cardiac death.  On March 17, 2009, Whang et al reported that antidepressants, as well, increase the rate of sudden cardiac deaths.

And yet, in an August 14, 2008 analysis of two of the four Charleston-area deaths, the Inspector General for Veterans Affairs concluded (Report No. 08-01377-185): “Although antipsychotic medications have been identified as possible causes of cardiac rhythm disturbances, a 2001 review…found no association with olanzapine (Zyprexa), quetiapine (Seroquel), or risperidone (Risperdal) and Torsades de Pointes (a fatal heart rhythm) or sudden death… we are unaware of any clinical practice guidelines recommending baseline or periodic electrocardiogram monitoring in young, healthy patients on quetiapine (Seroquel).”

However, in a literature review covering the years 2000-2007, entitled Sudden Cardiac Death Secondary to Antidepressant and Antipsychotic Drugs: [Expert Opinion on Drug Safety; 2008, Number 2, March 2008 , pp. 181-194(14)] Sicouri and Antzelevitch conclude: (1) “A number of antipsychotic and antidepressant drugs can increase the risk of ventricular arrhythmias and sudden cardiac death?” (2) “Antipsychotics can increase cardiac risk even at low doses whereas antidepressants do it generally at high doses or in the setting of drug combinations,” and (3) “These observations call for?an ECG at baseline and after drug administration.”

Read entire article:  http://www.earthtimes.org/articles/show/fred-a-baughman-jr-md,1312839.shtml

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Killing You with Drugs: Legally—Pharma’s attempts to bury increasing # of studies linking psychiatric drugs to suicide

Thursday, April 15th, 2010

The Market Oracle
By Michael Stathis
April 15, 2010

Is there any reason why Pfizer shares are down today?

Just yesterday, shares were trading at ~ $17.30. Today, with the DJIA up by 0.7%, Pfizer is down by nearly 1%.

A clue to this sell-off MIGHT be due to the anticipation by investors of increasing pressure to change the way drugs are prescribed. This could also trigger several lawsuits down the road.

Recently, another study was published in the Journal of the American Medical Association discussing elevated suicide risks associated with the use of anticonvulsant drugs. Anticonvulsants have been approved by the FDA for people diagnosed with epilepsy.

Of course, this is not the first study showing anticonvulsants raised the risk of suicide.

In 2008, the FDA required all anticonvulsant drugs to have a warning label that disclosed a two-fold increased risk of suicide. However, warning labels are rarely effective. They simply enable drug companies to continue to sell what many experts feel to be dangerous drugs, while having the safeguard of a disclaimer.

When patients receive a prescription for a drug to address a medical condition, they assume it’s a safe drug; otherwise, it wouldn’t be approved for use. And their doctor certainly wouldn’t prescribe it if it weren’t safe, would he?

According to DEA and FDA regulations, physicians are free to prescribe any drug for any condition they see fit, known as off-label use. As a result of off-label usage, anticonvulsants are prescribed for many different medical conditions like bipolar disorder, pain and migraine headaches. As you might imagine, in some cases, off-label use has accounted for a big chunk of drug sales.

The class of drugs prescribed most by physicians for off-label uses are the antipsychotics (Prozac, Xanax, Zyprexa, etc). The FDA has approved these drugs to treat a variety of neurologic conditions such as depression and bipolar disease. However, drug companies have used many methods to get physicians to prescribe them for a wide range of off-label uses.

Read entire article:  http://www.marketoracle.co.uk/Article18652.html

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Australia’s “growing problem” is child drugging—Antipsychotics given to toddlers linked to 45 child deaths in the U.S.

Tuesday, March 23rd, 2010

The Herald Sun
March 24, 2010

CHILDREN as young as one are being prescribed powerful anti-psychotic drugs that have been linked to deaths overseas.

The strong medication is designed to quell psychotic episodes normally experienced by adults with schizophrenia and bi-polar.

There are concerns some doctors are illegitimately writing scripts for pre-schoolers and primary school children for unapproved medical reasons, such as behavioural problems or ADHD.

Figures provided by the Therapeutic Goods Administration showed up to 3351 NSW children aged under 18 were prescribed the drugs in 2007-08.

Of them, at least 62 toddlers aged five and under — including five one-year-olds — were prescribed the drugs in NSW in that period.

“You can assume children under 12 are illegitimately being prescribed these drugs for behaviour problems. It should not be the case,” University of South Australia’s associate professor in psychiatry Dr Jon Jureidini said yesterday.

“These drugs are not marketed or recommended by the TGA for that use.”

Common medications such as Risperdal, Zyprexa and Abilify are not approved for children under five. The TGA has approved Risperdal to treat children with autism.

Side effects can be so severe in adults that elderly patients with dementia are warned they have a higher risk of sudden death.

Read entire article:  http://www.heraldsun.com.au/news/national/kids-prescribed-toxic-drug-cocktail-of-anti-depressants/story-e6frf7l6-1225844541982

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Australia: Documents reveal 10,000 kids prescribed powerful, dangerous anti-psychotic drugs including toddlers

Tuesday, March 23rd, 2010

The Herald Sun
March 24, 2010

CHILDREN as young as two are being prescribed anti-psychotic drugs that have been linked to deaths overseas.

Almost 2000 children aged under 18 were prescribed the drugs in Victoria in 2007-08.

Figures provided by the Therapeutic Goods Administration reveal at least four two-year-olds were among 422 under-10s given drugs designed to quell psychotic episodes normally found in adults with schizophrenia and bi-polar disorder.

But there are concerns some doctors are writing scripts for preschoolers and primary school children for unapproved medical reasons, such as behavioural problems.

“You can assume children under 12 are illegitimately being prescribed these drugs for behaviour problems. It should not be the case,” said University of South Australia’s Assoc Prof in psychiatry Dr Jon Jureidini.

“The vast majority of preschoolers who are prescribed are not for psychotic episodes but for behaviour problems,” he said.

“These drugs are not marketed, or recommended by the TGA, for that use.”

Common medications such as Risperdal, Zyprexa and Abilify are not approved for use in children under five due to the lack of evidence on their safety.

But the TGA has approved Risperdal to treat children with autism.

In 2007-08, almost 10,000 under-18s were prescribed anti-psychotic medication in Australia.

Side-effects can be so severe in adults that elderly patients with dementia are warned they have a higher risk of sudden death.

Read entire article:  http://www.heraldsun.com.au/news/victoria/toddlers-given-anti-psychotic-drugs/story-e6frf7kx-1225844491890

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After $1.4 billion criminal fine for illegal marketing, Eli Lilly tries something new—promoting “ethical behavior”

Monday, March 8th, 2010

IndyStar.com
John Russell
March 8, 2010

Eli Lilly and Co. has agreed to add four new senior positions to “promote highly ethical and compliant behaviors” as part of a settlement of two lawsuits arising from the company’s illegal marketing and promotion of several drugs.

The Indianapolis drugmaker also has agreed to upgrade its policies and procedures to ensure that patient safety “shall be of paramount importance,” according to a government filing the company made today.

Last year, Lilly paid $1.4 billion, the largest criminal fine ever imposed on a U.S. corporation, over the illegal marketing of Zyprexa. The company also pleaded guilty to a misdemeanor and agreed to additional oversight to resolve a 5-year-old federal investigation.

Federal prosecutors had said Lilly unlawfully promoted Zyprexa for agitation, aggression, hostility, dementia, depression and generalized sleep disorder, although the drug was approved only for schizophrenia and bipolar disorder.

The company had also improperly marketed Evista, its osteoporosis drug, and Prozac, its antidepressant.

In response, several shareholders sued the company, claiming it breached fiduciary duty in connection with the illegal marketing, exposing Lilly to substantial risk of damage. The suits are known as “derivative claims” as they were brought by shareholders on behalf of the company, rather than on behalf of shareholders, seeking to force the company to take corrective steps.

Read entire article:  http://www.indystar.com/article/20100308/BUSINESS/3080383/Eli-Lilly-adding-four-ethics-watchdogs

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