Posts Tagged ‘Zoloft’

FDA’s Continual Responsibility for Making Our Children Into a Nation of Drug Addicts

Monday, March 28th, 2011

Salem-News.com
By Marianne Skolek
March 28, 2011

Dexedrine

In 1997, 5 million children were listed as using psychotropic drugs, Ritalin being among the most common.  Ritalin use has increased by 700% since 1990. By the year 2000, it was prescribed for approximately 7 million children.

Attention Deficit Hyperactivity Disorder (ADHD) is diagnosed eight times more often in boys than in girls.

Of these diagnosed children, 90% use a stimulant to help control the disorder. 70% of children with ADHD are prescribed Ritalin. 20% use its counterpart, the generic form known as methylphenidate and an amphetamine known as Dexedrine.

Beginning in the 1960s, it was used to treat children with ADHD, or Attention Deficit Disorder (ADD), known at the time as hyperactivity or minimal brain dysfunction (MBD).

Production and prescription of methylphenidate rose significantly in the 1990s, especially in the United States, as the ADHD diagnosis came to be better understood and more generally accepted within the medical and mental health communities.

The benefits and cost effectiveness of methylphenidate, i.e. Ritalin long term are unknown due to a lack of research.

There is a lack of evidence of the effectiveness in the long term of beneficial effects of methylphenidate (Ritalin) with regard to learning and academic performance.

An analysis of the literature concluded that methylphenidate quickly and effectively reduces the signs and symptoms of ADHD in children under the age of 18 in the short term but found that this conclusion may be biased due to the high number of low quality clinical trials in the literature.

Some adverse effects of stimulant therapy may emerge during long-term therapy, but there is very little research of the long-term effects of stimulants.

The United States produces 90% of the world’s Ritalin. It produces, sells and distributes more methylphenidate than any other country worldwide. In addition to the United States, methylphenidate is frequently used in the United Kingdom and Germany.

It is used in many European countries, but in much smaller percentages than in the United States. Some countries don’t use the drug at all, such as Sweden, which has banned its use.

Intuniv

The FDA approved ”Intuniv” – the first non-stimulant extended release medication for the treatment of ADHD in children.  This means it can be administered in one daily dose and given in the morning or at night as a stand-alone medication or in conjunction with another ADHD drug to boost overall effectiveness. Because Intuniv is not a stimulant, parents can feel better knowing that their child is being treated with a medication that does not have addictive properties and is less likely to be abused since it is not a controlled substance.

In clinical trials, Intuniv has been shown to boost the effectiveness of treatment when combined with a stimulant, resulting in greater attention span and reduced levels of impulsivity and hyperactivity.  One possible drawback, however, is that it has not been tested for extended use, beyond  that of 8 to 10 weeks.  For this reason, physicians who prescribe Intuniv must closely monitor patients to determine whether it continues to be a successful protocol for longer term management of ADHD symptoms.

At the present time, Intuniv’s longer term efficacy is unknown and will be determined by physicians who carefully monitor patients being treated and report associated outcomes.  Shire, Intuniv’s biopharmaceutical developer, continues to focus their research on this drug’s long term use potential for maintenance of children with ADHD who need drug treatment in order to succeed academically — as well as socially.

Dr. Ann Blake Tracy

Dr. Ann Blake Tracy, executive director of the International Coalition for Drug Awareness and author of Prozac: Panacea or Pandora? – Our Serotonin Nightmare is an expert consultant in cases like Columbine in which anti-depressant medications are involved.

Tracy says the Columbine killers’ brains were awash in serotonin, the chemical which causes violence and aggression and triggers a sleep-walking disorder in which a person literally acts out their worst nightmare.

Columbine shooter Eric Harris

Shortly before the Columbine shooting, Eric Harris (one of the shooters) had been rejected by Marine Corps recruiters because he was under a doctor’s care and had been prescribed an anti-depressant medication.  Harris was taking Luvox, an anti-depressant commonly used to treat patients with obsessive-compulsive disorder.

Luvox is in a class of drugs called selective serotonin reuptake inhibitors (SSRI).  Other SSRIs include Prozac, Paxil and Zoloft.  An estimated 10 million Americans take anti-depressant medications.

Harris was taking Luvox

Mark Taylor, the first student shot at Columbine, brought a lawsuit against Solvay, the international pharmaceutical company that produces Luvox.  Taylor’s 2001 lawsuit said Luvox had caused Harris to become manic, psychotic, and homicidal/suicidal and had brought about “emotional blunting,” or a lack of inhibition.

Tayor’s lawsuit also faulted Solvay for failing to warn of the “risks and dangers” associated with the drug. *

Columbine victim Mark Taylor

(*Taylor told American Free Press two years after the Columbine shooting, as a 17-year old recovering victim, he had been taken alone, without counsel, into a room with lawyers representing Solvay and threatened with court costs and counter suits.  The fear of financial ruin led Taylor and others to withdraw the lawsuit.  Solvay Pharmaceuticals was able to silence disclosure of exactly what had happened at Columbine — and why — even after its product had played ab obvious role in slaughtering 13 people).

Solvay Pharmaceuticals

In early 1998, according to Taylor’s lawsuit, Harris had taken Zoloft for two months, but soon became “obsessional.”  Harris became obsessed with homicidal and suicidal thoughts “within weeks” after he began taking Zoloft, according to Dr. Tracy.  Due to his obsession with killing, Harris was switched to Luvox, which was in his system at the time of the shooting, according to his autopsy.  The change from Zoloft to Luvox is like switching from Pepsi to Coke, Dr. Tracy said.

Read entire article here:  http://www.salem-news.com/articles/march282011/child-addicts-ms.php

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Panel to Examine Murder and Suicide Associated With Antidepressants

Tuesday, March 22nd, 2011

The Huffington Post, March 22, 2011
by Dr. Peter Breggin

Click image to visit the Psychiatric Drug Database

On Saturday morning April 9th of this year, a panel discussion will be held for the public and professionals on the theme of “Psychiatric Drug Tragedies: Personal, Legal and Medical Perspectives.”

The two-hour presentation focuses on suicide and murder potentially caused by antidepressant medications. It is part of the international Empathic Therapy Conference put on by the Center for the Study of Empathic Therapy, Education & Living (April 8-10, 2011 in Syracuse, New York).

The panel will present a unique examination of an antidepressant-related suicide from three perspectives: Mathy Downing, the mother of a twelve-old-child who committed suicide; Karl Protil, the lawyer in her case, which was settled without any admission of negligence; and myself as the medical expert in the case. Mathy will be accompanied by her surviving daughter. Other family members will tell the stories of two more children who committed suicide, a father who committed suicide, and a husband who murdered his two young children–all while taking prescribed antidepressants.

A great deal is now known about suicide and violence in association with the newer antidepressants such as Prozac (fluoxetine), Paxil (paroxetine), Zoloft (sertraline), Luvox (fluvoxamine), Celexa (escitalopram), Lexapro (escitalopram), Cymbalta (duloxetine), Effexor (venlavaxine), Pristiq desvenlafaxine), and Wellbutrin (bupropion).

The FDA has imposed a Black Box on all antidepressant labels that warns against the risk of suicidal behavior in children, youth and young adults. Click here to find the example of Prozac’s official prescribing information. More importantly and more broadly, the new labels also warn about the risk of aggression, hostility, mania, and an overall worsening of the individual’s mental condition, for all ages. The new FDA-approved labels also include a Medication Guide, which the FDA urges prescribers to give to patients and their families. Originally intended for children taking antidepressants, it now has no age limitation and pertains to all ages. The Medication Guide warns patients and their families to be aware of the possibility of suicidal and violent behavior, mania, and a long litany of other dangerous mental abnormalities.

The new FDA-approved antidepressant labels confirm that the risks are highest at the start of medication therapy or during changes in dose, either up or down. To a great extent, the labels read like my prior publications, one of which was given by the FDA to its outside expert committee that recommended the changes to the labels.

Unfortunately, many psychiatrists, internists, family doctors, nurse practitioners and other professionals continue to prescribe these medications, too often without providing adequate information to the patient and the family. As a result, I was asked to write about the implications of these new labels for the most widely read psychiatric journal for primary care prescribers. The panel at the Empathic Therapy Conference, the first of its kind, will explore these tragedies and put a human face on them through the presence and presentations of surviving family members.

Other aspects of the conference will describe empathic approaches to helping a wide variety of emotional conditions and problems in children and adults. Speakers will bring unique and inspiring approaches to children and adults given psychiatric diagnoses, ordinary folks who are suffering from stress, street people overcome by psychosis, military personnel recovering from PTSD and head injuries, and elderly victims of dementia. Professionals and the general public are welcome at the Empathic Therapy Conference in Syracuse, New York, April 8-10, 2011. Continuing education credits (CEs) for 29.5 hours are available.

Peter R. Breggin, MD is a psychiatrist in private practice in Ithaca, New York, and the author of dozens of scientific articles and more than twenty books including Toxic Psychiatry: Why Therapy, Empathy and Love Must Replace the Drugs, Electroshock and Biochemical Theories of the “New” Psychiatry, as well as his newest book, Medication Madness. The Empathic Therapy Conference brings together more than forty presenters and a diverse audience from around the world. Professionals and nonprofessionals are welcome. Learn about the conference at http://www.empathictherapy.org.

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False peace of mind – Antidepressant Placebos

Thursday, March 10th, 2011

Antidepressant placebos remain a steady presence in clinical experiments, but not in public knowledge

The McGill Daily
Debbie Wang
March 10, 2011

Victor Tangermann | The McGill Daily

It’s the classic situation: with an imminent exam and a carefully planned cramming schedule, you awake one morning with the all too familiar symptoms of a common cold. Feeling sorry for yourself between sniffles and coughs, you self-medicate with the usual blend of OJ, vitamins and copious amounts of water, fervently hoping for a rapid recovery.

Most of us who catch a cold end up taking desperate measures to fix the situation, regardless of whether such measures are founded on scientific truth. Increased vitamin C intake? Not only is there zero proof that it prevents colds, there’s also none that it expedites recovery, according to a paper in Evidence-Based Child Health. Herbal remedies like echinacea? Hot liquids? Beyond the latter’s ability to provide temporary relief, neither will provide much help.

Indeed, the most powerful panacea of them all is our own gullible mind. Once convinced of the effectiveness of a cold cure through a lifetime of anecdotal accounts and lore, many of us will start feeling better after a day of downing orange juice even though it serves as much of a medical purpose as twiddling your thumbs. And while juice manufacturers don’t proclaim cold-fighting abilities on every carton, another highly lucrative industry relying heavily on the placebo effect does assert a claim: that antidepressants cure depression.

Beginning in 1998, a series of studies have repeatedly questioned the difference in efficacies between antidepressant drugs and placebos. Pioneering analysis work done by University of Connecticut researchers Irving Kirsch and Guy Sapirstein confirmed the effectiveness of antidepressants – but also their inert counterparts. In 38 studies conducted with over 3,000 depressed patients, placebos improved symptoms 75 per cent as much as legitimate medications.

“We wondered, what’s going on?” said Kirsch in a 2010 interview with Newsweek. The medical community, skeptical of his analysis, asked him to instigate a more comprehensive study with the results of all clinical trials conducted by antidepressant manufacturers, including those unpublished – 47 studies in total.

Over half of the studies showed no significant difference in the depression-alleviating effects of a medicated versus non-medicated pill. With this more thorough analysis, which now included strategically unpublished studies from pharmaceutical companies, placebos were shown to improve symptoms 82 per cent as much as the real pill.

Now also consider that any apparent advantage of the genuine medication might be more the mind’s handiwork than chemical effect. Patients in double blind clinical trials, where neither experimenter nor patient know if a placebo or real drug has been taken, may easily determine which is the placebo. The obvious side effects of the genuine pill, such as headaches or nausea, may alert the patient to which study group they’ve been placed in, and the knowledge that their pill is medicated may be enough to alleviate their depression.

Are antidepressant drugs really “a triumph of marketing over science,” as researchers have claimed? Kirsch and other experts are convinced that antidepressants do not chemically cure depression. A British agency charged with determining which treatments are effective enough for government funding has stopped endorsing antidepressants as the default treatment for anything but the most severe forms of depression. And drug manufacturers themselves don’t deny Kirch’s data. A spokesperson for Pfizer, producer of  Zoloft, has alluded to the existence of a “wealth of scientific evidence documenting [antidepressants’] effects,” yet the fact that treatment “commonly fail[s] to separate from placebo” is “well known by the FDA, academia, and industry.”

However, if experts and antidepressant manufacturers are aware of this, the general public certainly isn’t. Which is precisely why antidepressants work. Without the knowledge that even manufacturers of medications aren’t completely convinced of their product’s superiority, antidepressants will continue to be effective. This not a recommendation for current users to halt taking the pills; abrupt withdrawal is extremely dangerous, and there is still a range of perspectives on the topic of antidepressants versus sugar pills.

But you have it. Millions of people every year feel better, simply because they believe they’ll feel better. We’ve recovered from colds, headaches, pain, and depression, courtesy of the placebo effect. After all, there’s something to be said for feeling better.

http://www.mcgilldaily.com/2011/03/false-peace-of-mind/

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Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

Thursday, March 10th, 2011

By Bob Fiddaman and Shelia Matthews
March 10, 2011

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

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

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

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

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

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

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

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

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

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

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

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

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth

Medications for ADHD

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

Atypical Antipsychotics

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

Anti-anxiety

Hydroxyzine (2.5%)

Antidepressants

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

Mood Stabilizers

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

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

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

Dr Kant replied:

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

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

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

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

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

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

Forest Lab’s citalopram [Celexa] – APPROVED

Forest Lab’s escitalopram [Lexapro] – APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] – APPROVED

Pfizer’s sertraline [Zoloft] – APPROVED

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

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

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

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

The DCF Approved Medication List writes:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Dealing With Depression Naturally

Tuesday, March 8th, 2011

FOX News, March 8, 2011
by Chris Kilham

If your life is making you unhappy, then making positive changes may be the very best prescription of all

According to a study published in the Archives of General Psychiatry, approximately 10 percent of Americans are taking antidepressant medications.

This means that over 31 million Americans are gobbling Prozac, Zoloft, Celexa, Elavil, Norpramin, Luvox, Paxil, Wellbutrin and other antidepressant psychiatric drugs like M & M’s. This drug use accounts for billions of dollars in pharmaceutical sales annually (9.6 U.S. billion in 2008).

Yet according to a landmark study published in the Journal of the American Medical Association, antidepressant medications work – as well as placebos and not more. In other words, people in depression studies who are given sugar pills instead of antidepressant drugs do as well as the group who gets the drugs.

Before you ask yourself whether you should simply take a Tic Tac instead of a Paxil, there is more disheartening news about these drugs. Many Americans are taking antidepressant medications instead of changing their own behavior or life circumstances. According to Maryland medical doctor Ronald Dworkin, “Doctors are now medicating unhappiness. Too many people take drugs when they really need to be making changes in their lives.” If you are beating your nose with a hammer, do you stop hitting yourself, or do you continue, and take a pain pill?

Digging more deeply into the mystery of antidepressants, George Washington University health analyst Thomas Moore examined unpublished studies conducted by drug companies  with various antidepressants. Approximately 40 percent of the studies conducted on this class of drugs have never been published — because in those 40 percent of studies, antidepressants do not demonstrate effectiveness. In other words, in the unpublished studies, they didn’t work. In even further research, Irving Kirsch of the University of Connecticut looked at results from varying doses of antidepressants. The difference in effectiveness between small doses and large doses was virtually non-existent.

It gets even gloomier. A U.S. government study released in 2006 showed that fewer than 50 percent of people become symptom-free on antidepressants, even after trying two different medications. Many who do respond to medication slip back into major depression within a short while, despite sticking with drug treatment. And then there are the “side effects,” which are really effects pure and simple. The most common effects of antidepressant drugs include nausea, insomnia, anxiety, restlessness, loss of sex drive, dizziness, weight gain, tremors, sweating, sleepiness, fatigue, dry mouth,  diarrhea, constipation and headaches. People over 65 are at extra risk of falls, fractures and bone loss, newborns of mothers on SSRI antidepressants can go through drug withdrawal, and among teens, the use of antidepressants can increase suicidal tendencies. Any sober assessment of these effects points to the fact that there is something terribly wrong with this entire class of drugs. Remember what Hippocrates said “First of all, do no harm.”

Many intangibles add up to either a happy life or a sad one. Do you spend enough time with your family? Your friends? Do you relax? Do you do things you love? Do you enjoy your work? If you answer no to these questions, you probably have good cause to feel depressed. But popping a pill won’t help if you are not living in a fulfilled way.

What about natural approaches to depression? A number of doctors believe that nutritional deficiencies play a key role in many cases of depression. After all, brain chemistry depends on nutrient intake for proper balance. Really, it’s no surprise that a junk food-eating culture would be increasingly mentally out of sorts. No brain food means poor brain function. This is where omega 3 fatty acids come in, notably DHA, which is essential for proper brain function. These essential fats greatly enhance brain health and mood. The best way to get them is to eat fresh seafood, especially wild salmon. But omega 3 fatty acid supplements from fish oil are also available.

According to the National Institutes of Mental Health, anxiety and depression often go hand in hand. Many people find that they can relieve or reduce anxiety by meditating. There are many ways to meditate. By setting aside time every day, you can calm your body and mind, change your brainwaves, and alter your mood for the better.

Regular exercise is also associated with improved mood. Exercise enhances circulation, modifies brain chemistry for the better, enhances overall energy, improves vitality and contributes greatly to well being. You don’t need to go to a gym, either. Just get outside and walk. Do so briskly for at least half an hour each day, and notice how much better you feel.

On the herbal side, Rhodiola rosea is the big antidepressant. Many forward-thinking psychiatrists have turned to Rhodiola as a first line of treatment, instead of pharmaceuticals. Psychiatrists Richard Brown and Patricia Gerbarg in New York are ardent advocates of Rhodiola for depression and mood enhancement, and have written profusely about it. Dr Hyla Cass of UCLA also is an advocate. Meanwhile, dozens of studies demonstrate significant improvement in all parameters of mental function with Rhodiola rosea. My favorite brands? Rhodiola Energy by Enzymatic Therapy, and Rapid Rhodiola by EuroPharma.

If your life is making you unhappy, then making positive changes may be the very best prescription of all. Many people are so buried by work and stress that they forget to take time to live, to enjoy themselves and to savor life itself. I remember once meeting a psychiatrist at one of my talks. He was retired, and I was deeply impressed by what he shared.

“I practiced psychiatry for twenty-eight years,” he said. “And I never once gave anybody a prescription.” I asked him what he did for his patients instead.

“I talked with them,” he replied. As Rabbi Earl Grollman, author of several books on grief says, “the mentionable is manageable.” Maybe talking is a good place to start.

Chris Kilham is a medicine hunter who researches natural remedies all over the world, from the Amazon to Siberia. He teaches ethnobotany at the University of Massachusetts Amherst, where he is Explorer In Residence. Chris advises herbal, cosmetic and pharmaceutical companies and is a regular guest on radio and TV programs worldwide. His field research is largely sponsored by Naturex of Avignon, France. Read more at www.MedicineHunter.com

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Note to Press Re: Arizona Shooting—Before Touting Pharma’s “More Mental Health Treatment Needed” Line – Try Asking The Right Questions

Wednesday, January 12th, 2011

By CCHR International

10 recent massacres were committed by those under the influence of psychiatric drugs resulting in 54 dead and 105 wounded

Every single time there is a school shooting, or some senseless massacre, the press are quick to start touting the need for more mental health treatment to “prevent” these tragedies—well before the facts of the case have been investigated. In fact, most of the press don’t appear as interested in bringing the facts to light as they are in making “recommendations” based on assumptions and calling for more mental health services/treatments.   How one can make recommendations before finding out what actually occurred seems illogical to us, and we’re hoping we’re not the only ones.   What also seems illogical is the lack of direct questioning and demand for answers given the facts already known about prior massacres/shootings, such as:  The majority of those who committed such acts had already undergone mental health “treatment,”  and were already on psychiatric drugs.   Drugs documented by international drug regulatory agencies to cause violence, mania, psychosis, hallucinations, suicide and even homicidal ideation.

In the case of prior massacres/shootings, what has repeatedly occurred is that when the facts finally came out,  due solely to the efforts of those few  determined investigative reporters (such as Fox National News reporter Douglas Kennedy), and it was revealed that the shooter had been under the influence of psychiatric drugs, or in withdrawal from them,  most of the press were quick to counter the drug/violence connection by featuring some Pharma mouthpiece touting the “there is no evidence that these drugs cause violent or homicidal behavior” line.

Really?    No evidence? There have been 22 International Drug Regulatory Agency Warnings on psychiatric drugs causing violence, mania, psychosis and even homicidal ideation.   These warnings have been issued by drug regulatory agencies in the United States,  the European Union, Japan,  The United Kingdom, Australia and Canada.

And consider that just last week, TIME Magazine reported on a study from the Institute for Safe Medication Practices that  “based on data from the FDA’s Adverse Event Reporting System has identified 31 drugs that are disproportionately linked with reports of violent behavior towards others.”  And out of the Top 10, 8 were psychiatric drugs.

From Time Magazine: “When people consider the connections between drugs and violence, what typically comes to mind are illegal drugs like crack cocaine. However, certain medications — most notably, some antidepressants like Prozac — have also been linked to increase risk for violent, even homicidal behavior.

The Top 10 included  the Antidepressants Pristiq, Effexor, Luvox, Paxil, Prozac, ADHD Drugs, Strattera and the Anti-Anxiety drug,  Halcion.

Now, to be perfectly clear, we’re not saying for a fact that Loughner was taking  psychiatric drugs at the time of the shooting, or in the past, which studies show can cause long-term  damage long after an individual has stopped taking them.   We’re saying, why aren’t the press finding out?   Consider that 10 recent massacres were committed by those under the influence of psychiatric drugs documented to cause mania, psychosis, violence and even homicide, resulting in 54 dead and 105 wounded—and those are just the ones we know about. In several cases, medical records were sealed or autopsy reports not made public or, in some cases, toxicology tests were either not done to test for psychiatric drugs, or not disclosed to the public.   But let’s just consider what we do  know about the mental health “treatment” of those who committed these acts of violence:

  • Dekalb, Illinois – February 14, 2008: 27-year-old Steven Kazmierczak shot and killed five people and wounded 16 others before killing himself in a Northern Illinois University auditorium. According to his girlfriend, he had recently been taking Prozac, Xanax and Ambien. Toxicology results showed that he still had trace amount of Xanax in his system.
  • Omaha, Nebraska – December 5, 2007: 19-year-old Robert Hawkins killed eight people and wounded five before committing suicide in an Omaha mall.  Hawkins’ friend told CNN that the gunman was on antidepressants, and autopsy results confirmed he was under the influence of the “anti-anxiety” drug Valium.

  • Jokela, Finland – November 7, 2007: 18-year-old Finnish gunman Pekka-Eric Auvinen had been taking antidepressants before he killed eight people and wounded a dozen more at Jokela High School in southern Finland, then committed suicide.

  • Cleveland, Ohio – October 10, 2007: 14-year-old Asa Coon stormed through his school with a gun in each hand, shooting and wounding four before taking his own life.  Court records show Coon had been placed on the antidepressant Trazodone.

  • Blacksburg, Virginia – April 16, 2007: 23-year-old Seung Hui Cho shot to death 32 students and faculty of Virginia Tech, wounding 17 more, and then killing himself.  He had received prior mental health treatment, however his mental health records remained sealed.

  • Red Lake, Minnesota – March 2005: 16-year-old Jeff Weise, on Prozac, shot and killed his grandparents, then went to his school on the Red Lake Indian Reservation where he shot dead 7 students and a teacher, and wounded 7 before killing himself.

  • Greenbush, New York – February 2004: 16-year-old Jon Romano strolled into his high school in east Greenbush and opened fire with a shotgun.  Special education teacher Michael Bennett was hit in the leg.  Romano had been taking “medication for depression”.

  • El Cajon, California – March 22, 2001: 18-year-old Jason Hoffman, on the antidepressants Celexa and Effexor, opened fire on his classmates, wounding three students and two teachers at Granite Hills High School.

  • Williamsport, Pennsylvania – March 7, 2001: 14-year-old Elizabeth Bush was taking the antidepressant Prozac when she shot at fellow students, wounding one.

  • Conyers, Georgia – May 20, 1999: 15-year-old T.J. Solomon was being treated with antidepressants when he opened fire on and wounded six of his classmates.

  • Columbine, Colorado – April 20, 1999: 18-year-old Eric Harris and his accomplice, Dylan Klebold, killed 12 students and a teacher and wounded 26 others before killing themselves.  Harris was on the antidepressant Luvox.  Klebold’s medical records remain sealed.

  • Notus, Idaho – April 16, 1999: 15-year-old Shawn Cooper fired two shotgun rounds in his school, narrowly missing students.  He was taking a prescribed SSRI antidepressant and Ritalin.

  • Springfield, Oregon – May 21, 1998: 15-year-old Kip Kinkel murdered his parents and then proceeded to school where he opened fire on students in the cafeteria, killing two and wounding 22.  Kinkel had been taking the antidepressant Prozac.

So, given the fact that these shooters were on psychiatric drugs, given the fact that 22 international drug regulatory agencies warn these drugs can cause violence, mania, psychosis, suicide and even homicide, given the fact that a major study was just released confirming these drugs put people at greater risk of becoming violent,  here are the questions we think deserve to be answered.

1) Court records show that a case against Jared Loughner was dismissed on Dec. 9, 2008, after he completed some type of diversion program.    What was the diversion program?  Did it include mental health treatment or do the case notes include any information about any prior mental health treatment  Loughner may have undergone?  Such was the case of Columbine shooter Eric Harris’s “diversion program”, where case notes dated 4/16/98 revealed that “Eric has been having difficulty with his medication for depression.  A few nights ago he was unable to concentrate and felt restless.  He went to the doctor and the doctor is changing his medication.”

* Further note to press: Sometimes finding the psychiatric drug connection requires a bit more due diligence than just asking the question; case in point,  following the Columbine massacre, the Coroner’s office initially reported no drugs were found in Eric Harris’ tox reports.   Following this, an investigative reporter found that Harris was rejected from the military and psychiatric drug use was suspected as the cause for the rejection.   When this became known,  the coroner’s office seemed to find that  Harris did in fact have the antidepressant Luvox in his system.

2) The Wall Street Journal reported, “One high-school pal said Loughner had become suicidal”.  Considering the FDA has issued black box warnings that antidepressants can cause suicidal ideation (as can other psychiatric drugs) was Loughner already under the influence of these drugs?

3) The press has reported that Loughner was “barred from campus pending a psychological evaluation.”  So what happened?  Did he get one?  Was he ever in mental health treatment, or prescribed a psychiatric drug? Ever?

As a final note:  Whether or not Loughner was yet another in the long list of shooters under the influence of drugs documented to cause mania, psychosis, hallucinations, aggressive behavior, suicidal and homicidal ideation—Given the international drug regulatory agency warnings & studies, the just released Institute for Safe Medication Practices study, this much we know for certain; the  last thing we need is more kids on psychiatric drugs.    And given what we already know about the risks of these drugs, any recommendation for more mental health treatment, meaning more people and more kids put on these drugs, is not only negligent, but considering the possible repercussions, criminal.

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New Study Links ADHD Drugs, Antidepressants, Hypnotics & Anti-Smoking Drug to 1,527 Acts of Violence

Thursday, December 16th, 2010

Pharmalot, December 16, 2010

by Ed Silverman

For years, there were contentious debates about links between certain prescription meds, notably antidepressants, and suicidal behavior. Now, the focus is turning to violent behavior directed toward others. And a new study is linking 31 widely prescribed drugs – most notably, the Chantix anti-smoking pill – with 1,527 serious acts of violence, such as physical abuse, physical assault and homicide.

The study, which was published in PLoS One, identified 484 drugs that accounted for 780,169 serious adverse event reports of all kinds, including 1,937 cases meeting the violence criteria determined by the researchers. There were 387 reports of homicide, 404 physical assaults, 27 cases indicating physical abuse, 896 homicidal ideation reports and 223 cases described as violence-related symptoms.

Besides Pfizer’s Chantix, 11 antidepressants, three ADHD meds and five hypnotics or sedatives were linked to 79 percent of the violence cases. Looked at another way, no cases of violence were reported for 324 of the 484 drugs evaluated. And so an association with violence appeared “highly unlikely” for nearly 85 percent of all evaluated drugs in widespread clinical use.

This is not, by the way, the first time that Chantix has been linked to violent behavior. The same authors published a study last summer in The Annals of Pharmacotherapy that found Chantix is not only associated with violent and aggressive thoughts and acts, but they also identified some of the common characteristics among people using the pill and their subsequent behavior (see this).

“Acts of violence towards others are a genuine and serious adverse drug event associated with a relatively small group of drugs. (Chantix), which increases the availability of dopamine, and antidepressants with serotonergic effects were the most strongly and consistently implicated drugs,” the researchers write. Interestingly, this finding appears just after the infamous Zoloft defense case drew to a close. That involved a 12-year-old boy who killed his grandparents and his lawyers blamed the antidepressant (read here).

The authors do, however, cite some limitations. The submission of an individual adverse event report does not itself establish causality,” the note, “only that a reporting individual suspected a relationship existed.” And they add that the quality and detail in each report varies. On the other hand, they also say that, “given that violent thoughts or actions are not typically attributed to drug therapy or recorded in medical records, the reporting rate for violence cases could be very low. The selected violence cases do not provide a reliable estimate of how often they might occur.”

In the end, they recommend prospective studies to “establish the incidence, confirm differences among drugs and identify additional common features.”

http://www.pharmalot.com/2010/12/chantix-prescription-drugs-and-violent-acts/

Note from CCHR:  As far back as 1991, the FDA held hearings into antidepressants causing suicidal ideation and violence, largely prompted by CCHR’s demands for an investigation. CCHR testified along with dozens of victims and medical experts.   The FDA panel, largely Pharma funded, refused to issue warnings despite the evidence presented. It would take the FDA another 13 years to finally admit antidepressants cause suicidal ideation and issue black  box warnings on the drugs.  The FDA has still never fully investigated the overwhelming evidence linking antidepressants and other psychiatric drugs to acts of violence and homicide.

Watch this video, produced by CCHR, of the 1991 FDA hearings into antidepressants causing suicide and violence http://www.youtube.com/cchrint#p/c/B9EA75455D155D89/6/FxJomeak4V4

Also Watch This Fox National News Special Report’s from Douglas Kennedy Deadly Drugs - http://www.youtube.com/watch?v=9S-7aNPf33A

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Nation of Pill Poppers: 19 Potentially Dangerous Drugs Pushed By Big Pharma

Tuesday, December 7th, 2010
AlterNet — December 6, 2010
by Martha Rosenberg
Here are some of the dicey drugs many Americans are hooked on,
thanks to greedy pharmaceutical companies.

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

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

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

Seroquel, Zyprexa, Geodon, atypical antipsychotics

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

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

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

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

Ritalin, Concerta, Strattera, Adderall and ADHD drugs

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

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

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

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

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

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

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

Prozac, Paxil, Zoloft, SSRIs

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

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

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

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

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

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

Effexor, Cymbalta, Pristiq, SNRIs

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

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

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

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

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

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

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5 Myths About Depression Treatments

Friday, December 3rd, 2010

COUNTER PUNCH, December 3, 2010

By Bruce E. Levine,
Clinical Psychologist

A warning: for people satisfied with their standard depression treatments, debunking myths about them may be troubling. However, for critically thinking depression sufferers who have not been helped by antidepressants, psychotherapy, or other standard treatments, discovering truths about these treatments can provide ideas about what may actually work for them.

Critical thinkers have difficulty placing faith in any depression treatment because science tells them that these treatments often work no better than placebos or nothing at all, and if one lacks faith in a depression treatment, it is not likely to be effective. In fact, it is belief and faith—or what scientists call “expectations” and the “placebo effect”—that is mostly responsible for any depression treatment working. Critical-thinkers can find a way out of depression when their critical thinking about depression treatments is validated and respected, and they are challenged to think more critically about their critical thinking.

Myth 1: Antidepressants Are More Effective than Placebos

Many depressed people report that antidepressants have been effective for them, but do antidepressants work any better than a sugar pill? Researcher Irving Kirsch (professor of psychology at the University of Hull in the United Kingdom as well as professor emeritus at the University of Connecticut and author of The Emperor’s New Drugs) has been trying to answer that question for a significant part of his career.

In 2002, Kirsch and his team at the University of Connecticut examined 47 depression treatment studies that had been sponsored by drug companies on the antidepressants Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone. Many of these studies had not been published, but all had been submitted to the Food and Drug Administration (FDA), so Kirsch used the Freedom of Information Act to gain access to all the data. He discovered that in the majority of the trials, antidepressants failed to outperform sugar pill placebos.

“All antidepressants,” Kirsch reported in 2010, “including the well-known SSRIs [selective serotonin reuptake inhibitors], had no clinically significant benefit over a placebo.” While in aggregate, antidepressants slightly edge out placebos, the difference is so unremarkable that Kirsch and others describe it as “clinically negligible.”

Why are so many doctors unaware of the lack of superiority of antidepressants as compared to placebos? The answer became clear in 2008 when researcher and physician Erick Turner (currently at the Department of Psychiatry and Center for Ethics in Health Care, Oregon Health and Science University) discovered that antidepressant studies with favorable outcomes were far more likely to be published than those with unfavorable outcomes. Analyzing published and unpublished antidepressant studies registered with the FDA between 1987-2004, Turner found that 37 of 38 studies having positive results were published; however, Turner reported, “Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, [falsely] conveyed a positive outcome (11 studies).”

Myth 2: If the First Antidepressant Fails, Another Antidepressant Will Likely Succeed

In The Noonday Demon, the popular 2001 book about depression, writer and depression sufferer Andrew Solomon repeated the then urban legend that “more than 80 percent of depressed patients are responsive to medication.” Solomon accurately cites a journal article that states this statistic; however, following the “reference trail,” I discovered that the journal article that Solomon cited refers to a second article for evidence of this statistic, but this second journal article mentions nothing about 80 percent of depressed patients responding to some medication.

The National Institute of Mental Health (NIMH) was aware that there was no research to back up the assertion that 80 percent of depressed patients improve if they keep trying different medications, so NIMH funded “Sequential Treatment Alternatives to Relieve Depression” (STAR*D), the largest ever study of sequential depression treatments. STAR*D results were published in 2006.

In Step One of STAR*D, all depressed patients were given the antidepressant Celexa, and in Step Two, patients who failed to respond to Celexa were divided into different groups and received other treatments (mostly different drug treatments) in place of or in addition to Celexa. If their second treatment failed, there was a third and, if necessary, a fourth treatment step.

In every STAR*D treatment step, remission rates were either equal to or significantly lower than the customary placebo performance in other antidepressant studies, but to the exasperation of many scientists, there was no placebo control in this $35 million U.S. taxpayer funded STAR*D study. (STAR*D researchers disclosed receiving consulting and speaker fees from the pharmaceutical companies which manufacture the antidepressants studied in STAR*D.)

In March 2006, NIMH triumphantly announced that 50 percent of depressed people saw remission of symptoms after the first two STAR*D steps. However, NIMH failed to mention in its press release that in the same time it took to complete these first two steps—slightly over 6 months—previous research shows that depressed people receiving no treatment at all have a spontaneous remission rate of 50 percent.

In November 2006, following the completion of all four STAR*D steps, STAR*D authors claimed a 67 percent cumulative remission rate, which again exasperated many scientists because this number failed to incorporate STAR*D’s extremely high relapse and dropout rates. In an American Journal of Psychiatry editorial that accompanied STAR*D authors’ report, J. Craig Nelson, M.D, stated, “I found a cumulative sustained recovery rate of 43 percent after four treatments, using a method similar to the authors but taking relapse rates into account.” However, even 43 percent turns out to be an inflated rate.

Separate analyses of STAR*D in 2010 by psychologist Ed Pigott and medical reporter Robert Whitaker revealed that STAR*D researchers had inflated remission numbers by switching mid-study to a more lenient measurement, and also by including patients who were not depressed enough at baseline to meet study criteria. But even taking the STAR*D data as is, Pigott’s analysis revealed that less than 3 percent of the entire group of depressed patients who began the STAR*D study can be ascertained as having a sustained remission (i.e., actually participated in the final assessment without relapsing and/or dropping out).

Myth 3: Electroconvulsive Treatment (ECT) is an Effective Last Resort

Andrew Solomon in The Noonday Demon alsostates, “ECT seems to have some significant impact between 75 and 90 percent of the time. About half of those who have improved on ECT still feel good a year after treatment.” Is ECT really that effective?

In 2004, researcher Joan Prudic, M.D. and her team at New York State Psychiatric Institute conducted a major study of ECT, which involved 347 patients at seven hospitals. Reported were both the immediate outcomes and the outcomes over a 24-week follow-up period. With respect to immediate outcomes, Prudic reported: “In contrast to the 70 to 90 percent remission rates expected with ECT, remission rates, depending on criteria, were 30.3 to 46.7 percent.” Even worse for ECT advocates, Prudic noted that, “10 days after ECT, patients had lost 40 percent of the improvement.”

There are also studies comparing ECT with a placebo (called “sham ECT”). In sham ECT, patients receive muscle-relaxing and anesthetizing drugs that routinely accompany ECT, and they are hooked up to the ECT apparatus, but they receive no electric voltage. Psychiatrist Colin Ross reports, “No study has demonstrated a significant difference between real and placebo (sham) ECT at 1 month post-treatment.”

Myth 4: Cognitive Behavior Therapy (CBT) is the Best Psychotherapy for Depression

First, the good news about CBT. The only non-drug treatment examined in STAR*D was a form of cognitive therapy (which was not fully detailed by STAR*D authors and only administered in Step Two). Among those who failed Celexa in the first step, three groups in Step Two switched from Celexa to one of three antidepressants, and their remission rates ranged from 25 to 26.6 percent; but one group in Step Two switched from Celexa to cognitive therapy, and its remission rate was 41.9 percent. STAR*D researchers did not assess whether any differences in treatment effectiveness were statistically significant.

Another group in Step Two maintained Celexa and added cognitive therapy, and this “Celexa plus cognitive therapy” group’s remission rate was 29.4 percent, not as high as the group that received cognitive therapy without medication. This begs the question: Is it also a myth that “antidepressants plus psychotherapy” works better than either treatment alone? Research psychologist David Antonuccio at the University of Nevada School of Medicine reports, “Combined psychotherapy and drug treatment do not appear to be superior to therapy or drug treatment alone.”

What psychotherapy is best for depression? While Americans hear most about CBT, it turns out that CBT or some form of cognitive therapy is no more effective for depression than any of several other types of psychotherapy. In 2008, psychologists Pim Cuijpers and Annemicke van Straten at the University of Amsterdam reported on a meta-analysis of 53 studies, each of which compared two or more different types of psychotherapy for depression. Included were varieties of “cognitive-behavior therapy,” “psychodynamic therapy,” “behavioral activation therapy,” “social skills training,” “problem-solving therapy,” “interpersonal therapy,” and “nondirective supportive therapy.” The major finding? “No large differences in efficacy between major psychotherapies for mild to moderate depression.”

So, if psychotherapy technique is not all that important, what is? Psychologist Bruce Wampold at the University of Wisconsin reviewed the psychotherapy outcome literature, examining hundreds of studies and meta-analyses, for his book The Great Psychotherapy Debate. Wampold unequivocally states that outcome effectiveness does not depend on the specific techniques of psychotherapy but instead depends on so-called “non-specific” factors such as the nature of the alliance between therapist and their client, and clients’ confidence in the therapy and in their therapist. “Simply stated,” Wampold concludes, “the client must believe in the treatment or be led to believe in it.”

Myth 5: No Treatment for Depression Works

In April 2002, an NIMH-funded study on the antidepressant Zolof, the herb St. John’s wort, and a placebo had some curious results. The findings were that 32 percent of placebo-treated patients experienced remission, better than the 25 percent remission for the Zoloft-treated patients or the 24 percent remission for the St. John’s wort-treated patients. Most scientists would say that this study shows that neither Zoloft nor St. John’s wort worked, but those subjects who had positive outcomes with these two treatments would disagree. So, does this study show that antidepressants and St. John’s wort are not helpful, or does it show that “expectations,” belief,” and “faith” are the likely factors that make all treatments work?

When assessing whether a specific treatment is effective, scientists are trained to rule out the effect of expectations. Researchers evaluate a depression treatment as effective if, in a controlled study, the treatment outcome is significantly better than a placebo. However, the reality of depression treatments is that expectations, faith, belief, and the placebo effect are—far and away—the most important reasons why anything works.

Read the rest of the article here: http://www.counterpunch.org/levine12032010.html

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Antidepressant Drugs Are Not Safe During Pregnancy—No Matter What the Pharma Shills Say

Thursday, November 4th, 2010

by CCHR International

November 4, 2010

Medical News Today published an article entitled “Increased Depression Screening Needed During Pregnancy, Study Says,” that is so highly misleading,  we wonder if they ever bother checking the validity of what they’re forwarding under the guise of “medical news.”

We’re going to make this really simple—the study and its findings are bogus not to mention highly misleading and we’re only going to take up the two most egregious “facts” of the article to make our point.

The article states, “The authors of the study say their findings suggest that screening for depression should be a routine part of prenatal and postnatal care.  They conducted a 10-week pilot project at WIC clinics in Santa Fe and Las Vegas, N.M., finding that 109 of 467 women who were screened had a high enough score on the Edinburgh Postnatal Depression Scale to require a referral.”

FACT: The Edinburgh Postnatal Depression Scalealso called EPDS, is a screening method documented to triple the number of women diagnosed with Post partum depression, according to a study published in Obstecrics & Gynecology. The Scandinavian Journal of Public Health stated that EPDS screening was so unethical it should not be used.

So the authors are knowingly promoting a study which is known to triple the amount of women diagnosed postpartum depression,  has been called so unethical it should not be used.

Next, the article states, “There are antidepressants that are safe to take during pregnancy”

False.

FACT: Four countries have done nine studies on the effects of antidepressants during pregnancy or breast feeding.  They found that newer and older antidepressants can cause premature births, and increase the risk of cardiovascular interventions such as heart surgery in early childhood.  In addition, newer antidepressants could also cause withdrawal symptoms, respiratory problems, and neurological problems.

Six counties have issued a total of 15 drug regulatory warnings on antidepressants causing severe problems for newborns.

They warn of:

  • Newer antidepressants causing seizures,
  • Wellbutrin, Cipralex, Luvox, Remeron, Effexor and Zyban increasing the risk of a life-threatening lung condition in newborns,
  • Zoloft and Celexa causing withdrawal symptoms and increasing the risk of a life-threatening lung condition in newborns,
  • Paxil and Prozac causing withdrawal symptoms and increasing the risk of cardiovascular birth defects and a life-threatening lung condition in newborns

Like we said, the article and the “findings” are highly misleading to say the least.

We’d also like to suggest something to any press forwarding these psycho/pharma puff pieces— Its called Google Search.   Its pretty easy these days to check the facts before promoting bogus studies and or “findings”  that are not only false, but can harm pregnant women and can give false information under the guise of “medical news.”   We also recommend that anyone reporting on psychiatric drugs at least check  our psychiatric drug database to see what international drug regulatory agencies and international studies have warned about these drugs instead of just regurgitating the latest pro drug study http://www.cchrint.org/psychdrugdangers/

Here is  a very short video of what can happen to pregnant women when they are not given the facts about these drugs:

In Memory of Matthew Schultz / Effexor Baby Pregnancy Infant Death

http://www.youtube.com/watch?v=qnxuw2ufSug&p=7F22F2C419977E5A&playnext=1&index=70

And finally, the “Medical News” article:

Increased Depression Screening Needed During Pregnancy, Study Says

Medical News Today

Twenty-three percent of pregnant women screened at two Women, Infant and Children clinics in New Mexico met criteria for depression, according to a study by a work group of the New Mexico Health Department and state Human Services Department, the Albuquerque Journal reports.

Nationwide, 10% to 16% of pregnant women meet the criteria for depression, and 70% show some depressive symptoms, according to the American College of Obstetrics and Gynecologists.  In June, ACOG said that screening of pregnant women for depression should be “strongly considered” but that there is not enough evidence to recommend it.

The authors of the new study say their findings suggest that screening for depression should be a routine part of prenatal and postnatal care. They conducted a 10-week pilot project at WIC clinics in Santa Fe and Las Vegas, N.M., finding that 109 of 467 women who were screened had a high enough score on the Edinburgh Postnatal Depression Scale to require a referral. The work group recommended increased training on depression screening tools for providers and more support groups for women, in both English and Spanish.

Signs of depression in pregnant women include feeling dread about the pregnancy, anxiety, isolation from loved ones, suicidal thoughts, self-harm, constant sadness, changes in appetite and lack of ability to experience pleasure, according to therapist Stefanie Luna. Doctors say leaving severe depression untreated could increase the risk for low birthweight or premature birth. When women are depressed they also are less likely to care for themselves and more likely to drink or smoke. There are antidepressants that are safe to take during pregnancy (Schoenberg, Albuquerque Journal, 11/1).

http://www.medicalnewstoday.com/articles/206701.php

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