Separating the Facts from the Propaganda_Latest Findings of Depression Study

The optimistic headline news reports such as Associated Press/ MSNBC (below) promulgate industry's marketing propaganda by helping to turn evidence of treatment failure into a reason for "staying the course:"
 "For depression relief, try variety of medications" "Study: Antidepressants help most patients if they sample several kinds"

Fact 1:  In placebo-controlled clinical trials depressed patients treated with placebo achieved 80% of a perceived beneficial antidepressant drug effect.

This is the reason why Dr. Thomas Insel, director of the National Institute of Mental Health, cautions: "because there was no comparison group of people who got no treatment, it is hard to know how many of those got better on their own, with enough passage of time, or because of the drugs."

The question we have for Dr. Insel is: Why did the NIMH provide $35 million in taxpayer money for an uncontrolled, unscientific study rather than conduct a placebo-controlled trial that would answer the questions sought?

Fact 2: The natural course of depression fluctuates–it surfaces and remits without chemical intervention.

Given the high placebo effect and the natural course of the illness–even if not treated–the results of the study are decidedly negative:
 36.8% of patients went into remission after trying their first treatment: but  40% of these relapsed within a year.
 30.6% found relief with their second treatment: but 55% of these patients relapsed within a year.
 Of those whose depression remitted after 3 or 4 drug treatment attempts, 71%  relapsed within 12 months.

Furthermore, The Wall Street Journal reports (below) that 4,041 depressed patients had been enrolled in this government sponsored study, "but only 123 patients remained by the fourth phase."  That drop out rate is evidence of colossal treatment failure.

The widely disseminated advice of "staying the course" serves manufacturers' marketing interests but is a disservice to unsuspecting consumers who for the most part are unaware of the drugs' serious risks–including the twofold increased risk of drug-induced suicidality.  Consumers don't ordinarily see the drugs' FDA-approved label warnings in which the drugs' serious adverse effects are disclosed.

 What possible justification is there for continued exposure  to these drugs' serious risks of harm when it is apparent that they don't work?

 Contact: Vera Hassner Sharav
 Study Looks at Resistance
To Depression Treatment
November 1, 2006; Page D9

A high-profile U.S. study on depression found that two-thirds of patients achieve remission, if they stick with therapy. But those who needed more than two treatments had sharply lower rates of success.

The study underscores the pervasive problems that psychiatrists face treating the most difficult patients, who are resistant to many existing treatments, and the need for more innovative antidepressants. It also suggested that patients who don't respond to one type of antidepressant can still benefit from a different drug in the same class, and don't immediately need to be switched to a drug with a wholly different method of action. Persisting in treatment was found to be key.

The study, parts of which already have been published, was seen as a landmark, because it looked at depression treatment over a much longer period of time than studies done by the companies that make the drugs. It's expected to help determine practice guidelines. An overview of the $35 million program, called Sequenced Treatment Alternatives to Relieve Depression, or STAR*D, and funded by the National Institute of Mental Health, is being published today in the American Journal of Psychiatry.

The study, run over seven years, wrapped up its tests last year and is now producing a series of reports on its findings. In phases one and two, released earlier this year, the study found that 36.8% of patients went into remission after trying their first treatment, and that 30.6% of those remaining found relief with their second treatment. But harder-to-treat patients, who required third and fourth attempts, went into remission only 13.7% and 13% of the time, respectively. After 12 months, 71.1% of patients who had tried four treatments had relapsed back into depression.

The study has been unique in its length and methods. It was conducted in a real-world setting by following patients already seeing their doctors, rather than paying patients to join a trial. It also set as its treatment goal complete remission, rather than just a reduction in symptoms. The study was the largest-ever treatment study of depression, with 4,041 depressed patients enrolled at its highest point, but only 123 patients remained by the fourth phase.

A. John Rush, who led the study at the University of Texas Southwestern Medical Center at Dallas, called the findings a mix of good news and bad. "It's discouraging but not unanticipated. If you hit a home run with the first and second treatments, the people that are left are much harder to treat," Dr. Rush said. "With treatment-resistant depression, the kinds of treatments these people may need may be different than what we have right now."

Keris Myrick, a 45-year-old graduate student from Pasadena, Calif., suffers from some of the problems common to treatment-resistant patients. She said she has tried almost "everything," from medicines that work like Zoloft to a new antidepressant patch. "I'm investigating vagus-nerve stimulation, but the only other option is to start back anew, and try a medicine we've tried before at a different dose," she said.

Write to Avery Johnson at
For depression relief, try variety of medications
Study: Antidepressants help most patients if they sample several kinds

The final stage of a landmark federal study on treating depression suggests that two-thirds of sufferers eventually can be helped if they are patient enough to keep trying medications until they find one that works.
Thirteen percent of the 123 study participants who did not get better on the first three drugs they tried were helped by a fourth, researchers found.

But there is a downside to so many attempts: The more tries people made, the more likely it was that they later would relapse and slide back into depression.
“It’s a sobering message when you get down to requiring three or four steps,” said the chief researcher, Dr. A. John Rush of the University of Texas Southwestern Medical Center in Dallas. “It says that follow-up is critical” to make sure that people stay on the drugs, he said.

Results were published Wednesday in the November issue of the American Journal of Psychiatry.

About 15 million Americans each year suffer depression, the nation’s top mental health problem. Drugs to treat the disorder have had only limited testing until now. The government launched the six-year, $35 million study to test a variety of these medications in “real world” settings — people seeking help at community clinics and doctor’s offices.

Multiple treatment attempts
The project started out with 3,671 adults diagnosed with major depression. Half of them had a family history of it, and more than half had suffered multiple bouts of it themselves.
All were started on Celexa, made by Forest Laboratories and one of a widely used class of drugs called SSRIs. Nearly 37 percent had their depression go into remission after this first try. The rest switched to another antidepressant or continued with Celexa and added a second treatment. This second step helped 31 percent of that group.

The third and fourth attempts brought success rates of 14 percent and 13 percent, respectively. When all results from these various groups of participants were looked at collectively, 67 percent of the total group had been helped by one or more drugs.

However, 40 percent of those who achieved remission on their first drug relapsed within a year. That rose to 55 percent of those who took two tries to succeed and 65 percent and 70 percent of those requiring three and four tries, respectively. “More steps are still worthwhile, but you have a decreasing return,” Rush said.

Dr. Thomas Insel, director of the National Institute of Mental Health, said that because there was no comparison group of people who got no treatment, it is hard to know how many of those got better on their own, with enough passage of time, or because of the drugs.
“I think the overall results are hopeful,” he said. “The problem with depression is that people and their families feel hopeless. The message here is that medication can be helpful.”

Why did one-third of people not get better with any drugs? Possible explanations include genetic or biological differences, and life circumstances or other medical conditions that interfered with treatment. Medications may have been started too late to do any good, and some forms of depression may not respond to drugs.

Doctors say that 14 weeks is enough time for a drug to have a chance to work. After that, people should consider trying something else or adding a second treatment.
Soon to be published are separate results on the effectiveness of counseling, which some participants got in the second stage of the study.

Diagnosing depression: (Source: National Institute of Mental Health)
Depression is a serious medical illness that comes in many forms with a variety of symptoms.
If you have any of the following symptoms for a prolonged period, it may be time to seek help.
Persistant sad or anxious mood
Feelings of hopelessness or pessimism
Feelings of guilt or worthlessness
Loss of interest in hobbies or activities
Fatigue or decreased energy
Difficulty concentrating or making decisions
Insomnia or oversleeping
Changes in appetite or weight
Thoughts of death or suicide
Restlessness or irritability
Headaches or chronic pain

© 2006 The Associated Press. All rights reserved.

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