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The Douglass Report July 2004


The sad state of “happy pills”- and what over 50 percent of kids respond to instead

A strange thing happened on the way to the FDA hearing on children and antidepressants. The Feds suddenly decided they didn’t want their own hand-picked expert, Dr. Andrew Mosholder, to relate his findings. Quite a turnaround in just a few months: Back in 2003, the FDA asked Dr. Mosholder to write up a safety analysis about children taking antidepressants in response to reports of high rates of suicidal behavior among children taking such drugs.

Apparently, the Feds didn’t like what he had to say. Instead of being a whitewash of the charges, the report turned out to be an indictment of the “ethical” dope industry. During the course of his research, he reviewed 20 clinical trials involving more than 4,000 children and eight different antidepressants. In his written report, according to two sources inside the FDA, he concluded that there was a “definite link” between children who took antidepressants and suicidal behavior.

Well, the FDA medicrats weren’t going to put up with THAT type of behavior: They know their mission-and that mission does not include saying naughty things about the hand that feeds them. So the FDA informed Dr. Mosholder that he would not be presenting his analysis, saying it was not “finalized.” Instead, they chose to “present reports received by the agency from doctors and professionals.”

In other words, they would only be presenting information that would at worst show an inconclusive link between antidepressants and suicide and at best completely exonerate these so-called “happy pills.”

Even the FDA only gets a fraction of the truth

How can they get away with that, you might wonder? Well, as I reported in the Daily Dose a few months ago (3/26/04, subject line: “The depressing truth”), drug companies aren’t legally required to show doctors, patients, or the public ANY unfavorable findings research may reveal about their patented poisons.

Before a drug can be approved by the FDA, its maker is required to submit two trials that show clearly positive effects.

Even though a medication may strike out time and again in clinical trials, we typically only hear about the ones in which the drug produced a clearly favorable result. And in no segment of the drug market do these types of statistical shenanigans happen more frequently (or egregiously) than in the antidepressant realm.

The manufacturers of Prozac needed five separate trials to collect a pair with positive clinical results. And for the makers of Paxil and Zoloft, it took even more.

But, eventually, they got the two “positive” studies they needed, and they haven’t turned back since. And neither have doctors, who are convinced, based on those two studies and the ever-popular “FDA approval,” that these drugs are safe and effective. Unfortunately, it looks as if the patients-especially kids-are paying the price for all the drug companies’ sins of omission.

How “differences of opinion” could be putting you at risk

In a parallel FDA obstruction-of-justice case, the arthritis drug Arava was implicated in nine deaths and many adverse reactions. Dr. David Graham, a respected member of the FDA Office of Drug Safety, and other members of his department prepared a 37-page safety report on Arava but were not allowed to speak at the hearing-only an FDA member who was involved in the original approving process and a representative of the company that makes the drug did the talking. Graham and his colleagues were muzzled.

After the kangaroo court, Dr. Graham was cornered by a reporter and spoke, on camera, in defiance of the gag placed upon him: “We had a different perspective, and we really weren’t given an opportunity to present our side of the story, and the people who did present, the reviewing division [of the FDA] and the company [that makes the drug], you know, they didn’t see a problem. This was a very hostile process. And let’s just leave it at that.”

I added this similar story so that you can understand that this type of behavior is routinely practiced by government health agencies. So don’t expect anything to happen that will put the antidepressant manufacturers in jeopardy just because of a few suicides.

It all comes back to the families and the schools. That’s where the problem arises and where it must be fixed.

Actions to take:

(1) Don’t put your children on any drug until you’ve thoroughly researched it yourself-for all the hidden risks none of the commercials or pharmacy pamphlets are going to tell you. Just because the drug companies don’t have to present negative findings to the FDA doesn’t mean those negative studies don’t exist. One good place to find them is the PubMed website (www.ncbi.nlm.nih.gov). This site presents study abstracts from lots of different medical journals: They can get rather technical, but having a good medical dictionary with you while you search can help you decipher the medical-eze.

(2) And while you’re protecting your children and grandchildren from the potential unknowns of drugs, treat yourself with the same kid gloves. Drugs are a dangerous business, and if you’re going to accept the risks of being on them, you should, at the very least, know what those risks are.

(3) If the child in your life seems depressed, the first thing to do is try spending some time with him or her to see what they’re thinking.

Now, I’m not one for touchy-feely, sunshine-and-roses psychobabble, but with so many parents so absent from their children’s lives these days, what might seem like depression could actually be a sign that he or she isn’t getting enough attention. Unfortunately, many parents would rather medicate their kids than take the time to find out for sure.

If you think I’m reaching on this one, consider this: In the placebo branches of the vast majority of clinical trials on antidepressants, as many as 59 percent of children responded well to a combination of a daily placebo tablet and once- or twice-weekly visits to a therapist, who talked to the child and listened to what he or she had to say. According to Dr. David Healy, an internationally known psychopharmacologist (one of the few who is actually against the shady practices of drug companies), “This suggests that simple support can help children in many cases.”

Now, I’m not blaming parents for all the problems of today’s youth-not by any stretch of the imagination. But it seems to me that if taking a few minutes a day to have a real conversation with your son or daughter (or grandson/granddaughter) might keep them off of antidepressants-and away from the suicide risk-it certainly seems worth a try.

(4) Now, if he or she genuinely is depressed, and not deprived of some much-needed attention, there are plenty of other natural antidepressant therapies to try-St. John’s wort, for example-without resorting to the risk-laden pharmaceutical varieties. The natural methods can be just as effective, if not more so and are a lot safer than synthetic drugs.

Talk to a good natural medicine doctor who can help you decide which ones might be best. To find such a doctor in your area, call the American College for Advancement in Medicine at (949)583-7666, or visit their website at www.acam.org.

(5) Public schools are designed to drive children crazy-from boredom, mediocre teaching, and mayhem. Home schooling may help your deserving student get some peace of mind and an education.

References:

“Drug report barred by FDA: Scientist links antidepressants to suicide in kids,” San Francisco Chronicle, 2/01/04

“A suicide side effect? What parents aren’t being told about their kids’ antidepressants,” The San Francisco Chronicle Magazine, 1/4/04

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