Archive for August, 2010

New study finds Anti-seizure drugs, increasingly prescribed for people labeled “bipolar,” induce suicide & death

Tuesday, August 31st, 2010

Natural News
By David Gutierrez
August 31, 2010

Popular anti-seizure drugs may seriously increase a patient’s risk of suicide and violent death, according to a study conducted by researchers from Brigham and Women’s Hospital and Harvard Medical School, and published in the Journal of the American Medical Association.

The drugs, known as anticonvulsants, were initially designed for the treatment of epilepsy but are now widely prescribed “off-label” for conditions such as bipolar disorder, migraine headaches and pain.

“We all know the range of uses of these medications is very, very wide,” researcher Elisabetta Patorno said.

The researchers examined the prescription and medical records of more than 300,000 people above the age of 14 who had been prescribed an anticonvulsant for the first time between July 2001 and December 2006.

All of the drugs, they found, significantly increased a patient’s risk of attempted or successful suicide, as well as violent death by other causes. During the course of the study, there were 801 attempted suicides, 26 successful suicides and 41 violent deaths.

“We found increased risk for suicidal acts beginning within the first 14 days after treatment initiation, opening the possibility that anticonvulsant medications could induce behavioral effects prior to the achievement of their full therapeutic effectiveness,” the researchers wrote.

Based on prior studies, the FDA ruled in 2008 that all anticonvulsants must carry labels warning that they double the risk of suicidal thoughts and actions. These older studies had not been able to determine if any drugs posed higher risks than others, however.

Read entire article here:  http://www.naturalnews.com/029614_suicide_anti-seizure_drugs.html

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The US Military’s Drugged Troops: Survey finds at least 1 in 6 service members is on some form of psychiatric drug

Tuesday, August 31st, 2010

Pharmalot
By Ed Silverman
August 31, 2010

The widely used Seroquel antipsychotic was never approved to treat post-traumatic stress disorder or the insomnia sometimes related to the afflication, but that hasn’t stopped the drug from being prescribed for that purpose by the US Department of Veteran Affairs and, in the process, becoming one of the VA’s biggest expenditures.

Since 2001, VA spending on Seroquel jumped more than 770 percent, while the number of patients covered by the VA increased just 34 percent, the Associated Press writes. Seroquel is now the VA’s second-biggest prescription drug expenditure since 2007, behind the Plavix bloodthinner. The agency spent $125.4 million last fiscal year on Seroquel, up from $14.4 million in 2001, and the growth in spending outpaces the growth in personnel who have gone through the military during that time.

Meanwile, thousands of soldiers have taken the med, and several soldiers and veterans have died, raising concerns among some military families the government is not being forthcoming about the risks, the AP writes, noting that they want Congress to investigate. The trend, by the way, is not confined to Seroquel. An investigation earlier this year found that at least one in six service members is on some form of psychiatric drug (background).

According to the VA, Seroquel is only prescribed as a third or fourth option for patients with difficult-to-treat insomnia stemming from PTSD, the AP writes. And the US Defense Department’s deputy director for force health protection, Michael Kilpatrick, tells the news service that the government has not seen any increase in dangerous side effects from Seroquel and other drugs.

Read entire article:  http://www.pharmalot.com/2010/08/the-military-post-traumatic-stress-and-seroquel/

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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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Antipsychotic Drugs, U.S. Vets & Sudden Deaths: Families Call on Congress to Investigate

Monday, August 30th, 2010

Note from CCHR:  Our psychiatric drug database lists FDA advisory warnings on Seroquel causing sudden death, death, suicide, suicidal ideation, heart problems, as well as a Journal of Toxicology report dating back to 2001, warning of antipsychotic drugs causing stroke, cerebrovascular events (such as loss of brain function) seizures, toxicity, confusion and coma. Simply keyword search Seroquel here (or for a broader search, newer antipsychotics)  http://www.cchrint.org/psychdrugdangers/drug_warnings.php

Questions loom over drug given to sleepless vets

By MATTHEW PERRONE (AP) – 1 hour ago

WASHINGTON — Andrew White returned from a nine-month tour in Iraq beset with signs of post-traumatic stress disorder: insomnia, nightmares, constant restlessness. Doctors tried to ease his symptoms using three psychiatric drugs, including a potent anti-psychotic called Seroquel.

Thousands of soldiers suffering from PTSD have received the same medication over the last nine years, helping to make Seroquel one of the Veteran Affairs Department’s top drug expenditures and the No. 5 best-selling drug in the nation.

Several soldiers and veterans have died while taking the pills, raising concerns among some military families that the government is not being up front about the drug’s risks. They want Congress to investigate.

In White’s case, the nightmares persisted. So doctors recommended progressively larger doses of Seroquel. At one point, the 23-year-old Marine corporal was prescribed more than 1,600 milligrams per day — more than double the maximum dose recommended for schizophrenia patients.

A short time later, White died in his sleep.

“He was told if he had trouble sleeping he could take another (Seroquel) pill,” said his father, Stan White, a retired high school principal.

An investigation by the Veterans Affairs Department concluded that White died from a rare drug interaction. He was also taking an antidepressant and an anti-anxiety pill, as well as a painkiller for which he did not have a prescription. Inspectors concluded he received the “standard of care” for his condition.

It’s unclear how many soldiers have died while taking Seroquel, or if the drug definitely contributed to the deaths. White has confirmed at least a half-dozen deaths among soldiers on Seroquel, and he believes there may be many others.

Spending for Seroquel by the government’s military medical systems has increased more than sevenfold since the start of the war in Afghanistan in 2001, according to documents obtained by The Associated Press under the Freedom of Information Act. That by far outpaces the growth in personnel who have gone through the system in that time.

Seroquel is approved to treat schizophrenia, bipolar disorder and depression, but it has not been endorsed by the Food and Drug Administration as a treatment for insomnia. However, psychiatrists are permitted to prescribe approved drugs for other uses in a common practice known as “off-label” prescribing.

But the drug’s potential side effects, including diabetes, weight gain and uncontrollable muscle spasms, have resulted in thousands of lawsuits. While on Seroquel, White gained 40 pounds and experienced slurred speech, disorientation and tremors — all known side effects.

Last year, researchers at Vanderbilt University published a study suggesting a new risk: sudden heart failure.

The study in the January 2009 edition of the New England Journal of Medicine found that there were three cardiac deaths per year for every 1,000 patients taking anti-psychotic drugs like Seroquel. Seroquel’s unique sedative effect sets it apart from others in its class as the top choice for treating insomnia and anxiety.

AstraZeneca PLC, maker of the drug, said it is reviewing the study. The FDA is conducting its own review, citing the limited scope of the Vanderbilt study.

According to the Veterans Affairs Department, Seroquel is only prescribed as a third or fourth option for patients with difficult-to-treat insomnia stemming from PTSD.

Marine Cpl. Chad Oligschlaeger, 21, was being treated for PTSD when he died in his sleep at Camp Pendleton, Calif., in May 2008. Oligschlaeger was taking six types of medication, including Seroquel, to deal with anxiety and nightmares that followed two tours of duty in Iraq.

The military medical examiner attributed the death to “multiple drug toxicity,” indicating that Oligschlaeger, too, died from a drug interaction. Because of the complex reactions between various drugs, medical examiners do not attribute such deaths to any one medication.

After consulting with physicians, parents Eric and Julie Oligschlaeger now believe their son died of sudden cardiac arrest caused by Seroquel.

“Right now, I’m so angry, and I believe someone needs to be held accountable,” said Julie Oligschlaeger, of Austin, Texas. “The protocol absolutely has to change.”

The Defense Department’s deputy director for force health protection, Dr. Michael Kilpatrick, said the government has not seen any increase in dangerous side effects from Seroquel and other drugs.

Physicians interviewed by the AP said they began prescribing Seroquel because it was the only drug that offered relief from the nightmares and anxiety of PTSD.

“By accident, some people were giving them Seroquel for anxiety or depression, and the veterans said, ‘This is the first time I have slept six or seven hours straight all night. Please give me more of that.’ And the word spread,” said Dr. Henry Nasrallah of the University of Cincinnati, who has treated PTSD patients for more than 25 years.

Most of the soldiers and veterans seeking treatment for PTSD do so at hospitals run by the VA or the Defense Department.

The VA’s spending on Seroquel has increased more than 770 percent since 2001. In that same time frame, the number of patients covered by the VA increased just 34 percent.

Seroquel has been the VA’s second-biggest prescription drug expenditure since 2007, behind the blood-thinner Plavix. The agency spent $125.4 million last fiscal year on Seroquel, up from $14.4 million in 2001.

Spending on Seroquel by the Department of Defense, has increased nearly 700 percent since 2001, to $8.6 million last year, according to purchase records.

Read the rest of this article here: http://www.google.com/hostednews/ap/article/ALeqM5iPPHBQ6w28w4kTXzANGm6kCzPN1gD9HTRUQ80

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Antipsychotic drugs double fatal pneumonia risk in elderly—drugs responsible for up to 1800 annual deaths in UK alone

Friday, August 27th, 2010

BBC News
August 27, 2010

The use of anti-psychotic drugs in the elderly doubles the risk of potentially fatal pneumonia, say Dutch researchers.

A study of almost 2,000 patients found the increased risk starts soon after treatment begins and concluded that patients should be closely monitored.

An expert review published in 2009 found the drugs are overused in many cases and are responsible for up to 1,800 deaths in the UK every year.

Ministers have said they want to see a significant cut in their use.

The latest research published in the Annals of Internal Medicine compared the health records of 258 over-65s with pneumonia with 1,686 patients without the infection.

Of those with pneumonia, a quarter died within a month.

When they looked at prescribed drugs, they found current use of anti-psychotics was associated with a roughly two-fold increase in the risk of pneumonia.

Those on the newer types of anti-psychotic drugs were slightly less likely to have the infection than those on the older class of drugs but were still at significant increased risk.

The risk was found to start soon after treatment and increased the higher the dose of drugs the patient was prescribed.

Read entire article here:  http://news.bbc.co.uk/2/hi/health/8599443.stm

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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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Psychiatrists have come up with a ‘solution’ to psychiatric drugs—prescribe LSD, animal tranquilizers & mushrooms

Wednesday, August 25th, 2010

Note from CCHR: Due to the severe adverse reactions from psychiatric drugs finally becoming a matter of public knowledge, as well as studies proving psychiatric drugs are no more effective than placebo, the psychiatric drug lords have now come up with a more overtly drug dealer approach; prescribe patients lysergic acid diethylamide (LSD), Ketamine (An animal tranquilizer known as Special K on the the street) and psilocybin (mushrooms).

Medscape
By Deborah Brauser
August 25, 2010

Low doses of psychedelic drugs, including lysergic acid diethylamide (LSD), ketamine, and psilocybin, may reduce clinical symptoms in patients with depression, anxiety, obsession-compulsive disorders (OCDs), and chronic pain, without inducing depersonalization or hallucinations, according to a new Perspectives article published online August 18 in Nature Reviews Neuroscience.

The study authors note that this may be due to the drugs’ effect on patients’ altered brain circuits and neurotransmitter systems, including serotonin and glutamate systems, according to recent neuroimaging data.

“These findings raise the possibility that research into psychedelics might identify novel therapeutic mechanisms and approaches that are based on glutamate-driven neuroplasticity,” write Franz X. Vollenweider, MD, director of the Neuropsychopharmacology and Brain Imaging Research Unit at the University Hospital of Psychiatry in Zurich, Switzerland, and colleagues.

“These are serious, debilitating, life-shortening illnesses, and as the currently available treatments have high failure rates, psychedelics might offer alternative treatment strategies that could improve the well-being of patients and the associated economic burden on [them] and society,” they add.

Recent Research

Although research on psychedelics has been restricted for almost 40 years because of the drugs’ negative connotations, “recent advances in our understanding of the neurobiology of psychedelics” have led to renewed interest, write the study authors.

Read entire article here:  http://www.medscape.com/viewarticle/727438

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New poll shows 81% of consumers are concerned over Pharma’s financial relationships with their doctors

Wednesday, August 25th, 2010

FiercePharma
By Tracy Staton
August 25, 2010

Another poll is showing that Americans skip drug doses to save money. More than 27 percent of adults told Consumer Reports that they’d skimped on their prescription meds, by forgoing doses, splitting pills to stretch their supplies, postponing refills and more.

Another part of the poll reported that Americans don’t trust their doctors to think independently about prescription drugs, not when Big Pharma is involved. Almost 70 percent of consumers surveyed think drugmakers have too much influence on physicians, and 81 percent say they’re worried about pharma gifts to–and financial relationships with–their doctors.

Half of the 1,150 people polled said they think doctors pick up their prescription pads too quickly, preferring drugs to non-pharma treatments such as lifestyle changes. Almost half said doctors are unduly influenced by gifts from drugmakers. Some 41 percent think doctors tend to prescribe newer, pricier drugs rather than older, cheaper alternatives.

Read the entire article here:  http://www.fiercepharma.com/story/patients-worry-pharma-taints-doctors-decisions/2010-08-25

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New Review of FDA antidepressant drug trials suggests antidepressants only “marginally better” than placebo – Ineffectiveness of antidepressants called “jaw-dropping”

Tuesday, August 24th, 2010

Medscape
By Deborah Brauser
August 24, 2010

A new review of 4 meta-analyses of efficacy trials submitted to the US Food and Drug Administration (FDA) suggests that antidepressants are only “marginally efficacious” compared with placebo and “document profound publication bias that inflates their apparent efficacy.”

In addition, when the researchers also analyzed the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, “the largest antidepressant effectiveness trial ever conducted,” they found that “the effectiveness of antidepressant therapies was probably even lower than the modest one reported…with an apparent progressively increasing dropout rate across each study phase.

“We found that out of the 4041 patients initially started on the SSRI [selective serotonin reuptake inhibitor] citalopram in the STAR*D study, and after 4 trials, only 108 patients had a remission and did not either have a relapse and/or dropped out by the end of 12 months of continuing care,” lead study author Ed Pigott, PhD, a psychologist with NeuroAdvantage LLC in Clarksville, Maryland, told Medscape Medical News.

Sustained Benefit “Jaw Dropping”

“In other words, if you’re trying to look at sustained benefit, you’re only looking at 2.7%, which is a pretty jaw-dropping number,” added Dr. Pigott.

Overall, “the reviewed findings argue for a reappraisal of the current recommended standard of care of depression,” write the study authors.

“I believe there are likely some people where [antidepressants] are truly beneficial beyond placebo. The problem right now is that we simply have no way of knowing who those people are,” noted Dr. Pigott. “My hope is that this kind of analysis creates ‘more oxygen’ for looking at other kinds of approaches to treatment.”

The study was published in the August issue of Psychotherapy and Psychosomatics.

When registering new drug application trials with the FDA, drug companies must prespecify the primary and secondary outcome measures, the investigators report. “Prespecification is essential to ensure the integrity of a trial and enables the discovery of when investigators selectively publish the measures that show the outcome the sponsors prefer following data collection and analysis, a form of researcher bias known as HARKing or ‘hypothesizing after the results are known’,” they write.

For this article, Dr. Pigott and his team reviewed the following meta-analyses:

  • 1. Rising and colleagues (reviewed all efficacy trials for new drugs between 2001 and 2002)
  • 2. Turner and colleagues (reviewed 74 past trials of 12 antidepressants)
  • 3. Kirsch and colleagues, 2002 (reviewed 47 trials of 6 FDA-approved antidepressants)
  • 4. Kirsch and colleagues, 2008 (reviewed depression severity and efficacy in 35 trials)

The researchers also sought to reevaluate the methods and findings of STAR*D, a randomized, controlled trial of patients with depression. Its prespecified primary outcome measure was the Hamilton Rating Scale for Depression (HRSD), whereas the Inventory of Depressive Symptomatology–Clinician-Rated (IDS-C30) was secondary for identifying remitted and responder patients.

“STAR*D was designed to identify the best next-step treatment for the many patients who fail to get adequate relief from their initial SSRI trial,” the study authors write.

“When I first read about STAR*D’s step 1 phase, it just seemed biased to me,” explained Dr. Pigott. “I thought of it as the ‘tag, you’re healed’ research design. Patients who were scored as having a remission during the first 4 to 6 weeks of up to 14 weeks of acute care treatment were counted as remitted, taken out of the subject pool, and put into the follow-up care phase. In other words, they didn’t have the ability to have a relapse. But as most people know, depression ebbs and flows.

“So what made me want to continue to follow this study was that it became clear that the only way that people were really going to be able to evaluate the antidepressants’ effectiveness was to wait for the publication of the follow-up findings,” he added. “After their major final summary study was published, I felt as though the results weren’t really being portrayed in a manner that was consistent with the study’s prespecified criteria.”

High Dropout, Low Remission Rates

In addition to reporting on low efficacy of antidepressants compared with placebo, the 4 meta-analyses “also document a second form of bias in which researchers fail to report the negative results for the prespecified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure, as though it was their primary measure of interest,” the investigators write.

For example, they note, the meta-analysis from Rising and colleagues found that studies with favorable outcomes were almost 5 times more likely to be published and that over 26% of primary outcome measures were left out of journal articles. Turner and colleagues found that antidepressant studies were 16 times more likely to be published if favorable compared with those with unfavorable outcomes.

In reanalyzing the STAR*D methods, the researchers found that the high dropout rate resulted in frequently missed exit HRSD and IDS-C30 interviews. So the revised statistical analytical plan dropped the IDS-30 for the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), which was given at each visit.

“Even with the extraordinary care of STAR*D, only about one fourth of patients achieved remission in step 1 [and] the dropout rate was slightly larger than the success rate,” the study authors write. Steps 2 through 4 also each showed increasingly fewer success rates and larger dropout rates.

Of the 4041 patients at the study’s initiation, 370 (9.2%) dropped out within 2 weeks, and only 1854 patients (45.9%) obtained remission “using the lenient QIDS-SR criteria.” Of these, 670 dropped out within a month of their remission, and only 108 “survived continuing care” and underwent the final assessment.

Dr. Pigott described reanalyzing STAR*D as being “a bit like an onion. Each time we thought we understood the results, we found another layer. It wasn’t until about a year and a half ago that we discovered that the secondary outcome measure, the QIDS-SR, was not originally supposed to be used as a research measure. What was particularly disconcerting to me was that in their summary article, they basically used the QIDS-SR to report all of the results, which clearly had an inflationary effect on the outcome.”

He also noted that STAR*D did not have a placebo design. “Because the patients knew they were receiving the active medication, I would have expected a higher remission rate than what you’d find normally in a placebo-controlled study.

“The inescapable conclusion from the STAR*D results is that we need to explore more seriously other forms of treatment (and combination thereof) that may be more effective. This effort will require developing new service delivery models to ensure that as treatments are identified, they are widely implemented,” the investigators conclude.

Read entire article here:  http://www.medscape.com/viewarticle/727323
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Study finds 85% of new drugs offer few if any benefits & are significant cause of US deaths due to toxic side effects

Monday, August 23rd, 2010

Pharmalot
By Ed Silverman
August 23, 2010

The lemon, of course, is a metaphor and is not a pretty one. But Donald Light, a sociologist and professor of comparative health policy at the University of Medicine and Dentistry of New Jersey, contends that the spate of instances in which drugmakers hid or downplayed info about serious side effects – or overstated benefits – has transformed the market for medicines into one for lemons.

“The basic idea is simple but arresting: just as there are hidden dangers and flaws in used cars, so there are in drugs. And just as used car salesmen have an incentive to profit from not disclosing risks the consumer cannot see under the shiny exterior, so drug companies and their reps have an incentive to profit from not disclosing risks the physician and patient cannot see inside a shiny new pill. In a number of ways, however, drug markets differ from used car markets. One way is that bad drugs do not drive good drugs out of the market, as Akerlof famously predicted in the article that helped him win the Nobel Prize. Rather, they stay in, mixed with higher risk drugs,” Light tells us, after presenting a paper on the subject at the American Sociological Association annual meeting last week.

According to his study, which is not yet published, independent reviewers found that about 85 percent of new drugs offer few if any new benefits. At the same time, though, prescription drugs are now a significant cause of death in the US due to toxic side effects or misuse. He notes that drugmakers spend “two to three times more on marketing than on research,” which are dollars used to persuade docs to prescribe new drugs. But the docs, he maintains, may get misleading info and then pass along the same info to patients. In his view, this is a “two-tier market” for lemons.

And in his study, Light says drugmakers have taken advantage of this two-tier system information market and monopoly rights to create what can he calls “the risk proliferation syndrome,” which consists of corporate, government, and medical practices that maximize the number of drugs put on the market with risks of adverse reactions and then maximize the number of people induced to take them.

Read entire article here:  http://www.pharmalot.com/2010/08/drugmakers-actually-make-lemons-not-medicines/

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