Tell the Truth About Antidepressants On Drug Labels & in Medical Journals
Thu, 16 Sep 2004
An April, 2004 editorial in the New York Times noted: “What seems most astonishing is the skimpy evidence that these drugs work at all in most young patients.”
What is astonishing is how the commercial / academic psychiatric drug establishment–including the American Psychiatric Association, the National Institute of Mental Health, academic opinion leaders of psychiatry, including the “expert consensus panels” who make treatment determinations–were able to fool the American public for over a decade with false claims about the safety and efficacy of the new “miracle” antidepressants–the SSRIs.
The overall risk of suicide is characterized as “low” – two to three young people out of 100 patients are likely to have more suicidal thoughts compared to those given placebos.
But, as the Times Journal notes: “those numbers are flat out worrisome given the fact that the pediatric use of anti-depressants is soaring in the United States.”
FDA’s advisory panel recommendation is being criticized by both those with a stake in the drugs who regard any warning as “alarmist” and by those who want the drugs banned altogether: “The bottom line in the FDA panel’s recommendations is akin to changing the Hippocratic oath – “First do no harm” – with one that says, “Give it a shot, but warn them first.”
The Times Journal reports: Dr. Thomas Newman, a professor of pediatrics at the University of California, San Francisco, who was member of the FDA advisory panel, offered this summation: “We have very good evidence of harm and very little evidence of efficacy.”
The truth about the antidepression hoax has been laid out in numerous books and articles, but the authors were pilloried by industry’s stakeholders. Until now, the public has been deceived by a highly organized, extremely well financed promotional apparatus. Fake science has been passed off as “evidence-based” treatment strategies; selective, partial data has been manipulated to show “positive” results; physicians and parents have been deceived–and children were put in harm’s way, exposed to potentially lethal drugs that have not demonstrated an effect greater than placebo.
In today’s editorial (Sept. 16) the Times acknowledges: “The latest medical verdict on the use of antidepressant pills to treat teenagers and children is every bit as depressing as the original warnings raised months ago. There is remarkably little evidence that most of the pills are effective in treating depression in such young patients and increasing evidence that they can lead to suicidal thoughts and behavior…Unfortunately, nothing in their arsenal is notably effective.”
Based on the scientific evidence, it is clear that the safest and most effective treatment for childhood depression is placebo. Placebo carries no adverse side-effects, causes no stigma, and is free. To elicit a placebo effect, parents would do well to create a nurturing environment, provide lots of personal attention, listen attentively, and convey sense of optimism in the effectiveness of the treatment.
For parents who still want to expose their children to the drugs, an informed consent process must be established so that the risks are explained to parents BEFORE they are issued a prescription–NOT an after the fact Medication Guide.
Contact: Vera Hassner Sharav
Tel: 212-595-8974
http://www.nytimes.com/2004/09/16/opinion/16thu3.html?pagewanted=print&position=
THE NEW YORK TIMES
EDITORIAL
September 16, 2004
Risks of Antidepressants
The latest medical verdict on the use of antidepressant pills to treat teenagers and children is every bit as depressing as the original warnings raised months ago. There is remarkably little evidence that most of the pills are effective in treating depression in such young patients and increasing evidence that they can lead to suicidal thoughts and behavior. An advisory panel to the Food and Drug Administration was quite right this week when it urged the strongest possible warnings for doctors and patients about the potential dangers.
The panel shied away from urging a complete ban on antidepressants for children and teenagers, and for good reason. Left untreated, depression can create a far greater suicide risk than the pills. Doctors desperately need weapons to combat major depression, even if those weapons carry some risk.
Unfortunately, nothing in their arsenal is notably effective. One large trial showed that talk therapy was no better than a placebo at alleviating depression in these young patients, and a vast majority of antidepressant pills have also failed when tested for this age group. Only Prozac has shown consistent effectiveness, and only Prozac has been specifically approved for use in young patients, although there is new evidence that it, too, can cause suicidal tendencies. The other antidepressants are prescribed by doctors in the belief, perhaps mistaken, that they are effective in young people.
The F.D.A.’s expert panel thought the pills too important to ban. A third of the panelists opposed even an extra-strong warning on information sheets for doctors lest it discourage treatment that could be lifesaving for some young patients.
The F.D.A. typically gives great weight to the views of its advisory committees, but it is not obliged to adopt them. What patients, parents and doctors most need is not just a warning, but the clearest possible guidance as to which of these drugs are safer and more effective than the others.
Copyright 2004 The New York Times Company
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http://www.journaltimes.com/articles/2004/09/16/opinion/iq_3108268.txt
The Journal Times
FDA drags its heels on pediatric anti-depressants
Parents are a nervous lot to begin with.
And when a child struggles with depression, their concerns and worries multiply exponentially as they try to get their child some help.
But judging by some of the testimony and revelations before a Food and Drug Administration advisory committee this week, the treatments themselves are cause for alarm.
Studies presented to the committee found that teenagers and children who take anti-depressants are twice as likely to become suicidal as those who are given placebos. The overall risk of suicide is characterized as “low” – two to three young people out of 100 patients are likely to have more suicidal thoughts compared to those given placebos.
Yet those numbers are flat out worrisome given the fact that the pediatric use of anti-depressants is soaring in the United States. According to the FDA, doctors wrote 11 million prescriptions for anti-depressants like Zoloft, Prozac, Celexa, Luvox, Effexor and Paxil for teens and children in 2002 – and that accounts for almost eight percent of all anti-depressant prescriptions.
And last spring when questions over links between the use of anti-depressants and teen suicides were raised and the FDA ordered drug manufacturers to state on prescription sheets that they may be linked to suicide – prescriptions still rose by eight percent.
Worst of all there is no good evidence that the use of anti-depressants for children or teens is even effective. Only one drug, Prozac, is FDA approved to treat pediatric depression and it has not been linked to increased suicidal tendencies. Most other drugs commonly prescribed have failed to short their effectiveness and even Prozac didn’t show much.
That prompted one member of the advisory panel, Dr. Thomas Newman, a professor of pediatrics at the University of California, San Francisco, to offer this summation: “We have very good evidence of harm and very little evidence of efficacy.”
Yet despite the concerns raised, the FDA committee stopped short of recommending a ban on pediatric anti-depressants and, instead, urged a “black box” warning on physician prescription sheets. The panel also recommended requiring manufacturers to add a patient guide to the drugs’ packaging that describes the risks of suicide in plain language.
We could recommend some language: “Stop. This drug might cause your child to kill himself/herself.” That would be plain enough.
The bottom line in the FDA panel’s recommendations is akin to changing the Hippocratic oath – “First do no harm” – with one that says, “Give it a shot, but warn them first.”
That’s not really a standard we’re comfortable with.
What’s more, this lukewarm FDA action comes against a background of other shortcomings in dealing with the nation’s pharmaceutical industry and its failure to require public reporting of all clinical trials of drugs. Indeed, the FDA even refused to let one company warn that its drug was linked to suicidal behavior in children and told them to soften their wording.
Small wonder then, that the head of a house committee that oversees the FDA fumed recently that the acronym “actually stands for `foot-dragging and alibis.'”
The drug industry has belatedly offered up suggestions of a voluntary registry to make the results of drug trials available. That’s not good enough.
Congress should step in and require mandatory public reporting for all drugs tested – the good and the bad results – for doctors and all the rest of us to judge.
In the meantime, parents who still opt to use drugs to treat young Johnny for depression should keep a sharp eye on him, especially during the first few days of treatment. The “cure” may kill him.
Now that’s something for a parent to worry about.
http://www.usatoday.com/news/health/2004-09-15-antidepressants_x.htm
USA TODAY
Editorial
9/15/2004
Kids and antidepressants: The mix raises questions
A Food and Drug Administration advisory panel has recommended putting a “black box” warning on antidepressants to indicate they might raise the risk of suicidal behavior in children and teens. It raises questions for parents of the more than 1 million kids on the medications. USA TODAY’s Marilyn Elias gets answers from David Fassler of the American Psychiatric Association and FDA officials.
Q: Does this mean the “black box” will go on antidepressants and, if so, what will it say?
A: The FDA typically follows the advice of its scientific panels, but not always. A decision is expected this fall. A black box is the strongest warning label that can be put on a medication.
If approved, the box will warn that the drugs have been found to increase the risk of suicidal behavior in children and teens. It also may say whether the drug has been found to work in studies.
Only Prozac has been approved for use in depressed children because the drug has worked in two studies.
Other popular antidepressants are approved for adults, but they have been legally prescribed to children “off-label.”
Q: How serious is the risk of suicide?
A: For every 100 kids taking antidepressants, about two to three will think about or attempt suicide because they’re on the drug, according to 24 studies of more than 4,600 children on the drugs. There was not a single suicide in the studies. Some parents believe their children’s suicides were triggered by antidepressants; these kids were not in studies that carefully check for participants’ worsening mood.
Q: Are depressed children better off not taking the drugs?
A: Not necessarily. If an antidepressant is working well, with no bad side effects, a child may be better off on it. More than half of children with major depression try to kill themselves; about 7% do commit suicide. So the benefits of the pills may outweigh the risks for some young patients.
Q: Can children be taken off the drugs immediately if a parent desires?
A: Any parent with concerns should talk to the child’s doctor. Abruptly stopping antidepressants never should be done because it can trigger bad side effects. Patients are taken off drugs gradually.
Q: What is the best way to get treatment for a child who seems depressed?
A: Physical causes first should be ruled out by a doctor. Then a thorough evaluation should be done by a children’s mental health specialist. A child’s school behavior and any family history of mental illness should be considered before starting treatment. Parents should get as much information as possible on any drug prescribed, and children taking antidepressants almost always need to be in therapy, too.
Q: What study results did the FDA panel consider before deciding to recommend the label changes?
A: There were pediatric studies using Celexa, Luvox, Paxil, Prozac, Zoloft, Effexor XR, Remeron, Serzone and Wellbutrin.
http://www.newsday.com/news/health/ny-vpfda163972584sep16,0,7518138.story?coll=ny-health-headlines
Newsday
TELL TRUTH ABOUT ANTIDEPRESSANTS
On drug labels and in medical journals
September 16, 2004
The recent controversy over antidepressants, children and suicide is really about trust. Sick people have to trust their doctor’s judgment about the drugs they take. Doctors have to trust the information they get from drug companies. The public has to trust government regulators to ensure that drugs on the market are safe and effective. Unfortunately, for depressed children, that critical trust has been squandered. Washington has to find a way to get it back.
The Food and Drug Administration acknowledged for the first time this week that widely prescribed antidepressants could cause some children and teenagers to become suicidal. An advisory panel recommended putting that caution in a “black box” on container labels, and adding a notice that most antidepressants don’t lift depression in children. The FDA should adopt the recommendation. Mandating the black box, the FDA’s most prominent warning, will fill the notification void for antidepressants. But that’s not enough.
This problem arose because drug makers have been allowed to bury clinical trial results when outcomes were bad or inconclusive. That’s what happened with trials of antidepressants that yielded evidence of suicidal thoughts in children. They weren’t made public. Congress should require disclosure of all clinical trials. The industry is moving in that direction. It has developed a public database (www.clinicalstudyresults.org) that, beginning Oct. 1, will provide summaries of the final stages of clinical trials. But reporting the trials will be voluntary.
Eleven prestigious medical journals are assisting. The journal editors said they will publish results of clinical trials only if they were listed in a public registry before patients were enrolled. So readers could go there to find the results of other trials. Companies can choose not to register trials, but that would mean forgoing the marketing boost of journal publicity.
When it comes to powerful drugs of any kind, and the complex pluses and minuses inherent in their use, doctors and the public need all the information they can get. Copyright C 2004, Newsday, Inc. http://www.nytimes.com/2004/04/23/opinion/23FRI1.html?pagewanted=print&posit ion=
THE NEW YORK TIMES
EDITORIAL
April 23, 2004
Depressing News on Depression
Antidepressant drugs are being widely administered to children and adolescents despite increasing concern that the benefits have been oversold and some potentially dangerous side effects minimized. The jury is still out on whether the modest benefits of some of these drugs outweigh the small risks they impose. But the escalating debate makes us wonder, uneasily, whether doctors have been dispensing the pills far too cavalierly despite a dearth of evidence to support their value.
The issue that has dominated recent discussion is whether the most commonly prescribed antidepressants increase the risk of suicide in children and adolescents. British health authorities have cautioned against using most of them in children under 18, and a top expert at the United States Food and Drug Administration considers most of the drugs too risky. But the F.D.A. as a whole is not yet convinced that the risks outweigh the potential benefits.
Not a single participant in trials of the drug has actually committed suicide, and there is uncertainty as to whether all the events classified as suicide attempts or suicidal thoughts were really what they seemed. The F.D.A. has contracted for an evaluation of the evidence by outside experts. For now, the agency is simply urging doctors to monitor their patients closely and is seeking stronger warning labels for 10 antidepressant drugs.
It is extraordinarily important to get the final judgment right. Depression, left untreated, is a major cause of suicide, and there is ample testimony from many young people and their doctors that the pills are vital for their well-being even if the overall evidence of effectiveness is weak. It remains to be determined whether, on balance, it is riskier to give the drugs or to withhold them.
What seems most astonishing is the skimpy evidence that these drugs work at all in most young patients. All the antidepressant drugs were approved for marketing based on clinical trials in adults, but once they were on the market, doctors were free to prescribe them for any patients and any purpose. Under a federal law that was drawn up to coax drug companies into studying the effects of their drugs in young people in exchange for an extension of patent rights, the major manufacturers studied their antidepressants in patients under 18. So far, only Prozac has shown enough evidence of effectiveness and safety to win approval from the F.D.A. and British health authorities. The discouraging results underscore the need to test all drugs in children that will be used in children because the effects are often different from those found in adults.
Many leading psychiatrists are convinced that the drugs have value in young people, based on what they deem positive results from some studies. But a critical evaluation by Australian researchers in a recent British Medical Journal article concludes that the authors of the largest published studies “have exaggerated the benefits, downplayed the harms, or both,” possibly because of financial ties to the pharmaceutical industry.
Clearly, the companies and medical experts who believe that antidepressants can help young patients have a lot more work to do to make their case. The issue would seem important enough for the government, perhaps through the National Institute of Mental Health, to finance a large and well-designed study to get a definitive answer.
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