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Health Experts Warn of Antidepressant Dangers for Children, Teens
CBN News ^ | 02.18.04

Posted on 02/20/2004 9:33:45 AM PST by Coleus

(Current show is updated every weekday at 5pm EST.)

HEALTH
Health Experts Warn of Antidepressant Dangers for Children, Teens
By Darla Sitton
CBN News Producer

In America, Prozac is the only drug the FDA has "approved" for pediatric depression.

CBN.com(CBN News) - As many as one in eight adolescents suffers from clinical depression. And these kids are often treated with anti-depressant drugs that have been tested and approved for adult use. But the drugs may not be safe for children.

Corey Baadsgaard doesn't remember storming into his honors English class with a gun three years ago, and taking his classmates hostage.

Baadsgaard said, "I've never been in a fight before, never done anything like that, never wanted to hurt somebody."

Corey's parents blame his surprising aggression on an anti-depressant drug he was taking, called Effexor. They are thankful no one was hurt.

One month ago, British health officials sounded the alarm. They claimed that, other than Prozac, whose benefits outweigh the risks, anti-depressants are not safe for use by children, and they can cause violent or even suicidal behavior.

In America, Prozac is the only drug the FDA has "approved" for pediatric depression, although doctors can still legally prescribe other kinds of anti-depressants to minors. That has some health experts concerned.

Thomas Moore of George Washington University, said, "I believe there is not enough evidence that these drugs are safe, and there is practically no evidence that they are effective. And in that circumstance, it appears to me that you can't justify and use them in children for depression."

In October, the FDA told Americans that a clear link between drugs and problem behavior in minors has neither been confirmed nor ruled out. They are warning doctors to use caution when prescribing anti-depressants to teens or children.

The FDA’s Dr. Russell Katz said, "We don't believe we have the information at the moment to be able to make that decision, and we think it is very, very important to get this correct, because a mistake in either direction can have very significant public health consequences."

This week the FDA opened hearings on this emotionally-charged issue. But they don't expect to reach a decision until later this summer.

 
Suit over antidepressants unites an unlikely pair
2003-04-11 - Special Announcementt over antidepressants unites an unlikely pair
  Originally from January 17, 2003

Cory Baadsgaard sits with Columbine High School survivor Mark Taylor on Thursday during an interview for a television documentary. Baadsgaard was on antidepressants when he took an English class hostage at a high school in Washington state in April 2001. He blames the drugs for his actions, for which he spent 14 months in a correctional facility. Mark Taylor is suing the manufacturer of the antidepressant Luvox, which killer Eric Harris was taking at the time of the Columbine rampage. Gary Null & Associates of New York is filming the documentary, which could air in the summer, about the drugging of children and outcomes such as school shootings.

The other was a rifle-toting student who terrified his high school classmates in Washington state on April 15, 2001.

On Thursday, Columbine victim Mark Taylor and Cory Baadsgaard, the Mattawa, Wash., student who held a high school English class hostage, spent hours with each other.

Taylor was shot at least six times by Columbine killer Eric Harris.

Taylor wasn't sure he wanted to meet the 18-year-old Baadsgaard, who was flown to Denver for the filming of a documentary by Gary Null & Associates of New York.

"I was a little bit afraid. I just didn't know what kind of person he would be," said Taylor, 19.

But when Taylor met Baadsgaard on Wednesday night, he shook Baadsgaard's hand and said, "It's nice to meet you."

Then they talked for hours.

"He is a very sweet kid," Taylor said.

Baadsgaard, a tall, athletic-looking young man who was the starting center on his basketball team, was completely surprised by Taylor's reception.

"I thought, 'Wow, this kid (Taylor) went through all this and he has forgiven everybody,"' Baadsgaard said. "I think it is kind of ironic to have a friend who has been highly affected. It's cool to know he doesn't have a problem with me."

The common bond that brought them together is their crusade against pharmaceutical companies.

Taylor has a lawsuit against Solvay Pharmaceuticals, which manufactured the antidepressant Eric Harris was taking at the time of the rampage.

Baadsgaard, who was being treated for depression at the time he walked into Michelle Hansen's honors English class with a loaded big-game hunting rifle, blames the antidepressants he had been on for 10 months.

He says he can't remember a thing about the incident, something he directly attributes to the drugs, including one that was in the same family of antidepressants that Harris took. He stopped taking that drug, Paxil, three weeks before he invaded the classroom and was on a different drug at that time.

Baadsgaard, who spent 14 months in a correctional facility, hasn't filed a lawsuit against the antidepressant manufacturers. But his father, Jay, said Thursday that they are looking into it.

The companies that make the antidepressants say the drugs help people and don't cause people to become violent or suicidal, as claimed by Taylor.

In fact, Solvay Pharmaceuticals, which manufactured Luvox, the antidepressant Harris was taking, has accused Taylor of presenting "pseudo-scientific" theories to bolster his claims against the company.

Solvay has portrayed Taylor as lawsuit crazy and relying on unscientific gibberish to back his assertions that Luvox caused Harris to kill.

Gary Null, who says he is one of the country's leading health and fitness advocates, has also been attacked as a conspiracy theorist who particularly targets the pharmaceutical industry.

Manette Loudon, who is producing the documentary in Denver, said the company hopes to complete its work in June on the two-hour film, called "The Drugging of Our Children."

Baadsgaard, who has been banned for five years from Mattawa and can't come within 25 miles of the tiny town of 1,800, said he never drank or did illegal drugs before he burst into the classroom.

He said he is convinced the prescription medication made him do it. "I've been there. I know what it's like," Baadsgaard said. "It's horrible; it's terrible. I blame everything on the drugs. Obviously, I didn't know what I was doing."

Corey's father wrote paxilprogress personally recently and had the following to add:

My son Corey had been prescribed Paxil for social anxiety disorder. He still felt bad after months on Paxil and the Doctor suggested a new medication. Corey was told the stop paxil immediately and start on Effexor. For the next three weeks his dose went from 75mgs to 300mgs. The day he reached 300mgs is also the day he went to school with a gun. He luckily has no memory of his actions. A psychiatrist found him in diminished capacity because of the abrupt discontinuation and significant dose. Unfortunately people in the community did not want to understand and so we moved. Corey is doing fine and we try to warn others. These drugs are truly crap. We believe Corey experience drug induced Mania with a Psychotic break.

[]
http://www.paxilprogress.org/news.php?startnum=0


TOPICS: Culture/Society; Editorial; Extended News; Miscellaneous; News/Current Events
KEYWORDS: add; adhd; antidepressant; antidepressants; autism; benny; cbn; children; classifiedstudent; classroom; clinicaldepression; columbine; corporalpunishment; dairy; depression; diet; discipline; disorders; drugs; edni; education; educationnews; educationreform; fishoil; fishoils; health; homeschooling; hyperactive; hyperactivity; luvox; medication; mentalhealth; mentalillness; nutrition; paxil; prozac; retards; ritalin; schools; schoolshooters; schoolshootings; spanking; specialed; specialeducation; ssri; students; supplements; teens; wheat
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From what I've read in the past, most of the school shooters were on an SSRI

Snoring and ADD/ADHD Behavior

Ritalin Debate:
Some Experts Doubt Existence of ADHD


Neal Boortz on ADD/HD Research

Accentuate the Positive, Eliminate the Excitotoxins in your Children's Diet

1 posted on 02/20/2004 9:33:45 AM PST by Coleus
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To: Johnny Gage; Eaker; bang_list; *Education News; EdReform; ladylib; .45MAN; bets; ExSoldier; ...
`
2 posted on 02/20/2004 9:39:06 AM PST by Coleus (Help Tyler Schicke http://tylerfund.org/ Burkitt's leukemia)
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To: Coleus
Which were prescribed because the kids had psychological problems. Kids with psychological problems sometimes do violent things. It's not a simple problem and it will take a lot of real, controlled study to sort out, not ancedotal info.
3 posted on 02/20/2004 10:04:52 AM PST by Kozak (Anti Shahada: " There is no God named Allah, and Muhammed is his False Prophet")
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To: Coleus
Let me first say that I believe we over diagnose and over-treat our teenagers for behavior problems. (I had one I wanted on meds who charmed his evaluators out of thinking he needed treatment for ADD without hyperactivity and one we actually refused to treat, even though she was in no uncertain terms ADHD. One was unhappy and doing badly in school, the second was happy and doing well in her grades while she drove her teachers crazy with her lack of impulse control. They each grew up into adults that I like.)


Effexor (the drug Baadsgaard was on) and Luvox (the one Harris was on) aren't first choices for antidepressants. They're usually only used when other drugs fail to treat severe depression that's causing the patient symptoms he or she can't live with.

Corey Baadsgaard was "still feeling bad after months," so his doctor started him on another medicine, with a taper from a low dose to the usual dose. Presumably, his symptoms were bad enough for his family to take him to the doctor.

(BTW, It's irrelevant that Corey had never drank or used illegal drugs before, unless he was also drinking or on illegal drugs the day he took the gun to school. What is relevant is his prior symptoms, his age and developmental stage, and how much his symptoms got in the way of his activiities of daily living.)

In the case of the Columbine killers, didn't the time frame for the plans for the killing spree predate the medication change?

4 posted on 02/20/2004 10:10:14 AM PST by hocndoc (Choice is the # 1 killer in the US)
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To: hocndoc
In the case of the Columbine killers, didn't the time frame for the plans for the killing spree predate the medication change? >>

I'm not sure, I'll look into it.

I've read a lot about omega-3 fatty acits, DHA, which seems to help both children and adults with mild depression and ADD. I understand Dr. Lanfranchi is using EPA and DHA for the prevention of breast cancer.
5 posted on 02/20/2004 10:18:09 AM PST by Coleus (Help Tyler Schicke http://tylerfund.org/ Burkitt's leukemia)
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To: Coleus
Our schools and society have become much more violent than before without psychiatric medications. To blame misbehaviors on psychiatric medications are too simplistic.
6 posted on 02/20/2004 10:31:34 AM PST by Fishing-guy
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To: Coleus
From what I've read in the past, most of the school shooters were on an SSRI
While your links talk mostly about Ritalin and ADD/ADHD, Ritalin is not an SSRI.
7 posted on 02/20/2004 10:59:45 AM PST by drjimmy
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To: Coleus
Yes, but that correlation hardly proves causation. Kids who are on SSRIs are have clearly shown serious psychological disturbances BEFORE they began taking them. Not surprising that many of them continue to exhibit serious psychological disturbances after they start taking them. These drugs are no panacea, even in the cases where they're clearly providing some improvement in symptoms. In many cases, they show no effect whatsoever.
8 posted on 02/20/2004 11:03:46 AM PST by GovernmentShrinker
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To: Coleus
Interesting. My son was on Celexa, then Paxil for behavior problems. I ended up taking him off the meds because they didn't do any good.
9 posted on 02/20/2004 11:47:15 AM PST by TheSpottedOwl (Until Kofi Annan rides the Jerusalem RTD....nothing will change.)
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To: TheSpottedOwl
You will probably be better off going the nutritional route with Omega 3's from fish oil, Sam-e, phosphitidal serene, and some amino acids, finding food allergies and excitotoxins.
10 posted on 02/20/2004 1:24:39 PM PST by Coleus (Help Tyler Schicke http://tylerfund.org/ Burkitt's leukemia)
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To: GovernmentShrinker
There does seem to be a correlation with these SSRI's pushing people over the edge in some cases, before the prescriptions they had problems, after Prozac they committed crimes or suicide, 60 minutes did a piece on this a few yrs. ago. Many kids have symptoms before taking any drug, back in the 50's we had depressed kids and yet they didn't take a gun and kill their classmates, teachers and parents as they do today while on these drugs. Back then, many homes had guns and many schools had shooting clubs with guns in the schools and there were no incidents like you have today.
11 posted on 02/20/2004 1:29:53 PM PST by Coleus (Help Tyler Schicke http://tylerfund.org/ Burkitt's leukemia)
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To: Kozak; All
We have history.

Yrs. ago back in the 40's and 50's, when many homes had guns and high schools had shooting clubs with guns in schools,  kids did suffer from depression and had other problems and yet they did not shoot thier parents, teachers and classmates as they do today. Here is a fact: Every school shooter was on Ritalin and most were on both Ritalin and SSRI's.  And while we are doing studies they should do one about the long-term effects on personality and brain development while they put the children, mostly boys, on these powerful drugs for 10 and more yrs. while their brains and bodies are developing.

Search: Ritalin School Shootings

Seeking Remedy for Pathologized Boys - Insight on the News
A terrible solution has been to pump drugs into them - Ritalin and Prozac particularly. ... a bad time to be a boy in America,"

Federal Observer Articles - Federal Observer
currently taking mind-altering, prescription drugs like Ritalin and Prozac

Ritalin: Better Living Through Chemistry? - The World & I Online

12 posted on 02/20/2004 1:50:21 PM PST by Coleus (Help Tyler Schicke http://tylerfund.org/ Burkitt's leukemia)
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To: Coleus
you give anti depressants to people who are depressed.

Depressed patients kill themselves.

Ergo it is the anti depressant medications--not.

Actually, you see a higher rate of suicide in teens given antidepressants than in those not given them (that is, teens who are suicidal commit suicide more than teens who are not suicidal even when they take medications)...

But the REAl story is that the suicide rate is down in ALL teenagers, probably because we are treating depression whereas ten or twenty years ago we do not.

I use anti depressants in menopausal ladies all the time (if hormones, herbs and vitamins didn't help their mood swings), but try to avoid using them in teens, explaining that they have to learn how to cope with life's problems without medications. About half come back after counselling and don't need medicine, and about half ask for them.
13 posted on 02/20/2004 4:06:41 PM PST by LadyDoc (liberals only love politically correct poor people)
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To: LadyDoc
About half come back after counseling and don't need medicine, and about half ask for them.

thanks, sounds like a sensible approach to me.
14 posted on 02/20/2004 7:55:27 PM PST by Coleus (Help Tyler Schicke http://tylerfund.org/ Burkitt's leukemia)
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To: Coleus
I'd like to see your factual reference that EVERY shooter was on Ritalin. Second in the 40 and 50's, the problem kids would have been expelled from the system long before their behavior escalated to the point that they were a threat. Clearly SOMETHING is happening at the schools, they are a reflection of larger changes ( NOT for the better ) in society. I think it's just too simple to place all the blame on a some medication.
15 posted on 02/21/2004 6:11:54 AM PST by Kozak (Anti Shahada: " There is no God named Allah, and Muhammed is his False Prophet")
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To: Kozak
I'd like to see your factual reference that EVERY shooter was on Ritalin. >>>

You would have to go back to read the original articles in the newspapers as the investigations were being made by the authorities, I did not save such articles, just remembered that point about the ritalin since it was pointed out to me. And I would like to see your facts that they were Not. I'm sure if you do a search for each incident, the facts would apparent for you. Kipland Kinkel, Kleibold, Harris, et. al. all were on Ritalin.

Medical and Govt. Resarchers are now looking into the trend. I just hope they start looking into the long-term effects on the brain development, of these mostly boys, to see if any permanent damges is being done.

Trends in Prescribing Psychotropic Medications to Preschoolers

16 posted on 02/21/2004 9:49:14 AM PST by Coleus (Help Tyler Schicke http://tylerfund.org/ Burkitt's leukemia)
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To: Coleus
I did not save such articles, just remembered that point about the ritalin since it was pointed out to me. And I would like to see your facts that they were Not.

No no no. YOU made the blanket statement, it's up to YOU to prove it. I never stated they were not, I wanted to see your proof they were. Obviously you can't back it up.
17 posted on 02/21/2004 3:26:32 PM PST by Kozak (Anti Shahada: " There is no God named Allah, and Muhammed is his False Prophet")
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To: Kozak
Yes, I did make the statement and I stand by it and as I said, I don't have the "print" articles with me just a brain which noted that ALL were on Ritalin and MOST were on SSRI's. It seems the SSRI's were the drugs which pushed them over the edge and not the Ritalin. I provided some links where the govt. and physicians are looking into the matter and I don't do research for free for uninformed freepers, nor do I have to prove anyting for you, ha ha, I stand by what I say and I hope nobody in your family are on these mind-altering drugs.
18 posted on 02/21/2004 4:20:41 PM PST by Coleus (Help Tyler Schicke http://tylerfund.org/ Burkitt's leukemia)
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To: Johnny Gage

Antidepressants and Suicide in Children

A warning has been issued that common antidepressants prescribed to children are not only largely ineffective, but they also may increase the risk of suicidal behavior and self-harm among children. Despite this warning, physicians are often told that depression is often missed in patients, and a lack of diagnosis and treatment can lead to serious harm. The recommended “treatment of choice” is antidepressant drugs.

The inconsistency displayed by this contradiction is the subject of two commentaries in the Canadian Medical Association Journal as they seek to explain why the lack of benefit and potential for harm from antidepressant use among children took so long to be exposed. They bring up important points including:

Canadian Medical Association Journal (Full-Text Article) February 17, 2004; 170(4):487

Canadian Medical Association Journal (Full-Text Article) February 17, 2004; 170(4):489

New Warnings on Antidepressants’ Link to Suicide

New warnings have surfaced about the risk of suicide from selective serotonin reuptake inhibitor (SSRI) antidepressant drugs, which include Paxil, Prozac and Zoloft.

Drug regulators have reported that Paxil, which is closely related to the other SSRIs, may increase the risk of suicide among teenagers and children, especially during the first few weeks of treatment. Regulators have recommended that no new Paxil prescriptions be written for patients under the age of 18 years. Some say the suicide risk may extend to adults as well.

Recent studies have focused on the antidepressants’ effectiveness, as studies have found that the drugs are no more effective than a placebo, rather than their safety. SSRIs bring in billions of dollars in sales each year.

New York Times August 7, 2003

Sugar Pills Work as Well As Antidepressants

Sugar pills cure depression just as well as antidepressants. What’s more is that sometimes they work better.

According to a new analysis, the majority of antidepressant trials conducted by drug companies have found that sugar pills, or placebos, produce results similar to or better than antidepressant drugs. In one study of 96 antidepressant trials conducted between 1979 and 1996, no difference could be determined between the effects of antidepressants and sugar pills in some 52 percent of trials.

Drug companies are required to conduct two trials that yield positive results before the product will be approved by the Food and Drug Administration (FDA), and reportedly numerous trials had to be conducted before positive results could be shown. The makers of Prozac ran five trials before obtaining two that were positive, while the makers of Paxil and Zoloft had to conduct even more, according to researchers.

In one recent trial, which compared the effectiveness of the herb St. John’s wort to that of antidepressant drug Zoloft, St. John’s wort alleviated depression in 24 percent of study participants compared with 25 percent for Zoloft. However, the placebo cured depression in 32 percent of participants.

The findings do not mean that antidepressants such as Prozac, Paxil and Zoloft do not work, however researchers say that Americans may be overestimating the drugs’ effectiveness. Much of the improvement shown during clinical trials may be due to the close attention and evaluation the patients receive during the study -- a phenomenon that does not occur for most patients who use the drugs in everyday life.

Moreover, the sugar pills actually cause changes to occur in the same areas of the brain affected by the antidepressant drugs, according to recent research. It was also found that more patients’ depression is being alleviated due to placebos now than 20 years ago.

Placebos, or pills that have no effect, have long been used by scientists to distinguish the real effects of medicine from the illusive feelings of patients. Often in the field of medicine patients experience what is known as the placebo effect -- the feeling of getting better after being treated with placebos.

However, it seems that placebos may actually make a difference in the treatment of depression, as the disease is characterized by how people feel.

Many psychiatrists say that drugs alone will not cure depression. Instead, a combination of medication and psychotherapy appears to yield the best results. Despite this, antidepressants have become the automatic treatment for most cases of depression.

In 2002, there were close to 25 million doctor visits for depression, up from 14 million in 1987. Of these visits, medications were prescribed for nine out of 10 patients, according to recent research.

It is not known how many of these patients received therapy in addition to the medication, however, in 2001 less than one-third of doctor visits for depression were to psychiatrists and two-thirds of them were to primary care physicians. According to researchers, psychiatrists are more likely to administer medicines along with therapy, while physicians, who are less knowledgeable about therapy, are less likely to offer therapy to their patients.

Other studies have shown that in an average eight-week trial, each study participant, whether taking drugs or placebos, is questioned and examined by experts and caregivers for about 20 hours. Comparatively, the average depressed patient likely sees a doctor for only 20 minutes a month.

To add a piece to the puzzle, researchers say that often patients with similar symptoms have different problems with their brain chemistry. The neural mechanisms behind this, and the reasons why antidepressant medications work, are not fully understood.

In one study that followed changes in the brain associated with antidepressant drugs, results showed that many of same changes occurred in patients who took placebos. The parts of the brain that were primarily affected are thought to play a role in mood.

In this particular study, 38 percent of depressed patients got better from taking the placebo, compared with 52 percent from the medicines.

However, once the trial ended and the patients were told what they had been taking, the patients who had been on placebos fell back into their depression. It appears that one’s belief in the effect of antidepressant may account for the improved feeling in patients.

While some say that antidepressants drugs work primarily because of the placebo effect, others believe that the drugs produce an effect of their own. A related study found, through the use of a brain imaging technique, that these medications do in fact produce changes in the brain stem that did not occur in patients taking placebos. However, the effects of these changes are not yet understood.

The analysis led many to say that an integrated treatment that takes into account both biological and mental aspects may prove beneficial in the treatment of depression.

International Journal Neuropsychopharmacology September 2002;5(3):193-7

Antidepressant Paxil May Increase Suicide Risk

While drug manufacturers and regulators claim that antidepressants reduce the risk of suicide, a leading expert in psychopharmacology has uncovered evidence that shows otherwise.

The expert gained access to confidential company documents of GlaxoSmithKline and found that results of the company’s own clinical trials of Paxil, a selective serotonin reuptake inhibitor (SSRI) antidepressant, show that the drug increases the risk of suicide.

The results show that about one out of every 60 people on Paxil attempt to commit suicide, compared with one out of every 550 people taking a placebo. This means that the risk of committing suicide while on Paxil is nine or 10 times greater than the risk on a sugar pill.

According to experts, the drug company and U.S. and U.K. regulators have known about the data for 13 years.

The report was broadcast last year by BBC, which subsequently received close to 1,400 e-mail reports and over 5,000 telephone calls mostly from people who had suffered drug withdrawal symptoms and thought they were alone.

Along with reports from adults, BBC reported that they received 23 about children who had had bad experiences with Paxil. Although the drug has not been approved for use in people under 18 years of age in the U.K., doctors can prescribe it if they think it is necessary.

In the United States, however, the Food and Drug Administration (FDA) has approved SSRIs for children.

Moreover, according to BBC, the number of suicides linked to Paxil may be significantly underestimated, as the FDA receives reports for only one percent to 10 percent of actual adverse drug reactions.

Despite the association, U.S. news media have averted their gaze and are not conducting an investigation that would shed light on the scope of the problem in America, where most of the psychotropic drugs--including SSRI antidepressants--are sold.

Some speculate that the media may be reluctant to investigate the drug industry for fear that it may threaten their advertising revenue.

The psychiatric community, including the American Psychiatric Associatio and the American College of Neuropsychopharmacology, has also remained silent on the problem of drug-induced suicide.

According to experts, vital information is being suppressed and clinicians are prescribing these drugs without knowledge of their potentially lethal side effects, and millions of people who are taking the drugs, even for minor discomforts, are doing so without knowledge of the potential for harm.

Research Protection May 21, 2003

Teen Sex, Linked to Depression & Suicide

Teenagers who engage in sexual intercourse are more likely to suffer from depression and attempt suicide than teens who are abstinent, according to a study.

The findings are especially significant for young girls. About 25 percent of sexually active girls say they are depressed all, most, or a lot of the time, compared to eight percent of girls who are not sexually active.

The study used selected federal data on 2,800 students aged between 14 and 17 years. The youth were not diagnosed as clinically depressed but rather rated their own “general state of continuing unhappiness.”

Researchers noted that they did not find a causal link between unhappiness and sexual activity, as that would be nearly impossible to prove.

The study found that about 14 percent of girls who have had intercourse have attempted suicide compared with five percent of girls who have not had intercourse.

About six percent of sexually active boys have attempted suicide compared with less than one percent of sexually inactive boys.

According to researchers, the findings send a different message from the one portrayed by popular culture, in which “all forms of non-marital sexual activity are wonderful and glorious, and the younger the teen the better.”

USA Today June 3, 2003

Heritage Foundation Study
Sexually Active Teenagers Are More Likely to Be Depressed

Appendix A: Explanation of Data Sources

Antidepressants Proven to Work Only Slightly Better Than Placebo

By Dr. Irving Kirsch
E-mail: irving.kirsch@uconn.edu

Although antidepressant medication is widely regarded as effective, a recent meta-analysis of published clinical trials indicates that 75 percent of the response to antidepressants is duplicated by placebo.

The report analyses the data submitted to the U.S. Food and Drug Administration (FDA) for approval of recent antidepressant medications.

We analyzed the efficacy data submitted to the FDA for the six most widely prescribed antidepressants approved between 1987 and 1999:

  • Prozac
  • Paxi
  • Zoloft
  • Effexor
  • Serzone and
  • Celexa.

Results are reported from all well controlled efficacy trials of the use of these medications for the treatment of depression. FDA medical and statistical reviewers had access to the raw data and evaluated the trials independently. The findings of the primary medical and statistical reviewers were verified by at least one other reviewer, and the analysis was also assessed by an independent advisory panel.

More important, the FDA data constitute the basis on which these medications were approved. Approval of these medications implies that these particular data are strong enough and reliable enough to warrant approval. To the extent that these data are flawed, the medications should not have been approved.

In order to generalize the findings of the clinical trial to a larger patient population, FDA reviewers sought a completion rate of 70% or better for these typically 6-week trials. Only 4 of 45 trials, however, reached this objective.

In clinical trials, the effect of the active drug is assumed to be the difference between the drug response and the placebo response.

This report showed that the FDA clinical trials data indicate that 18% of the drug response is due to the pharmacological effects of the medication. Overall, the drug/placebo difference was less than 2 points on the HAM-D, a highly reliable physician-rated scale that has been reported to be more sensitive than patient-rated scales to drug/placebo differences.

Although mean differences were small, most of them favored the active drug, and overall, the difference was statistically significant. There were only 4 trials in which mean improvement scores in the placebo condition were equal to or higher than those in the drug condition, and in no case was placebo significantly more effective than active drug. This may indicate a small but significant drug effect. However, it is also possible that this difference between drug and placebo is an enhanced placebo effect due to the breaking of blind.

These data raise questions about the criteria used by the FDA in approving antidepressant medications. The FDA required positive findings from at least two controlled clinical trials, but the total number of trials can vary. Positive findings consist of statistically significant drug/placebo differences. The clinical significance of these differences is not considered.

To summarize, the data submitted to the FDA reveal a small but significant difference between antidepressant drug and inert placebo. This difference may be a true pharmacological effect, or it may be an artifact associated with the breaking of blind by clinical trial patients and the psychiatrists who are rating the severity of their conditions.

In any case, the difference is relatively small (about 2 points on the HAM-D), and its clinical significance is dubious. Research is therefore needed to assess the additivity of antidepressant drug and placebo effects. If there is a powerful antidepressant effect, then it is being masked by a nonadditive placebo effect, in which case current clinical trial methodology may be inappropriate for evaluating these medications, and alternate methodology need to be developed.

Conversely, if the drug effect is as small as it appears when drug/placebo differences are estimated, then there may be little justification for the clinical use of these medications.

The problem, then, would be to find an alternative, as the clinical response to both drug and placebo is substantial. Placebo treatment has the advantage of eliciting fewer side effects. However, the deception that is inherent in clinical administration of placebos inhibits their use. Thus, the development of nondeceptive methods of eliciting the placebo effect would be of great importance.

Prevention & Treatment, Volume 5, Article 23, July 15, 2002

First Posted in Red Flags Weekly July 17, 2002


19 posted on 03/03/2004 9:48:23 AM PST by Coleus (Roe v. Wade and Endangered Species Act both passed in 1973, Murder Babies/save trees, birds, algae)
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To: Coleus
Very informative. Thanks for the ping!
20 posted on 03/03/2004 9:53:26 AM PST by Johnny Gage (If you tied buttered toast to the back of a cat and dropped it from a height, what would happen?)
[ Post Reply | Private Reply | To 19 | View Replies]


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