Posted on 04/07/2004 7:56:26 PM PDT by Nov3
WASHINGTON -- Ten months ago, when concerns arose about a possible link between children taking antidepressant drugs and suicide attempts, senior officials at the Food and Drug Administration ordered their leading expert to head up an examination of the evidence.
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When the government scientist filed his report last winter, however, his bosses decided to keep it secret — even though it found that children who took the drugs were twice as likely to be involved in serious suicide-related behavior as those who did not.
Instead of revealing the findings, senior FDA officials ordered more studies, which are not expected to be completed until summer. They also squelched plans to have the author, Dr. Andrew Mosholder, present his conclusions to an FDA advisory committee when it took up the issue in February.
Mosholder's report still has not been made public, but news of his conclusions first surfaced in a CBS News report last week. His findings were detailed in an internal FDA document obtained by The Los Angeles Times and authenticated by government officials.
In March, when the agency issued a warning about the possibility of problems for young patients taking the drugs, FDA officials said no conclusive scientific evidence existed on the link between antidepressants and potentially suicidal behavior by children. Officials said they based their action on anecdotal complaints from physicians and families that had been presented to the advisory committee.
They gave no hint that their own chief expert on the subject had examined the results of more than two dozen clinical trials conducted by antidepressant manufacturers and had found an unusually high correlation between their use by young patients and potentially suicidal behavior.
(Excerpt) Read more at ajc.com ...
Keep drinking the kool-aid. These drug companies have lied through their teeth about these drug's side-effects. I have seen them with my own eyes. I wish the trial lawyers good pickings on these people and hopefully congress will write laws to allow the veil of the corporation and government to be pierced so that the criminals who foisted this upon us can be ripped in the pocketbook and jailed. Prescribing "Serafem" for PMS or prosac to a juvenile is not right.
Perhaps, perhaps not, it's all situation based. That's why psychiatrists spend 4 years in med school and 4 more years of post-doctrate training, There are subtle differences with each of these drugs, and any drugs within a category. Furthermore, complex cases have shown that some drugs are very useful for other problems, such as using buproprion, an antidepressant, for smoking sessation. Every drug has adverse reactions, in fact just about every medical treatments has it unforseen complications. That's the trade-off for treatment. SSRI's have their uses, and for some people they are a God-send. One OCD patient I had was actually able to leave his house and go to the grocery because of the SSRI.
1) The majority of doctors prescribing SSRI's have absolutely no specialized training in prescribing them. They are GPs who get few perks from drug reps, read a journal article or two and hand them out.
2) These same doctors are handing out these drugs with no supervision of the patients. (Come back in six weeks.)
3) Even if they were supervising the patients they don't have the training to recognize the side effects in their infancy and have no clue how to handle them. I, aside from the dramatic incident I described above have witnessed many people spend all their money, sleep with everyone, and generally ruin their life because of the mania response some have on these drugs. Now I like a girl going through this as much as the next guy (Everybody loves a party girl)but it ruins people's lives. Of course it is not the drug - the girl, or guy is just bipolar type 2 - right? The solution, just stack a few mood stabilizers and maybe some lithium if they don't respond to that. Strangely the bipolar symptoms disappear if they taper off the SSRI. Still it is not a side effect - it is a "kindled" bipolar condition.
4) The drug companies have lied about the side effect rates and causes to all the doctors leaving them handicapped in dealing with them.
5) The marketing of these drugs to tap a goldmine - peoples wishful desire for a pill to fix everything is SHAMELESS.
6) The "research" that is published on these drugs is almost completely OWNED by the companies. If there are bad results the research never sees the light of day unless as above there is a whistle blower. The researchers also make a tidy profit off this research and if they get a bad result, no more research. That leads to predictable results in research.
Know I will say something very radical. I know the pill is a cure but I will step out there and say this. If you eat 2-300 grams of sugar, an equivalent amount of refined flour, your only vegetables are potatoes and rice, eat very little protein, get 5 shitty hours of sleep and your liquid intake consists almost entirely of coffee and other caffeinated drinks you are going to be depressed and feel like shit. I have been in AA for nearly 20 years, worked in treatment centers, worked personally with many alcoholics, chaired conventions and have seen countless alcoholics go down this road with antidepressants. IMHO about 5 percents needed an SSRI. Of all the people I have worked with only one had a doctor who worked on their patients diet beyond a cursory review and advice to eat "good carbs" and lean meat. He had the patient fill out a food log and insisted on changes. He also later tapered off the patient and worked himself out of a job. A lot of doctors won't do that. There were no lifestyle changes insisted upon in the vast majority of the patients.
These drugs are a Godsend for a small portion of the people they are prescribed for. No doubt. But lets get real. The "disease" of depression in the commercials on TV are absurd. Hey folks - sometimes life sucks. You have boring friends, your job sucks, you are worn out, and you need a real rest and change of pace. It sucks but it is life. A pill is not going to change that. That is what spurs people to change - pain. Kill the pain - no change.
That's why psychiatrists spend 4 years in med school and 4 more years of post-doctrate training,
The stampede toward these drugs like the stamped against fat and real food will eventually be seen for what it is. Unfortunately trial lawyers and whistle-blowers will lead this. Till then it will be a bunch of herd thinking.
I know the drug company's rep won't give you a trip to Barbados but try treating one of your OCD patients with Dilantin 100mg B.I.D. and GABA 750 mg once a day before slapping a SSRI on them. It works wonders especially the GABA.
Good luck with your practice.
Thank you - you are right my thoughts on these drugs is very similar to you. Perhaps we were talking past each other. Let me say that I would never give an SSRI to an adolescent as a first line of defense - would use upon a case by case basis if appropriate. It is my opinion - take that for what its worth - is that these drugs are safer than you think, but will definitely admit that they are WAY too over perscribed. I would have no problem starting any mildly depressed adult on an anti-depressant (SSRI or atypical) with low occurance of side-effects. Some folks just need help "up" for six months.
That sounds like the copy out of the drug company's ads. You are evidently a psychiatrist who hopefully follows his patients. If so you are qualified. I do however feel strongly that drugs especially SSRI's should be a last resort. The truth about these drugs and the company's behavior will come out.
For people who have the akathisia side effect, I believe this drug can possibly cause a permanent psychotic break. No documentation just 2 people I have seen this occur with. Now they may have been schizophrenic the whole time but I never saw evidence of an inkling of anything other than mild depression. Strangely both ended up on 2 SSRI's and mood stabilizers after the "side effect". I don't understand the idea behind stacking two SSRI's in this situation, but I and no one else for that matter actually knows how they work.
Again no evidence - but if I was a doctor and saw this side effect I would remove the patient from the drug and try something else.
Here's the latest on that subject, from Reuters Health citing an analysis published in the British Medical Journal: (Bold highlighting is mine)
| Objectivity of SSRI Pediatric Research Findings Questioned
NEW YORK (Reuters Health) Apr 08 - Biased reporting on the benefits of selective serotonin reuptake inhibitors (SSRIs) for children with depression has exaggerated the drugs' benefits and downplayed their adverse effects, according to a review published in the April 10th issue of the British Medical Journal. The US Food and Drug Administration, the UK Committee on Safety of Medicines, and some drug companies have recently issued warnings about using SSRIs in children. However, other researchers support their continued use. Dr. Jon N. Jureidini, of the Women's and Children's Hospital in North Adelaide and chair of the organization "Healthy Skepticism," and his team reviewed six major, placebo-controlled studies published in peer-reviewed journals since 1990. Included were 477 children diagnosed with depression treated with paroxetine, fluoxetine, sertraline or venlafaxine and 464 treated with placebo. Only two studies reported statistically significant benefits of the drugs compared with placebo on primary outcome measures. A meta-analysis revealed an effect size "equivalent to a very modest 3 to 4 point difference on [the revised children's depression rating] scale, which has a range of possible scores from 17 to 113," Dr. Jureidini's group writes. They suggest the studies were affected by drug-company sponsorship, high rates of withdrawal, use of categorical outcomes, questionable blinding and large placebo effects. The Australian research team concludes that "antidepressant drugs cannot confidently be recommended as a treatment option for childhood depression." Dr. Graham Emslie, at the University of Texas Southwestern Medical Center in Dallas, who co-authored studies of fluoxetine and sertraline, told Reuters Health that among adolescents, there has been "about a 30% decrease in suicide rate in the last 10 years" as the rate of SSRI prescriptions has increased. Commenting on the Australian group's charges, Eli Lilly spokesperson Jennifer Yoder said: "After thoroughly reviewing Lilly's clinical trial data in pediatric patients, the U.S. FDA found Prozac [fluoxetine] to be safe and effective in the pediatric population on January 3, 2003 when it approved Prozac for use in both children and adolescents." She added, "Lilly stands behind its research. Prozac...is one of the most studied drugs in the history of medicine, having first received approval in 1986. Prozac's safety and efficacy is well studied, well documented and well established. Prozac has been prescribed to more than 40 million people and has significantly improved millions of lives." Dr. Jureidini and associates also question "whether the journals that published the research reviewed the studies with a sufficient degree of scrutiny, given the importance of the subject." In response, Dr. Catherine D. DeAngelis said: "JAMA stands behind the quality and integrity of our review process." Dr. DeAngelis is editor-in-chief of the Journal of the American Medical Association, one of the journals in which referenced trial results were reported. BMJ 2004;328:879-883. |
Here's the FR thread on it: Antidepressant Use for Kids Gains Support.
Good to see my comments in that thread backed up by a prestigious journal like the BMJ, although I'm sure they said it a lot more nicely than I did.
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