Posts Tagged ‘placebo’

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Study: Antidepressants actually cause many people to have worse depression

Tuesday, December 20th, 2011

NaturalNews – December 20, 2011

Most who received placebo saw a gradual improvement in depression symptoms, while nearly 20% of those taking antidepressants became worse

A recent industry-funded study on antidepressant drugs has revealed that the medications can cause roughly 20 percent of patients to get worse depression symptoms than if they simply took nothing. Published in the journal Archives of General Psychiatry, the study, which was largely controlled by drug giant Eli Lilly, is an eye-opener for those who still put their faith in antidepressants like Cymbalta (duloxetine), which carry with them life-altering side effects.

Ralitza Gueorguieva, lead author of the study from the Yale University School of Health, and her colleagues conducted trials on 2,500 people, all of whom were given either Cymbalta, various other antidepressant drugs, or a drug-free placebo for two months. At the conclusion of the study, most of those who received the placebo saw a gradual improvement in their depression symptoms, while nearly 20 percent of those taking antidepressants saw a worsening of their symptoms.

Those taking antidepressants rather than a placebo were grouped into one of two groups — “responders” or “non-responders.” Responders allegedly saw some improvement from the drugs, while non-responders saw no improvement at all. Eighty-four percent of all patients in the drug groups reportedly saw some improvement, while 16 percent saw no improvement at all — and this 16 percent actually saw a worsening of symptoms, as well as various other harmful side effects.

According to Reuters Health one of the study’s three authors is an employee of Eli Lilly, the company that makes Cymbalta, while another is on the company’s scientific advisory board.

What this all means is that patients who choose to use antidepressants, despite the numerous studies showing that they really do not work and can cause tremendous harm (http://www.naturalnews.com/antidepr…), as well as their doctors, need to pay close attention to what effect the drugs are having. If no improvement is seen, it is perhaps best to stop using the drugs completely and turn to alternatives.

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The Drugging of America

Thursday, September 29th, 2011

The Journal – September 29, 2011

by Barry Evans

The theory that psychological problems are mainly caused by a chemical imbalance in the brain can be traced back 60 years, when French researchers accidentally discovered that Thorazine (chlorpromazine) dramatically improved the emotional behavior of institutionalized mental patients. Within a few years, the anti-psychotic properties of Thorazine and related drugs led to the trend in this country to reintegrate into society people who had previously been confined to mental hospitals (“deinstitutionalization”).

Prozac advertisement

Today, the “chemical imbalance” revolution is almost complete, as one in 10 Americans over the age of 6 take antidepressants. As Marcia Angell, former editor-in-chief of The New England Journal of Medicine, wrote in a controversial two-part essay in The New York Review of Books (June 23 and June 30, 2011), the pharmaceutical solution to psychological disorders has now become the norm, as more and more health professionals accept the theory that mental illness, including depression and anxiety, is essentially caused by a chemical imbalance in the brain.

The wholesale acceptance of this theory, by both the medical profession and the public, came with the introduction of Prozac (fluoxetine) in 1987. While Thorazine was thought to correct a deficiency of dopamine, Prozac was marketed as an SSRI (selective serotonin reuptake inhibitor), designed to compensate for a presumed deficit of the neurotransmitter serotonin. (SSRIs block neurons from re-absorbing serotonin, leaving more of it available to activate adjacent neurons.) Because SSRIs alleviate depression, researchers speculated that depression was caused by too little serotonin in the brain.

Maybe. Or maybe not. Angell argues that by the same logic “one could argue that fevers are caused by too little aspirin.” Perhaps SSRIs do something quite unrelated to neurotransmitters, and depression is unrelated to serotonin levels.

Whether the “chemical imbalance” theory is true or not, the real question is, Do antidepressants work better than placebos? Psychologist Irving Kirsch, one of the authors reviewed by Angell, used the Freedom of Information Act to obtain drug companies’ records of their negative studies from the FDA. Unlike the positive results, negative results are normally not published. (Incredibly to this writer, negative results are considered proprietary and therefore confidential.) Taking both positive and negative results into consideration, Kirsch discovered that six popular drugs — Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor — scored unimpressively when compared with placebos. Yet, as Angell writes, “because the positive studies were extensively publicized, while the negative ones were hidden, the public and the medical profession came to believe that these drugs were highly effective antidepressants.” It gets more surreal. When depressed patients were prescribed drugs such as opiates, sedatives, stimulants and even herbal remedies, Kirsch and others found their symptoms were relieved to about the same degree as with SSRI-type antidepressants.

Angell’s essay was, as I say, controversial. One of the more curious responses, published as an opinion piece in the New York Times on July 9, came from Dr. Peter Kramer, author of the 1993 best-seller Listening to Prozac. This book-length endorsement of the drug (which predicted a Brave New World-style “cosmetic psychopharmacology” future for us all) probably did more than anything else to turn Americans on to SSRIs. In his Times piece, Kramer largely sidestepped the alarming questions posed by Angell and the three books she reviewed. Instead, he focused on the difficulties of distinguishing the effects of placebos from those of real drugs. And as he had done in his book, he relied largely on unconvincing anecdotal evidence to make his case.

What we do know about placebos is that they’re not dangerous. However, even as increasing numbers of adults and children take powerful psychoactive drugs (because more of us are suffering?), researchers still have no clear handle on their potentially damaging long-term effects.

Barry Evans  gets depressed just thinking about antidepressants.

http://www.northcoastjournal.com/outdoors/2011/09/29/drugging-america/

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Mental health services have become increasingly dominated by psychiatry’s ”medical model”

Friday, September 16th, 2011

The Sydney Morning Herald, Australia – “With More Talk in Mind” – Sep 15, 2011

by Dr. John Reed, Professor of Clinical Psychology

SERIOUS problems in Victoria’s mental health system have been revealed recently in The Age. The important thing now is to find solutions. In doing so we should remember that although Victoria is in the spotlight, similar ”crises” occur regularly all over the world. Perhaps this is because Victoria is not alone in having a system based on fundamentally flawed principles.

Mental health services have become increasingly dominated by psychiatry’s ”medical model”, which claims that feeling depressed, anxious or paranoid is primarily caused by genetic predispositions and chemical imbalances.

This has led to alarming rises in chemical solutions to distress. In New Zealand, one in nine adults (and one in five women) is prescribed antidepressants every year.

The public, however, in every country studied, including Australia, believes that mental health problems are caused by issues such as stress, poverty and isolation. The public also prefers talking therapies to drugs and electroconvulsive therapy (ECT).

Research suggests the public is right. For example, the single best predictor of just about every mental health problem is poverty, followed by other social factors such as abuse, neglect and early loss of parents in childhood, and – once in adulthood – loneliness and a range of adverse events including losses and defeats of various kinds.

Meanwhile, reviews of studies on anti-depressants (which only recently have been able to include those previously kept secret by drug companies) conclude that they are superior to placebos only for those at the extreme end of the ”most severe” group of depressed people. This represents less than 10 per cent of the people who are receiving these drugs.

A recent Cochrane review (the type most highly regarded in the scientific community) for risperidone, a leading anti-psychotic drug, ”suggests that there is no clear difference between risperidone and [a] placebo”.

A placebo (from the Latin meaning ”I please”) is not necessarily a bad thing. Indeed the talking therapies are effective partly because, if done well, they too instil hope and expectations of recovery.

The problem is that psychiatric drugs often have serious adverse effects. Anti-psychotics, for instance, can cause rapid weight gain, loss of sexual function, diabetes, heart disease, neurodegeneration and reduced life span.

As previously reported, my review of ECT studies (with Professor Richard Bentall of Liverpool University) found that this treatment is ineffective for most recipients and frequently causes permanent memory loss. This in itself can be depressing.

ECT also has a slight but significant risk of death, most frequently from cardiovascular failure.

Inpatient units are equally ineffective and can also be damaging. When will we learn that putting large numbers of extremely distressed people in the same building is not a good idea?

What I conclude from all this is that any review of mental health services in Victoria, or anywhere else for that matter, should probably be led by anyone other than a psychiatrist – and certainly not in Victoria’s case the state’s Chief Psychiatrist, whose job, according to Dr Ruth Vine herself, is “to watch over how the system is functioning”.

It is unfair to expect Dr Vine to take an objective view on the failure of the system for which she is responsible. That lack of objectivity is amply demonstrated by her claims that ECT is “safe and effective” and that the problem is the public’s “negative” views.

Perhaps a lawyer from the Mental Health Legal Centre might be a good choice.

Read the rest of the article here: http://www.smh.com.au/opinion/society-and-culture/with-more-talk-in-mind-20110914-1k9m2.html#ixzz1Y8tVJQlv

 

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Beware the ghost(writer)s of medical research

Friday, June 17th, 2011

The One Click Group – June 16, 2011

By Dr. Marc-André Gagnon
 and Dr. Sergio Sismondo
 Expert Advisors – EvidenceNetwork.ca

The medical research world has been concerned about the problem of ghostwriting for more than a decade.

The issue has been repeatedly raised in the mainstream media over the past few years, with most of the commentary focused on the ethics of academics serving as authors on papers they did not write and on some of the most egregious actions by pharmaceutical companies.

But these efforts miss the ways in which Big Pharma has developed new forms of medical research to serve its own interests.

How ghostwriting feeds Big Pharma profits

Big Pharma firms spend twice as much on promotion as on research and development (R&D). But it is worse than that: more and more medical R&D is organized as promotional campaigns to make physicians aware of products. The bulk of the industry’s external funding for research now goes to contract research organizations to produce studies that feed into large numbers of articles submitted to medical journals.

Internal documents from Pfizer, made public in litigation, showed that 85 scientific articles on its antidepressant Zoloft were produced and coordinated by a public relations company. Pfizer itself thus produced a critical mass of the favourable articles placed among the 211 scientific papers on Zoloft in the same period. Internal documents tell similar stories for Merck’s Vioxx, GlaxoSmithKline’s Paxil, Astra-Zeneca’s Seroquel, and Wyeth’s hormone-replacement drugs.

To promote the now-notorious Vioxx, Merck organized a ghostwriting campaign that involved some 96 scientific articles. Key ones did not mention the death of some patients during clinical trials. Through a class action lawsuit against Vioxx in Australia, it was discovered that Elsevier had created a fake medical journal for Merck – the AustralasSian Journal of Joint and Bone Medicine – and perhaps 10 other fake journals for Merck and other Big Pharma companies.

In another example, GlaxoSmithKline organized a ghostwriting program to promote its antidepressant Paxil. According to internal documents made public in 2009, the program was called “Case Study Publication for Peer-Review”, or CASPPER, a playful reference to the “friendly ghost”. Such strategies are not exceptions; they are now the norm in the industry. Most new drugs with blockbuster potential are introduced accompanied by 50, 60, or even 100 medical journal articles. Any firm that refused to play this game in the name of ethics would likely lose market share. Profits in the pharmaceutical industry depend on companies’ capacity to influence medical knowledge and create market share and market niches for their products.

A call for Evidence-Based medicine

In 2008, research showed that pharmaceutical companies systematically failed to publish negative studies on their SSRIs, the Prozac generation of antidepressants. Of 74 clinical trials, 38 produced positive results and 36 did not: 94 per cent of the positive studies were published, but only 23 per cent of the negative ones were, and two-thirds of those were spun to make them look more positive.

Physicians reading the scientific literature got a biased view of the benefits of SSRIs. This helps to explain the huge number of antidepressant prescriptions, in spite of the fact that, according to a meta-analysis in JAMA in January 2010, for 70 per cent of people taking SSRIs, the drug did not bring more benefits than a placebo. Compared to placebo, however, SSRI antidepressants can result in serious adverse drug reactions.

There we see one of the problems with the ghost management of medical research and publication. Pharmaceutical companies want upbeat reports on their drugs. They design, write, and publish studies that are likely to show their drugs in positive lights – and there are myriad ways to do so. Ghosts sometimes bend the truth, and sometimes even commit fraud, with grave results.

Why do academics serve as authors on scientific articles they did not write, using research they did not perform? Because they are rewarded, both by their universities and by their colleagues for how much they publish and for its prominence. Pharmaceutical companies and their agents are very good at placing articles in prestigious journals, and then make them even more prominent by having their armies of sales reps circulate them and talk them up.

Researchers who serve as authors on studies and analyses (perhaps scientifically correct) that are favourable to the industry can expect to see these articles increase their prestige and influence, and possibly even funding.

What happens, however, when a researcher produces studies and analyses (also scientifically correct) showing that some products are dangerous or inefficient, as some did about Vioxx before the scandal broke? Reading Merck’s internal e-mails, revealed during the class lawsuit, it was exposed that the company drew up a hit list of “rogue” researchers who needed to be “discredited” or “neutralized” – “seek them out and destroy them where they live,” reads one e-mail. Eight Stanford researchers say they received threats from Merck after publishing unfavourable results.

Corporate science

In the ghost management of research and publication by drug companies we have a new model of science. This is corporate science, done by many unseen workers, performed for marketing purposes, and drawing its authority from traditional academic science. The high commercial stakes mean that all of the parties connected with this new corporate science can find reasons or be induced to participate, support, and steadily normalize it. It also biases the available science by pushing favourable results and downplaying negative ones – and sometimes through outright fraud.

As long as pharmaceutical companies hold the purse strings of medical research, medical knowledge will serve to market drugs, not to promote health. And as long as universities grovel for more partnerships with these companies, the door will remain wide open to proceed with the corruption of scientific research.

http://www.theoneclickgroup.co.uk/news.php?id=6349#newspost

Dr. Marc-André Gagnon is assistant professor with the School of Public Policy and Administration at Carleton University. He is also an expert advisor with EvidenceNetwork.ca, a comprehensive and non-partisan online resource designed to help journalists covering health policy issues in Canada. Dr. Sergio Sismondo is professor of Philosophy and Sociology at Queen’s University. His current research is on the pharmaceutical industry’s relationships with academic medicine and practicing physicians.

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The Small Group of Thoughtful, Committed Citizens Has Been Drugged

Tuesday, May 24th, 2011

OpEdNews
By David Swanson
May 23, 2011

Movements for justice have historically been driven by a small percentage of any population. One percent of Americans nonviolently occupying Washington, D.C., could make Cairo and Madison and Madrid look like warm-up acts. It is certainly true that a small group of thoughtful, committed citizens is the only thing that ever has changed the world for the better.

So, what happens if a society picks out a significant slice of its population, one including many thoughtful and committed citizens, and drugs them?

The Drug Enforcement Administration (DEA) held a first-time, one-day, little publicized event last September that allowed people to turn in their extra prescription drugs. The DEA reports collecting 242,000 pounds or 121 tons. A second such day was held in April with 376,593 pounds or 188 tons of pills collected. This is the stuff nobody wants and is willing to hand in to the government. This is not the amount that’s out in circulation. That amount is no doubt in proportion to the roaring flood of television ads for the stuff. “More Americans currently abuse prescription drugs,” says the DEA, “than the number of those using cocaine, hallucinogens, and heroin combined. . . . [I]ndividuals that abuse prescription drugs often obtained them from family and friends, including from the home medicine cabinet.” And that’s just the users said to be abusing.

Ted Rall suggested drugging to me as a possible explanation for the big mystery staring us in the face, namely why Americans sit back and take so much more than other people from their government. The Patriot Act is being put on steroids with hardly a peep of protest. The “Defense Authorization Act” now before Congress would give presidents virtually limitless power to single-handedly make wars or imprison people. This is the biggest formal transfer of power in the U.S. government since the drafting of its Constitution. This undoes the American War for Independence. But perhaps we’d still be 13 colonies if Prozac and Zoloft had come along sooner.

“Like many people,” says Rall, “I have often wondered why so many Americans seem so emotionally flat and politically apathetic in response to a political and economic landscape that cries out for protest, or at least complaint. Could it be that our society’s most angry — justifiably angry — are being medicated into quiescence?” It does seem possible. I don’t mean to discount the fact that the United States imprisons record numbers of people. I’m willing to share some blame with our education system, our so-called news media, our religiosity, the two-party trap, and several other likely factors. But drugs looks like the big one that is nonetheless hardest to see. People don’t usually tell you they’re drugged, but chances are at least one in 10 people you meet is.

Two years ago, a study found that “the number of Americans taking antidepressants doubled to 10.1 percent of the population in 2005 compared with 1996, increasing across income and age groups.” One year earlier, another study had found that close to 10 percent of men and women in America were taking drugs to combat depression, and that 11 percent of women were taking antidepressants.”

Author and clinical psychologist Bruce Levine tells me this may be even worse than it sounds. “If you are around certain populations,” Levine says, “that 10 percent stat seems very low, especially among healthcare professionals and college students.” College students? I can remember them getting pretty thoughtful and committed in times past. “And that 10 percent,” Levine adds, “only includes the ‘official antidepressants’ such as Prozac, Paxil, Zoloft, Lexapro, Wellbutrin, Effexor, etc. This stat doesn’t include people using ADHD drugs such as Ritalin, Adderall, etc. to stimulate themselves.”

Adderall, Levine explained, is an amphetamine that affects the same neurotransmitters as cocaine (dopamine, serotonin, and norepinephrine), “and if one takes the antidepressant Effexor (affects serotonin and norepinephrine) at the same time one is taking the antidepressant Wellbutrin (affects dopamine), one can sense the hypocrisy in labeling certain psychotropics (drugs that affects neurotransmitters) as ‘antidepressants’ and other psychotropics as ‘ADHD psychostimulants.’ Lots of people — especially young people — are popping ‘Addies’ (street name for Adderall) to ‘motivate’ them to get them through their lives, especially during exam time.”

Levine said he’s counseling a young man who is supplementing his income by selling ADHD psychostimulant drugs to his fellow college students. He gets the best price around final exam time. “He told me, ‘Bruce, you’ve got to do better improving the self-esteem of these young kids who you are counseling.’ Why, I ask him, why do you care? ‘Well,’ he says, ‘these little brats who are getting their freebie prescription Addies feel so crappie about themselves that they are giving away their Addies to their older brothers for free just so they will hang out with them, and all those freebie Addies on the market are driving price down for me.”

Levine stresses that Adderall, like nicotine or caffeine or cocaine, provides a buzz that antidepressants do not. In fact, he points out, the so-called antidepressant drugs make people twice as likely to commit suicide. Levine concedes that some people swear antidepressants have saved their lives, but points out that people will say that about a placebo as well. The evidence, Levine says, shows antidepressants working no better than a placebo at lifting people out of depression.

Antidepressants may bear as Orwellian a name as the Patriot Act, but Levine finds the latter easier to talk about with people. “I get less grief,” Levine tells me, “when I talk about something like anarchism and Emma Goldman than when I talk about antidepressants’ effectiveness and [author] Irving Kirsch, as abstract political ideologies are far less threatening than people’s very own drugs.” Political movements may in fact be less threatening to those in power, because of people’s drugs.

Read article here:  http://www.opednews.com/articles/The-Small-Group-of-Thought-by-David-Swanson-110523-181.html

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Dealing With Depression Naturally

Tuesday, March 8th, 2011

FOX News, March 8, 2011
by Chris Kilham

If your life is making you unhappy, then making positive changes may be the very best prescription of all

According to a study published in the Archives of General Psychiatry, approximately 10 percent of Americans are taking antidepressant medications.

This means that over 31 million Americans are gobbling Prozac, Zoloft, Celexa, Elavil, Norpramin, Luvox, Paxil, Wellbutrin and other antidepressant psychiatric drugs like M & M’s. This drug use accounts for billions of dollars in pharmaceutical sales annually (9.6 U.S. billion in 2008).

Yet according to a landmark study published in the Journal of the American Medical Association, antidepressant medications work – as well as placebos and not more. In other words, people in depression studies who are given sugar pills instead of antidepressant drugs do as well as the group who gets the drugs.

Before you ask yourself whether you should simply take a Tic Tac instead of a Paxil, there is more disheartening news about these drugs. Many Americans are taking antidepressant medications instead of changing their own behavior or life circumstances. According to Maryland medical doctor Ronald Dworkin, “Doctors are now medicating unhappiness. Too many people take drugs when they really need to be making changes in their lives.” If you are beating your nose with a hammer, do you stop hitting yourself, or do you continue, and take a pain pill?

Digging more deeply into the mystery of antidepressants, George Washington University health analyst Thomas Moore examined unpublished studies conducted by drug companies  with various antidepressants. Approximately 40 percent of the studies conducted on this class of drugs have never been published — because in those 40 percent of studies, antidepressants do not demonstrate effectiveness. In other words, in the unpublished studies, they didn’t work. In even further research, Irving Kirsch of the University of Connecticut looked at results from varying doses of antidepressants. The difference in effectiveness between small doses and large doses was virtually non-existent.

It gets even gloomier. A U.S. government study released in 2006 showed that fewer than 50 percent of people become symptom-free on antidepressants, even after trying two different medications. Many who do respond to medication slip back into major depression within a short while, despite sticking with drug treatment. And then there are the “side effects,” which are really effects pure and simple. The most common effects of antidepressant drugs include nausea, insomnia, anxiety, restlessness, loss of sex drive, dizziness, weight gain, tremors, sweating, sleepiness, fatigue, dry mouth,  diarrhea, constipation and headaches. People over 65 are at extra risk of falls, fractures and bone loss, newborns of mothers on SSRI antidepressants can go through drug withdrawal, and among teens, the use of antidepressants can increase suicidal tendencies. Any sober assessment of these effects points to the fact that there is something terribly wrong with this entire class of drugs. Remember what Hippocrates said “First of all, do no harm.”

Many intangibles add up to either a happy life or a sad one. Do you spend enough time with your family? Your friends? Do you relax? Do you do things you love? Do you enjoy your work? If you answer no to these questions, you probably have good cause to feel depressed. But popping a pill won’t help if you are not living in a fulfilled way.

What about natural approaches to depression? A number of doctors believe that nutritional deficiencies play a key role in many cases of depression. After all, brain chemistry depends on nutrient intake for proper balance. Really, it’s no surprise that a junk food-eating culture would be increasingly mentally out of sorts. No brain food means poor brain function. This is where omega 3 fatty acids come in, notably DHA, which is essential for proper brain function. These essential fats greatly enhance brain health and mood. The best way to get them is to eat fresh seafood, especially wild salmon. But omega 3 fatty acid supplements from fish oil are also available.

According to the National Institutes of Mental Health, anxiety and depression often go hand in hand. Many people find that they can relieve or reduce anxiety by meditating. There are many ways to meditate. By setting aside time every day, you can calm your body and mind, change your brainwaves, and alter your mood for the better.

Regular exercise is also associated with improved mood. Exercise enhances circulation, modifies brain chemistry for the better, enhances overall energy, improves vitality and contributes greatly to well being. You don’t need to go to a gym, either. Just get outside and walk. Do so briskly for at least half an hour each day, and notice how much better you feel.

On the herbal side, Rhodiola rosea is the big antidepressant. Many forward-thinking psychiatrists have turned to Rhodiola as a first line of treatment, instead of pharmaceuticals. Psychiatrists Richard Brown and Patricia Gerbarg in New York are ardent advocates of Rhodiola for depression and mood enhancement, and have written profusely about it. Dr Hyla Cass of UCLA also is an advocate. Meanwhile, dozens of studies demonstrate significant improvement in all parameters of mental function with Rhodiola rosea. My favorite brands? Rhodiola Energy by Enzymatic Therapy, and Rapid Rhodiola by EuroPharma.

If your life is making you unhappy, then making positive changes may be the very best prescription of all. Many people are so buried by work and stress that they forget to take time to live, to enjoy themselves and to savor life itself. I remember once meeting a psychiatrist at one of my talks. He was retired, and I was deeply impressed by what he shared.

“I practiced psychiatry for twenty-eight years,” he said. “And I never once gave anybody a prescription.” I asked him what he did for his patients instead.

“I talked with them,” he replied. As Rabbi Earl Grollman, author of several books on grief says, “the mentionable is manageable.” Maybe talking is a good place to start.

Chris Kilham is a medicine hunter who researches natural remedies all over the world, from the Amazon to Siberia. He teaches ethnobotany at the University of Massachusetts Amherst, where he is Explorer In Residence. Chris advises herbal, cosmetic and pharmaceutical companies and is a regular guest on radio and TV programs worldwide. His field research is largely sponsored by Naturex of Avignon, France. Read more at www.MedicineHunter.com

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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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