Guest guest Posted February 11, 2004 Report Share Posted February 11, 2004 Wed, 11 Feb 2004 08:01:44 -0500 HSI - Jenny Thompson Minor Concerns Minor Concerns Health Sciences Institute e-Alert February 11, 2004 ************************************************************** Dear Reader, " A complicated web of money, emotion, science and regulation. " That's how a reporter for National Public Radio (NPR) described the recent hearing conducted by an FDA advisory panel, convened to examine the negative effects that antidepressant drugs have on children. No comment was expected from the panel until summer. So it came as a surprise when the panel issued a statement last week recommending that warnings are needed immediately to elevate the level of concern for doctors who might prescribe antidepressants to treat young patients. But any doctor who's not already concerned - who hasn't been aware, for instance, of the disturbing number of young people who have committed suicide while taking these drugs - simply hasn't been paying attention. ----------------------------- Secret keepers ----------------------------- Last October, the FDA issued a warning that doctors should be cautious in prescribing selective serotonin reuptake inhibitors (SSRIs, such as Prozac, Paxil and Zoloft) to children. The warning cited the possibility that SSRIs may be linked to suicides when taken by patients under the age of 18. Then in December, regulators in the UK issued a warning that SSRIs may be unsuitable for children because of an estimated 3.2 percent increased risk of suicide among children who take these drugs. The warning also revealed that several negative studies of SSRI effects on young patients have been withheld from publication. This supposed revelation was referred to as a " smoking gun " by some, but no one who's familiar with the drug approval process is surprised. When drug makers conduct trials in preparation for an FDA review, they routinely withhold studies that could be damaging - submitting only the studies that would encourage FDA approval. This is their right under the current system. They fund all of the research, so they can keep any study secret if the results would negatively affect a pending approval. The problem with this system is obvious: When negative results are withheld, doctors may end up prescribing a drug without knowing about some of the associated problems. But because SSRIs are such popular drugs, their effects on children have also been researched in government-funded studies. And according to a report on NPR, analysts have found that government studies are far more likely than industry-funded studies to conclude that antidepressants may not work well for children. Show of hands: Is anyone really shocked by this? ----------------------------- Safe alternatives ----------------------------- An FDA analysis of available SSRI studies involving children suggests that more than 100 subjects experienced suicide- related behaviors. Advocates of SSRI use in children (and there are many) say that the number of suicides by users of the drugs are offset by the number of kids who would commit suicide without the drugs. But this argument only holds water if you completely ignore the natural alternatives to treating depression. Prescribing drugs to address depression has become so common that the idea of giving SSRIs to kids makes perfect sense to doctors with pharmaceutical tunnel vision. Apparently, most of them never imagine that nutritional changes can often provide effective treatment for depression in young and old alike. In the e-Alert " Omega Delta Blues " (10/28/02), I told you how those who experience mild to moderate depression often find relief with an increased intake of omega-3 fatty acids (in fish or fish oil supplements). And people who are depressed are often deficient in magnesium, which is found in whole grains, nuts and leafy green vegetables. Herbal supplements like valerian root, chamomile, black cohosh, and rosemary may also help manage depression. And the standout among the herbs for mild to moderate depression is, of course, St. John's wort, which is sometimes called the " natural Prozac " for its apparent ability to help manage the proper functioning of seratonin in the brain. High levels of B vitamins have also been shown to relieve symptoms of depression. In addition to supplements, good dietary sources of vitamin B are: tuna, salmon, avocados, bananas, mangoes, potatoes, broccoli, cauliflower, poultry and meat. Note that stress (which often goes hand in hand with depression) is believed to deplete the body's store of B vitamins. If you're the parent or grandparent of a child who's struggling with depression, I urge you to explore the dietary and supplement options before you choose to medicate with a powerful drug whose effects in children have been studied, but not completely revealed. ************************************************************** To start receiving your own copy of the HSI e-Alert, visit: http://www.hsibaltimore.com/ealert/freecopy.html Or forward this e-mail to a friend so they can sign-up to receive their own copy of the HSI e-Alert. ************************************************************** ... and another thing I've lost count of all the e-Alerts I've sent telling you about the various hormone replacement therapy (HRT) studies that have been shut down because of concerns for the safety of subjects participating in the studies. The latest HRT study to be abruptly concluded involved 345 women. Half of them were taking HRT, while the other half took a non-hormonal treatment for menopause symptoms. Two years into the study, researchers at the University Hospital in Uppsala, Sweden, found that more than 25 women in the HRT group were diagnosed with a new case or a recurrence of breast cancer. During that same period, seven women in the non-HRT group were diagnosed with breast cancer. The study was stopped three years short of its planned end date. Now imagine if instead of HRT they were studying, let's say, the herb black cohosh (a natural alternative to HRT), and had found, again and again, that it increased the risk of a specific type of cancer. You can be sure the medical establishment drums would be pounding loud and long with demands to ban the herb worldwide. Would any treatment that wasn't a pharmaceutical be tolerated like this? It's inconceivable. It makes you wonder why we're still hearing about these studies being closed down. If others are still ongoing, isn't time to consider shutting them down too? How many more cases of breast cancer will it take before the mainstream is finally convinced that synthetic HRT is simply an unsafe | risk? To Your Good Health, Jenny Thompson Health Sciences Institute ************************************************************** Sources: " Antidepressant Makers Withhold Data - Info From Clinical Trials on Children Kept Secret " Shankar Vedantam, Washington Post, 1/29/04, msnbc.com " Antidepressants Too Risky for Kids? " Associated Press, 2/2/04, cnn.com " Advisers Urge Warnings of Kids' Antidepressant Risks " Associated Press, 2/3/04, cnn.com " FDA Weighs Antidepressants' Safety " Joanne Silberner, NPR Morning Edition, 2/2/04, npr.org " Prozac Cleared for Kids " Associated Press, 1/3/03, ap.org " FDA Approves Prozac for Pediatric Population " Reuters Health, 1/3/03, reutershealth.com " Hormone Therapy Study Halted Over Cancer Concerns " Associated Press, 2/3/04, cnn.com Copyright ©1997-2004 by www.hsibaltimore.com, L.L.C. The e-Alert may not be posted on commercial sites without written permission. ************************************************************** Before you hit reply to send us a question or request, please visit here http://www.hsibaltimore.com/ealert/questions.html ************************************************************** If you'd like to participate in the HSI Forum, search past e-Alerts and products or you're an HSI member and would like to search past articles, visit http://www.hsibaltimore.com Finance: Get your refund fast by filing online Quote Link to comment Share on other sites More sharing options...
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