Posts Tagged ‘antidepressants’

One Million UK Patients Addicted to Prescription Drugs

Tuesday, March 16th, 2010

Natural News
By David Gutierrez
March 15, 2010

Approximately 1.5 million people in the United Kingdom are addicted to prescription or over-the-counter drugs, many of which were legally acquired.

In July, the Department of Health launched a review of the problem, after the House of Commons All-Party Group on Drug Misuse called for greater awareness, better doctor training and more treatment options.

Although medical guidelines discourage doctors from prescribing benzodiazepine tranquilizers such as Valium for more than four weeks at a time, many patients still become addicted.

“There are still lots and lots of patients being put on these drugs and kept on them for a long time,” said Pam Armstrong of the Council for Information on Tranquillizers and Antidepressants. “I have some sympathy with [doctors] — they get a lot of pressure from patients who want these drugs. But the problem has been ignored.”

Other highly addictive drugs include sleeping pills and narcotic painkillers. A recent study found that painkillers containing codeine can be addictive within as little as three days.

Read entire article:  http://www.naturalnews.com/028375_painkillers_addiction.html

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Pharma Backed Australian of the Year Psychiatrist Wants Millions in Government Funding for Brave New World of “Pre-Drugging” Kids

Monday, March 15th, 2010

By CCHR Int
March 15, 2010

Who is Patrick McGorry and what does he promote?  He’s a psychiatrist just named Australian of the Year for his work in “youth mental health reform.”  What does that reform consist of?  What he calls a “new form of climate change.” It sure is.

[See TIME Magazine Article "Drugs Before Diagnosis?"]

He not only promotes youths being put on antipsychotics and antidepressants, cited by international drug regulatory agencies as causing hallucinations, hostility, personality change, life-threatening diabetes, strokes, suicide and death, McGorry goes a giant step further—drug them before they’ve even developed a “psychiatric” disorder.

The Association for the Accreditation of Human Research Protection Programs (AHRPP) likens such concepts to “performing mastectomies on women who are at risk of—but do not have—breast cancer.”[i]

The UN Committee on the Rights of the Child has expressed “serious concerns” about child drugging and Senate investigations in the United States have found high profile psychiatrists who were pharmaceutically funded and using fraudulent research being among the heaviest promoters of psychiatric drug use on children. While the rest of the world is experiencing serious alarm at the rampant use of deadly psychiatric drugs on children, McGorry pushes full steam ahead to increase the amount of children being needlessly subjected to psychiatry’s most powerful drugs—antidepressants and antipsychotics.

His theory and practices are so controversial that even his colleagues in the United States have backed away from it.  And a parallel study done in the United States based on the same theory that McGorry uses was considered an abject failure—even by the investigators themselves.  Other psychiatrists have criticized McGorry’s pre-drugging practice as unethical and harmful to adolescents.  More on that later.

This is especially so as the “symptoms” McGorry and cohorts invented to “pre-label” youths as potential candidates for psychosis and “schizophrenia” (to start with) are, according to one U.S. psychiatrist, “remarkably common…adolescence is a period of life that is normally marked by tumultuous changes in personality.”

And what was the first thing he did to capitalize on his winning his “Australian of the Year” award?  He demanded the Australian government hand over another $200 million to fund more of his centers where he can drug more children.  Worse, the government is entertaining the idea.

Yet, for who ever nominated him—apparently an “anonymous supporter”—due diligence wasn’t done on what McGorry advocates.

A cursory look at his research shows that while behavioral symptoms are evaluated and, on a hunch, drugged to see if they “prevent” the onset of a “mental” disorder, there’s no mention of the teens being given full and searching physical exams to first rule out undiagnosed and untreated medical conditions that may be causing it.  Yet dozens of physical conditions can manifest as behavioral problems.

  • Australia, like the U.S., has recently seen major media and legislative exposure of the conflicts of interest between psychiatrists and the pharmaceutical industry.  McGorry has received unrestricted research grant support from Eli Lilly, Janssen-Cilag, Bristol Myer Squibb, AstraZeneca, Pfizer, and Novartis.

  • He is also a paid consultant for, and has received speaker’s fees from all or most of these companies.[ii] His recent report on “early intervention” for young people acknowledges AstraZeneca, Janssen, Eli Lilly, Novartis, Sanofi, Bristol Myers Squibb and Pfizer.[iii] [Since 2001, the U.S. Federal and state governments have recovered more than $4 billion from many of these companies that settled criminal or civil charges of fraud and misleading advertising filed against them.]

  • Even Big Pharma is bowing out of psychiatric drug research. In February, the CEO of GlaxoSmithKline said it was dumping antidepressant research because it is too hard to prove that antidepressants work because “patient improvement is measured by subjective mood surveys” and not by any blood or biological test used to confirm medical diseases. AstraZeneca followed with the head of development, Anders Ekblom, announcing it would no longer research and develop drugs for depression, bipolar, anxiety and schizophrenia, saying the decision reflects the unpredictable and risky nature of clinical trials to assess medicine working on the brain. [emphasis added]
  • Yet, despite the unpredictability and risk of these drugs, McGorry wants to go full steam ahead, increasing the funding to increase the number of children being placed on them.

A Closer Look at McGorry’s Brave New World

  • In 1996, Patrick McGorry and fellow pharmaceutical company-funded researcher Alison Yung set up a clinic in Australia to monitor young people considered at a “high risk” for developing psychosis.  They invented a subjective method for assessing symptoms that, while not based on science—claimed to predict early onset of psychosis or schizophrenia called prodromal (early symptoms), and drugged the teens and young adults.  In other words, gave them toxic chemicals for a mental disorder they did not have.[iv]
  • The theory wasn’t McGorry’s alone, but he decided to test it in a world-first trial that had psychiatry’s skeptics and even psychiatrists themselves aghast.  The Australian program inspired the development of similar programs worldwide.[v]
  • A follow up study was conducted in 2002, funded with an unrestricted grant from Janssen-Cilag pharmaceuticals, and supported by psychiatric-pharmaceutical front groups NARSAD and Stanley Foundation, as well as several Australian agencies.  McGorry and colleagues said that risperidone (Risperdal)—made by Janssen—reduced the risk of “transition to psychosis” in young people.[vi]
  • Risperdal has been linked to diabetes and, more specifically, Type 2 diabetes. Other serious side effects include Neuroleptic Malignant Syndrome (NMS), a potentially fatal syndrome involving muscle rigidity, and irregular blood pressure and pulse.[vii]
  • McGorry’s friend and colleague, Yale University professor of Psychiatry, Dr. Thomas McGlashan, conducted a parallel study (1997-2003), the results of which were published in the American Journal of Psychiatry.   Eli Lilly funded the experiment.  Sixty adolescents, who did not meet any criteria for a diagnosis of mental illness, were prescribed Lilly’s antipsychotic Zyprexa (olanzapine).[viii]
  • The experiment failed to demonstrate any significant benefit of Zyprexa, and 54.8% of adolescents prescribed the drug compared to 34.5% on placebo refused to complete the study (the 20% difference indicating substantial intolerable safety problems with the drug).[ix]
  • Even McGlashan later admitted to The New York Times in May 2006 that, “the drugs were more likely to induce weight gain than to produce a significant, measurable benefit….” Those on medication gained an average of about 20 pounds. The entire process changed Dr. McGlashan’s thinking.[x]
  • In fact he distanced himself from McGorry in a TIME Magazine article the same year on McGorry titled, “Drug Before Disorder?”  “There may be gold in the early-intervention hills,” McGlashan conceded, “but the data are not plentiful enough and the findings not replicated enough for us to recommend anything more than further research at this point.”[xi]
  • Undeterred, and buoyed by an Australian government $A54 million funding of a National Youth Mental Health Foundation, McGorry plowed on to expand his unproven and potentially risky methods to the early diagnosis and treatment for “a range of mental health problems in young people: substance abuse, personality disorders, bipolar—the whole lot, really.”[xii]
  • Richard Warner, MB, DPM, director of Colorado Recovery in Boulder, Colorado, and professor of psychiatry at the University of Colorado, completely debunks McGorry’s theory, writing: Medicating at the earliest appearance of symptoms, without thought for the natural history of the condition, may lock the person experiencing a brief psychosis into a long-term career as a psychiatric patient.”[xiii]
  • Further refuting McGorry’s theory, Honorary Professor Anthony Pelosi from the Department of Psychiatry, Hairmyres Hospital, East Kilbride, wrote, “So far, evidence from randomized trials does not support the use of psychological therapies or drugs as preventive interventions.”[xiv]

No Science to “Pre-Disorder” Screening

  • Dr. Warner counters any idea that science drives McGorry’s pre-disorder assessment: “As for the claim that we can prevent psychosis by intervening before the illness has become fully evident, this effort requires effective screening to detect those at risk.”  Something that McGorry clearly doesn’t have.
  • “Patrick McGorry and colleagues at the PACE clinic in Melbourne…report that their screening instrument is capable of 80 per cent accuracy in their clinic.  But the instrument is not that accurate in routine use.  In the PACE sample, 35 per cent developed psychosis within one year.  Probability theory tells us that if the same instrument were used to screen a general population sample…it would be correct only seven per cent of the time.”
  • “In fact, in another Australian clinic, the PACE instrument only achieved nine per cent accuracy. False-positive rates of the order of 70 to 90 per cent are clearly unrealistic for intervening with medication or other forms of treatment.”

Harmful Drug Outcomes

  • Further, the antipsychotic drug interventions McGorry suggests as one intervention approach are dangerous. Given the expected number of false positives, the potential for harm is significant,” Dr. Warner stated.[xv]

  • Dr. Pelosi concurs: “[M]ost patients who enter these specialist programs will unnecessarily receive potentially dangerous treatments.  Data are emerging from the clinics of early intervention enthusiasts that illustrate nicely what they have been warned about for years.  When psychiatrists referred selected patients to a schizophrenia prodrome clinic, about half went on to develop a psychosis.  After teachers, college counselors, and families were encouraged to refer young people with possibly prodromal symptoms directly to the same clinic for the same care plans…almost 90% were receiving unnecessary ‘preventive’ interventions.”[xvi]
  • Dr. Jerald J. Block, a U.S. psychiatrist, writing in Bioethics Forum, says that “preventive pharmacology” (what McGorry is practicing) is “ethically questionable territory” because the treatments given “frequently have side effects and complications” and you are potentially harming people.  Further, the symptoms used to identify them as at risk of schizophrenia are “also remarkably common…adolescence is a period of life that is normally marked by tumultuous changes in personality.”[xvii]
  • He says, “[I]t is unclear how the quality of one’s life will be affected during and after one year of getting daily neuroleptic,” especially for a condition you haven’t even developed. “Forming and solidifying new relationships occupies much of the time in adolescence and young adulthood.  As neuroleptics affect cognition and emotionality, we might expect [an antipsychotic] to influence one’s ability to build relationships, for better or worse.”[xviii]
  • Moreover, Dr. Warner points out, if left untreated, the person exhibiting so-called “prodromal” symptoms is likely to recover without drug treatment. “The Soteria projects in California and Berne, Switzerland, and a multi-center study in Finland demonstrated that medication is not essential for good outcome.”[xix]

Despite the Failure, Keep Lobbying for the $

  • Dr. Pelosi points out that when the leaders of the early intervention movement are pinned down, while they accept the criticisms against them, “this has not stopped their skilful lobbying of politicians, journalists, patients, and carers with upbeat messages about the prevention and attenuation of schizophrenia.”
  • Which is precisely what McGorry is doing now—using his award and unquestionably unscientific theories to advocate for more funds.[xx]

Australia’s Joseph Biederman?

  • McGorry has been equated with America’s Dr. Joseph Biederman, the psychiatrist who came under U.S. Senate Finance Committee investigation for failing to disclose more than $1.6 million he’d earned in consulting fees from drug makers while conducting research for universities.  Biederman was on the Advisory Board of Eli Lilly, which manufactures antipsychotics and antidepressants. The New York Times said that Biederman helped to fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric “bipolar disorder” and corresponding increase in children taking antipsychotics.
  • How much McGorry may have impacted on pediatric and youth prescriptions of antipsychotics and antidepressants in Australia is unknown, but certainly warrants a closer look. As do the outcomes of his studies and what, if any, influence the drug companies that funded him may have had.
  • Australia’s Therapeutic Goods Administration (TGA) has received reports of 26,506 adverse reactions linked to antipsychotics, including 477 deaths.  That’s since they were introduced over many years.  By January 2009 there were 36,804 adverse reactions reported to the TGA linked to antidepressants, including 217 deaths, of which 4 were from the 10 to 19 age group.
  • But add to that the Food and Drug Administration’s adverse drug reaction reports (ADRs) during a five-year period alone (2004-2008) and the magnitude of where the potential risk of this “Drugs before Disorder” practice is heading.  For antipsychotics, there were 91 deaths for those under 18.  For antidepressants, there were 321 deaths, of which 251 were suicides. As these reports represent between one and ten percent of the ADRs, that figure could be as high as 3,210 deaths, and for antipsychotics, nearly 1,000.

Australia’s health care system ranks well internationally, and preventative measures may seem the way to enhancing it; however, the last thing the country needs, then, is a psychiatrist banner heading the idea that children and youths should be gotten to early and drugged on the precept that they might become mentally ill.  Rather, they need proper medical—not psychiatric—care and educational solutions.  The last thing they need is $200 million of taxpayers’ dollars funding what could be a lifetime sentence to taking mind-altering drugs.

Someone needs to care for Australia’s children and youth, but it’s definitely not Patrick McGorry.


[i] http://www.ministryoflies.com/pdf-articles/Yale-Lilly.pdf.

[ii] http://www.bmj.com/cgi/content/full/337/aug04_1/a695.

[iii] http://www.mhanet.ca/documents/2008/Research-Colloquium/0920%20-%20Keynote%20MCGORRY.pdf.

[iv] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2632176/.

[v] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2632176/.

[vi] Arch Gen Psychiatry, Vol 59, Oct. 2002, http://www.meb.uni-bonn.de/psychiatrie/zebb/literatur/mcgorry.pdf.

[vii] http://www.coreynahman.com/atypical-antipsychotic-lawsuits.html.

[viii] http://www.ministryoflies.com/pdf-articles/Yale-Lilly.pdf.

[ix] http://www.ministryoflies.com/pdf-articles/Yale-Lilly.pdf.

[x] http://www.nytimes.com/2006/05/23/health/psychology/23prof.html?pagewanted=3&_r=1.

[xi] http://www.time.com/time/magazine/article/0,9171,1205408,00.html#ixzz0i0DykBNV.

[xii] http://www.time.com/time/magazine/article/0,9171,1205408,00.html#ixzz0i0NMJQyd.

[xiii] http://www.camh.net/Publications/Cross_Currents/Winter_2007-08/futureorfad_crcuwinter0708.html.

[xiv] Anthony Pelosi, “Head to Head, Is early intervention in the major psychiatric disorders justified? No,” BMJ 2008;337:a710, http://www.bmj.com/cgi/content/full/337/aug04_1/a710.

[xv] http://www.camh.net/Publications/Cross_Currents/Winter_2007-08/futureorfad_crcuwinter0708.html.

[xvi] http://www.bmj.com/cgi/content/full/337/aug04_1/a710.

[xvii] http://www.ahrp.org/cms/index2.php?option=com_content&do_pdf=1&id=386; http://www.bioethicsforum.org/ethics-of-preventive-psychopharmacologic-treatments.asp.

[xviii] http://www.ahrp.org/cms/index2.php?option=com_content&do_pdf=1&id=386; http://www.bioethicsforum.org/ethics-of-preventive-psychopharmacologic-treatments.asp.

[xix] http://www.camh.net/Publications/Cross_Currents/Winter_2007-08/futureorfad_crcuwinter0708.html.

[xx] http://www.bmj.com/cgi/content/full/337/aug04_1/a710.

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Congressional Hearings Held On Antidepressant-Induced Suicide In The Military

Wednesday, March 3rd, 2010

The Huffington Post
By Peter Breggin
March 3, 2010

On February 24, 2010 the Veterans’ Affairs Committee of the U. S. House of Representatives chaired by Bob Filner (D-CA) held hearings on “Exploring the Relationship Between Medication and Veteran Suicide.” Military suicides have risen rapidly in recent years at the same time that the prescription of antidepressants and other psychiatric drugs has escalated. The hearing focused on the dangers of the newer antidepressants like Prozac, Paxil, Zoloft, Celexa, Lexapro, Cymbalta, and Effexor.

Starting in the early 1990s, I was the first psychiatrist to write and speak extensively about the newer antidepressants causing suicide, violence, and mania. It was gratifying when Rep. Filner decided to hold the hearings after reading my new book, Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime (2008) and called me as his lead witness. I presented scientific evidence that antidepressants cause suicide, violence and mania. I also emphasized the profound danger of prescribing drugs that cause impulsivity, hostility and suicidality to heavily armed young men and women under stress on active military duty. I recommended that the armed services curtail the use of these drugs and rely instead on psychotherapeutic and educational processes that have already proved effective. I also called for additional research in the military and the VA concerning suicide and violence caused by antidepressants.

There is scant evidence for the effectiveness of antidepressants, and overwhelming evidence for their harmfulness. The military is already moving toward the implementation of better educational programs to help active duty soldiers handle stress. These educational programs, and counseling, need to replace the use of psychiatric drugs.

Read entire article:  http://www.huffingtonpost.com/dr-peter-breggin/congressional-hearings-on_b_480613.html

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The New Yorker — “Head Case: Can psychiatry be a science?”

Wednesday, March 3rd, 2010

The New Yorker
By Louis Menand
March 3, 2010

You arrive for work and someone informs you that you have until five o’clock to clean out your office. You have been laid off. At first, your family is brave and supportive, and although you’re in shock, you convince yourself that you were ready for something new. Then you start waking up at 3 A.M., apparently in order to stare at the ceiling. You can’t stop picturing the face of the employee who was deputized to give you the bad news. He does not look like George Clooney. You have fantasies of terrible things happening to him, to your boss, to George Clooney. You find—a novel recognition—not only that you have no sex drive but that you don’t care. You react irritably when friends advise you to let go and move on. After a week, you have a hard time getting out of bed in the morning. After two weeks, you have a hard time getting out of the house. You go see a doctor. The doctor hears your story and prescribes an antidepressant. Do you take it?

However you go about making this decision, do not read the psychiatric literature. Everything in it, from the science (do the meds really work?) to the metaphysics (is depression really a disease?), will confuse you. There is little agreement about what causes depression and no consensus about what cures it. Virtually no scientist subscribes to the man-in-the-waiting-room theory, which is that depression is caused by a lack of serotonin, but many people report that they feel better when they take drugs that affect serotonin and other brain chemicals.

There is suspicion that the pharmaceutical industry is cooking the studies that prove that antidepressant drugs are safe and effective, and that the industry’s direct-to-consumer advertising is encouraging people to demand pills to cure conditions that are not diseases (like shyness) or to get through ordinary life problems (like being laid off). The Food and Drug Administration has been accused of setting the bar too low for the approval of brand-name drugs. Critics claim that health-care organizations are corrupted by industry largesse, and that conflict-of-interest rules are lax or nonexistent. Within the profession, the manual that prescribes the criteria for official diagnoses, the Diagnostic and Statistical Manual of Mental Disorders, known as the D.S.M., has been under criticism for decades. And doctors prescribe antidepressants for patients who are not suffering from depression. People take antidepressants for eating disorders, panic attacks, premature ejaculation, and alcoholism.

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Manufacturing Depression—Are Docs Over Prescribing Antidepressants to a Tune of $10 Billion a Year for Drug Companies?

Wednesday, March 3rd, 2010

AlterNet
By Amy Goodman
March 3, 2010

A psychotherapist says depression can be debilitating — but that it’s also been largely created by doctors and drug companies as a medical condition.

Is depression manufactured? Two decades after the introduction of antidepressants, it’s become commonplace to assume that our sadness can be explained in terms of a disease called depression. The National Institute of Mental Health estimates more than 14 million Americans suffer from major depression every year and more than three million suffer from minor depression. Some 30 million Americans take antidepressants at a cost of over $10 billion a year.

My next guest argues while depression can be debilitating, it’s also been largely manufactured by doctors and drug companies as a medical condition with a biological cause that can be treated with prescription medication. Psychotherapist and writer Gary Greenberg participated in a clinical trial for antidepressant medication and found that more often than not the drugs failed to outperform placebos. His latest book is a scientific, medical, historical and cultural exploration of the antidepressant revolution here in the United States. It’s called Manufacturing Depression: The Secret History of a Modern Disease.

Read entire article:  http://www.alternet.org/health/145850/%27manufacturing_depression%27:_are_doctors_over-prescribing_antidepressants_to_a_tune_of_$10_billion_a_year_for_drug_companies/

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The Emperor’s New Drugs: Exploding the Antidepressant Myth—Debunking the Chemical Imbalance Theory & Drug Efficacy

Wednesday, February 24th, 2010

PopMatters
By Chris Barsanti
February 24, 2010

What if antidepressants were not just too easily available and overly prescribed by doctors—as has been argued in many venues for years now, though to no discernible effect—but didn’t even work? That’s the takeaway premise of psychology professor Irving Kirsch, Ph.D., in his new book, The Emperor’s New Drugs: Exploding the Antidepressant Myth.

By examining a broad spectrum of research, using both the published drug studies and the deep well of unpublished research which many drug companies would prefer stay hidden, Kirsch presents the all-too-plausible theory that there is essentially no positive effect from taking antidepressants. In fact, comparing test results between patients taking antidepressants and those taking active placebos (a drug that isn’t an antidepressant but has other, noticeable side effects, so that the patient can tell something is working on them), Kirsch found no statistically significant difference. Actually, he found that it didn’t seem to matter what drug patients were taking, as long as they knew they had ingested some kind of active drug, they improved by about the same degree. So much for the last few decades’ great advances in pharmacology, it would seem.

If what Kirsch is saying is true, then not only are untold millions being wasted on essentially worthless drugs, but an entire school of psychological thought is utterly wrong. Kirsch spends an entire chapter of his tightly argued book tearing down the oft-recited belief that depression is frequently or always caused by a chemical imbalance in the brain. After relating several studies which purport to show that drugs which increase, decrease, or have no effect on the serotonin levels in patients brains (something long described as crucial to pharmacological therapy) all have about the same effect, Kirsch concludes very simply that “the data just do not fit the theory”.

Read entire article:  http://www.popmatters.com/pm/post/121266-the-emperors-new-drugs-exploding-the-antidepressant-myth/

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Taking Antidepressants During Pregnancy Doubles Heart Defect Risk of Newborns

Friday, February 19th, 2010

Natural News
By David Gutierrez
February 19, 2010

Women who take certain antidepressant drugs while pregnant may double their child’s risk of being born with a certain variety of heart defect, according to a study conducted by researchers from Aarhaus University in Denmark and published in the medical journal BMJ.

“Anyone who is pregnant or considering becoming pregnant and has any concerns about the treatment for depression should speak to their doctor,” said Cathy Ross of the British Heart Foundation.

Researchers compared the risk of birth defects in 1,370 children born to women who took at least one selective serotonin reuptake inhibitor (SSRI) while pregnant with the risk in 400,000 other children whose mothers had not taken any SSRIs while pregnant. They found that the drugs fluoxetine (marketed as Prozac), sertraline (marketed as Zoloft) and citalopram (marketed as Celexa) all significantly increased the risk that a child would be born with a defect in the septum, which separates the right and left halves of the heart.

Septum defects include a variety of conditions from minor blood vessel problems to outright holes in the heart. The researchers found that one extra septum defect would develop for every 246 pregnant women taking an SSRI during the time period from 28 days before through 112 days after conception.

Taking more than one SSRI drastically increased the risk of septum defects. While the risk of the defects was 0.5 percent in mothers not taking the drugs and 0.9 percent in those taking one drug (an 80 percent increase), it was 2.1 percent in mothers taking two or more (a more than 300 percent increase).

Read entire article:  http://www.naturalnews.com/028202_antidepressants_heart_defects.html

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Wake Up FDA—Even Drug Giants Are Admitting No Lab Tests Exist To Prove If Antidepressants Work

Friday, February 5th, 2010

By CCHR
February 5, 2010

With drug giant GlaxoSmithKline (GSK) now stating it will abandon future antidepressant research, one can only wonder if the U.S. Food and Drug Administration (FDA) noted GSK’s CEO Andrew Witty’s admission that it is “hard to prove that a depression drug is working” because “patient improvement is measured by subjective mood surveys, and not by the clear-cut blood tests and biological measures used in other diseases.”

To put this in perspective, the head of GSK is pointing out an obvious flaw in the psycho/pharmaceutical cash cow of psychiatric drugs.  There is no way to prove if a drug is working because there are no lab tests to prove anyone has a mental disorder in the first place—unlike medical diseases where blood and lab tests can show the effect of any drug upon the disease.

Given this statement, the next logical question is how did the FDA ever approve any psychiatric drug as safe and effective when the drug makers admit there is no proof of efficacy, only “subjective mood surveys.”

It seems the drug companies are catching on while the FDA is still promoting junk science in order to grant drug approval.

And that’s on top of the Journal of the American Medical Association (JAMA) landmark study published last month that found antidepressants no more effective than placebo. Add to that, 40% of antidepressant clinical trials have not been published because of negative results—they failed to show any significant benefit.  So, even with a “subjective mood survey,” they can’t get the drug to make the mark.  And the studies that did “prove” it did so, as Newsweek put it, for “the same reason why Disney’s Dumbo could initially fly only with a feather clutched in his trunk—believing makes it so.”

The FDA says: “Drugs must undergo a rigorous evaluation of safety, quality, and effectiveness before they can be sold.” Clearly, there is nothing rigorous about testing efficacy in antidepressants.  GSK’s confession is on par with former American Psychiatric Association president, Steven Sharfstein admitting that there is no lab test to confirm a chemical imbalance in the brain.  Reiterating this was his APA cohort Mark Graff, who told CBS Studio 2 that this theory was “probably drug industry derived”—in other words, a marketing ploy in the same vein as antidepressants are “effective.”

John Swann, Ph.D., historian at the FDA, once said: “To establish fraud, the bureau had to show that the manufacturer knew the product was worthless, and this proved difficult in many cases.”[i]

Well, FDA, if a drug company can admit what the FDA has known all along—that the efficacy of an antidepressant or any psychiatric drug is entirely subjective and, therefore, not based on science, how can the FDA continue to approve and condone the use of these drugs as “safe and effective?”

Instead of the potential fraud of a manufacturer, a more pertinent question we should be asking is this:
What if the government agency in charge of approving drugs, the FDA, knew a product was worthless and approved its use anyway? What happens then?


[i] http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/default.htm

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Glaxo stops antidepressant research: patient improvement can’t be measured w/ blood tests only subjective mood surveys

Friday, February 5th, 2010

Wall Street Journal
By Jeanne Whalen
February 5, 2010

GlaxoSmithKline PLC said it will stop research into new antidepressants and focus on diseases for which it believes it can develop more valuable drugs, a major shift for a company that developed some of the biggest-selling antidepressants of the past 20 years.

Profits at the U.K. drug giant, which posted a 66% increase in fourth-quarter earnings Thursday, were long fueled by the antidepressants Paxil and Wellbutrin, which at their peak generated billions of dollars a year in sales. Similar medicines, such as Eli Lilly & Co.’s Prozac and Pfizer Inc.’s Zoloft, also generated big sales for those companies.

However, low-cost generic copies have eroded demand for name-brand antidepressants, which accounted for just 2.3% of Glaxo’s total sales last year, down from 14% in 2002. Chief Executive Andrew Witty said Thursday that the company thinks further investment in the market wouldn’t be prudent.

Part of the reason is financial risk. Clinical trials of antidepressants are among the “most expensive and highest-risk” of all drug trials, Mr. Witty said, because companies often don’t know until the end of very large studies whether a drug works. It is also hard to prove that a depression drug is working, he said, because patient improvement is measured by subjective mood surveys, and not by the clear-cut blood tests and biological measures used in other diseases.

That’s a drawback in an era when insurers and other health-care payers want to see clear value for their money, Mr. Witty said.

Payers “want big benefits to make it worth their while to invest their resources,” he said, adding that Glaxo would scrap research into pain drugs for the same reasons, focusing instead on diseases including Alzheimer’s, Parkinson’s, multiple sclerosis and a clutch of rare diseases.

Read entire article:  http://online.wsj.com/article/SB10001424052748704041504575044901266169316.html

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Antidepressants: The Emperor’s New Drugs? “Depression is not a brain disease, and chemicals don’t cure it.”

Monday, February 1st, 2010

The Huffington Post
By Irving Kirsch, Ph.D.
January 29, 2010

Antidepressants are supposed to be the magic bullet for curing depression. But are they? I used to think so. As a clinical psychologist, I used to refer depressed clients to psychiatric colleagues to have them prescribed. But over the past decade, researchers have uncovered mounting evidence that they are not. It seems that we have been misled. Depression is not a brain disease, and chemicals don’t cure it.

My awareness that the chemical cure of depression is a myth began in 1998, when Guy Sapirstein and I set out to assess the placebo effect in the treatment of depression. Instead of doing a brand new study, we decided to pool the results of previous studies in which placebos had been used to treat depression and analyze them together. What we did is called a meta-analysis, and it is a common technique for making sense of the data when a large number of studies have been done to answer a particular question.

It is rare for a study to focus on the placebo effect–or on the effect of the simple passage of time, for that matter. So where were we to find our placebo data and no-treatment data? We found our placebo data in clinical studies of antidepressants. All told, we analyzed 38 published clinical trials involving more than 3,000 depressed patients. What we found came as a big surprise. It turned out that 75 percent of the antidepressant effect was also produced by placebos – sugar pills with no active ingredients that are used to control the effects of hope and expectation in clinical trials. In other words, most of the improvement seen in patients given antidepressants was a placebo effect.

Read entire article:  http://www.huffingtonpost.com/irving-kirsch-phd/antidepressants-the-emper_b_442205.html

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