Posts Tagged ‘placebo’

Antidepressant Found ‘Ineffective and Potentially Harmful’

Monday, November 1st, 2010

The Epoch Times, November 1, 2010

by Dr. John Briffa

CLOSET SKELETONS: Of all the drug trials that have been done, how many more skeletons in the closet are there? (Photos.com)

If we wanted to find out if a drug or another treatment were any good, we would have to conduct some randomized controlled trials. This means individuals are randomly assigned to the drug being tested, a placebo, or another drug.

Neither the researchers nor the study participants know what’s being taken. Symptoms or other markers of health are monitored as well as side effects. After a period of time, the code is cracked, and we can learn who was taking what.

Now we can know if the drug being tested was more effective at helping people than the placebo and how safe it is. A few studies showing favorable results will usually get a drug passed as “fit for purpose.” This is how drugs end up getting licenses so that doctors can prescribe them to their patients.

Not so fast. While some (often the manufacturers) claim that there is a lot of research supporting a drug, it can sometimes be the case that the published research does not tell the full story.

Sometimes there exists other research that is not so supportive of the drug being tested—research that may not have seen the light of day. Drug companies want to publish supportive studies and shelve more-negative findings. There is an expression for this practice—publication bias.

Publication bias has gone on for decades but only relatively recently have some members of the scientific community taken steps to stamp it out. One huge step forward has been a decision in the United States for trials to be registered on a central database before or during a trial. That way the study has been logged, and if the results mysteriously fail to appear, then questions can be asked.

Not so long ago, trial results had to be forced out of the drug companies making the cholesterol-reducing agents simvastatin and ezetimibe. It took two years for the manufacturers to cough up their data after the conclusion of the study. Once the data came out, we learned why: This drug combo didn’t work to reduce signs of cardiovascular disease.

Subsequent studies have also proved negative. Not that long ago, such data would have been easily hidden, even from prying eyes. These days, drug companies don’t have things so easy.

Things are better now than they were. Now a natural question to ask is how many drugs earned their stripes based on publication bias? Some principled researchers are keen to answer this question by reassessing drugs using not only published data but also unpublished data.

An example of such a piece of work appeared online on Oct. 12 in the British Medical Journal. German researchers decided to assess unpublished and published data on the anti-depressant reboxetine, a relatively new type of antidepressant.

Reboxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI). This means it helps maintain brain levels of the chemical norepinephrine, which is believed to enhance mood. It is similar to the more commonly prescribed anti-depressants known as the selective serotonin reuptake inhibitors or SSRIs.

Previously published evidence showed that reboxetine was more effective in treating depression than placebo and was about as effective as the commonly prescribed SSRIs. It’s been licensed for use for depression in many European countries, including the U.K. and Germany, since 1997.

The researchers found that almost three-quarters of data on reboxetine was unpublished. This is disquieting in itself. And when they put this data into the mix, an altogether different picture emerged. When the totality of the evidence was assessed, it turns out that reboxetine was no better than placebo. Most researchers would summarize this by concluding that it doesn’t work.

Perhaps not surprisingly, reboxetine turns out to cause more harm than placebo and more adverse effects than the most-commonly prescribed SSRI (fluoxetine). The authors conclude that reboxetine is “an ineffective and potentially harmful antidepressant.” Yet here in Europe, it’s been licensed for more than a decade.

The authors of this re-analysis mention that here in the U.K., the National Institute of Health and Clinical Excellence (NICE) describes reboxetine as “superior to placebo and as effective as other antidepressants in the treatment of depression.” As the authors point out, “This conclusion can no longer be upheld.”

It is interesting to note that in the United States, reboxetine was originally licensed, but then its license was revoked. While it appears the U.S. authorities made the right decision, the discrepancy with some European countries suggest that the U.S. authorities had more data to go on or perhaps set different licensing criteria.

Such discrepancies and this flagrant example of publication bias do not instill confidence.

The good news is that at least some researchers are not content to do what paymasters in industry tell them to and genuinely appear to be seekers of the truth. I’d say we could expect many more skeletons to emerge from the closet over the coming years.

http://www.theepochtimes.com/n2/content/view/45212/

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Making a Market in Antipsychotic Drugs: An Ironic Tragedy

Thursday, September 23rd, 2010

The Huffington Post

September 23, 2010

by Dr. Peter Breggin

Remember not so long ago when Prozac became the world’s largest selling medication of any kind, and then for years how Prozac, Paxil and Zoloft took over many of the top 10 spots? Remember the explanations at the time–that they were wonder drugs and that 15-50 percent or more of Americans would need them some time in their lives? To many people this seemed like a scientific breakthrough when in reality it was … a triumph of marketing.   Some studies suggest that the antidepressants are little or no more effective than a sugar pill and a lot more dangerous. Recent research examined all antidepressant studies submitted in recent years to FDA in regard to antidepressant efficacy and found that the drug performed no better than placebo except in “severely depressed patients,” reaching “clinical significance” only “at the upper end of the very severely depressed category.” Even then, the difference between the antidepressant and the placebo was “relatively small.”

In addition to being largely ineffective, the antidepressants can be very distressing to withdraw from, which keeps the market artificially inflated by people who would desperately like to stop but find the process too emotionally or physically painful. Often these individuals fail to realize that they are undergoing withdrawal and instead mistakenly conclude that they “need” the medication to control their original psychiatric problems.

Now look what have become the new top selling drugs in the world: antipsychotic drugs like Risperdal, Zyprexa, Abilify, Seroquel, Geodon and Invega. Although the FDA has been expanding the approved use of some of these drugs to some cases of autism, Tourettes and a variety of other problems, their original purpose and their main use in psychiatry until now has been largely confined to psychosis and acute mania. Psychosis and acute mania afflict a very small portion of the the population. Yet these drugs are now at the top of the list of most widely prescribed medications worldwide. How did these incredibly toxic chemicals become daily pharmacological mainstays for so many millions of children and adults? It’s time to face the truth that the prescription of psychiatric drugs is driven by marketing trends–and now for the first time by something even more dreadful and insidious than mere marketing.

To begin their market campaigns for the newer antipsychotic agents, the drug companies created the myth that these products were not as dangerous as the old antipsychotic drugs, which were becoming recognized as highly toxic. Especially hard to ignore, it was demonstrated that the old antipsychotics cause tardive dyskinesia, a disfiguring and sometimes disabling array of abnormal movements in 5-8 percent per year cumulative of otherwise healthy patients and more than 20 percent of older patients. But even the unproven and ultimately false claim that the newer drugs were safer could not make a huge market for them. Even if these were wonder drugs, they were wonderful for a relatively tiny percent of the population. The drug companies had to create a new patient population market and that market became “bipolar disorder.”

Once much rarer than schizophrenia, bipolar disorder would soon become one of the most common diagnoses made in medicine and psychiatry. Indeed, while ordinary folks used to talk about their biochemical imbalances and depression, now they’ve upgraded to having bipolar disorder.

Lithium, once the magic bullet without side effects for bipolar disorder–then called manic-depressive disorder–had turned out to be a severe central nervous system toxin that over the years ruins mental function while also producing thyroid disorders, kidney failure and a host of other serious problems. The discrediting of lithium created a new niche for antipsychotic drugs–to be used as “mood stabilizers” for people with severe ups and downs. But it was a relatively smalll niche to begin with.

Where would all the new bipolar patients come from? Many of them would come from the fertile imagination of drug company sponsored psychiatrists who found bipolar disorder in everything from toddlers with temper tantrums to adults with bursts of energy followed by a natural period of feeling fatigued. Leaders in child psychiatry like Harvard’s Joseph Biederman were literally paid under the table to push antipsychotic medications for bipolar disorder in children. A recent study showed that children labeled bipolar actually receive more adult antipsychotic drugs than adults labeled bipolar . Another recent study covering 2000-2002 showed that 18 percent of child visits to a psychiatrist included antipsychotic treatment, and 92 percent of those were for the newer so-called second generation drugs. It took a great deal of marketing to convince physicians that these relatively untried and highly toxic antipsychotic drugs are that safe and effective in children.

But even marketing bipolar disorder to the professions and the public was insufficient to create a huge enough market to satisfy the drug companies. Here’s where the irony of ironies came into play. The newer antidepressants–once the leading drugs in the world–frequently cause mania. They do so in millions of patients, children and adults alike, every year. These once most popular drugs in the world by causing mania made and continue to make the market for the next wave of most popular drugs–the antipsychotic drugs being used as mood stabilizers.

How common is antidepressant-induced mania? Very common. Several studies have found that 6 to 8 percent of patients exposed to antidepressants will develop a manic disorder. One research study, for example, found in a retrospective study that Paxil produced mania in 8.6 percent of patients exposed. Other studies find the rates as high as 17 percent And if a person has already shown a manic tendency or has experienced a manic-like episode, antidepressants will push one-quarter to one-third into new manias (For a review, see P. Breggin, Brain-Disabling Treatments in Psychiatry, 2008, pp. 157-165) . Yet misguided psychiatrists commonly give antidepressants to patients diagnosed with bipolar disorder. The result? Millions of people suffer from medication-induced mania and other expressions of what I call “medication madness.”

When I took my psychiatric residency at Harvard in Boston and at SUNY in Syracuse in the early 1960s, we never saw or diagnosed bipolar disorder in children. In my four years of training, I saw one 19-year-old in a manic state and a few adults. When a person was admitted in a manic condition talking a mile a minute, imagining grand things about themselves, making outrageous plans, bursting with anger and energy, unable to sleep and otherwise euphoric, the condition was so unusual that we would hold grand rounds, a medical show-and-tell, to discuss the patient.

Now psychiatric wards are filled with patients having their second and third or umpteenth manic episode and every psychiatrist’s day is filled with patients diagnosed bipolar. It’s mostly about antidepressant-induced mania. Every single child I have evaluated who has suffered what looks like a manic episode has been taking stimulants or antidepressants, both of which cause mania. At least 9 out of 10 adults I’ve seen in the last two decades who have suffered emotional episodes that could be diagnosed as mania had them in direct response to stimulants or antidepressants–mostly the newer antidepressants starting with Prozac.

In the official diagnostic system, these are not cases of bipolar mania but cases of medication induced mood disorder with manic features; but they are almost always mistakenly called bipolar disorder in order to avoid identifying the drug and the prescriber as the causative agents.

For those who want further details, I have reviewed all the studies mentioned in this report in my medical book, “Brain-Disabling Treatments in Psychiatry, Second Edition” (2008). In my popular book, “Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime” (2008), I have provided dozens of in-depth illustrations of lives ruined by psychiatric drugs, especially the newer antidepressants.

Read the rest of the article here http://www.huffingtonpost.com/dr-peter-breggin/making-a-market-in-antips_b_720861.html

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PTSD and Anti-Depressant Drugs: the Worst Notorious Modern Medical Fraud

Tuesday, September 21st, 2010

Salem-news.com

September 21, 2010

by Dr. Phillip Leveque

Afghanistan
Afghanistan by Tim King Salem-News.com

(MOLALLA, Ore.) – I’m sure some people will take umbrage at my title. Keep on reading. First of all there are about 30 of them – why? It’s easy, most don’t work. In fact placebos (fake sugar pills) frequently work better.

Another point, their adverse side effects are horrible. Some even cause worse depression and even suicide. The main side effects are nausea, insomnia, anxiety, restlessness, decreased sex drive, dizziness, weight gain or loss, tremors, sweating, sleepiness, fatigue, dry mouth, diarrhea, constipation, headache, et cetera. Who needs that stuff?!? They also screw up ones head and balance with falls and fractures. If one stops taking them, the withdrawal symptoms sound worse than heroin. In addition to all this, some are addicting and it is very difficult to stop taking them.

This kind of drug or drugs has an extremely interesting origin. Around 1950 the first drug in this class was actually an anti-tuberculosis drug Isoniazid. For some reason it also acted as a brain stimulant, much like amphetamine. When this side effect was published by the T.B. doctors, other doctors decided to try it on depression patients. Prior to this certain Morphine-like cousin drugs and amphetamines were used for depression. They had severe addiction liability.

Isoniazid, the T.B. drug, was used on an experimental basis and the patients brain function improved dramatically. The psychiatrists who read about this tried Isoniazid on their depression patients and they coined the word ANTI-DEPRESSANT.

From then on starting about 1957 the Tricyclic drugs were born. They were relatives of anti-histamine drugs and they did combat depression. I think the first well known one was Elavil which is still in use. This type of drug drifted around quietly for several years searching for a disease all of the sudden it erupted – CLINICAL DEPRESSION. The first REAL drug Fluoxetine or PROZAC came out in 1988 by Ely Lilly & Co. It was heavily advertised and we soon had a epidemic of clinical depression spread all over the world.

I’m not going into a recital of the various kinds of anti-depressants. I think there is enough to indicate that at least 500,000,000 prescriptions are written per year and for the 14 or so leaders, each is worth up to several billion dollars to the drug companies.

As I said in the beginning placebos, or fake pills, work about as well as these chemicals and exercise or just plain talking to a psychologist may work as well. The drug companies advertise heavily in the millions of dollars to sell these drugs to doctors and patients. It is worth it. The anti-depressants bring in billions of dollars.

A side comment is that the drug companies have sold the idea to the Veterans Administration and they prescribe these drugs by the ton to PTSD Veterans. The evidence is that they don’t help much and cause a lot of harm.

http://www.salem-news.com/articles/september212010/ptsd-depressants-pl.php

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The Over-Prescribing of Psychoactive Drugs to Children: A Scourge of Our Times

Wednesday, September 1st, 2010

The Huffington Post

September 1, 2010

by Dr. Ronald Ricker and Dr. Venus Nicolino

Today, the administration of psychoactive drugs to children (6-17) is all too common and growing at an alarming rate. These drugs often cause the opposite of the intended effect, often condemning children to a life of misery and ill health. The prescription of these drugs is said to treat “chemical imbalances” which were said to cause ADHD, Depression and Bi-polar disorder. It turns out, however, that what we were calling “disease-causing chemical imbalances,” is simply incorrect . The sad irony is, the inappropriate use of these medications is in fact creating different chemical imbalances, which do cause mental disorders, many of which are both life-long and debilitating.

Furthermore, it is now clear that often we are diagnosing ordinary childhood and adolescent behavior as mental disorders (Wait, children are supposed to be bursting with energy? It’s normal for a teenager to be moody and aloof?). This diagnosing is not only based on this idea of “chemical imbalances,” but also a general and pervasive notion that every non-acceptable behavior is due to a mental illness. And last, but certainly not least, the prescribing of these medications by doctors is based on the disinformation provided them by the FDA, drug manufactures and often fraudulent studies, all in the name of making money, on the backs of our children.

In a recent lecture, respected journalist, writer and Nobel Prize Nominee, Robert Whitaker (PBS, Boston, June 15, 2010) highlighted not only the appallingly unscientific methodology used in the development, prescription and use of psychotropic drugs in school-aged children, but also how hopelessly corrupt and failed the systems that should be regulating the safety of medicines are in this country.

Unfortunately, many drug companies exist for one reason: to make money. As such, the people who run these companies have developed a worldview bereft of any more notion of ethics or morality than British Petroleum. Some drug companies’ success is not based on a drug’s usefulness or the safety of its products, but whether it makes money. The path to more money is simple: find new uses for their old drugs, invent new drugs and find new markets for both new and old drugs. Unfortunately, children are today’s newest market.

The FDA requires a “Successful Drug Trial” to approve new medications. “Trial” is often a misnomer, as the word implies some notion of impartiality and unknown outcome. These “trials” often are more like kangaroo courts. In one “trial,” in this case to prove the usefulness of Prozac, corruption and dishonesty were the rule. Children who responded to placebos were removed from the data, as were negative responders to the actual drug. This meant that the only children who were left in the study group were so-called “positive responders.” And, even then, the researchers and doctors, whose “research” funding was provided by the makers of Prozac, were the very ones to decide which subjects, if any, actually did respond “positively” to the drug. This, of course, is a massive conflict of interest. The doctors, researchers and drug companies all want the same thing — FDA approval and to make more money.

In a 2004 article published in perhaps the most prestigious British medical journal, Lancet, said the trial studies used to provide proof of the usefulness of anti-depressant drugs in children, were “nothing but fraudulent.” Following that assessment, all anti-depressants but Prozac were banned in the UK for use on children. (The fact that Prozac was not banned was based on very dubious, some say dishonest, research as documented above).

The true damage caused by the use of anti-depressant drugs like Paxil, Zoloft, Prozac, etc. (AKA of SSRI’s: Selective serotonin reuptake inhibitors) by school-aged children is only found by legitimate, longer studies, like those that continued from 17 months to six years. In one study, 25 percent of children who had been on SSRI’s for three years were re-diagnosed with the much more serious disorder of Bi-polar disease. This number increased to 50 percent after six years of SSRI use. Long-term use of new anti-psychotics may lead to even greater problems than the initial disease. Diabetes, morbid obesity and early death have all been linked to the use of these drugs. And, as written by us in a previous blog both short and long term use of stimulant drugs such as Adderall), have numerous serious side effects.

Read the rest of this article here: http://www.huffingtonpost.com/dr-ronald-ricker-and-dr-venus-nicolino/the-prescribing-of-psycho_b_665838.html

Note: To view all international drug regulatory warnings and studies on psychiatric drugs including those issued specifically for children,visit CCHR’s psychiatric drug search engine here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

Also see this video – Drugging Our Children: Side Effects – http://www.cchrint.org/videos/

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Psychiatrists have come up with a ‘solution’ to psychiatric drugs—prescribe LSD, animal tranquilizers & mushrooms

Wednesday, August 25th, 2010

Note from CCHR: Due to the severe adverse reactions from psychiatric drugs finally becoming a matter of public knowledge, as well as studies proving psychiatric drugs are no more effective than placebo, the psychiatric drug lords have now come up with a more overtly drug dealer approach; prescribe patients lysergic acid diethylamide (LSD), Ketamine (An animal tranquilizer known as Special K on the the street) and psilocybin (mushrooms).

Medscape
By Deborah Brauser
August 25, 2010

Low doses of psychedelic drugs, including lysergic acid diethylamide (LSD), ketamine, and psilocybin, may reduce clinical symptoms in patients with depression, anxiety, obsession-compulsive disorders (OCDs), and chronic pain, without inducing depersonalization or hallucinations, according to a new Perspectives article published online August 18 in Nature Reviews Neuroscience.

The study authors note that this may be due to the drugs’ effect on patients’ altered brain circuits and neurotransmitter systems, including serotonin and glutamate systems, according to recent neuroimaging data.

“These findings raise the possibility that research into psychedelics might identify novel therapeutic mechanisms and approaches that are based on glutamate-driven neuroplasticity,” write Franz X. Vollenweider, MD, director of the Neuropsychopharmacology and Brain Imaging Research Unit at the University Hospital of Psychiatry in Zurich, Switzerland, and colleagues.

“These are serious, debilitating, life-shortening illnesses, and as the currently available treatments have high failure rates, psychedelics might offer alternative treatment strategies that could improve the well-being of patients and the associated economic burden on [them] and society,” they add.

Recent Research

Although research on psychedelics has been restricted for almost 40 years because of the drugs’ negative connotations, “recent advances in our understanding of the neurobiology of psychedelics” have led to renewed interest, write the study authors.

Read entire article here:  http://www.medscape.com/viewarticle/727438

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New Review of FDA antidepressant drug trials suggests antidepressants only “marginally better” than placebo – Ineffectiveness of antidepressants called “jaw-dropping”

Tuesday, August 24th, 2010

Medscape
By Deborah Brauser
August 24, 2010

A new review of 4 meta-analyses of efficacy trials submitted to the US Food and Drug Administration (FDA) suggests that antidepressants are only “marginally efficacious” compared with placebo and “document profound publication bias that inflates their apparent efficacy.”

In addition, when the researchers also analyzed the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, “the largest antidepressant effectiveness trial ever conducted,” they found that “the effectiveness of antidepressant therapies was probably even lower than the modest one reported…with an apparent progressively increasing dropout rate across each study phase.

“We found that out of the 4041 patients initially started on the SSRI [selective serotonin reuptake inhibitor] citalopram in the STAR*D study, and after 4 trials, only 108 patients had a remission and did not either have a relapse and/or dropped out by the end of 12 months of continuing care,” lead study author Ed Pigott, PhD, a psychologist with NeuroAdvantage LLC in Clarksville, Maryland, told Medscape Medical News.

Sustained Benefit “Jaw Dropping”

“In other words, if you’re trying to look at sustained benefit, you’re only looking at 2.7%, which is a pretty jaw-dropping number,” added Dr. Pigott.

Overall, “the reviewed findings argue for a reappraisal of the current recommended standard of care of depression,” write the study authors.

“I believe there are likely some people where [antidepressants] are truly beneficial beyond placebo. The problem right now is that we simply have no way of knowing who those people are,” noted Dr. Pigott. “My hope is that this kind of analysis creates ‘more oxygen’ for looking at other kinds of approaches to treatment.”

The study was published in the August issue of Psychotherapy and Psychosomatics.

When registering new drug application trials with the FDA, drug companies must prespecify the primary and secondary outcome measures, the investigators report. “Prespecification is essential to ensure the integrity of a trial and enables the discovery of when investigators selectively publish the measures that show the outcome the sponsors prefer following data collection and analysis, a form of researcher bias known as HARKing or ‘hypothesizing after the results are known’,” they write.

For this article, Dr. Pigott and his team reviewed the following meta-analyses:

  • 1. Rising and colleagues (reviewed all efficacy trials for new drugs between 2001 and 2002)
  • 2. Turner and colleagues (reviewed 74 past trials of 12 antidepressants)
  • 3. Kirsch and colleagues, 2002 (reviewed 47 trials of 6 FDA-approved antidepressants)
  • 4. Kirsch and colleagues, 2008 (reviewed depression severity and efficacy in 35 trials)

The researchers also sought to reevaluate the methods and findings of STAR*D, a randomized, controlled trial of patients with depression. Its prespecified primary outcome measure was the Hamilton Rating Scale for Depression (HRSD), whereas the Inventory of Depressive Symptomatology–Clinician-Rated (IDS-C30) was secondary for identifying remitted and responder patients.

“STAR*D was designed to identify the best next-step treatment for the many patients who fail to get adequate relief from their initial SSRI trial,” the study authors write.

“When I first read about STAR*D’s step 1 phase, it just seemed biased to me,” explained Dr. Pigott. “I thought of it as the ‘tag, you’re healed’ research design. Patients who were scored as having a remission during the first 4 to 6 weeks of up to 14 weeks of acute care treatment were counted as remitted, taken out of the subject pool, and put into the follow-up care phase. In other words, they didn’t have the ability to have a relapse. But as most people know, depression ebbs and flows.

“So what made me want to continue to follow this study was that it became clear that the only way that people were really going to be able to evaluate the antidepressants’ effectiveness was to wait for the publication of the follow-up findings,” he added. “After their major final summary study was published, I felt as though the results weren’t really being portrayed in a manner that was consistent with the study’s prespecified criteria.”

High Dropout, Low Remission Rates

In addition to reporting on low efficacy of antidepressants compared with placebo, the 4 meta-analyses “also document a second form of bias in which researchers fail to report the negative results for the prespecified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure, as though it was their primary measure of interest,” the investigators write.

For example, they note, the meta-analysis from Rising and colleagues found that studies with favorable outcomes were almost 5 times more likely to be published and that over 26% of primary outcome measures were left out of journal articles. Turner and colleagues found that antidepressant studies were 16 times more likely to be published if favorable compared with those with unfavorable outcomes.

In reanalyzing the STAR*D methods, the researchers found that the high dropout rate resulted in frequently missed exit HRSD and IDS-C30 interviews. So the revised statistical analytical plan dropped the IDS-30 for the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), which was given at each visit.

“Even with the extraordinary care of STAR*D, only about one fourth of patients achieved remission in step 1 [and] the dropout rate was slightly larger than the success rate,” the study authors write. Steps 2 through 4 also each showed increasingly fewer success rates and larger dropout rates.

Of the 4041 patients at the study’s initiation, 370 (9.2%) dropped out within 2 weeks, and only 1854 patients (45.9%) obtained remission “using the lenient QIDS-SR criteria.” Of these, 670 dropped out within a month of their remission, and only 108 “survived continuing care” and underwent the final assessment.

Dr. Pigott described reanalyzing STAR*D as being “a bit like an onion. Each time we thought we understood the results, we found another layer. It wasn’t until about a year and a half ago that we discovered that the secondary outcome measure, the QIDS-SR, was not originally supposed to be used as a research measure. What was particularly disconcerting to me was that in their summary article, they basically used the QIDS-SR to report all of the results, which clearly had an inflationary effect on the outcome.”

He also noted that STAR*D did not have a placebo design. “Because the patients knew they were receiving the active medication, I would have expected a higher remission rate than what you’d find normally in a placebo-controlled study.

“The inescapable conclusion from the STAR*D results is that we need to explore more seriously other forms of treatment (and combination thereof) that may be more effective. This effort will require developing new service delivery models to ensure that as treatments are identified, they are widely implemented,” the investigators conclude.

Read entire article here:  http://www.medscape.com/viewarticle/727323
(Free registration required)

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Leading psychologist says antidepressants no better than placebo—the difference is no suicidal side effects with placebo

Tuesday, August 3rd, 2010

The Daily Mail
By Professor Irving Kirsch
August 3, 2010

We spend more than £250 m a year on antidepressants in the UK – and it’s a complete waste of money.

They are not much better than sugar pills, they have nasty side – effects, such as sexual dysfunction, and they increase young people’s risk of suicide.

New research shows they don’t even work on the brain in the way we thought they did.

For years we were told depression was caused by low levels of a brain chemical called serotonin, and that antidepressants worked by boosting it.

But an Australian study published in the Archives of General Psychiatry shows that rather than low levels, depressed people might have double the normal amount in some parts of their brains.

Many people were surprised by these new findings, but I wasn’t.

I’ve been studying antidepressants for more than a decade, and I knew that if they worked at all, it wasn’t by changing brain chemistry.

The major reason you feel better when taking an antidepressant – maybe the only reason – is the placebo effect.

When I first published a paper back in 1998 saying that antidepressant drugs such as Prozac and Seroxat were not much better than a placebo, almost everyone thought it couldn’t be true.

There was so much evidence they worked. Thousands of people claimed the drugs had turned their lives round.

My colleagues said that I must have made a mistake: either I had looked at the wrong data, or I hadn’t analysed it properly.

In fact, what I’d done was to look at the research on antidepressants in a different way from everyone else.

Other researchers were concentrating on how much better the drugs were than a placebo.

What I was interested in was finding out how strong the placebo effect was in treating depression.

I compared the placebo effect to having no treatment at all – no one had done that before.

We already knew that placebos could have a powerful effect in conditions such as pain, angina, ulcers and asthma.

Depression was an obvious next step, because when you are depressed you lose hope, and placebos give you hope.

But I was flabbergasted by just how big the placebo effect was.

Read entire article here:  http://www.dailymail.co.uk/health/article-1299791/Why-antidepressants-simply-confidence-trick-A-leading-psychologist-claims-taking-sugar-pills-work-just-well.html?ito=feeds-newsxml

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Pharmaceutical companies deceive public—case in point; Antidepressants

Thursday, July 29th, 2010

The Star Phoenix
By Mark Lemstra
July 29, 2010

We could save $2 billion a year on health-care costs in Saskatchewan while improving health outcomes if we adopt evidence-based protocols.

To do so, we need to find about $40 million of efficiency in each of about 50 areas.

This is the third article in a five-part series on depression. My first column discussed the limitations in diagnosing depression. The second presented literature reviews that concluded antidepressants are no more effective than placebos in treating depression.

This column explains how the drug companies deceive us. Let’s start with some general information and proceed to specific examples for antidepressants.

In 2008, the editor of the New England Journal of Medicine wrote an editorial for the Journal of the American Medical Association, titled: Industry sponsored research: A broken system?

Based on her tenure as the editor of the world’s most prestigious medical journal, Dr. Marcia Angell made some accusations. She wrote that drug companies often design studies, conduct the data analysis, decide which data will be included or suppressed, write the papers, pay for prestigious clinicians to put their name on papers already written by the drug company, and then decide how and when the paper will be published.

Dr. Angell concluded: “Drug companies now finance most clinical research on prescription drugs, and there is mounting evidence that they often skew the research they sponsor to make their drugs look better and safer. Physicians can no longer rely on the medical literature for valid and reliable information.”

She also published a best selling and award-winning novel, The Truth about Drug Companies: How They Deceive Us and What to Do About It.

Let’s look at some examples from anti-depressants.

A research team from the United States, which was skeptical about the benefits of antidepressants, used the Freedom of Information Act to obtain results from the U.S. Food and Drug Administration for all placebo-controlled trials. The team was startled to learn that 40 per cent of the studies had been suppressed because of negative results.

When all the studies were included, incorporating the negative studies, the authors concluded that “antidepressants are little more than active placebos, drugs with very little specific benefit, but with serious side-effects.”

The resulting publication in Prevention and Treatment made headlines around the world. And although regulatory agencies in Europe have begun to respond, there has been no response in North America.

At this point, let’s discuss the potential side-effects of antidepressants in a review from Harvard Medical School, titled: What are the real risks of antidepressants?

The most serious of these includes the increased risk of attempted suicide, especially among children. Other side-effects include insomnia, skin rashes, headaches, joint and muscle pain, stomach upset, nausea, diarrhea, reduced blood clotting capacity, stomach bleeding, uterine bleeding, tics, muscle spasms, trembling limbs, restlessness, severe anxiety, reduced sexual interest, reduced sexual performance, reduced sexual satisfaction, disturbed heart rhythms and reduced liver function.

There are also complications when antidepressants are taken with other drugs, and there is a long list of side-effects when antidepressant use is discontinued, including dizziness, loss of co-ordination, fatigue, burning sensations, blurred vision, insomnia, vivid dreams, nausea, diarrhea, flu-like symptoms, irritability, anxiety and crying spells.

Recently, the antidepressant Serzone was removed from the market after it was associated with hepatitis and liver failure.

The most worrisome side-effect is the increased risk of suicide attempt so let’s take a closer look.

Another review from the Food and Drug Administration found that not only do antidepressants provide no benefit to children, but the drugs are associated with a 50 per cent increase in suicidal behaviour.

Regrettably, these negative results, too, were buried by the drug companies.

Read the rest of this article here:  http://www.thestarphoenix.com/news/Pharmaceutical+companies+deceive+public/3336124/story.html

Previous articles in this series: Effect of antidepressants, placebos similar by Mark Lemstra
http://www.thestarphoenix.com/health/Effect+antidepressants+placebos+similar/3307896/story.html

Expanding mental disorders list adds to cost by Mark Lemstra
http://www.thestarphoenix.com/health/Expanding+mental+disorders+list+adds+cost/3280676/story.html

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The Total Failure of Modern Psychiatry

Sunday, June 27th, 2010

Natural News
By David Gutierrez
June 27, 2010

Modern psychiatry went wrong when it embraced the idea that the mind should be treated with drugs, says Edward Shorter of the University of Toronto, writing in the Wall Street Journal.

Shorter studies the history of psychiatry and medicine.

Modern U.S. psychiatry has adopted a philosophy that psychological diseases arise from chemical imbalances and therefore have a very specific cluster of symptoms, he says, in spite of evidence that the difference between many so-called disorders is minimal or nonexistent. These “disorders” are then treated with expensive drugs that are no more effective than a placebo.

“Psychiatry seems to have lost its way in a forest of poorly verified diagnoses and ineffectual medications,” he writes.

Shorter calls for U.S. psychiatry to abandon its emphasis on “psychopathology” and instead adopt the European approach, which focuses on the symptoms and needs of people as individuals. Yet the draft of the latest edition of psychiatric diagnostic “Bible,” the Diagnostic and Statistical Manual of Mental Disorders (DSM), shows that U.S. psychiatry has no intention of changing course.

“With DSM-V, American psychiatry is headed in exactly the opposite direction: defining ever-widening circles of the population as mentally ill with vague and undifferentiated diagnoses and treating them with powerful drugs,” Shorter writes.

U.S. psychiatry was not always obsessed with psychopharmacology, he notes. Its early years were marked by a psychoanalytic approach that categorized mental disorders in broad, fluid categories such as “nerves,” “melancholia” or “manic-depressive illness.” These categories sufficed because similar treatments would work for people suffering from any version thereof: lithium treated both mania and severe depression, for example, while the specific symptoms experienced by an anxious person had little influence on the therapies needed.

“Our psychopathological lingo today offers little improvement on these sturdy terms,” Shorter said. “A patient with the same symptoms today might be told he has ‘social anxiety disorder’ or ‘seasonal affective disorder.’ … The new disorders all respond to the same drugs, so in terms of treatment, the differentiation is meaningless and of benefit mainly to pharmaceutical companies that market drugs for these niches.”

In the 1950s and ’60s, a new wave of psychiatrists sought to turn away from psychoanalysis — perceiving it as focusing excessively on “unconscious psychic conflicts” — and toward a more “scientific” model instead. As a result, the DSM-III introduced the vague new categories of “major depression” and “bipolar disorder,” even though evidence suggests that there is no substantial difference between the two conditions. At the same time, “major depression” absorbed what Shorter calls two very different conditions, “neurotic depression” and “melancholia.”

“This would be like incorporating tuberculosis and mumps into the same diagnosis, simply because they are both infectious diseases,” he writes.

DSM-V only continues the trend of extending the disordered label to more and more normal people, Shorter warns: “To flip through the latest draft of the American Psychiatric Association’s Diagnostic and Statistical Manual, in the works for seven years now, is to see the discipline’s floundering writ large.”

For example, the new disorder of “psychosis risk syndrome” associates a whole new class of people with full-blown schizophrenia, under the logic, Shorter says, that “even if you aren’t floridly psychotic with hallucinations and delusions, eccentric behavior can nonetheless awaken the suspicion that you might someday become psychotic.” The implication, of course, is that such people should be treated with antipsychotics.

Symptoms of “psychosis risk syndrome” include such vague descriptors as “disorganized speech.”

Other new “disorders” include hoarding, mixed anxiety-depression and binge eating. “Minor neurocognitive disorder” describes a reduction in cognitive function over time, such as that normally experienced by people over the age of 50, while “temper dysregulation disorder with dysphoria” refers to children who suffer from outbursts of temper.

“DSM-V accelerates the trend of making variants on the spectrum of everyday behavior into diseases,” Shorter says, “turning grief into depression, apprehension into anxiety, and boyishness into hyperactivity.”

Read entire article:  http://www.naturalnews.com/029088_psychiatry_failure.htmll

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The Globe and Mail — “Is Depression a Disease? Big Pharma says yes, but others aren’t so sure”

Friday, June 18th, 2010

Big Pharma says yes, but others aren’t so sure

The Globe and Mail
By Leah McLaren
June 18, 2010

“It’s all in your head” isn’t something a chronically depressed person likes to hear. In the age of Prozac, when adjusting your serotonin level is as normal as checking the oil in your car, it seems unhelpful to suggest that someone might think their way into – or out of – a disease of the mind.

And yet depression is all in our heads. Where else would it be? The real question, still hotly debated in the scientific community, is whether its cause is chemical and ultimately curable (good news for Big Pharma) or something far more complex (good news for poets and pot-smoking students of existential philosophy).

There is no doubt that depression exists. Inexplicable sadness – or “melancholia,” as it was historically known – has been with us since Hippocrates conceived his famous oath. But a groundbreaking new study has found that not only is depression affected by the way we think about it, so too is its cure.

Last week Irving Kirsch, a professor at the University of Hull in the U.K., presented a study that found Prozac and its ilk are no more effective than placebos in treating depression. In his view, there is no substantial link between serotonin – the brain chemical that antidepressants are supposed to regulate – and chronic depression.

It’s a controversial study – one that many members of the psychiatric community reject out of hand – but it also raises a nagging question about depression: How did it come to be recognized as a disease in the first place?

Like Hirsch, psychologist and writer Gary Greenberg is part of a growing number of psychiatric professionals who have begun to publicly question the underpinnings of popular thinking on depression.

Read entire article:  http://www.theglobeandmail.com/life/style/is-depression-a-disease/article1609422/

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