Guest guest Posted June 14, 2004 Report Share Posted June 14, 2004 Mon, 14 Jun 2004 08:34:40 -0500 HSI - Jenny Thompson Talk To Me Talk To Me Health Sciences Institute e-Alert June 14, 2004 ************************************************************** Dear Reader, When a clinical study is described by The New York Times as a " landmark government-financed " study, that's a pretty good tip off that we're all supposed to give a respectful bow and accept the results as gospel. After all, landmarks stand for the ages, and government financing, well, that's the gold standard of impartiality... right? All of my skeptical alarm bells started clanging earlier this month when the Times and other mainstream media outlets reported that a National Institutes of Health (NIH) study showed that Prozac was more effective than counseling (or " talk therapy " ) in helping teens overcome depression. And just as I suspected, there's a cow in the ointment, because: A) Drawing conclusions from the current results is ridiculously premature, and B) If you insist on jumping to conclusions, then the real headline is not about the effectiveness of the drug, its about the drug's danger. There's your landmark right there. ----------------------------- The kids are alright ----------------------------- The new study won't be published until this summer. But drawing on reports from several news outlets we can piece together the basic nuts and bolts. The NIH enlisted about 440 kids, aged 12 to 17, who were diagnosed with moderate to severe depression. The subjects were then assigned to four groups: * Daily dose of Prozac * Daily placebo * Talk therapy with no medication * Prozac and talk therapy combined Treatments lasted for 36 weeks, but during the first 12 weeks, 61 subjects dropped out of the study for reasons unreported at this point. Using a common psychological measurement scale, the combined talk therapy and Prozac group had the best outcome, with 71 percent responding well to treatment. Among those who received only Prozac, 61 percent responded well, while 43 responded well to talk therapy alone. In the placebo group, 35 percent responded well. " Case closed, " was the general tone of the news reports. Combine Prozac with counseling, and well over two-thirds of the kids improve, they said. Don't want to bother with therapy? No problem - just back up the Prozac truck and plenty of kids will be chipper again in no time. Unless they decide to harm themselves. ----------------------------- High stakes ----------------------------- As I mentioned above, these results are far too premature for the Times or anyone else to start throwing around a term like " landmark. " The subjects in the study were tested for 36 weeks, but the reported results are only based on an analysis of the first 12 weeks. So since we don't know what the analysis of the remaining 24 weeks might bring, maybe we should keep the corks in the champagne bottles for just awhile longer. Or at the very least, the NIH shouldn't deliver thumbs-up information that doctors and parents of young patients may act on. But what received even less attention was the rate of attempted suicides among the subjects. Buried deep in the Times report is the information that among those who finished the study but didn't take Prozac, there was one suicide attempt. And among those who did take the drug: five attempts. If I'm a parent with a depressed teen, I can't like those odds. ----------------------------- Pass it on ----------------------------- Most people never lay eyes on a drug company study - they get their information about studies from the mainstream media. And it's been obvious for a long time that some of the gritty and most revealing details of most of these studies never make the 6:00 o'clock news. Of course, the media isn't completely to blame for this. When drug companies conduct studies that produce unwanted outcomes, the results may end up as part of the FDA's public record, but only the studies that deliver positive conclusions are promoted for high-profile publication and then given a big shove into the mainstream spotlight. That's one of the reasons why New York State is suing GlaxoSmithKline (GSK), makers of the antidepressant Paxil. The NY suit charges that GSK suppressed four studies that concluded the drug was ineffective in treating adolescents. The suit also claims that the studies draw a possible link between Paxil use and suicidal thoughts among adolescent users. Did you hear about those four studies on the news? Nope. Not a peep. Not until the NY attorney general decided to do something about them. And although the outcome of this lawsuit will be a long time coming, I'm hoping that the notoriety of it will be enough to create my favorite kind of regulation: Water Cooler Regulation. When people start talking about the dangers of antidepressants for kids around the water cooler, that will do more to inform the public than any number of government-mandated warning labels. ************************************************************** 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 You could probably use some meat on your bones. Literally. For many years there was a misconception in the nutrition community that protein intake compromised bone mass density (BMD). This idea stemmed mostly from the fact that increased protein may prompt a discharge of calcium into the urine. Based on this, many doctors and nutritionists jumped to the conclusion that protein must have a negative effect on BMD. But times have changed. In the e-Alert " Good to the Bone " (11/6/03), I told you about a study in the American Journal of Clinical Nutrition that showed how postmenopausal women with the highest protein intake may actually have a significantly higher BMD compared to women with low amounts of protein in their diets. Now a new study in the Journal of Clinical Endocrinology & Metabolism confirms those results. US Department of Agriculture researchers recruited 32 men and women over the age of 50 whose diets contained the recommended daily calcium intake of 800 mg. For nine weeks, subjects followed either a high-protein or low-protein diet, and were advised to decrease carbohydrate intake to balance calorie levels with the increase in protein. At the end of the study period, researchers found that urinary calcium excretion was statistically the same in both groups. But when a bone growth factor was measured, those in the high-protein group had higher levels of the factor. Contrary to the conventional wisdom that a high-protein diet may contribute to osteoporosis, the UDSA team concluded that such a diet " may have a favorable impact on the skeleton in healthy older men and women. " Mainstream nutritionists who refuse to let go of the low-fat diet mindset often talk about the health hazards of low- carb/high-protein diets. Little by little we see that argument eroding, and this study just adds to that erosion. To Your Good Health, Jenny Thompson Health Sciences Institute ************************************************************** To start receiving your own copy of the HSI e-Alert, visit: http://www.hsibaltimore.com/ealert/freecopya.html Or forward this e-mail to a friend so they can sign-up to receive their own copy of the HSI e-Alert. ************************************************************** Sources: " Antidepressant Seen as Effective in Treatment of Adolescents " Gardiner Harris, The New York Times, 6/2/04, nytimes.com " Prozac Use by Teen Seen as Effective " Reuters, 6/2/04, msnbc.msn.com " Prozac 'Best for Children' " Mark Sage, The Journal, 6/3/04, icteesside.icnetwork.co.uk " NY State Sues Drug Giant " CBS News, 6/3/04, cbsnews.com " Effect of Dietary Protein Supplements on Calcium Excretion in Healthy Older Men and Women " Journal of Clinical Endocrinology Metabolism, Vol. 89, No. 3, March 2004, ncbi.nlm.nih.gov " Higher Protein Levels Could Strengthen Bones " NutraIngredients.com, 4/5/04, nutraingredients.com Friends. 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