A report in BNET, the business publication, by its pharmaceutical industry analyst, Jim Edwards, reveals that GlaxoSmithKline is conducting a clinical trial to test its dubious antidepressant, Paxil, on Japanese children, aged 7 to 18–despite the drug’s documented, acknowledged high risk for triggering violence and suicide–as its warning label indicates.
The Paxil pediatric trial is medically unjustifiable. Indeed, its use in children is banned in the UK.
Of note, although, more than 30 locations are listed on the website, www.clinicaltrials.gov , not a single doctor is named as investigator. Instead, the entry states: Study Director: GSK Clinical Trials GlaxoSmithKline.:
This is an example of a marketing-driven drug trial that exploits children’s vulnerability, exposing them to risk without a proven medically justifiable benefit.
Below, is an in-depth commentary by Dr.Joseph Mercola:
Glaxo Is Testing Paxil on 7-Year-Olds Despite Well Known Suicide Risks
By Jim Edwards
May 21, 2010
It was established years ago that Paxil carries a risk of suicide in children and teens, but GlaxoSmithKline (GSK) has for the last 18 months been conducting a study of the antidepressant in kids as young as seven — in Japan. It’s not clear why the company would want to draw more attention to its already controversial pill, but it appears as if GSK might be hoping to see a reduced suicide risk in a small population of users — a result the company could use to cast doubt on the Paxil-equals-teen-suicide meme that dominates discussion of the drug.
GSK didn’t immediately respond to a request for comment. A staffer on GSK’s trials hotline confirmed the study was ongoing, however. The drug carries a “black box” warning on its patient information sheet, warning doctors and consumers that the antidepressant is twice as likely to generate lethal thoughts than a placebo.
The trial criteria listed on ClinicalTrials.gov, however, provide an interesting lesson in how managers can carefully design drug trials designed to flatter their products — something good companies don’t do.
The primary aim of the study is not to find out why Paxil makes some children kill themselves. Rather, it’s yet another efficacy study, which the drug doesn’t need because it was approved years ago — we already know the drug works.
Paxil is being tested against a placebo, so the results won’t be very surprising — even terrible drugs work better than sugar pills.
To what degree Paxil triggers suicide is only a secondary aim of the study. If the results suggest a lower suicide risk, expect GSK to play them up. If they’re bad, expect the company to dismiss them in favor of the primary endpoint results.
About 130 children have been enrolled, according to ClinicalTrials.gov, which puts about 65 patients in each arm. That means the results won’t be too statistically robust — there only need to be two or three outlier results to skew the numbers by several percentage points.
The trial will wrap up in September.
Dr. Joseph Mercola’s Comments:
The link between suicide and antidepressants like Paxil is so strong that they are required to carry black box warning labels detailing the risk. In young adults, particularly, the link is glaring and GlaxoSmithKline (GSK) even sent a warning letter to physicians in 2006 alerting them that Paxil may increase the risk of suicide attempts in young adults.
Despite this, or more likely because of it, the company is now carrying out a study in Japan to test the efficacy of Paxil versus a placebo in children with depression. They are actively recruiting children between the ages of 7 and 17 years, who may be among the most vulnerable to Paxil’s suicidal side effects.
Why would GlaxoSmithKline test Paxil on kids?
It’s clearly not to find out whether it’s effective — the drug is already approved, so this is a moot point. Instead, they are likely hoping that, come September 2010 when the study is supposed to be completed, they can somehow present their results to show that Paxil is not so bad after all.
As Big Pharma analyst Jim Edwards wrote on BNET:
It’s not clear why the company would want to draw more attention to its already controversial pill, but it appears as if GSK might be hoping to see a reduced suicide risk in a small population of users "a result the company could use to cast doubt on the Paxil-equals-teen-suicide meme that dominates discussion of the drug."
Kids Increasingly Targeted With Antidepressants
Every year, 230 million prescriptions for antidepressants are filled, making them one of the most prescribed drugs in the United States.
The UK banned nearly all antidepressants in kids in 2004, due to the increased risk of suicide. The United States, however, is still allowing Big Pharma to rake in the profits from selling these deadly, mind-altering drugs to kids.
The amount of drugs being given to U.S. children is outrageous, and the extent of the problem becomes clear when you compare the statistics with other countries. U.S. children are getting three times more prescriptions for antidepressants and stimulants, and up to double the amount of antipsychotic drugs than kids from Germany and the Netherlands.
Depression can indeed progress to suicide if left untreated. One would think that antidepressant drugs would be useful here but interestingly they actually have been shown to CAUSE both suicidal and homicidal thoughts and behaviors. For example, seven of the last 12 school shootings were done by children who were either on antidepressants or going through withdrawal.
It’s not just the drugs prescribed, but the diagnoses that are in question, particularly in children. Six million children have been diagnosed with serious psychiatric disorders warranting drug treatment — 1 million with bipolar disorder, long believed to occur only in adults.
The fact remains that most of the kids being given antidepressants should simply not be taking them.
What Happens When You Take Your Child to a Psychiatrist
Mental health issues, including depression and unresolved emotional traumas, are among the most significant factors contributing to disease. And psychiatry is the branch of medicine that should be best suited to address this wounding.
Unfortunately, psychiatry has long ago elected to follow a drug-based paradigm in their resolution of this wounding and in so doing has done its patients an extreme disservice.
This is not a new occurrence, but rather one that has been going on for years and seems to only be getting worse. It reminds me of one particularly poignant letter written by Dr. Loren Mosher, a board-certified psychiatrist who received his BA from Stanford University and M.D. from Harvard Medical School in 1961, where he also subsequently took his psychiatric training.
In his letter, which is a resignation letter sent to the president of the American Psychiatric Association in 1998, Dr. Mosher stated:
"After nearly three decades as a member it is with a mixture of pleasure and disappointment that I submit this letter of resignation from the American Psychiatric Association. The major reason for this action is my belief that I am actually resigning from the American Psychopharmacological Association.
Luckily, the organization’s true identity requires no change in the acronym.
Unfortunately, APA reflects, and reinforces, in word and deed, our drug dependent society"
APA likes only those drugs from which it can derive a profit-directly or indirectly. This is not a group for me. At this point in history, in my view, psychiatry has been almost completely bought out by the drug companies.
The APA could not continue without the pharmaceutical company support of meetings, symposia, workshops, journal advertising, grand rounds luncheons, unrestricted educational grants etc. etc. Psychiatrists have become the minions of drug company promotions. This type of blatant conflict of interest continues to plague the psychiatric profession today.
One of the most telling examples surrounds Dr. Joseph Biederman of Harvard Medical School, who is a world-renowned child psychiatrist. His work has helped fuel an explosion in the use of powerful antipsychotic medicines in children and he earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007.
So you should know, plain and simple, that if you’re worried your child may be depressed or suffering from any other mental health issue, and you take him or her to a psychiatrist, you will most likely leave with a prescription and the advice to start medicating your child. his is especially concerning in light of new findings that indicate antidepressants may actually worsen depression.
Antidepressants May Lead to Chronic Depression
In my recent interview with medical journalist and Pulitzer Prize nominee Robert Whitaker, he shared some very concerning insights about long-term use of antidepressants, which often happens when kids start taking them at young ages.
According to Whitaker:
" that’s one of the things I looked at in this book and there are really two things that you find.
You find that even with major depression, in the pre-antidepressant era and this is depression so severe people were hospitalized they could expect to get better. The episode would eventually pass.
So when antidepressants were introduced, the thought was okay, we really can hope to improve on this sort of natural recovery, but maybe we can help people recover quicker? So that really was the rationale for the use of antidepressants.
But it’s really interesting if you follow this course through, forward in history. The minute they start using antidepressants in any sort of large numbers, doctors start saying, "Well, you know, my patients may be getting better, the depression maybe lifting faster, but then we’re noticing that they’re also relapsing more frequently than before, back into depression."
"This begs the question, does the drug treatment actually put people on a more chronic course than before? Long-term studies now indicate that of people with major depression, only about 15 percent that are treated with an antidepressant go into remission and stay well for a long period of time.
The remaining 85 percent start having continuing relapses and become chronically depressed."
"By the 1990s, this change in the long term course of depression was so pronounced that finally it was addressed by researchers," says Whitaker.
"Giovanni Fava from Italy said, "Hey, listen, the course is changing with antidepressants. We’re changing it from an episodic illness to a chronic illness, and we really need to address this."
Not only that, but the depression is sinking into people [on antidepressants] in a deeper way than before.
According to Whitaker’s research, this tendency to sensitize the brain to long-term depression appears to be the same both for the earlier tricyclic antidepressants and the newer SSRIs (selective serotonin reuptake inhibitors).
Another famous psycho pharmacologist named Ross Baldessarini at the Harvard Medical School also began asking whether or not these drugs may in fact be depressogenic (causing depression).
Unfortunately, the evidence points that way, and the long-term prognosis when taking antidepressants is quite bleak, as this type of drug treatment has a whopping 85 percent chronic relapse rate.
Antidepressants are NOT the Solution
If your child is suffering from an emotional or mental challenge, please seek help, but do so from someone who does not regard psychotropic drugs as a first line of defense.
The research is very clear that, along with the side effects, antidepressants do not work any better than sugar pills. Some studies have even found that sugar pills may produce better results than antidepressants.
Even meta-analysis of published clinical trials indicates that 75 percent of the response to antidepressants can be duplicated by placebo!
Personally, I believe the reason for these astounding findings is that both pills work via the placebo effect, but the sugar pills produce far fewer detrimental side effects
Unfortunately, antidepressants are far less innocuous than sugar pills, and aside from increasing the risk of suicidal thoughts they also increase your risk of diabetes and harm your immune system, among other risks.
Resolving Depression Naturally
If your child is depressed, you will likely need to find someone outside of the conventional psychiatric medical community to help you work through the problem without drugs.
When someone very close to me was suffering from depression, it was energetic techniques that assisted this person in full recovery from depression.
In that case, a very advanced form of cranial osteopathy was administered by a skilled physician, however, there are other similar tools, such as Emotional Freedom Technique/Meridian Tapping Technique (EFT/MTT), which I’ve found can make an enormous difference if you suffer from depression or any other kind of emotional dysfunction.
For serious problems, it would be best to contact a trained health care professional to assit you in these techniques. Here’s a helpful list of certified practitioners worldwide.
I strongly believe that energy psychology is the single most important tool to resolve depression, but its effectiveness will certainly be significantly improved if combined with an appropriate Nutritional Type diet, along with dramatically lowered intake of sugar, grains, and processed foods.
This is particularly true for children. I have treated many hundreds of children with behavioral and mental disorders and have consistently seen them improve once underlying toxicities and food changes were addressed.
Artificial colors, flavors, sweeteners, and preservatives can have a very negative impact on your mental state as well as your physical health, so browse through my nutrition plan to find out what type of diet your child should be eating.
Using Exercise to Treat Depression
Regular exercise is one of the "secret weapons" to overcoming depression.
As Dr. James S. Gordon, MD, a world-renowned expert in using mind-body medicine to heal depression, said:
"What we’re finding in the research on physical exercise is, the physical exercise is at least as good as antidepressants for helping people who are depressed" physical exercise changes the level of serotonin in your brain.
It changes, increases their levels of "feel good" hormones, the endorphins. And also — and these are amazing studies — it can increase the number of cells in your brain, in the region of the brain, called the hippocampus.
These studies have been first done on animals, and it’s very important because sometimes in depression, there are fewer of those cells in the hippocampus, but you can actually change your brain with exercise. So it’s got to be part of everybody’s treatment, everybody’s plan.This is a very effective and beneficial treatment strategy. One study conducted by Duke University in the late 1990s divided depressed patients into three treatment groups:
Exercise plus antidepressant
Antidepressant drug only
After six weeks, the drug-only group was doing slightly better than the other two groups. However, after 10 months of follow-up, it was the exercise-only group that had the highest remission and stay-well rate.
Some countries are taking these types of research findings seriously, and are starting to base their treatments on the evidence at hand. The UK, for example, does not routinely recommend antidepressants as the first line of therapy for mild to moderate depression anymore, and doctors there can write out a prescription to see an exercise counselor instead.
I suggest you take these findings to heart now, and encourage your child to stay active if he or she is struggling with depression.
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