DO THE DRUGS WORK?

“There is nothing to fear, but fear itself,” Franklin Delano Roosevelt, US President

By Charlene Smith
“People obtain considerable benefits from many medications, but they also can experience symptom improvement just by knowing they are being treated. This is called the placebo effect.”[1]
John Teasdale, a leading researcher on depression at Oxford and Cambridge universities writes that most depressed people will say they are depressed about being depressed.

Professor Irving Kirsch writes, he “labeled this phenomenon, ‘depression about depression’ and claimed that effective treatments for depression work – at least in part – by altering the sense of hopelessness that comes from being depressed about one’s own depression.” Hope, is said, lies at the core of the placebo effect.

A psychologist with many years of experience, he has analyzed 38 clinical trials with more than 3,000 patients over 15 years. He found that people get better when given placebos, “although not as great as the improvement following drugs or psychotherapy” which had similar rates of success.

Tom Moore performed similar evaluations of data from the Food and Drug Administration that found that about 50% of the “effects of a pain medication can also be produced by placebos, whereas the placebo effect in drugs used to treat blood-sugar levels is nil.”  Kirsch notes that “conditions that have a strong psychological component – such as pain, anxiety and depression – are particularly prone to placebo influence, whereas conditions like bone fractures, diabetes and infertility are less likely to be affected by placebo treatments.”

The human mind is so powerful that when patients on a clinical trial are told that the side effects of an antidepressant are a dry mouth, drowsiness, diarrhea, nausea and forgetfulness even those receiving placebos (sugar-coated pills with no drugs) experience the same side effects.

But there are also times when drug companies deliberately distort information and organizations that the public believe are acting on their behalf, like the World Health Organization and the Federal Drug Administration, may often be compromised with key researchers in the pay of drug companies.

Kirsch writes, “One might expect to find a negative association between side effects and improvement. Side effects of SSRIs include sexual dysfunction, insomnia, short-term weight loss, long-term weight gain, diarrhea, nausea, drowsiness, skin reactions, nervousness, anorexia, dry mouth and sweating. One would think that experiences like this would make people feel more depressed. Indeed, some of these side effects could also be interpreted as symptoms of depression. But in fact… the more side effects a person experiences when taking Prozac, the more he or she improves on the drug. I can think of only one reason … and that is (because the side effects) lead patients to conclude that they have been given the active drug, rather than the placebo.”

Kirsch notes that the conventional view of depression, “is that it is caused by a chemical imbalance in the brain … it is actually a rather controversial theory and there is not much scientific evidence to support it.”

Psychologist, Michael Brown of Minneapolis who has been in practice for more than three decades and lectures psychiatry students says that it is human interaction and not drugs that are most likely to see a turn-around in patient moods.

“It is being listened to, heard, cared about that causes the greatest change and not drugs which may make a bad situation worse.” 

It is a view Kirsch would support.

Brown is vociferous about the way pharmaceutical companies profit, in his view, from human misery using drugs that are not very effective and points to a litany of failed psychiatry methods over the years, some of which, in today’s world would be seen as human rights abuses and even torture.[2]

Indeed, drug companies are active in suppressing negative results from clinical trials and only publishing positive results. Kirsch cites the example of Glaxo Smith Kline’s research in the 1990s into paroxetine, which is sold under the brand name of Seroxat for major depression in children and adults. One study showed mixed results, a second showed no real difference between placebo and drug and a third suggested that the placebo might be more effective for children aged seven to 11. Only one trial was published. The Canadian Medical Association Journal published a confidential GSK memo which noted that: “it would be commercially unacceptable to (note) that efficacy had not been demonstrated, as this would undermine the profitability of paroxtene.” They released the drug and the mixed results study in 2001 with the statement that “paroxtene is effective for major depression in adolescents.”[3]

Or drug companies cherry pick data, Kirsch gives the example of a multi-center study of Prozac presented to the FDA showing a drug-placebo effect of three points on the Hamilton scale. “When data from this clinical trial was published, the difference was reported as 15 points – a five times increase in effectiveness. How was this magical augmentation of the benefits of Prozac accomplished? The full study was conducted on 245 patients. The published paper reported data from only 27 of these patients … making the drug seem much more effective than it really was.”

He also gives the example of the regulatory agencies of the European Union, France, the Netherlands and Sweden who issued a ‘regulatory apologia’ after research from Kirsch and his colleague Guy Spairstein came out in a meta-analysis in 2008. “’Against this background,” the wrote, “one can ask why the new-generation antidepressant medicinal products were ever approved.’”  The regulatory agencies conducted their own research and found similar results to Kirsch indicating that the drugs were only effective in 16 percent of cases.

Commonly abused antidepressants
Brand Names US

Prozac

Paxil

Zoloft

Effexor

Serzone

Celexa

Caution

Do not come off anti depressants or painkillers without medical supervision. The abrupt cessation of SSRIs produces withdrawal symptoms in 20 percent of patients. These included abdominal cramping and pain, diarrhea, nausea, vomiting, dizziness, flu-like symptoms, anxiety, depression, blurred vision, numbness, sleep disturbances, electric shock symptoms, headaches, twitches and tremors.  The book Coming Off Antidepressants by Joseph Glenmullen of Harvard Medical School is an excellent source of information on how to discontinue antidepressant drug treatment.

Alternatives:

Psychotherapy.

St John’s Wort but be careful about not taking too much. 

Physical exercise.

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[1] The Emperor’s New Drugs: Exploding the Antidepressant Myth by Irving Kirsch, Ph.D., Basic Books, New York, 2010

[2] Correspondence and discussions with Michael Brown, Minneapolis, February to April, 2011

[3] In 2004, Eliot Spitzer then Attorney General of New York sued GlaxoSmithKline charging that the company had ‘engaged in repeated and persistent fraud by concealing and failing to disclose to physicians information about Paxil (the brand name for Seroxat in the US).’ The case was settled two months later, with the company agreeing to pay $2.5 million to the State and to establish an online clinical-trial register containing summaries of the results of all of the clinical trials they sponsor.