Blowing Smoke: Smoking Cessation and Drug Safety

BLOOMBERG VIA GETTY IMAGES

via Journal of Clinical Psychiatry:

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Varenicline for Smoking Cessation in Patients With Schizophrenia or Schizoaffective Disorder

Jill M. Williams, MD; Robert M. Anthenelli, MD; Chad D. Morris, PhD; Joan Treadow, RN, BSN; John R. Thompson, PhD; Carla Yunis, MD, MPH; and Tony P. George, MD

J Clin Psychiatry 2012;73(5):654–660

10.4088/JCP.11m07522

Copyright 2012 Physicians Postgraduate Press, Inc.

Objective: Effective smoking cessation treatments are needed for patients with schizophrenia, who, compared with the general population, have high rates of cigarette smoking and more difficulty quitting. We evaluated the safety and efficacy of varenicline for smoking cessation in outpatients with stable schizophrenia or schizoaffective disorder.

Method: In this 12-week, randomized, double-blind, multicenter trial (May 8, 2008, to April 1, 2010), 127 smokers (≥ 15 cigarettes/d) with DSM-IV–confirmed schizophrenia or schizoaffective disorder received varenicline or placebo (2:1 ratio). The primary outcome was safety and tolerability of varenicline assessed by adverse events frequency and changes in ratings on the Positive and Negative Syndrome Scale and other psychiatric scales from baseline to 24 weeks. Abstinence was defined as no smoking 7 days prior to weeks 12 and 24, verified by carbon monoxide level.

Results: Eighty-four participants received varenicline; 43, placebo. At 12 weeks (end of treatment), 16/84 varenicline-treated patients (19.0%) met smoking cessation criteria versus 2/43 (4.7%) for placebo (P = .046). At 24 weeks, 10/84 (11.9%) varenicline-treated and 1/43 (2.3%) placebo-treated patients, respectively, met abstinence criteria (P = .090). Total adverse event rates were similar between groups, with no significant changes in symptoms of schizophrenia or in mood and anxiety ratings. Rates of suicidal ideation adverse events were 6.0% (varenicline) and 7.0% (placebo) (P = 1.0). There was 1 suicide attempt by a varenicline patient with a lifetime history of similar attempts and no completed suicides.

Conclusions: Varenicline was well tolerated, with no evidence of exacerbation of symptoms, and was associated with significantly higher smoking cessation rates versus placebo at 12 weeks. Our findings suggest varenicline is a suitable smoking cessation therapy for patients with schizophrenia or schizoaffective disorder.

Trial Registration: ClinicalTrials.gov identifier: NCT00644969

J Clin Psychiatry 2012;73(5):654–660

© Copyright 2012 Physicians Postgraduate Press, Inc.

Submitted: November 8, 2011; accepted February 28, 2012(doi:10.4088/JCP.11m07522).

Corresponding author: Jill M. Williams, MD, UMDNJ-Robert Wood Johnson Medical School, 317 George St, Ste 105, New Brunswick, NJ 08901 (williajm@umdnj.edu). here

I can't help but be suspicious of the conclusion offered in this article. "Varenicline was well tolerated, with no evidence of exacerbation of symptoms."  This conclusion definitely helps secure a place in the market for Chantix as a stop smoking aid for people with a diagnosis of schizophrenia or schizoaffective disorder. What is strange is the trial was conducted at nine different sites.  Why? There were only 128 participants...This article only mentions one suicide attempt; it does not mention any incidences of adverse effects commonly associated with Chantix.  The  trial was conducted by Pfizer, in it's own facilities, the primary outcome measure was safety, and no safety issues were identified in the study. 

This trial trial was conducted for the primary purpose of exploiting psychiatric patients as a means to an end, the end being increasing the market for Chantix, to fulfill Pfizer's marketing agenda... It's obvious from reading this, they expected to have serious safety problems; yet luckily for Pfizer's marketing department and for Pfizer it's stockholders, there was, the authors state, "no evidence of problems." Pfizer found no evidence that Chantix can cause and/or exacerbate psychosis, as is well-documented in the FDA AERS data.

According to the FDA Adverse Event Reporting System: CHANTIX had the highest number of adverse events reported to the FDA for psychiatric symptoms in the second quarter of 2010. The reason? Increased levels of hostility, aggression, and increased symptoms of psychosis... 

via The Institute For Safe Medication Practices:

QuarterWatch: 2010 Quarter 2

Monitoring MedWatch Reports

January 27, 2011

Signals for Varenicline, Levofloxacin and Fentanyl

Varenicline (CHANTIX) 

Safety Problems Continue

"Despite a prominent boxed warning, a mandatory Medication Guide for every patient and declining use, the stop-smoking drug varenicline (CHANTIX) continued to account for large numbers of reported serious psychiatric side effects. In the second quarter the drug was suspect in more possible cases of hostility-aggression, depression and psychosis than any other monitored drug." here

31 Prescription Drugs Are Linked to 387 Homicides 

and 1,527 acts of violence... 

via PLoS ONE:

Prescription Drugs Associated with Reports of Violence Towards Others
Moore TJ, Glenmullen J, Furberg CD (2010) Prescription Drugs Associated with Reports of Violence Towards Others. PLoS ONE 5(12): e15337. doi:10.1371/journal.pone.0015337
a couple of excerpts:
"These data provide new evidence that acts of violence towards others are a genuine and serious adverse drug event that is associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and serotonin reuptake inhibitors were the most strongly and consistently implicated drugs."

"This study, however, contains numerous features intended to minimize the limitations of adverse event data from postmarketing surveillance. The proportional reporting ratio takes into account two possibilities: a) that wider use or a higher reporting rate exposes a drug to a greater chance of having a violence case attributed, and b) that a higher number of reports might have occurred by chance. The varying results among drugs for smoking cessation and the mood stabilizers show it is unlikely that the violence events are attributed to existing problems in the patient populations treated. Also, the focus of this study was on specific event terms that unequivocally described a violent act or thought – such as homicide or physical assault. By excluding more general adverse event terms such as “aggression” or “anger” many thousands of less specific cases were eliminated under the study criteria. While this means that the study did not count many possible cases of violence towards others (a loss of sensitivity) the restrictive criteria increased specificity. However, 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."

The SSRIS with the most reports of adverse events between 2004 and September 2009 were Prozac with 72 reports for violence defined as homicide, homicidal ideation, physical assault, physical abuse or violence related symptoms; Paxil had 177. read here

picture found at Time Healthland

Champions of Change? God Bless America and Protect Her Defenders...

The NIMH is honored by the White House as "Champions of Change."  I want to scream, cry stomp my feet---How in the hell can an agency with such a seriously  ethically challenged Director be a champion of anything?   How much studying does it take for   Champions, who are Public Servants and  "America's "experts" to see what is right in front of them?  The  research the American People have already paid for holds the answers...

via the NIMH

Back in 2008, the Army came to the National Institute of Mental Health and said, you know, we realize we have a problem, and during this timeframe, the Army had seen a doubling of their risk for suicide. Traditionally, the Army had had a much lower risk of suicide than the general civilian population. But over this time period, from the early 2000s to 2008, this risk for suicide within the military, and within the Army in particular, had continued to grow to the point where it had just then begun to exceed the civilian population’s risk. And so Army STARRS is a basic research project designed to provide the Army with vital information about, you know, what’s going on, what might lie behind this rise in suicide. With the urgency that the Army has and being able to take these findings and turn them into things that are actionable.

The Director of the NIMH, Thomas Insel, knows that psychiatric drugs used to treat PTSD and other psychiatric issues are contributing to the suicide rate. So are multiple longer deployments. These two factors are unique to veterans of Afghanistan and Iraq which have strangely not been mentioned in discussions as to why so many are killing themselves--more commit suicide than die in Afghanistan and Iraq. If Insel is unaware of these facts, then he should not be the Director of the NIMH.

I did not finish High School and have two years of college. At one time, I was majoring in psychology with the intent of going into research. For those who know where to look and how to read with comprehension, the answers are easy to find---I can not help but be very angry about this announcement that there will be three more years of "studying" this issue, because, "you know we realize we have a problem," and now there is a plan to work with researchers about three years to "study" what the cause of drug-induced suicide is!!?

I started writing this blog on September 4, 2010 on September 11, 2011 the post was about Thomas Insel here is a quote from a psychiatrist who blogs: 


"In World War I, we learned from the trench warfare that prolonged, sustained combat causes epidemic mental illness – the longer the exposure, the worse it gets. It was erroneously called Shell Shock in that war.  Then in World War II, we named it Combat Fatigue. In Viet Nam, it became PTSD. Our literature is filled with data supporting this intuitively obvious fact. So as Director of the National Institute of Mental Health, why in the hell wasn’t Tom Insel testifying to Congress and the Joint Chiefs about the insanity in their policy of letting [in fact incentivizing] our adolescents go back for five or more contiguous tours of duty in middle east wars – wars where they live with the constant knowledge that any person on the street might be another human bomb? It may be cleaner than the trenches, but psychologically it’s equally grim."  read the whole thing at 1 Boring Old Man




For an update on the true nature of this program, e.g. Experimental project with no scientific validity The Comprehensive Soldier Fitness Program


November 15,2010 Do Veterans Receive Care and Protection Needed?


November 21, 2010 American Veterans They Made it Back Alive to Die Here at Home


April 14,2011 Putting Troops in Harms Way: it's not accident or oversight

I wrote about this August 23, 2011 Psychiatric Drugs are Killing American Soldiers

March 20,2011 Female Soldier's suicide rate triples when at war--USA Today


May 20, 2011 is First Line Treatment for PTSD Developed From Insufficient Evidence?
This post has a report from the Institute of Medicine on effective PTSD treatment


From the Project on Government Oversight:
A Leader in Ethics Reform at NIMH Doesn't Think the Rules Apply To Him


NIH Needs New Leader On Ethics Reform


One more scandal

Is Thomas Insel, NIMH Director Too Biased to Be Objective?

below is a recent blog post from the National Institutes of Mental Health Director, Thomas Insel, M.D. dated January 11, 2010 that takes liberties with the truth. Insel's words are promptly used to by DJ Jaffe as validation of his quest for a not so Brave New World; where anyone diagnosed with psychosis, and particularly with schizophrenia, is drugged under color of law for the remainder of their life. Isn't this the same way that the Germans instituted social policies leading up to WWII?  What kind of a plan is this for any so-called advocate to repeatedly hit America over the head with?  It is a plan based on ignorance, fear, and bigotry; absent altruistic intent and action. 

January 11, 2011

Understanding Severe Mental Illness

Posted by Thomas Insel

"When a tragedy occurs like the shooting in Tucson this past weekend, all of us seek an explanation. While there remain many questions, a leading hypothesis is that the suspect has a serious mental illness (SMI), such as schizophrenia. The topic of violence and mental illness is never an easy discussion: with issues such as stigma, incarceration, public safety, and involuntary treatment in the mix. There is a legitimate concern that talking about violence and mental illness in the same sentence increases the likelihood that people with serious illness will be further marginalized and less likely to receive appropriate care. But tragic events, whether at a Safeway in Tucson or a classroom at Virginia Tech, require us to address this uncomfortable subject with the science available."

"Is violence more common in people with SMI? Yes, during an episode of psychosis, especially psychosis associated with paranoia and so-called “command hallucinations”, the risk of violence is increased. People with SMI are up to three times more likely to be violent and when associated with substance abuse disorders, the risk may increase much further."ⁱ DJ Jaffe used the preceding, but not the following, which would have put into perspective the actual percentage of violent crime committed by those diagnosed with schizophrenia, in comparison with all violent crime; and that those with a diagnosis are at increased risk of being victimized by violent crime.

As Insels states, "But, mental illness contributes very little to the overall rate of violence in the community. Most people with SMI are not violent, and most violent acts are not committed by people with SMI. In fact, people with SMI are actually at higher risk of being victims of violence than perpetrators. Teplin et al found that those with SMI are 11 times more likely to be victims of violent crime than the general population."ⁱⁱ

"The most common form of violence associated with mental illness is not against others, but rather, against oneself. In 2007, the most recent year for which we have statistics, there were almost 35,000 suicides, nearly twice the rate of homicides. Suicide is the 10th leading cause of death in the United States.ⁱⁱⁱ Although it is not possible to know what prompted every suicide, it is safe to say that unrecognized, untreated mental illness is a leading culprit."

This above italicized statement is pure speculation. A statement like this coming from a scientist, who is in charge of directing the National Institutes of Mental Health, it is wholly irresponsible.  Particularly since research shows that antidepressants are not statistically any better than placebo for treating depression; and even cause some people to feel worse, and SSRIs can actually increase the suicide risk!  Citing overall suicide statistics, instead of data specific  to those with "serious mental illness" avoids having to extrapolate relevant information from subjective reports from people  who survived suicide attempts who are diagnosed with schizophrenia, bipolar and schizoaffective disorder who state that the horrendous adverse neurological and cognitive effects the drugs cause is what compelled  them to attempt suicide.  

Insel's inference that suicide is because not enough people receive treatment, i.e. psychotropic drugs; but failing to mention that many people can't tolerate the terrible adverse effects of the drugs, presents a biased and incomplete picture.  Are we expected to believe that the permanent neurological, cognitive and emotional negative effects of the drugs that many cite as the reason for their suicide attempt, is due to a supposed lack of insight?  Insel's inference is simplistic, biased and ignores the subjective experiences of an entire group of patients.  Insel's high suicide rate theory that not enough people are being drugged, is not grounded in anything but thin air.  The  blatant failure to acknowledge, or validate the subjective experiences of a single patient, let alone an entire group of patients, is unacceptable.  In this paragraph, Insel in effect, ignores the subjective experiences and treatment outcomes for thousands of patients.  In so doing, Insel neatly avoids telling the truth about the real world outcomes for people given neuroleptic drugs.  Insel fails his duty to the American people by failing to provide unbiased, accurate  information on the suicide data for an entire class of people. 

"Treatment may be the key to reducing the risk of violence, whether that violence is self-directed or directed at others. Research has suggested that those with schizophrenia whose psychotic symptoms are controlled are no more violent than those without SMI.^iv It’s likely that treatment not only helps ease the symptoms of mental illness, but also curbs the potential for violence as well."

"As we learn more about the circumstances surrounding the tragedy in Tucson, we should be working harder to ensure people with SMI receive the care they need. Early intervention offers the best hope to prevent more tragedies in the future."  

"For more information on SMI and other mental health statistics, please visit NIMH’s Statistics page."

"Information on coping with trauma."

---

ⁱSwanson JW. Mental disorder, substance abuse, and community violence: an epidemiological approach. In: Monahan J, Steadman HJ, eds. Violence and mental disorder: developments in risk assessment. Chicago: University of Chicago Press, 1994:101-36.

ⁱⁱTeplin et al. Crime victimization in adults with severe mental illness. Archives of General Psychiatry.2005 Aug. 62. 911-921.

ⁱⁱⁱCenters for Disease Control and Prevention, National Center for Injury Prevention and Control. Web-based Injury Statistics Query and Reporting System (WISQARS). www.cdc.gov/ncipc/wisqars.

^ivSteadman HJ, Mulvey EP, Monahan J, et al. Violence by people discharged from acute psychiatric inpatient facilities and by others in the same neighborhoods. Arch Gen Psychiatry 1998;55:393-401.

my thoughts
This is beyond believable!   What is likely true is that while use of neuroleptics may initially "curbs the potential for violence as well," it is causing neurological and cognitive damage.  With continued treatment, the damage may progress to cause an increase in aggression due to the BRAIN DAMAGE!  The drugs used to "treat" schizophrenia also often cause akathisia  which is associated with aggression and violence.  Patients who develop akathisia describe an inner restlessness that some have further described as relentless torture; a compulsion to always be pacing, rocking and be in constant movement.  Some, after stopping the drugs, find the effects are permanent. 

Akasthisia statistically associated with physical aggression 

I agree with Dr. Insel that, "Early intervention offers the best hope to prevent more tragedies in the future." I do not agree that drugs are always the intervention needed.  With the serious deleterious effects and the potential for dependence, withdrawal and rebound psychosis which are adverse effects inherent with the use of all neuroleptic drugs, it is hard to fathom current standard clinical practice.   

These well documented risks are not disclosed in the Consent process; causing me to wonder about the integrity of  psychiatry, as an ethical medical specialty.  This is a fundamental failing that is widely accepted that is ignored when writing clinical "standards of care." While failing almost universally and totally to disclose the potential for harm, Psychiatrists label patients who are traumatized,  protest the harmful effects, and claim  the drugs are not helpful as "noncompliant;" or  worse declare that they have anosognosia. While it may be true  that some patient's lack insight; it is equally true that psychiatrists can have biases which prevent recognition of their own lack of insight.  Worse, are the professionals who minimize a patient's complaints about the prescribed drug's adverse effects, because they seem to be willfully blind to the patient's iatrogenic injuries, which are medically neglected. 

Many psychiatrists are  apparently afflicted by an inability to think critically or understand that the patient's subjective experiences and opinions truly do matter in a supportive, therapeutic relationship.  A therapeutic relationship requires mutual respect, particularly respect for the patient's human rights, and the ability to empathize with a pateint in distress.   These are fundamental to earning a patient's trust on a human level and critical to the ethical practice of psychiatry.  Why do so many psychiatrists not seem to realize this? Some don't even seem to understand that even a person in distress is aware if they are actually respected, or that trust needs to be earned by a psychiatrist who hopes to be able to help a person; even if the professional doesn't believe that a patient has any insight.

It seems to me, the way psychiatry is practiced relying on biased information, abuse of power and authority, coercion, police powers, and court orders; psychiatry is making sure, "that people with serious illness will be further marginalized and less likely to receive appropriate care." (and less likely to seek it!) As for Insel's, "legitimate concern that talking about violence and mental illness in the same sentence increases the likelihood" of those psychiatrically labeled being further marginalized; his concern does not appear to motivate the director of NIMH to rely on unbiased and valid information when writing his blog. It is dishonest (and unethical) for Thomas Insel to neglect mentioning that the very drugs he claims are "necessary medical treatment" in the prevention of aggressive and violent behavior in people diagnosed with mental illnesses, are in fact well-known to increase violent, aggressive, suicidal and homicidal behaviors for a statistically significant number of people who are prescribed neuroleptic, and other psychotropic drugs...

Shame on you, Thomas Insel!