Ducktor Quack
via Psychology Today:Fighting Fear
Confronting phobias and other fears.
"Determining the Real Side-Effects of Drugs."
Published on June 28, 2012 by Fredric Neuman, M.D.
excerpts:
"There are many people who worry excessively about their health. They carry various diagnoses: hypochondriasis, somatization disorder, obsessive-compulsive disorder, and, often, depression. It turns out that these same people worry considerably about drugs and their side-effects, often to the point where they take untested, but “natural” substances, rather than drugs that the manufactures have spent hundreds of millions of dollars testing. I run groups treating these cases of “health anxiety.” There is an exercise I like to conduct in these classes. I take down a glossy pamphlet which is marked “Prozac” on the outside. I ask the group, “would you be willing to take a drug that has these side effects?” and I read to them out loud from the pamphlet:
"Headache—15.5% of all the patients taking this drug. Nervousness—8.5% Insomnia—7.1% Drowsiness—6.3% Anxiety –5.5% Nausea—10.1% Diarrhea—7.0% Dry Mouth—6.0%
Sweating—3.8%
"Usually, by the time I get half-way through this list, they are shaking their heads, “no.”
"Then I tell them that I have been reading from the list of side-effects in the placebo arm of the study! These are the side-effects patients get when they take a sugar pill that they think might be the real pill. Of course, my patients, who are especially suggestible, are still more likely to develop these placebo responses." (emphasis mine)
I started this post without reading the entire article; because I determined that I would write about the article because of my gut reaction to a tweet shared in my twitter feed this evening: "@psychfeed Determining the Real Side-Effects of Drugs.: There are many people who worry excessively about... bit.ly/N0aXtc (via @PsychToday)" I responded by tweeting back: "@psychfeed If the author is being honest, and this is how he has treated a patient; I would say he is unethical, and possibly sadistic..." Then I started this post, posted the links and the excerpts from the article above. THEN, I finished reading the article. NOW I have absolutely no doubt the author is sadistic; and unethical.
The cavalier attitude the author seems to have is troubling for a number of reasons, however, I will keep my critique to two of them. First, it seems that the author has an apparent lack of respect for his patients as people in distress who come to him for help in dealing with their problems. Second, if this article is representative of his 'expert knowledge' about Prozac, also known as fluoxetine, or Serafem, and SSRIs in general; he is ill-informed about the potential risks involved with taking Prozac. I do not believe that 'side-effects' is an accurate term which describes the serious negative effects people can experience. The term is only descriptive of the negative effects a person who also experiences a measurable benefit, i.e. by having a reduction in symptoms the drug was taken for. When there is no appreciable benefit experienced by a patient taking an SSRI, or any other psychiatric drug, the effects which are unwanted, negative effects are not 'side-effects' and calling them 'side-effects' is dishonest; it is a gross mis-characterization of adverse effects that can be debilitating and fatal.
more excerpts from the article:
"So, that leaves the question, what are the real side-effects of Prozac? I read from a second list, the patients who were taking Prozac:
"Headache—20.3% about one third higher than the placebo-responders. Therefore, there is a tendency (slight) for Prozac to cause headaches.
"Nervousness—14.9% again, about one third higher than the placebo-responders. Therefore, there is a real tendency for the drug to cause nervousness. (Usually, this effect disappears in about 3 weeks.)
"Nausea—21.1% vs. 10.1 % for placebo responders. There is, therefore, a distinct tendency for nausea to come from taking Prozac. (This symptom, too. is likely to go away after three weeks.)
"Diarrhea—12.5% vs.7.0% for placebo responders, indicating a mild tendency for Prozac to cause diarrhea.
"Sweating-- 8.4% vs. 3.8% for placebo responders. A very mild tendency to cause sweating.
"All the other side effects for Prozac are close in range to the side-effects in the placebo groups, indicating that the drug does not cause these side-effects. (Any more than a sugar pill would.)
"What does all this mean? It means, first of all, that someone who develops these side-effects upon taking a new drug may not be reacting to the drug itself! They may be reacting to the idea of the drug. Yet, if a patient is told that the particular physical reaction they are having after taking the drug cannot be reasonably attributed to the effect of the drug itself, they often become offended." here
It ALSO means Dr. Neuman, that you seem to believe that it is acceptable for you invalidate your patients; and to minimize or dismiss altogether their complaints. Complaints that, you should be cognizant of having an ethical duty to pay careful attention to. Whether you believe the complaints to be valid or not; what is important or relevant to your patients, should merit more than your contempt and ridicule. The complaints ARE real to your patients doctor; and your patients should have your respect---you ARE working FOR them... Based on this article, it does not seem as if you have much respect for your patients. It is apparent from this article that it is acceptable to you to have less than a respectful, forthright, open and honest dialogue with your patients about the drugs you prescribe to them. One wonders, do you consider patients unworthy of your respect? I ask, because it seems that you have a callous attitude about your patients' need for reassurance, and a lackadaisical attitude about providing pertinent information to them...
This lackadaisical attitude is alarming. Your remarks evince far too casual an attitude about your ethical duty to your patients. Specifically, the ethical duty to provide accurate, appropriate and complete information to your patients so that they are able to give Informed Consent prior to actually follow your professional advice and treatment recommendations! So, I find it very strange that you ridicule your patients' need for reassurance. In light of the biased clinical trial research conducted; the ongoing fraudulent reporting of incomplete and/or biased trial data; and the fraud underlying the FDA-approval process as well as the illegal marketing of Prozac and the other SSRIs; your attitude is despicable.
Are you unaware or willfully blind? Patients have experienced grievous irreparable harm caused by Prozac and other SSRIs; patients who often were misled about the safety and the efficacy of the drugs. Some people in fact come to mistrust psychiatric professionals and be called paranoid and for being downright suspicious. Psychiatric patients are offered no commiseration, understanding or empathy from most professionals. They are not respected, but are invalidated for having their suspicions; and feelings of mistrust grow. Even though these suspicions, attitudes and feelings are a direct result from having been misinformed, disrespected, and sometimes, coerced and manipulated, they are treated as if they are 'a problem patient' who is simply being non-compliant because they 'lack insight.' What a freaking racket...Whether the author is or is not aware of these realities faced by patients who have been harmed; and witnessed by those who love them, and are also labeled as lacking insight for supporting and validating the patient; the author's attitude is strange, and wholly inappropriate for a healer/doctor who is treating emotionally fragile people. I can assure the author, and every other professional, that the patients who have experienced lasting harm; the family members who grieve the loss of a loved one; and the family members who care for a loved one; find your cavalier attitude insulting. Your callous disregard for psychiatric patients whom you treat is morally reprehensible.
via PLoS ONE:
Prescription Drugs Associated with Reports of Violence Towards Others
Thomas J. Moore 1, Joseph Glenmullen 2, Curt D. Furberg 3
1 Institute for Safe Medication Practices, Alexandria, Virginia, United States of America, 2 Department of Psychiatry-Cambridge Hospital, Harvard Medical School, Cambridge, Massachusetts, United States of America, 3 Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States of America
The article's ABSTRACT in it's entirety:
Context
Violence towards others is a seldom-studied adverse drug event and an atypical one because the risk of injury extends to others.
Objective
To identify the primary suspects in adverse drug event reports describing thoughts or acts of violence towards others, and assess the strength of the association.
Methodology
From the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) data, we extracted all serious adverse event reports for drugs with 200 or more cases received from 2004 through September 2009. We identified any case report indicating homicide, homicidal ideation, physical assault, physical abuse or violence related symptoms.
"Headache—15.5% of all the patients taking this drug. Nervousness—8.5% Insomnia—7.1% Drowsiness—6.3% Anxiety –5.5% Nausea—10.1% Diarrhea—7.0% Dry Mouth—6.0%
Sweating—3.8%
"Usually, by the time I get half-way through this list, they are shaking their heads, “no.”
"Then I tell them that I have been reading from the list of side-effects in the placebo arm of the study! These are the side-effects patients get when they take a sugar pill that they think might be the real pill. Of course, my patients, who are especially suggestible, are still more likely to develop these placebo responses." (emphasis mine)
I started this post without reading the entire article; because I determined that I would write about the article because of my gut reaction to a tweet shared in my twitter feed this evening: "@psychfeed Determining the Real Side-Effects of Drugs.: There are many people who worry excessively about... bit.ly/N0aXtc (via @PsychToday)" I responded by tweeting back: "@psychfeed If the author is being honest, and this is how he has treated a patient; I would say he is unethical, and possibly sadistic..." Then I started this post, posted the links and the excerpts from the article above. THEN, I finished reading the article. NOW I have absolutely no doubt the author is sadistic; and unethical.
The cavalier attitude the author seems to have is troubling for a number of reasons, however, I will keep my critique to two of them. First, it seems that the author has an apparent lack of respect for his patients as people in distress who come to him for help in dealing with their problems. Second, if this article is representative of his 'expert knowledge' about Prozac, also known as fluoxetine, or Serafem, and SSRIs in general; he is ill-informed about the potential risks involved with taking Prozac. I do not believe that 'side-effects' is an accurate term which describes the serious negative effects people can experience. The term is only descriptive of the negative effects a person who also experiences a measurable benefit, i.e. by having a reduction in symptoms the drug was taken for. When there is no appreciable benefit experienced by a patient taking an SSRI, or any other psychiatric drug, the effects which are unwanted, negative effects are not 'side-effects' and calling them 'side-effects' is dishonest; it is a gross mis-characterization of adverse effects that can be debilitating and fatal.
more excerpts from the article:
"So, that leaves the question, what are the real side-effects of Prozac? I read from a second list, the patients who were taking Prozac:
"Headache—20.3% about one third higher than the placebo-responders. Therefore, there is a tendency (slight) for Prozac to cause headaches.
"Nervousness—14.9% again, about one third higher than the placebo-responders. Therefore, there is a real tendency for the drug to cause nervousness. (Usually, this effect disappears in about 3 weeks.)
"Nausea—21.1% vs. 10.1 % for placebo responders. There is, therefore, a distinct tendency for nausea to come from taking Prozac. (This symptom, too. is likely to go away after three weeks.)
"Diarrhea—12.5% vs.7.0% for placebo responders, indicating a mild tendency for Prozac to cause diarrhea.
"Sweating-- 8.4% vs. 3.8% for placebo responders. A very mild tendency to cause sweating.
"All the other side effects for Prozac are close in range to the side-effects in the placebo groups, indicating that the drug does not cause these side-effects. (Any more than a sugar pill would.)
"What does all this mean? It means, first of all, that someone who develops these side-effects upon taking a new drug may not be reacting to the drug itself! They may be reacting to the idea of the drug. Yet, if a patient is told that the particular physical reaction they are having after taking the drug cannot be reasonably attributed to the effect of the drug itself, they often become offended." here
It ALSO means Dr. Neuman, that you seem to believe that it is acceptable for you invalidate your patients; and to minimize or dismiss altogether their complaints. Complaints that, you should be cognizant of having an ethical duty to pay careful attention to. Whether you believe the complaints to be valid or not; what is important or relevant to your patients, should merit more than your contempt and ridicule. The complaints ARE real to your patients doctor; and your patients should have your respect---you ARE working FOR them... Based on this article, it does not seem as if you have much respect for your patients. It is apparent from this article that it is acceptable to you to have less than a respectful, forthright, open and honest dialogue with your patients about the drugs you prescribe to them. One wonders, do you consider patients unworthy of your respect? I ask, because it seems that you have a callous attitude about your patients' need for reassurance, and a lackadaisical attitude about providing pertinent information to them...
This lackadaisical attitude is alarming. Your remarks evince far too casual an attitude about your ethical duty to your patients. Specifically, the ethical duty to provide accurate, appropriate and complete information to your patients so that they are able to give Informed Consent prior to actually follow your professional advice and treatment recommendations! So, I find it very strange that you ridicule your patients' need for reassurance. In light of the biased clinical trial research conducted; the ongoing fraudulent reporting of incomplete and/or biased trial data; and the fraud underlying the FDA-approval process as well as the illegal marketing of Prozac and the other SSRIs; your attitude is despicable.
Are you unaware or willfully blind? Patients have experienced grievous irreparable harm caused by Prozac and other SSRIs; patients who often were misled about the safety and the efficacy of the drugs. Some people in fact come to mistrust psychiatric professionals and be called paranoid and for being downright suspicious. Psychiatric patients are offered no commiseration, understanding or empathy from most professionals. They are not respected, but are invalidated for having their suspicions; and feelings of mistrust grow. Even though these suspicions, attitudes and feelings are a direct result from having been misinformed, disrespected, and sometimes, coerced and manipulated, they are treated as if they are 'a problem patient' who is simply being non-compliant because they 'lack insight.' What a freaking racket...Whether the author is or is not aware of these realities faced by patients who have been harmed; and witnessed by those who love them, and are also labeled as lacking insight for supporting and validating the patient; the author's attitude is strange, and wholly inappropriate for a healer/doctor who is treating emotionally fragile people. I can assure the author, and every other professional, that the patients who have experienced lasting harm; the family members who grieve the loss of a loved one; and the family members who care for a loved one; find your cavalier attitude insulting. Your callous disregard for psychiatric patients whom you treat is morally reprehensible.
via PLoS ONE:
Prescription Drugs Associated with Reports of Violence Towards Others
Thomas J. Moore 1, Joseph Glenmullen 2, Curt D. Furberg 3
1 Institute for Safe Medication Practices, Alexandria, Virginia, United States of America, 2 Department of Psychiatry-Cambridge Hospital, Harvard Medical School, Cambridge, Massachusetts, United States of America, 3 Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States of America
The article's ABSTRACT in it's entirety:
Context
Violence towards others is a seldom-studied adverse drug event and an atypical one because the risk of injury extends to others.
Objective
To identify the primary suspects in adverse drug event reports describing thoughts or acts of violence towards others, and assess the strength of the association.
Methodology
From the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) data, we extracted all serious adverse event reports for drugs with 200 or more cases received from 2004 through September 2009. We identified any case report indicating homicide, homicidal ideation, physical assault, physical abuse or violence related symptoms.
Main Outcome Measures
Disproportionality in reporting was defined as a) 5 or more violence case reports, b) at least twice the number of reports expected given the volume of overall reports for that drug, c) a χ2 statistic indicating the violence cases were unlikely to have occurred by chance (p<0.01).
Results
"We identified 1527 cases of violence disproportionally reported for 31 drugs. Primary suspect drugs included varenicline (an aid to smoking cessation), 11 antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The evidence of an association was weaker and mixed for antipsychotic drugs and absent for all but 1 anticonvulsant/mood stabilizer. Two or fewer violence cases were reported for 435/484 (84.7%) of all evaluable drugs suggesting that an association with this adverse event is unlikely for these drugs." (emphasis mine)
a couple of excerpts from the full article:
"The next drugs most often linked to unprovoked violent outbursts--some resulting in murder--are 11 of 13 SSRI antidepressants. These not so, "magic bullets," whose mode of action (reuptake inhibition) increases serotonin, were involved in 578 cases of violence."
"Two drugs within the SSRI class--Prozac and Paxil--have been linked to the greatest number of reported cases of violence toward others: Prozac ranks 10.9 in the PRR, with 72 reported cases of violence, and Paxil (Paroxetine) ranks 10.2 in PRR, with 177 reported cases of violence."
emphasis mine here
via numbdoc1:
"Dr. David Healy speaking at a Press Conference prior to the 2006 FDA Advisory Committee Public Hearing on the connection between antidepressants and suicidal thoughts and actions. The press conference was put together by the family of Woody Witczak. This clip is part 2 of 3. I shot this clip while in Washington DC working on my documentary, NUMB." www.numbdocumentary.com
via SSRI Stories:
Just a small sample of the cases listed at the link above:
School Shooting Prozac WITHDRAWAL 2008-02-15 Illinois ** 6 Dead: 15 Wounded: Perpetrator Was in Withdrawal from Med & Acting Erratically
Disproportionality in reporting was defined as a) 5 or more violence case reports, b) at least twice the number of reports expected given the volume of overall reports for that drug, c) a χ2 statistic indicating the violence cases were unlikely to have occurred by chance (p<0.01).
Results
"We identified 1527 cases of violence disproportionally reported for 31 drugs. Primary suspect drugs included varenicline (an aid to smoking cessation), 11 antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The evidence of an association was weaker and mixed for antipsychotic drugs and absent for all but 1 anticonvulsant/mood stabilizer. Two or fewer violence cases were reported for 435/484 (84.7%) of all evaluable drugs suggesting that an association with this adverse event is unlikely for these drugs." (emphasis mine)
a couple of excerpts from the full article:
"The next drugs most often linked to unprovoked violent outbursts--some resulting in murder--are 11 of 13 SSRI antidepressants. These not so, "magic bullets," whose mode of action (reuptake inhibition) increases serotonin, were involved in 578 cases of violence."
"Two drugs within the SSRI class--Prozac and Paxil--have been linked to the greatest number of reported cases of violence toward others: Prozac ranks 10.9 in the PRR, with 72 reported cases of violence, and Paxil (Paroxetine) ranks 10.2 in PRR, with 177 reported cases of violence."
emphasis mine here
via numbdoc1:
"Dr. David Healy speaking at a Press Conference prior to the 2006 FDA Advisory Committee Public Hearing on the connection between antidepressants and suicidal thoughts and actions. The press conference was put together by the family of Woody Witczak. This clip is part 2 of 3. I shot this clip while in Washington DC working on my documentary, NUMB." www.numbdocumentary.com
via SSRI Stories:
Just a small sample of the cases listed at the link above:
School Shooting Prozac WITHDRAWAL 2008-02-15 Illinois ** 6 Dead: 15 Wounded: Perpetrator Was in Withdrawal from Med & Acting Erratically
School Shooting Prozac Antidepressant 2005-03-24 Minnesota **10 Dead: 7 Wounded: Dosage Increased One Week before Rampage
School Shooting Paxil [Seroxat] Antidepressant 2001-03-10 Pennsylvania **14 Year Old GIRL Shoots & Wounds Classmate at Catholic School
School Shooting Zoloft Antidepressant & ADHD Med 2011-07-11 Alabama **14 Year Old Kills Fellow Middle School Student
School Shooting Zoloft Antidepressant 1995-10-12 South Carolina **15 Year Old Shoots Two Teachers, Killing One: Then Kills Himself
School Shooting Med For Depression 2009-03-13 Germany **16 Dead Including Shooter: Antidepressant Use: Shooter in Treatment For Depression
School Hostage Situation Med For Depression 2010-12-15 France **17 Year Old with Sword Holds 20 Children & Teacher Hostage
School Shooting Plot Med For Depression WITHDRAWAL 2008-08-28 Texas **18 Year Old Plots a Columbine School Attack
School Shooting Anafranil Antidepressant 1988-05-20 Illinois **29 Year Old WOMAN Kills One Child: Wounds Five: Kills Self
School Shooting Luvox/Zoloft Antidepressants 1999-04-20 Colorado **COLUMBINE: 15 Dead: 24 Wounded
School Stabbings Antidepressants 2001-06-09 Japan **Eight Dead: 15 Wounded: Assailant Had Taken 10 Times his Normal Dose of Depression Med
School Shooting Prozac Antidepressant WITHDRAWAL 1998-05-21 Oregon **Four Dead: Twenty Injured
School Stabbing Med For Depression 2011-10-25 Washington **Girl, 15, Stabs Two Girls in School Restroom: 1 Is In Critical Condition
School Shooting Antidepressant 2006-09-30 Colorado **Man Assaults Girls: Kills One & Self
School Machete Attack Med for Depression 2001-09-26 Pennsylvania **Man Attacks 11 Children & 3 Teachers at Elementary School
School Shooting Related Luvox 1993-07-23 Florida **Man Commits Murder During Clinical Trial for Luvox: Same Drug as in COLUMBINE: Never Reported
School Hostage Situation Cymbalta Antidepressant WITHDRAWAL 2009-11-09 New York **Man With Gun Inside School Holds Principal Hostage
School Shooting Antidepressants 1992-09-20 Texas **Man, Angry Over Daughter's Report Card, Shoots 14 Rounds inside Elementary School
School Shooting SSRI 2010-02-19 Finland **On Sept. 23, 2008 a Finnish Student Shot & Killed 9 Students Before Killing Himself
MANY MORE here
