Upgrading the Chantix Black Box Warning

Upgrading the Chantix Black Box Warning

In response to a request from drug giant Pfizer to remove the “black box” warning on the smoking-cessation drug Chantix (varenicline – an addictive benzodiazepine-based psychotropic anti-anxiety drug), the FDA has decided to not only retain the warning but expand it.

The current label for Chantix already warns that patients taking the drug may develop aggressive or suicidal behavior. That warning will be expanded to note that the drug has also been linked to reduced alcohol tolerance leading to seizures.

The new safety announcement (March 9, 2015) says, “The U.S. Food and Drug Administration (FDA) is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. In addition, rare accounts of seizures in patients treated with Chantix have been reported. We have approved changes to the Chantix label to warn about these risks. Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately.”

We knew about the dangers of drinking and driving. Now we have one more side effect to worry about — drinking and Chantix. So it’s likely OK to drink and smoke, but not to drink and quit smoking. (That was a joke.)

But it’s no joke that Chantix is an addictive, psychotropic, psychiatric drug with potentially severe side effects. If you want to quit smoking, there are certainly better non-drug alternatives.

For more truthful information about this and other psychiatric drugs, click here.

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Feds Pay for Drug Fraud

Feds Pay for Drug Fraud

92 Percent of Foster Care, Poor Kids Prescribed Antipsychotics Get Them for Unaccepted Uses
This Huffington Post article on April 30, 2015 exposes the fact that poor and foster care kids covered by Medicaid are being prescribed too many dangerous antipsychotic drugs at young ages for far too long — mostly without any medical justification at all.
“92 percent of all kids on Medicaid receiving antipsychotics don’t have any of the limited ‘medically accepted pediatric conditions’ supposedly justifying their use. These ‘accepted conditions’ include the authority to use antipsychotics even for autistic children as young as 5 for such dubious FDA-approved conditions as ‘irritability.'”

“Medicaid spends about $3.5 billion a year on antipsychotics for all ages, largely for unaccepted uses, with nearly 2 million kids prescribed them. Nationally, about 12 percent of all the nation’s 500,000 foster care children have received Medicaid-paid antipsychotics at some point, often because they haven’t been offered proven, “trauma-informed” intensive therapies, according to Kamala Allen, director of Child Health Quality for the Center for Health Care Strategies.”

“… it shouldn’t be surprising to learn that federal officials aren’t too keen on enforcing drugging protections for either nursing home residents (whose meds are usually paid by Medicare) or children on Medicaid. ‘The federal government has done absolutely nothing of significance to rein in overprescribing,’ says Bill Grimm, a senior counsel with the San Francisco-based National Center for Youth Law (NYCL) that has launched a PsychDrugs Action Campaign, now focused primarily on pending reform bills in the California legislature.”

“… just two months ago, a Philadelphia jury found that Janssen hid the breast-growth dangers of the drug Risperdal and owed $2.5 million to a 20-year-old autistic man who developed size 46 DD breasts as a teenager. ‘This was the first case related to the condition called gynecomastia that went to a jury, but thousands more lawsuits are lined up in Philadelphia, California, Missouri, and other locations,’ The Philadelphia Inquirer reported.”

“… what’s especially absurd … is the notion that federal officials think they’re not allowed to suggest to state Medicaid authorities to stop paying for the unaccepted uses of these and other drugs.”

“As Dr. David Rubin, the director of the Policy Lab at the Children’s Hospital of Philadelphia, told Mental Health Weekly, ‘The medications are being used particularly for disruptive behavior and to control the children.’ Yet nearly half of all kids getting the drugs aren’t getting other behavioral health services such as therapy, according to research by the Center for Health Care Strategies.”

“A shocking five-part series by The San Jose Mercury News, published last year, highlighted dangerous overprescribing that showed that thousands of foster care kids over a decade — nearly one in four foster teens — had been essentially ‘chemically restrained’ for their behavior with antipsychotics drugs that left many drooling, lethargic and obese.”

“Edward Opton, an attorney with the National Center for Youth Law’s PsychDrugs Action Campaign, has underscored why foster care kids are especially vulnerable. Even though they make up just 3 percent of all Medicaid children, they account for roughly 30 percent of all Medicaid behavioral spending for kids: ‘Foster children are a lucrative market for psychotropic drug sales. Unlike adults, they can’t say, “No, I won’t take any more of that drug,”‘ he wrote in a recent column on the Mad in America website.”

You should read the full Huffington Post article, it is most illuminating.

You should also contact your local, state and federal officials and ask them why this Medicaid fraud persists.

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Disturbing New Research on Psych Drugs

Disturbing New Research on Psych Drugs

An increasing number of researchers are finding fault with psychiatric drugs in one form or another. Keep up the pressure by contacting your local, state and federal officials about the dangers of psychiatric fraud and abuse. Here are some examples.

Bias in Antidepressant Studies

Investigators at the University Medical Center Groningen, the Netherlands, found that trials which the FDA deemed positive were five times more likely to be published compared with trials deemed not positive. In other words, there is less evidence to support the effectiveness of antidepressants than what appears from the published studies. [March 25, 2015 JAMA Psychiatry]

This means that the published studies reporting on the effectiveness of antidepressants are overestimating the benefits and underestimating the harm of antidepressants.

Other researchers commenting on these results note that antidepressants are not very useful at all.

High-Dose Antidepressants Increase Risk of Self-Harm

In this study [April 28, 2015 JAMA Internal Medicine] children and young adults who are started on higher doses of antidepressants than are typically prescribed are at least twice as likely to engage in acts of deliberate self-harm. Of course, they don’t have a clue why this occurs.

Antidepressants Linked to First-Time Seizures

Antidepressants have now been linked to an increased risk for first-time seizures. Of course, they already knew that an overdose of antidepressants is associated with an increased risk of seizures. Now they are admitting that, among patients who have never had seizures previously, the use of therapeutic doses (i.e. not overdoses) of antidepressants can trigger the onset of seizures. [23rd Congress, European Psychiatric Association]

Patient Expectations Dictate Antidepressant Response

People’s expectations about how effective their antidepressant is going to be almost entirely predicts their response to it. This means that there is almost no difference between the effect of an antidepressant and a placebo. [September 11, 2014, British Journal of Psychiatry]

There is also a much higher relapse rate in those using psychiatric drugs than those who do not.

Good, compassionate, non-psychiatric care is more significant for well-being than any psychiatric drug. So there is really no reason at all for using them; and because of the potential for greatly harmful side effects, there is no reason to continue their use.

Fully informed consent is your defense against the scourge of psychiatric drugs.

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Migrant Children, a New Psychiatric Patient Pool?

Migrant Children, a New Psychiatric Patient Pool?

While we hesitate to comment on the controversy surrounding the federal government’s amnesty program for illegal immigrants, we do see a potential effect of interest to the concerns of CCHR and those who recognize the potential for psychiatric fraud and abuse.

The Wall Street Journal reported that “Such students [illegal aliens, or “migrant children”] often require a variety of services, including subsidized meals, English-language instruction, tutoring and psychological counseling…”

It’s that last phrase, “psychological counseling”, that caught our attention.

Could migrant children be considered a new pool of patients to be abused by the psychiatric and psychological industries?

There are already research articles being published on the “mental health of migrant children.” Look out for a proliferation of media, studies, and requests for funding for this expanding population as a new pool of “mental health care” patients.

Contact your local, state and federal officials and your school boards to be on the lookout for psychiatric fraud and abuse within the migrant population.

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Commercial Airline Pilots & Mind-Altering Drugs

Commercial Airline Pilots & Mind-Altering Drugs

Medical records indicate that Andreas Lubitz, the co-pilot who crashed the Germanwings plane in the French Alps, was on medications for depression, anxiety and panic attacks, including lorazepam [an anti-anxiety drug] that can have dangerous side effects, German newspaper Bild reported.

Mania, psychosis, hallucinations, depersonalization and suicidal and homicidal ideation. These all are documented side effects from 134 international drug regulatory agency warnings on the very drugs that commercial airline pilots are allowed to take. While not everyone taking these drugs will experience these side effects, what is certain, based on hundreds of drug warnings and studies, is that a percentage of the population will.

Andreas Lubitz, co-pilot of Germanwings flight 9525 blamed for purposefully flying the aircraft into the French Alps and killing all on board, had a long history of mental “treatment” and psychiatric drug use. According to German police investigators, numerous prescriptions for psychiatric drugs were found at Lubitz’s home, including antidepressants. His former girlfriend, who ended the relationship in 2014, also said he was in psychiatric treatment, according to Germany’s Bild newspaper.

The Food and Drug Administration (FDA), a federal agency charged with protecting consumer safety, placed its most serious “black box” warning on all antidepressants citing suicidality in addition to other side effects on the drug labels including hallucinations, mania and a host of other abnormal behaviors. Incredibly, despite being fully aware of this, the Federal Aviation Administration (FAA) reversed its 70-year ban restricting pilots taking antidepressants and other mind-altering psychiatric drugs from flying.

Does the FAA have a choice about whether to revisit its pilot psychiatric drug policy? Can the FAA be in direct contradiction with the FDA about the possible deadly consequences associated with psychiatric drugs? Not if the public has any say in the flying experience. Click here to read this article in full.

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Take Action – Missouri Legislature

Take Action – Missouri Legislature

Periodically we let you know the progress of various proposed legislation making its way through the Missouri General Assembly and suggest ways for you to contribute your viewpoint to your state Representative and state Senator.

You can find your Representative and Senator, and their contact information, by entering your 9-digit zip code here.

This time, we’d like to discuss House Bill HB118 and Senate Bill SB239. Often, the same (or similar) bills are introduced simultaneously in the House and in the Senate. These two bills address the same issue. The apparent problem these bills are attempting to resolve relates to the fact that English common law, rather than Missouri Statute, rules claims for damages arising out of the rendering of or failure to render health care services by a health care provider, which can lead to claims for very large sums of money. The proposed legislation places limits on such claims.

Basically, someone can claim that a “health care provider failed to use that degree of skill and learning ordinarily used under the same or similar circumstances by members of the defendant’s profession and that such failure directly caused or contributed to cause the plaintiff’s injury or death.”

This is often called a “standard of care”. All too often, however, when it comes to psychiatric treatment, the standard of care is “she’s depressed and she has Medicare.” This so-called standard of care is often being dictated by the pharmaceutical industry and the insurance industry, rather than competent and knowledgeable (non-psychiatric) physicians and health care providers.

We do understand the problem this legislation is trying to fix. Claims for damages can be out of line with reality, leading to a greedy and litigious justice system. Placing a Statute on the matter, with limits on damages, is an attempt to resolve this.

Here’s the HOWEVER. Psychiatric “treatments” are inherently damaging. Psychiatric drugs are inherently damaging. The psychiatric “standard of care” is psychiatric drugs. Therefore, suing a doctor for damages who failed to follow the psychiatric profession’s standard of care by not prescribing psychiatric drugs, thus claiming that damage to the patient was caused by not prescribing psychiatric drugs — well, we trust you get the point. This legislation places an undeserved degree of legal legitimacy on the prescription of psychiatric drugs and other psychiatric treatments, just because all the psychiatrists do it.

The psychiatric “standard of care” in this case is itself damaging. We’ll be suing doctors for doing the right thing!

It’s not that the proposed legislation is bad — it’s that it doesn’t really address the correct issue. A better focus point would be, did the patient provide fully informed consent to the treatment? Did the doctor provide full disclosure of both benefit and harm of the treatment to the patient?

Contact your Missouri state Representative and Senator, and let them know what you think about this. An amendment to the proposed legislation might help — such as, this law does not apply to electroshock, psycho-surgery, and psychiatric drugs, since they are all inherently damaging to patients and should not be held as standards of care.

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Germanwings Co-pilot Who Purposefully Crashed Plane Had Spent 18 Months In Psychiatric Treatment

Germanwings Co-pilot Who Purposefully Crashed Plane Had Spent 18 Months In Psychiatric Treatment

Numerous reports are now surfacing that Germanwings co-pilot Andreas Lubitz who purposefully crashed Flight 9525 into the French Alps, killing all 150 people on board, had in fact been under psychiatric care.

What media had not initially been reporting is the fact that Lubitz, in all likelihood was under the influence of antidepressants, drugs documented to cause depersonalization, mania, psychosis, and even homicidal ideation, considering he spent more than 18 months undergoing “psychiatric care.”

Late-breaking news from The Straits Times indicates that “German police have found medical treatments for psychological illness at the home of the co-pilot” and “Investigators made the discovery in a search of the home of Andreas Lubitz in the western city of Duesseldorf and seized a number ‘of medicines for the treatment of psychological illness’, Welt am Sonntag weekly said.”

Moreover, Lubitz would not be the first commercial pilot to purposefully crash a plane while under the influence of psychotropic drugs — In 2010, the National Transportation Safety Board (NTSB), issued a report on the probable cause of a 2008 plane crash in Mount Airy that killed everyone on board, showing that toxicology tests revealed the pilot had the antidepressant Zoloft in his system. The NTSB report stated, “Officials say the pilot ‘displayed non-professional behavior’ and that a cockpit voice recording documented the pilot singing, ‘Save my life, I’m going down for the last time'” shortly before crashing the plane.

The emerging facts regarding Lubitz’ psychiatric treatment:

Russia Today (RT) reports, “Lubitz had spent 18 months overall under psychiatric treatment, Bild (a German newspaper) reported on Friday, citing anonymous sources within Lufthansa, Germanwings’ parent company. The pilot was diagnosed with a ‘severe depressive episode’ in 2009.”

According to Reuters, “The pilot who appears to have deliberately crashed a plane carrying 149 others into the French Alps received psychiatric treatment for a ‘serious depressive episode’ …. Citing internal documents and Lufthansa sources, Bild said Lubitz spent a total of one and a half years in psychiatric treatment.”

The Guardian reports, “Investigators searching the Düsseldorf apartment of the co-pilot on the Germanwings flight that crashed into the French Alps on Tuesday have found evidence he hid an illness from his employers, prosecutors said on Friday. The evidence is a torn-up doctors’ note, signing him off work on the day of the crash. ‘Medical documents were found that indicate an ongoing illness and suitable medical treatment,’ Düsseldorf prosecutors said in a statement.”

Mirror states that, “Killer co-pilot Andreas Lubitz was treated in hospital just two weeks before the plane crash which killed 150 people. The 27-year-old attended a clinic at the University of Dusseldorf Hospital in February and March. The most recent visit was March 10, exactly a fortnight before he guided the Germanwings Airbus A320 into its fatal descent. The hospital said Lubitz attended for ‘diagnostic evaluation’ but insisted he was not treated for depression…. They confirmed he was suffering from a serious illness which he had concealed from his employers Germanwings. One of the sick notes was reportedly signed by either a local neurologist or psychologist.”

While the psychotropic drug policies of Lufthansa, the parent company of Germanwings, are unknown, in the U.S, the Federal Aviation Administration (FAA) allows the use of antidepressants among pilots, a policy instituted in 2008. This is despite the fact there have been 134 regulatory warnings from eleven countries, including the United Kingdom, Canada, Japan, Australia, New Zealand, Ireland, Russian, Italy and Germany on antidepressants causing suicidal ideation.

Given the increasing number of questionable aircraft disasters, which, on their surface, provide no rhyme or reason for a motive, one may begin to question the use of antidepressants, especially in light of a 2007 FAA report that revealed that of the 61 air crashes between 1990-2001, “the pilot’s psychological condition and/or SSRI use was reported to be the probable cause or a contributing factor in 31% (19/61) of the accidents.”

The fact is, whether Lubitz was on psychiatric drugs, or in withdrawal from them, there is enough evidence to show that the use of antidepressants or other mind-altering psychiatric drugs by commercial pilots, in the U.S. and abroad, should be banned.

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Drugging Missouri Foster Children

Drugging Missouri Foster Children

 In light of a San Jose Mercury News investigation “Drugging Our Kids” exposing the massive psychotropic drugging of children under California’s foster care system, which found nearly 25% of adolescents in California’s foster care system are prescribed mind-altering psychotropic drugs, lawmakers are now understanding the urgency of legislation to curb this abusive practice.

More than 30 percent of Missouri’s foster children take psychotropic drugs, even beating California, and most of the drugs are approved only for children with severe mental problems, according to Columbia Missourian news.

Often neglected and abused, foster children are one of Missouri’s most vulnerable populations. But “experts” say the state cannot always give children the emotional support they need. Instead, their problems are dealt with another way — by prescribing harmful and addictive psychiatric drugs.

Nationally, 18 percent of foster children are given psychotropic drugs. In Missouri, it’s nearly twice that amount.

The overprescription of psychoactive drugs to foster children is alarming. Well over 5,000 Missouri foster children are taking psychiatric drugs. At least 20 percent were taking an average of two or more psychiatric drugs. Missouri spent more than $81 million on psychiatric drugs for foster children in the last five years. Antipsychotics account for more than half of the state’s spending on psychiatric medication for foster children.

In Missouri, prescription records indicate that foster children as young as 2 have been given antipsychotics.

Sign CCHR’s Petition to Prevent the Dangerous Psychotropic Drugging of California’s Foster Care Youth here.

Contact your state legislators and let them know what you think about this; urge them to do something about drugging our most vulnerable children with harmful and addictive psychotropic drugs. Find your Missouri legislators here.
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CCHR St. Louis Holds Three Successful February Events

CCHR St. Louis Holds Three Successful February Events

CCHR St. Louis had a successful February, holding three events to spread the word about psychiatric fraud and abuse.

Our annual trip to Jefferson City to speak with Missouri state legislators was February 2 through 4. We set up in the Rotunda of the state Capitol Building, and walked the halls to distribute CCHR DVDs and speak with all available Representatives and Senators.

Jeff City Statistics

Distributed 124 Public Relations Kits with Documentary DVDs
Distributed 22 Individual Documentary DVDs
Distributed 152 Handouts & Pamphlets
Staffed by 5 CCHR Volunteers (Thank you very much!)

Our annual booth at the Working Women’s Survival Show in the St. Charles Convention Center was February 20 through 22.

WWSS Statistics

Distributed 258 Pamphlets
Distributed 9 Booklets
Sold 28 Documentary DVDs
Distributed 2,716 pieces of Literature
Talked to (at least) 190 People
Received (at least) 149 Positive Comments
Staffed by 12 CCHR Volunteers (Thank you very much!)

In addition, we spoke at a meeting of the St. Louis Bible Fellowship February 10 to discuss psychiatric suppression of religion, and distributed 15 Documentary DVDs to the attendees.

Needless to say, we had great fun educating our main public (people who need to know about psychiatric fraud and abuse and who may be in a position to Do Something About It); you are all welcome to contribute in this manner. Let us know if you would like to help by emailing CCHRSTL@CCHRSTL.ORG.

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Diagnosisgate: Conflict of Interest at the Top of the Psychiatric Apparatus

Diagnosisgate: Conflict of Interest at the Top of the Psychiatric Apparatus

“Diagnosisgate” — It is probably the most stunning story of corruption in the history of the modern mental-health system. Mysteriously, it has been kept out of major media for two decades.

In recent years, the man who has been called the world’s most important psychiatrist has painted himself as the white knight who warns the public about the dangers of Big Pharma and psychiatric diagnosis. But Allen Frances, the longest-running head of psychiatry’s “bible,” the Diagnostic and Statistical Manual of Mental Disorders — which earned more than $100 million under his reign — actually worked hand-in-glove with a major drug company to misrepresent research on a massive scale in order to market misleadingly one of their most dangerous drugs, Risperdal.

Nearly a year ago, my attention was drawn to a blockbuster of a document that revealed these distortions of science and the whopping conflicts of interest. It was essential to inform the public, because it is the mental health system’s Watergate and has led to enormous harm. One editor after another of both general publications and scholarly journals fled from publishing the story. This surprised me, given how important the story is and the fact that it was almost completely unknown to the public and professionals.

The brave Dr. David Holmes, editor of the journal APORIA, based at the University of Ottawa, has just published the article, and I hope that you will read it at http://www.oa.uottawa.ca/journals/aporia/articles/2015_01/commentary.pdf and help spread the word.

This scandal affects vast numbers of people … two enormous groups are military servicemembers and veterans (though by no means only them). Have a look at this quotation from http://www.nextgov.com/defense/2012/04/broken-warriors-test/55389/:

“Veterans Affairs Department reported in August 2011 that Risperidone was no more effective in PTSD treatment than a placebo. VA spent $717 million on the drug over the past decade. The military has spent $74 million over the past 10 years on Risperidone, a spokeswoman for the Defense Logistics Agency said.”

Thank you for any assistance you can give in making sure this truth will be widely known — feel free to forward this email, post the URL on Facebook and Twitter, etc.

Paula J. Caplan, Ph.D.
Associate, DuBois Research Institute, Harvard University

www.paulajcaplan.net

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