Bruce Levine, Ph.D.
February 10, 2013
After the American Psychiatric Association (APA) approved the latest version of its diagnostic bible, the DSM-5, psychiatrist Allen Frances, the former chair of the DSM-4 taskforce and currently professor emeritus at Duke, announced, “This is the saddest moment in my 45-year career of practicing, studying and teaching psychiatry” (“A Tense Compromise on Defining Disorders”).
The DSM-5 (the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders) will be released by the APA in spring 2013. However, a forlorn Frances states, “My best advice to clinicians, to the press, and to the general public—be skeptical and don’t follow DSM-5 blindly down a road likely to lead to massive over-diagnosis and harmful over-medication.”
For mental health professionals, this advice from the former chair of the DSM-4 taskforce is shocking—almost as if Colin Powell were to advise U.S. defense and state department employees not to blindly follow all administration orders.
Particularly upsetting for Frances is the DSM-5’s pathologizing of normal human grief. On January 7, 2013 in “Last Plea To DSM-5: Save Grief From the Drug Companies,” Frances writes, “Making grief a mental disorder will be a bonanza for drug companies, but a disaster for grievers. The decision is also self-destructive for DSM-5 and further undermines the credibility of the APA. Psychiatry should not be mislabeling the normal.”
In the DSM-4, which Frances helped create, there had been a so-called “bereavement exclusion,” which stated that grieving the loss of a loved one, even when accompanied by symptoms of depression, should not be considered the psychiatric disorder of depression.
Prior to the DSM-5, the APA had acknowledged that to have symptoms of depression while grieving the loss of a loved one is normal and not a disease. Come this spring, normal human grief accompanied by depression symptoms will be a mental disorder.
Psychiatry’s official diagnostic battle is over. Mental illness gatekeepers such as Frances who are concerned about further undermining the credibility of the APA have lost, and mental illness expansionists —psychiatry’s “neocons”— have won.
Read the rest here
Showing posts with label FDA's MedWatch system. Show all posts
Showing posts with label FDA's MedWatch system. Show all posts
Monday, February 11, 2013
Sunday, November 7, 2010
Diagnostic and Statistical Manual of Mental Disorders - Home Page
Diagnostic and Statistical Manual of Mental Disorders - Home Page
The Diagnostic and Statistical Manual of Mental Disorders—the Psychiatrist's Billing Code Bible
The DSM IV (The Diagnostic and Statistical Manual of Mental Disorders, volume 4) is the latest and current version of the standard handbook of "mental illnesses" as determined by the American Psychiatric Association (APA). What comes into question with this manual is the manner and method by which these supposed mental illnesses are determined and by whom. Using the DSM IV, a psychiatrist need only label the patient with a "mental disorder", prescribe him a drug and bill the patient's insurance or Medicaid. The psychiatrist with the DSM in hand can try various labels on the patient as if they were different sizes of apparel until he finds one that either fits the patient's symptoms or comes close enough to allow him to bill the patient's insurance. The question is: Do any of these "disorders" or "mental illnesses" actually exist? Does the DSM have any relationship to a patient's actual condition or is it a convenient and simplistic method of compartmentalizing symptoms without actually working to isolate the true cause of the patient's real problems. Read the Full Article
The Diagnostic and Statistical Manual of Mental Disorders—the Psychiatrist's Billing Code Bible
The DSM IV (The Diagnostic and Statistical Manual of Mental Disorders, volume 4) is the latest and current version of the standard handbook of "mental illnesses" as determined by the American Psychiatric Association (APA). What comes into question with this manual is the manner and method by which these supposed mental illnesses are determined and by whom. Using the DSM IV, a psychiatrist need only label the patient with a "mental disorder", prescribe him a drug and bill the patient's insurance or Medicaid. The psychiatrist with the DSM in hand can try various labels on the patient as if they were different sizes of apparel until he finds one that either fits the patient's symptoms or comes close enough to allow him to bill the patient's insurance. The question is: Do any of these "disorders" or "mental illnesses" actually exist? Does the DSM have any relationship to a patient's actual condition or is it a convenient and simplistic method of compartmentalizing symptoms without actually working to isolate the true cause of the patient's real problems. Read the Full Article
Wednesday, August 5, 2009
FDA Reported Psychiatric Drug Side Effects Search Engine Decrypted and Made Public
Citizens Commission on Human Rights International Announces FDA Reported Psychiatric Drug Side Effects Search Engine: Decrypted FDA reports reveal 4,260 suicides, 2,452 additional deaths, 195 homicides from 2004-2006 alone
Los Angeles, CA August 4, 2009 -- For the first time the side effects of psychiatric drugs that have been reported to the U.S. Food and Drug Administration (FDA) by doctors, pharmacists, other health care providers and consumers have been decrypted from the FDA's MedWatch reporting system and been made available to the public in an easy to search psychiatric drug side effects database and search engine. The database is provided as a free public service by the mental health watchdog, Citizens Commission on Human Rights International (CCHR).
The report totals reveal that between 2004-2008 the FDA's MedWatch system received pregnancy-related psychiatric drug adverse reaction reports which included 2,442 babies born with heart disease, 3,372 other birth defects, as well as 1,072 miscarriages, abortions and other deaths.
The database also reveals that, between 2004-2008 there were reports submitted to MedWatch including 4,895 suicides, 3,908 cases of aggression, 309 homicides and 6,945 cases of diabetes from people taking psychiatric drugs. These numbers reflect only a small percentage of the actual side effects occurring in the consumer market, as the FDA has admitted that only 1-10% of side effects are ever reported to the FDA.
The database is searchable by individual reports (for the 2004-2006 period), type of drug, age of patient, the side effect reported (suicide, homicide, heart attack, stroke, mania, etc.), and whether the drug in question carries a black box warning (the agency's strongest warning--short of banning a drug).
It is searchable by drug name and age group and includes who reported the psychiatric drug reaction (doctor, pharmacist, consumer, etc.). It also includes the top 20 reported adverse reactions to all psychiatric drugs to the FDA and combined summaries of all psychiatric drug reactions for the years 2004-2006 and 2004-2008.
Since the reform of the Prescription Drug User Fee Act (PDUFA) in 2007, ads for psychiatric and other drugs must include statements encouraging consumers to report adverse drug reactions to the FDA's MedWatch system--Adverse Events Reporting System (AERS). However, consumers or doctors attempting to access the AERS online were confounded by a system so complex that it was impossible to use. Although the FDA should have made the information collected readily accessible, it failed in that duty to the public. It took a computer programmer over 1,000 hours to decipher four years' worth of data to make this information available.
The programmer identified the main psychiatric drugs in the AERS, wading through quarterly reports of seven different reporting systems, including the drug name, demographics, adverse reactions, patient outcomes, reporting source, therapy start and end dates and the indication (diagnosis). The result: A database and search engine that unravels the 94,000 pages of codified psychiatric drug adverse reactions reported each year from 2004-2006 and 2004-2008 to the FDA's MedWatch system.
Reporting of adverse reactions to psychiatric drugs by doctors, pharmacists, other health care providers and consumers once those drugs are out in the consumer market, is fundamental to drug safety monitoring. Yet these reports have been frequently ignored or dismissed as "anecdotal" by the FDA even when serious side effects number in the thousands. The FDA approves the majority of psychiatric drugs only after Phase 2 (short term) clinical trials. However, once the drugs are out in the consumer market, the FDA is supposed to require longer clinical trials, or post-marketing studies of the drugs, however this rarely happens. Subsequently, dangerous and deadly drugs have been left without black box warnings, or on the market for far too long. The best "signal" event for the FDA to direct its resources in identifying or pulling dangerous drugs is what is happening out in the real world, with consumers and patients, not in a controlled short term clinical trial, funded by the pharmaceutical companies seeking approval for their drugs to go to market.
For years the information contained in the FDA's MedWatch reporting system has been inaccessible and therefore virtually useless for consumers and doctors. CCHR's stance has always been that consumers have the right to this information for then ̶ and only then ̶ can consumers have full "informed consent" regarding the risks of psychiatric drugs, and so it has provided this database as a free public service.
The psychiatric drug search engine features a promotional video as well as an instructional video for users on CCHR's newly launched website so they can get the information from the database they are looking for in the shortest amount of time.
About The Citizens Commission on Human Rights:
The Citizens Commission on Human Rights is a mental health watchdog co-founded in 1969 by Professor of Psychiatry Emeritus Thomas Szasz and the Church of Scientology. It is a non-profit, non political, non-religious organization that has been responsible for more than 100 reforms that help protect patients rights against abuses in the field of mental health. For more information about CCHR go to http://www.cchrint.org
For More Information Please Contact:
Marla Filidei (800) 869-2247
Los Angeles, CA August 4, 2009 -- For the first time the side effects of psychiatric drugs that have been reported to the U.S. Food and Drug Administration (FDA) by doctors, pharmacists, other health care providers and consumers have been decrypted from the FDA's MedWatch reporting system and been made available to the public in an easy to search psychiatric drug side effects database and search engine. The database is provided as a free public service by the mental health watchdog, Citizens Commission on Human Rights International (CCHR).
The report totals reveal that between 2004-2008 the FDA's MedWatch system received pregnancy-related psychiatric drug adverse reaction reports which included 2,442 babies born with heart disease, 3,372 other birth defects, as well as 1,072 miscarriages, abortions and other deaths.
The database also reveals that, between 2004-2008 there were reports submitted to MedWatch including 4,895 suicides, 3,908 cases of aggression, 309 homicides and 6,945 cases of diabetes from people taking psychiatric drugs. These numbers reflect only a small percentage of the actual side effects occurring in the consumer market, as the FDA has admitted that only 1-10% of side effects are ever reported to the FDA.
The database is searchable by individual reports (for the 2004-2006 period), type of drug, age of patient, the side effect reported (suicide, homicide, heart attack, stroke, mania, etc.), and whether the drug in question carries a black box warning (the agency's strongest warning--short of banning a drug).
It is searchable by drug name and age group and includes who reported the psychiatric drug reaction (doctor, pharmacist, consumer, etc.). It also includes the top 20 reported adverse reactions to all psychiatric drugs to the FDA and combined summaries of all psychiatric drug reactions for the years 2004-2006 and 2004-2008.
Since the reform of the Prescription Drug User Fee Act (PDUFA) in 2007, ads for psychiatric and other drugs must include statements encouraging consumers to report adverse drug reactions to the FDA's MedWatch system--Adverse Events Reporting System (AERS). However, consumers or doctors attempting to access the AERS online were confounded by a system so complex that it was impossible to use. Although the FDA should have made the information collected readily accessible, it failed in that duty to the public. It took a computer programmer over 1,000 hours to decipher four years' worth of data to make this information available.
The programmer identified the main psychiatric drugs in the AERS, wading through quarterly reports of seven different reporting systems, including the drug name, demographics, adverse reactions, patient outcomes, reporting source, therapy start and end dates and the indication (diagnosis). The result: A database and search engine that unravels the 94,000 pages of codified psychiatric drug adverse reactions reported each year from 2004-2006 and 2004-2008 to the FDA's MedWatch system.
Reporting of adverse reactions to psychiatric drugs by doctors, pharmacists, other health care providers and consumers once those drugs are out in the consumer market, is fundamental to drug safety monitoring. Yet these reports have been frequently ignored or dismissed as "anecdotal" by the FDA even when serious side effects number in the thousands. The FDA approves the majority of psychiatric drugs only after Phase 2 (short term) clinical trials. However, once the drugs are out in the consumer market, the FDA is supposed to require longer clinical trials, or post-marketing studies of the drugs, however this rarely happens. Subsequently, dangerous and deadly drugs have been left without black box warnings, or on the market for far too long. The best "signal" event for the FDA to direct its resources in identifying or pulling dangerous drugs is what is happening out in the real world, with consumers and patients, not in a controlled short term clinical trial, funded by the pharmaceutical companies seeking approval for their drugs to go to market.
For years the information contained in the FDA's MedWatch reporting system has been inaccessible and therefore virtually useless for consumers and doctors. CCHR's stance has always been that consumers have the right to this information for then ̶ and only then ̶ can consumers have full "informed consent" regarding the risks of psychiatric drugs, and so it has provided this database as a free public service.
The psychiatric drug search engine features a promotional video as well as an instructional video for users on CCHR's newly launched website so they can get the information from the database they are looking for in the shortest amount of time.
About The Citizens Commission on Human Rights:
The Citizens Commission on Human Rights is a mental health watchdog co-founded in 1969 by Professor of Psychiatry Emeritus Thomas Szasz and the Church of Scientology. It is a non-profit, non political, non-religious organization that has been responsible for more than 100 reforms that help protect patients rights against abuses in the field of mental health. For more information about CCHR go to http://www.cchrint.org
For More Information Please Contact:
Marla Filidei (800) 869-2247
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