Patient Beware: Negative Results Of Psych Drug Tests Were Not Revealed To Your Doctor

 

Image by Petr Kratochvil
Image by Petr Kratochvil

Analysis of articles published on the outcomes of clinical trials of psychiatric drugs found that many unfavorable results never appeared in the professional journals doctors rely on to make informed decisions for their patients.

A new report published in PLoS Medicine found that drug companies seeking FDA approval for eight newer, so-called atypical antipsychotic drugs performed a total of 24 studies.  But four of the studies were never published in professional journals – and all four of those studies had negative results for the drugs in question.

Three of those unpublished studies showed that the new drugs were no better than sugar pills.

Lead author Erick Turner, M.D., a former drug reviewer for the FDA and now at Oregon Health & Science University and the Portland VA Medical Center, called the results of the analysis “unsettling” and called on the FDA for greater disclosure of drug trial results.

Doctors subjected to aggressive marketing by pharmaceutical companies, but not getting full disclosure of negative clinical trial results, are fueling the skyrocketing use of these expensive antipsychotic drugs, increasingly using them for purposes for which the drugs have not been approved.  A study published last year found that off-label antipsychotic prescriptions doubled between 1995 and 2008, from 4.4 million to 9 million.  Sales of the drugs exceeded $16 billion in 2010, according to IMS Health, a data tracking firm for the health-care industry.

And antipsychotic drugs were not the only psych drugs for which negative clinical trials were squelched.  In 2008, Dr. Turner and his colleagues found an even greater publication bias for antidepressants.  Nearly one of every three clinical trials of antidepressants by drug companies produced troubling results that were never revealed in professional publications.

Without access to this negative information, doctors do not get the complete picture of the dangers and ineffectiveness of the psych drugs they may be prescribing to their patients – and both doctors and their patients need to know this.

 

WARNING: Anyone wishing to discontinue psychiatric drugs is cautioned to do so only under the supervision of a competent medical doctor because of potentially dangerous withdrawal symptoms.

If you or someone you know has experienced harmful side effects from a psychiatric drug, we want to talk to you. You can contact us privately by clicking here or by calling 303-789-5225. All information will be kept in the strictest confidence. We welcome your comments on this article below.

Government Needs To Improve Oversight of Psychiatric Drugging of Vulnerable Populations

Federal lawmakers received two major reports last week on the troubling lack of oversight at the federal level of the prescribing of psychiatric drugs to two of our nation’s most vulnerable populations:  foster children and the elderly in care facilities.

A Government Accountability Office (GAO) report on the massive psychiatric drugging of foster children recommended that federal health officials do more to monitor how state agencies oversee Medicaid doctors’ prescribing of powerful, mind-altering drugs to children who end up in the state’s care after being abused, neglected or abandoned.

Sen. Tom Carper, D-Del., requested the GAO investigation after receiving numerous complaints about the quantity of drugs being prescribed and the adverse effects of the drugs experienced by foster kids.

The GAO recommended that the US Department of Health and Human Services  come up with guidance for states on how to oversee the prescribing of psychiatric drugs for foster children.

In a separate investigation, government inspectors called on Medicare officials to do more to stop doctors from prescribing powerful psychiatric drugs for the elderly living in care facilities.

In particular, antipsychotics are given to hundreds of thousands of elderly nursing home patients to sedate them and make them more manageable.

But the drugs carry an increased risk of death for seniors, which led the FDA to issue warnings against prescribing the drugs to the elderly.

Despite repeated government warnings, the unapproved practice has continued.

The HHS Inspector General told the Senate Committee on Aging that Medicare should begin penalizing nursing homes that overdrug with antipsychotics .  Medicare could force nursing homes to pay for drugs that are prescribed wrongly and bar the facilities from the Medicare program.

If you know a foster child or nursing home patient who has been harmed by psychiatric drugs, we want to talk to you. You can contact us privately by clicking here or by calling 303-789-5225. All information will be kept in the strictest confidence. We welcome your comments on this article below.

ABC News Reports Shocking Use of Psychiatric Drugs With Foster Children

Citing the fact that foster children are given powerful, mind-altering psychiatric drugs at an alarming 13 times the rate of other children, ABC News rolled out a series of reports based on a year-long investigation into the use of these drugs – antidepressants, antipsychotics, psycho-stimulants and other psychotropic drugs – with American foster children.

The investigation found that these children, who have already been traumatized by abuse, neglect, and abandonment, were prescribed heavy-duty psychiatric drugs in shocking amounts, in combinations considered too risky even for adults, and for disorders they don’t have.  It found kids who have taken these drugs say they are in a kind of chemical prison.

In response to the shocking findings, ABC reporter Diane Sawyer asks:

“Is there something else we owe these kids who have already endured so much?”

The ABC News reports coincide with the release of a report by the US Government Accountability Office (GAO), which revealed foster kids are prescribed psychiatric drugs more often than non-foster kids and at higher doses – often at doses higher than the maximum levels approved by the Food and Drug Administration (FDA).   The report also found a significant number of foster children were prescribed five or more psychiatric drugs at the same time despite no evidence supporting the use or safety of this number of psychiatric drugs taken simultaneously.

You can listen to the stories of these kids by clicking on the links to the ABC News reports here:

New Study Show US Government Fails to Oversee Treatment of Foster Children Prescribed Mind-Altering Drugs

Doctors Put Foster Children at Risk with Mind-Altering Drugs

Foster Kid Felt Like “Guinea Pig”

20/20:  Overmedication in Foster Care

If you know about a foster child who has been harmed by psychiatric drugs, we want to talk to you. You can contact us privately by clicking here or by calling 303-789-5225. All information will be kept in the strictest confidence. We welcome your comments on this article below.

GAO Study Details Massive Psychiatric Drugging Of Foster Children

A report by the Government Accountability Office (GAO) to be released tomorrow reveals that American foster children are drugged with powerful, mind-altering psychiatric drugs at many times the rate of non-foster children.

The GAO’s report, based on a two-year-long investigation, looked at five states — Florida, Massachusetts, Michigan, Oregon and Texas.  Among the key findings:

  • Foster children were nearly five times more likely to be prescribed psychiatric drugs than non-foster children.
  • Overall, nearly one-third of the foster children in the five states under investigation were prescribed at least one psychiatric drug.  (Other studies have shown that as many as half of foster kids in other areas are on psychiatric drugs.)
  • Thousands of foster children were being prescribed psychiatric drugs at doses higher than the maximum levels approved by the Food and Drug Administration (FDA) in these five states alone, and hundreds received five or more psychiatric drugs at the same time despite absolutely no evidence supporting the simultaneous use or safety of this number of psychiatric drugs taken together.
  • Foster children were more than nine times more likely than non-foster children to be prescribed drugs for which there was no FDA-recommended dose for their age.
  •  Foster children less than 1 year old were twice as likely to be prescribed a psychiatric drug as non-foster 1-year-olds.

When U.S. Senator Thomas Carper, D-Delaware, lead requestor of the GAO report, first learned of the report’s findings, he said:

“I was almost despondent to believe that the kids under the age of one, babies under the age of one were receiving this kind of medication.”

Carper requested the study after receiving numerous reports of waste and abuse in the prescribing of psychiatric drugs to foster children.

Taxpayers foot much of the bill.  Medicaid spends more than $6 billion per year on psychiatric drugs, or nearly 30 percent of its entire drug budget, more than double what was spent in 1999, according to the Centers for Medicaid and Medicare Services.

The report has already raised calls for states to report pharmacy claims of the psychiatric drugs given to foster children for more transparency on the issue.

ABC News was given advance access to the GAO report.  The ABC report can be accessed by clicking here.

If you know about a foster child who has been harmed by psychiatric drugs, we want to talk to you. You can contact us privately by clicking here or by calling 303-789-5225. All information will be kept in the strictest confidence. We welcome your comments on this article below.

Psychiatry’s Deadliest Scam

New CCHR Video Exposes History and Harm Of Psychiatry’s Billing Bible.

Calling it psychiatry’s deadliest scam, CCHR International has just released a blistering exposé of psychiatry’s billing bible, the Diagnostic and Statistical Manual (DSM).

Tracking the history of the DSM and following the enormous money trail between psychiatry and the pharmaceutical industry, the video documents how psychiatry’s psychobabble is being used to turn every aspect of human behavior – even the fussing of newborns – into a mental disorder that can be “treated” with drugs, and how that has impacted schools, government, the courts, and the military and is tearing families apart.

The documentary details the harmful effects of these drugs and the costs of this psycho-pharmaceutical sham in terms of human suffering and deaths.  As a former director of the Office of Drug and Chemical Control with the U.S. Drug Enforcement Administration (DEA) puts it, “We’re rolling dice with life, we’re rolling dice with our children…”

The video also tallies the massive rip-off to taxpayers and the increase in private health insurance costs – all by an industry that has never produced a single cure and all supported by the bogus DSM.  Another expert sums it up this way: “It’s a runaway train, and the DSM is the locomotive.”

Professionals in the fields of medicine, law, education, biochemical research and pharmaceutical sales reveal what psychiatrists and the drug companies don’t want you to know.  You will want to pay particular attention to the number of startling revelations by psychiatrists themselves about the DSM and the field of psychiatry.

The video can be viewed online by clicking here and then clicking on “Diagnostic and Statistical Manual.”   Watch it and then contact us to find out how you can help put an end to psychiatry’s gambling with human lives.

If you or someone you know has been harmed by a psychiatric diagnosis or drugs, we want to talk to you.  You can contact us privately by clicking here or by calling 303-789-5225.  All information will be kept in the strictest confidence.  We welcome your comments on this article below.

CHADD Gets Big Financial Support From ADHD Drug Makers

It Doesn’t Take A Brain Surgeon To Figure Out Why.

An article in yesterday’s Denver Post fails to disclose the substantial financial ties between a group that pushes for the acceptance of so-called “attention deficit hyperactivity disorder” (ADHD) and the pharmaceutical companies that manufacture the drugs prescribed for it.

The organization, Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD), has been severely criticized by both the United Nations International Narcotics Control Board (INCB) and the United States Drug Enforcement Administration (DEA) for its financial ties to the manufacturers of ADHD drugs.  (For more information on these ties, see CCHR International’s report, “Marketing ‘Disorders’ to Sell Drugs.”)

Direct pharmaceutical financial support of CHADD in the year ending June 30, 2009, the latest year for which CHADD has provided data online, totaled $1,174,626, or 27% of the organization’s budget.  The drug companies providing this money included Eli Lilly, McNeil, Novartis, and Shire US – all makers of ADHD drugs.

 ADHD Drug Manufacturers Supply 36% of CHADD Revenues

Additionally, the drug companies paid another $412,500 to CHADD in sales and advertising.  Thus, the total financial support of CHADD by the drug manufacturers was $1.6 million, or 36% of total revenues.  Why all this financial support?

Pharmaceutical companies have slick marketing plans for selling psychiatric drugs.  They create new “disorders,” as well as elevate the seriousness of existing “disorders,” with the goal of worrying normal people that they are worse off than they thought they were and need treatment – with drugs.  Support groups such as CHADD forward the drug companies’ aim of gaining acceptance of these “disorders.”  (For more information on the psycho-pharmaceutical industry’s plans, you can view CCHR International’s DVD, “The Marketing of Madness,” online here.)

CHADD continues to falsely claim that ADHD is a “neurobiological disorder” when there is no valid, conclusive scientific proof of this.  In fact, no such claim is made in the 1999 Surgeon General’s Report on Mental Health, in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), by the National Institutes of Health, or in the American Academy of Pediatrics Clinical Practice Guideline for ADHD.  Even Clarke Ross, CEO of CHADD for the 10 years through 2010, is quoted by The Washington Times Insight Magazine as saying about ADHD:  “It really is a matter of belief.”

ADHD remains merely a subjective list of behaviors, which became a “mental disorder” in 1987 when members of the American Psychiatric Association voted it into existence so psychiatrists could bill insurance for treating it.  That same year, CHADD was formed.  With large-scale financial support from the pharmaceutical companies, the number of CHADD chapters exploded.

 ADHD Drugs May Cause Dangerous Side Effects

Common ADHD drugs are amphetamines – highly addictive and 10 times more likely than other prescription drugs to be linked to violence.  The FDA warns that ADHD drugs can cause heart attacks, strokes and sudden death.  There are no long-term studies on the safety and effectiveness of ADHD drugs.  (Research studies, warnings from international regulatory authorities, and reports to the U.S. Food and Drug Administration on the harmful side effects of ADHD and other psych drugs can be accessed through CCHR International’s psychiatric drug side effects search engine.)

WARNING: Anyone wishing to discontinue ADHD drugs or other psychiatric drugs is cautioned to do so only under the supervision of a competent medical doctor because of potentially dangerous withdrawal symptoms.

If you or someone you know has been harmed by taking an ADHD drug or other psychiatric drug, we want to talk to you.  You can contact us privately by clicking here or by calling 303-789-5225.  All information will be kept in the strictest confidence.  We welcome your comments on this article below.

 

Message to Moms: Teenagers Who Eat Fish and Omega-3 Fats Have A Lower Risk of Feeling Depressed

 

Image by Petr Kratochvil
Image by Petr Kratochvil

Serve it with ketchup, salsa, or smothered with cheese if necessary, but get your kids to eat more fish.

Yet another study links higher levels of omega-3 fats to a lower chance of feeling depressed.

Japanese researchers studied 6,500 boys and girls, ages 12 to 15 years old, to find any relationship between their consumption of fish and omega-3 fats and their feelings of depression.

Their conclusion: teenagers who eat fish and omega-3 fats have a relatively low risk of feeling depressed.  (Reference:  Murakami K, Miyake Y, Sasaki S, et al.  Fish and n-3 polyunsaturate fatty acid intake and depressive symptoms: Ryukyus child health study. Pediatrics, 2010: doi 10.1542/peds.2009-3277.)

Some common sources of omega-3 fats are salmon, herring, mackerel, halibut, tuna and other fish, as well as eggs, flaxseeds and flaxseed oil, canola oil, soybean oil, olive oil, walnuts, pumpkin seeds, and fish oil supplements.  For more information on getting omega-3 fats into your child’s diet, consult a nutritionist, dietician, or other health professional.

Urgent Message for Colorado and Wyoming Veterans: Antipsychotics Are Reportedly Ineffective Against PTSD

Known Side Effects Of The Drugs Include Diabetes, Stroke and Sudden Death

First, antidepressants were found to be no more reliably effective than sugar pills.  (See: “Review of Studies Finds Antidepressants Not Reliably Better Than Sugar Pills”)

Now comes the news that the same thing can be said about antipsychotics in the treatment of post-traumatic stress disorder (PTSD).

According to a report in the New York Times, a new study found that antipsychotic drugs widely prescribed for PTSD are no more effective than placebos (sugar pills).

The finding comes from the largest study of its kind in veterans, and directly and immediately challenges the drug treatment of returning military personnel.

The use of antipsychotics to treat stress in veterans has increased sharply over the past decade.  But the new study showed that after six months of treatment, veterans taking antipsychotics were doing no better than veterans given a placebo.

Worse still, antipsychotics have serious side effects, including obesity, diabetes, cognitive decline, heart problems, stroke, and sudden death.  (Adverse reactions to psychiatric drugs, as detailed in research studies, warnings from international regulatory authorities and reports to the FDA, can be accessed through CCHR International’s psychiatric drug side effects search engine.)

The new study, published in The Journal of the American Medical Association, focused on Risperdal, but experts said the same results most likely apply to other antipsychotics, including Seroquel, Geodon and Abilify.

Dr. Charles Hoge, a senior scientist at the Walter Reed Army Institute of Research, said about the study: “It’s very rigorously done, and it definitely calls into question the use of antipsychotics in general for PTSD.”

WARNING: Veterans currently taking antipsychotics are cautioned against suddenly discontinuing them.  No one should stop taking any psychiatric drug without the advice and supervision of a competent medical doctor.

If you or someone you know has been wrongly put on antipsychotics, we want to talk to you.  You can contact us privately by clicking here or by calling 303-789-5225.  All information will be kept in the strictest confidence.  We welcome your comments on this article below.

Review of Studies Finds Antidepressants Not Reliably Better Than Sugar Pills

Are Antidepressants Just Placebos With Side Effects?

Reviews of large numbers of studies on antidepressants – including studies the drug companies never published because they did not have positive outcomes – continue to show that improvement in patients given antidepressants is due largely, if not entirely, to the placebo effect and not the drugs.

In 2010, Irving Kirsch, Ph.D., professor of psychology at the University of Hull in England and author of “The Emperor’s New Drugs: Exploding the Antidepressant Myth,” published an article on the conclusions he and his colleagues reached after reviewing data the drug companies had sent to the FDA.  The data, obtained by using the Freedom of Information Act, included results that had never been published because the results were not favorable to the drugs the companies were testing.

Kirsch termed the results of the review “shocking.” His group’s meta-analysis (the analysis of many clinical trials on the same subject – in this case, antidepressants) found that placebos – sugar pills – are 82% as effective as antidepressants.  However, they further found that even this “relatively small difference between drugs and placebos might not be a real drug effect at all.  Instead, it might be [nothing more than] an enhanced placebo effect.”

The placebo effect refers to perceived or actual improvement in health that does not come from the treatment the patient is receiving, which may be a dummy pill, but from the patient’s belief that the treatment will help.

The FDA only requires two clinical trials that show any statistical difference between drug and placebo in order to approve a drug – even if a much larger number of studies failed to show positive results.  And the positive result can be so small that it makes no real difference in people’s lives.  The FDA does not require results to be clinically significant, just statistically significant.

Kirsch’s results are supported by another group of researchers who reviewed four meta-analyses of clinical trials on antidepressants that were submitted to the FDA.

Their conclusion, published in Psychotherapy and Psychosomatics last year, stated that “antidepressants are only marginally efficacious [effective] compared to placebos,” and even this modest benefit might be inflated by “profound publication bias.”  Publication bias means the tendency of researchers and publications to publish results that are favorable for the drugs being tested and to hide or reject results that are unfavorable, thereby shaping both professional and public opinion by unscientific means.

These same researchers also analyzed the data from STAR*D (Sequenced Treatment Alternatives to Relieve Depression), the largest antidepressant effectiveness trial ever conducted.  They found that “the effectiveness of antidepressant therapies was probably even lower than the modest one reported by [that study’s] authors, with an apparent progressively increasing dropout rate across each study phase.”  The progressively increasing dropout rate, as more and more participants dropped out of the study because of adverse effects they experienced, means the study became more and more biased towards a favorable outcome.

The researchers found results on the antidepressant studies to be so inflated that they call for a complete reconsideration of the use of antidepressants: “The reviewed findings argue for a reappraisal of the current recommended standard of care of depression.”

Their concern is shared by Marcia Angell, former editor-in-chief of The New England Journal of Medicine and now a senior lecturer in social medicine at Harvard Medical School.  In the first part of her recent, two-part essay in The New York Review of Books,  she writes about the disturbing extent to which the pharmaceutical companies that sell psychoactive drugs – through both legal and illegal marketing and “what many people would describe as bribery” – have come to determine the “diagnosis” and treatment of mental illness.

In the second part of her essay, she calls for more research into alternatives to antidepressants:  “More research is needed to study alternatives to psychoactive drugs, and the results should be included in medical education.”

Indeed.  If antidepressants are no more effective than placebos, but come at a great cost and expose individuals to a lengthy and growing list of devastating and even life-threatening side effects, including deepening and chronic depression and suicide, it only makes sense that diet, nutritional supplements, exercise, and meaningful activities be explored as alternatives.

Just as important, depression is very often a mental symptom of an undiagnosed, untreated physical condition.  A complete physical examination by a non-psychiatric physician should always be done to look for underlying physical conditions before antidepressants or other psychotropic drugs are prescribed.

Individuals currently taking antidepressants are cautioned against suddenly discontinuing them.  No one should stop taking any psychiatric drug without the advice and supervision of a competent medical doctor.

If you or someone you know has been harmed by antidepressants or other psychiatric drugs, you can contact us privately by clicking here or by calling 303-789-5225.  All information will be kept in the strictest confidence.  We also welcome your comments below.

Chance of Autism Doubles with Antidepressant Use During Pregnancy

A study just published in the Archives of General Psychiatry found that the odds of having an autistic child doubled for mothers who took newer antidepressants known as SSRIs (selective serotonin reuptake inhibitors) during the year before delivery.

SSRIs include Prozac, Zoloft, Celexa and Lexapro, among others.

The study found that the rate was greater than two autistic children per 100 mothers on SSRIs, with the rate higher still if mothers took SSRIs in the first trimester of their pregnancy.

The research was undertaken because the rising incidence of autism in recent years parallels a rise in the use of SSRIs during pregnancy.

A second study just released also suggests that environmental factors, including prenatal conditions, play a significantly larger role in autism.

Dr. Joseph Coyle, editor-in-chief of the psychiatry journal, called the two studies “game changers.”

Clara Lajonchere, an author of one of the studies and vice president of clinical programs for the research and advocacy organization Autism Speaks, said that “much more emphasis is going to be put on looking at prenatal and perinatal [around the time of childbirth] factors with respect to autism susceptibility.”

Pregnant women currently taking SSRIs are cautioned against suddenly discontinuing them.  No one should stop taking any psychiatric drug without the advice and supervision of a competent medical doctor.

If you or someone you know gave birth to a child with birth defects or other problems after taking psychiatric drugs during pregnancy, we want to talk to you.  You can contact us privately by clicking here or by calling 303-789-5225.  All information will be kept in the strictest confidence.  We welcome your comments on this article below.