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    The FDA’s Flawed System of How Antidepressants Get Approved; Negative Trials Ignored


    Posted by .(JavaScript must be enabled to view this email address)
    Sunday, August 14, 2016 10:38 am Email this article

    Irving Kirsch, PhD from Harvard Medical School tells how antidepressants get approved by the FDA and why it is a flawed system.

    Only Two Positive Drugs Studies Needed for Approval, While Negative Trials Ignored

    He notes that drug companies only have to provide two studies showing positive results to get a drug approved regardless of how many trials failed to show any benefit.

    “The FDA requires two adequately conducted clinical trials showing a significant difference between drug and placebo,” Kirsch writes.

    “But there is a loophole: There is no limit to the number of trials that can be conducted in search of these two significant trials.

    “Trials showing negative results simply do not count.

    “Furthermore, the clinical significance of the findings is not considered.

    “All that matters is that the results are statistically significant.”

    Example of Something that Might Be Statistically Significant, but Clinically Meaningless

    Kirsch gives an example of something that might be statistically significant, but not clinically significant, saying that if they studied a large group of people and found that smiling increases life expectancy by 5 minutes, this might be statistically significant, but clinically meaningless.

    Approval of Vilazodone (Viibryd®)

    “The most egregious example of the implementation of this criterion is provided by the FDA’s approval of vilazodone [Viibryd®] in 2011,” Kirsch continues.

    “Seven controlled efficacy trials were conducted.

    “The first five failed to show any significant differences on any measure of depression, and the mean drug-placebo difference in these studies was less than 1/2 point on the [Hamilton Depression Scale], and in two of the three trials, the direction of the difference actually favored the placebo.

    “The company ran two more studies and managed to obtain small but significant drug-placebo differences (1.70 points).

    “The mean drug-placebo difference across the seven studies was 1.01 [Hamilton Depression Scale] points.

    “No mention is made of the five failed trials that preceded the two successful ones.

    “The failure to mention the unsuccessful trials was not merely an oversight; it reflects a carefully decided FDA policy dating back for decades.

    FDA Director Thinks Excluding Info About Negative Drug Trials is Potentially ‘False and Misleading’

    Kirsch continues by saying,

    “To my knowledge, there is only one antidepressant in which the FDA included information on the existence of negative trials.

    “The exception is citalopram [Celexa], and the inclusion of the information followed an objection raised by Paul Leber, who was at the time the director of the FDA Division of Neuropharmacological Drug Products.

    “In an internal memo dated May 4, 1998, Leber wrote:

        “One aspect of the labeling deserves special mention.

        “The [report] not only describes the clinical trials providing evidence of citalopram’s antidepressant effects, but make mention of adequate and well-controlled clinical studies that failed to do so…

        “The Office Director is inclined toward the view that the provision of such information is of no practical value to either the patient or prescriber.

        “I disagree.

        “I believe it is useful for the prescriber, patient, and 3rd-party payer to know, without having to gain access to official FDA review documents, that citalopram’s antidepressants effects were not detected in every controlled clinical trial intended to demonstrate those effects.

        “I am aware that clinical studies often fail to document the efficacy of effective drugs, but I doubt that the public, or even the majority of the medical community, is aware of this fact.

        “I am persuaded that they not only have a right to know but that they should know.

        “Moreover, I believe that labeling that selectively describes positive studies and excludes mention of negative ones can be viewed as potentially ‘‘false and misleading.”

    (Leber, May 4, 1998).

    Irving Kirsh’s book The Emperor’s New Drugs: Exploding the Antidepressant Myth

    Irving Kirsh is the author of the book The Emperor’s New Drugs: Exploding the Antidepressant Myth.

    Robert Whitaker’s book Anatomy of an Epidemic Talked About All of This

    Robert Whitaker’s wonderful book Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America (2010) talks about all of this also.

    Whitaker found that:

    This article was originally published on May 31, 2016.

    Reference

    Kirsch I. Antidepressants and the Placebo Effect. Z Psychol, 2014; 222(3): 128-134.

    The paper is posted here.

    Author’s Contact Info

    Irving Kirsch, PhD
    Beth Israel Deaconess Medical Center Gen. Med. Pricare
    330 Brookline Avenue
    Boston, MA 02215 USA
    Tel. +1 617 945-7827
    Fax +1 617 492-3182
    .(JavaScript must be enabled to view this email address)

     

     

     

    Other Articles About Antidepressants

    Here are links to other articles about antidepressants.

    Antidepressants benefits mostly, if not entirely, due to the placebo effect says Harvard researcher

    If you ask me, no one should take antidepressants, Peter Gotzsche, MD

    Fluoxetine (Prozac), a terrible drug, Peter Gotzsche, MD

    3 False Epidemics: ADHD, Autism and Childhood Bipolar Disorder, Peter Gotzsche, MD

    Risk of suicide caused by SSRI’s grossly underestimated, Peter Gotzsche, MD

    Likely to have been 15 times more suicides on antidepressant than reported by FDA, Peter Gotzsche MD

    ‘Virtually all trials of psychotropic agents are flawed’ says Peter Gotzsche, MD

    Survey found 60% felt emotional numb on antidepressants says Peter Gotzsche, MD

    Antidepressants don’t work for depression, Peter Gotzsche, MD

    DSM-IV created three false epidemics: ADHD, autism and childhood bipolar disorder, Peter Gotzsche MD

    Psychiatry Has Spiraled Out of Control, Peter Gotzsche, MD

    1% of US children up to only four years of age are on psychotropic drugs, Peter Gotzsche, MD

    It Should Be Forbidden To Make a Second Diagnosis While Someone Is On Drugs, Peter Gotzsche, MD

    All Psychiatric Diagnoses and Interventions Can Cause Harm, Peter Gotzsche, MD

    Screening for Depression is Harmful, Peter Gotzsche, MD

    Psychiatric drugs kill more than 500,000 people 65 and older each year, Peter Gotzsche, MD

    Psychiatric drug use could be reduced by 98 percent, Peter Gotzsche, MD

    There is a Huge Epidemic of drug overuse with SSRI’s, Peter Gotzsche, MD

    Psychiatrists Think Psychiatric Drugs Are Effective, Patients Do NOT, Peter Gotzsche, MD

    It Is Doubtful Whether Antidepressants Are Effective For Depression, Peter Gotzsche, MD

    SSRI’s Kill One Of 28 People Above 65 Years Of Age Treated For One Year, Peter Gotzsche, MD

    Many People Suffer Disabling Symptoms For Years Following Antidepressant Withdrawal, Peter Gotzsche

    Prescriptions for antidepressants written in 3 minutes or less, Peter Gotzsche, MD

    Many People Are Wrongly Diagnosed With Schizophrenia, Peter Gotzsche, MD

    One-Fourth of Healthy People [Wrongly] Got A Psychiatric Diagnosis, Peter Gotzsche, MD

    Before and After picture of depressed woman treated with natural approach, Joan Mathews Larson, PhD

    SSRI’s increase risk of suicides, Parkinson’s and restless legs notes Joan Mathews Larson PhD

    SSRI’s may increase risk of breast cancer, notes Joan Mathews Larson PhD

    SSRI’s make things worse notes Joan Mathews Larson, PhD

    Merck hid 3 heart attacks in VIGOR trial of Vioxx, Peter Gotzsche, MD

    Drug studies published in the New England Journal of Medicine are advertisements, Peter Gotzsche, MD

    8 children on the SSRI antidepressant paroxetine (Paxil) had suicidal thoughts, Peter Gotzsche, MD

    Stopping an antidepressant can make people feel depressed or suicidal, Peter Gotzsche, MD

    Psychiatric drugs, drug industry cheated in drug trials, withholding suicides, Peter Gotzsche, MD

    Psychiatry is the drug industry’s paradise, Peter Gotzsche, MD

    Psychiatric drugs can CAUSE psychiatric diseases, Peter Gotzsche, MD

    Psychiatry’s lies, Peter Gotzsche, MD

    Psychiatric drugs has INCREASED the number of people on disability, Peter Gotzsche, MD

    Antidepressants are dangerous, Peter Gotzsche, MD

    Antidepressants increase risk of suicide, Peter Gotzsche, MD

    Psychiatric drugs do ‘more harm than good’ notes Prof. Peter Gotzsche, MD

    Psychiatric drugs create ‘more harm than good’ notes Prof. Peter Gotzsche, MD

    ‘Drug companies don’t sell drugs, they sell lies about drugs’ notes Prof. Peter Gotzsche, MD

    You can get the same benefit without drugs if you are mildly or moderately depressed, Irving Kirsch

    Physical exercise improves mild depression as much as antidepressants notes UK’s Dr. Tim Kendall

    The FDA says unpublished drug trials are unpublished because they were flawed, but Britain disagrees

    Great Britain found that for mild to moderate depression, antidepressants were not effective

    The FDA requires only two studies show positive results to approve a drug

    The serotonin deficiency theory of depression is probably not correct says Walter Brown, MD

    For mild to moderate depression, antidepressants are no better than a placebo, Irving Kirsch, PhD

    17 million Americans taking antidepressants

    Sales of antidepressants total $11.3 billion per year

    Antidepressants and antipsychotic drugs do more harm than good

    Risperdal (risperidone) plus Paxil (paroxetine) causes weight gain of 30-31 lbs in 4-5 months

    Zoloft (sertraline) increases risk of diabetes 25%

    Paxil (paroxetine) increases risk of diabetes 33%

    Elavil (amitriptyline) increases risk of diabetes 43%

    Anafranil (clomipramine) increases risk of diabetes 123%

    Surmontil (trimipramine) increases risk of diabetes 146%

    Antidepressants benefits mostly, if not entirely, due to the placebo effect says Harvard researcher

    180 to 720 mg of rubidium chloride had a significant antidepressant effect in two-thirds of patients

    360-720 mg of rubidium chloride per day for 2 months had rapid antidepressant action in 20 people

    540 mg of rubidium chloride for 3 weeks had antidepressant effect in 15 depressed people

    History of the mineral rubidium as an antidepressant

    If you ask me, no one should take antidepressants, Peter Gotzsche, MD

    Fluoxetine (Prozac), a terrible drug, Peter Gotzsche, MD

    3 False Epidemics: ADHD, Autism and Childhood Bipolar Disorder, Peter Gotzsche, MD

    Risk of suicide caused by SSRI’s grossly underestimated, Peter Gotzsche, MD

    Likely to have been 15 times more suicides on antidepressant than reported by FDA, Peter Gotzsche MD

    ‘Virtually all trials of psychotropic agents are flawed’ says Peter Gotzsche, MD

    Survey found 60% felt emotional numb on antidepressants says Peter Gotzsche, MD

    Antidepressants don’t work for depression, Peter Gotzsche, MD

    DSM-IV created three false epidemics: ADHD, autism and childhood bipolar disorder, Peter Gotzsche MD

    Psychiatry Has Spiraled Out of Control, Peter Gotzsche, MD

    1% of US children up to only four years of age are on psychotropic drugs, Peter Gotzsche, MD

    It Should Be Forbidden To Make a Second Diagnosis While Someone Is On Drugs, Peter Gotzsche, MD

    All Psychiatric Diagnoses and Interventions Can Cause Harm, Peter Gotzsche, MD

    Screening for Depression is Harmful, Peter Gotzsche, MD

    Psychiatric drugs kill more than 500,000 people 65 and older each year, Peter Gotzsche, MD

    Psychiatric drug use could be reduced by 98 percent, Peter Gotzsche, MD

    There is a Huge Epidemic of drug overuse with SSRI’s, Peter Gotzsche, MD

    Psychiatrists Think Psychiatric Drugs Are Effective, Patients Do NOT, Peter Gotzsche, MD

    It Is Doubtful Whether Antidepressants Are Effective For Depression, Peter Gotzsche, MD

    SSRI’s Kill One Of 28 People Above 65 Years Of Age Treated For One Year, Peter Gotzsche, MD

    Many People Suffer Disabling Symptoms For Years Following Antidepressant Withdrawal, Peter Gotzsche

    Prescriptions for antidepressants written in 3 minutes or less, Peter Gotzsche, MD

    Many People Are Wrongly Diagnosed With Schizophrenia, Peter Gotzsche, MD

    One-Fourth of Healthy People [Wrongly] Got A Psychiatric Diagnosis, Peter Gotzsche, MD

    High histamine levels cause compulsion, low levels irritability, Joan Mathews Larson PhD

    180 to 720 mg of rubidium chloride had a significant antidepressant effect in two-thirds of patients

    360-720 mg of rubidium chloride per day for 2 months had rapid antidepressant action in 20 people

    540 mg of rubidium chloride for 3 weeks had antidepressant effect in 15 depressed people

    History of the mineral rubidium as an antidepressant

    Articles on the same subject can be found here:


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