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	<title>Food, Beverage &#38; Nutrition Law Blog &#187; research</title>
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		<title>Vitamin D: Pumped up by the media</title>
		<link>http://nutrisuplaw.com/vitamin-d-pumped-up-by-the-media/</link>
		<comments>http://nutrisuplaw.com/vitamin-d-pumped-up-by-the-media/#comments</comments>
		<pubDate>Mon, 18 Jan 2010 13:23:01 +0000</pubDate>
		<dc:creator>Hugo Ottolenghi</dc:creator>
				<category><![CDATA[research]]></category>
		<category><![CDATA[supplements]]></category>
		<category><![CDATA[Daily Value]]></category>
		<category><![CDATA[IOM]]></category>
		<category><![CDATA[labeling]]></category>
		<category><![CDATA[vitamin]]></category>
		<category><![CDATA[vitamin D]]></category>
		<category><![CDATA[vitamins]]></category>

		<guid isPermaLink="false">http://nutrisuplaw.com/?p=1504</guid>
		<description><![CDATA[GUEST POST BY DAVID MARK The Washington Post recently published an article asserting that vitamin D is shaping up to be the nutrient of the year, if not the decade. The article started factually strong but weakened at the end when it made specific recommendations. The Post references an article in Consumer Reports titled “Most [...]]]></description>
			<content:encoded><![CDATA[<p>GUEST POST BY DAVID MARK</p>
<p>The Washington Post recently published an <a href="http://www.washingtonpost.com/wp-dyn/content/article/2010/01/11/AR2010011103357.html" target="_blank">article</a> asserting that vitamin D is shaping up to be the nutrient of the year, if not the decade. The article started factually strong but weakened at the end when it made specific recommendations.</p>
<p>The Post references an article in <a href="http://www.consumerreports.org/cro/index.htm" target="_blank">Consumer Reports</a> titled “Most people get insufficient Vitamin D, but extra supplements may not be needed.&#8221; That article correctly notes that vitamin D blood levels in U.S. residents are on average below what is now thought by some experts to be what is needed for optimal health; the magazine perhaps overstates the case by writing that “…77% of Americans have insufficient amounts.”</p>
<p>In an <a href="http://www.ajcn.org/cgi/content/abstract/88/2/558S" target="_blank">article</a> published last year in the American Journal of Clinical Nutrition, <a href="http://ods.od.nih.gov/About/Elizabeth_A_Yetley.aspx" target="_blank">Elizabeth Yetley</a> uses <a href="http://www.cdc.gov/nchs/nhanes.htm" target="_blank">NHANES</a> data to show approximately 6 percent of adults are below the traditional cut-off defining vitamin D deficiency and 77 percent are below what some nutritionists now opine to be the preferred target of 80 nmol/L.</p>
<p>The Consumer Reports article also points out what is putting the U.S. population at risk, primarily increases in obesity (fat sequesters some of the vitamin D synthesized in the skin) and less skin exposure to sunlight’s ultraviolet radiation.</p>
<p>The Institute of Medicine is currently reviewing the Dietary Reference Intake value for vitamin D, which was last updated in 1997. A final report is expected this May.  Currently, people 19 to 50 years of age are advised to consume at least 200  International Units per day,  those 51 to 70 at least 400 units, and those over 70 at least 600 units. Estimates are that adults get 100 to 150 units daily from food.</p>
<p>Consumer Reports goes astray when it writes: that people don’t need a special supplement; that overdosing is unlikely; and who should be advised to have their blood levels tested. Although makers of nutritional supplements are planning reformulations of their multivitamin products pending the institute&#8217;s report, most of what is on the shelves now is still at only 400 units.</p>
<p>What defines overdosing is up in the air. Officially, the Tolerable Upper Intake Level is 2,000 International Units per day. While bets are that the Institute will raise the adequate intake to 1,000 units per day, it is less clear whether the upper limit will also be increased. <a href="http://www.ajcn.org/cgi/content/abstract/85/1/6" target="_blank">Writing</a> in the American Journal of Clinical Nutrition, John Hathcock and his colleagues make a case for 10,000 units as a safe limit. The Institute has a conservative approach to upper limits.</p>
<p>Finally, people should not wait to get a blood test until they are diagnosed with weak bones or an absorption problem, contrary to what Consumer Reports says. Better advice would be for all adults to start taking 1,000 units per day from supplements. If you are in a higher-risk group for low vitamin D levels (obese, female, older, bypass surgery, Hispanic, African-American), get tested a few months later.</p>
<div class="wp-caption alignleft" style="width: 98px"><img src="http://www.dmarknutrition.com/images/DavidMark.jpg" alt="DavidMark Vitamin D: Pumped up by the media" width="88" height="111" title="Vitamin D: Pumped up by the media" /><p class="wp-caption-text"> </p></div>
<p>David A. Mark, Ph.D., is president of dmark consulting LLC, a science consulting company serving the dietary supplement and functional food industry. Contact him at <a href="mailto:david@dmarknutrition.com">david@dmarknutrition.com</a> or 978-897-0890.</p>
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		<title>Good news, bad news and more bad news on vitamins</title>
		<link>http://nutrisuplaw.com/good-news-bad-news-and-more-bad-news-on-vitamins/</link>
		<comments>http://nutrisuplaw.com/good-news-bad-news-and-more-bad-news-on-vitamins/#comments</comments>
		<pubDate>Mon, 23 Nov 2009 06:24:03 +0000</pubDate>
		<dc:creator>Hugo Ottolenghi</dc:creator>
				<category><![CDATA[supplements]]></category>
		<category><![CDATA[nutraceutical]]></category>
		<category><![CDATA[research]]></category>
		<category><![CDATA[supplement business]]></category>
		<category><![CDATA[vitamins]]></category>

		<guid isPermaLink="false">http://nutrisuplaw.com/?p=1405</guid>
		<description><![CDATA[News reports bring into question the efficacy and safety of some vitamins. However, there is an even greater threat from a product with no proven side effects and a very low price.]]></description>
			<content:encoded><![CDATA[<div class="wp-caption alignleft" style="width: 143px"><img src="http://helios.hampshire.edu/~msbNS/ns121/images/vitaminb6.jpg" alt="vitaminb6 Good news, bad news and more bad news on vitamins" width="133" height="140" title="Good news, bad news and more bad news on vitamins" /><p class="wp-caption-text">Vitamin B6</p></div>
<p>The headline in the <a href="http://online.wsj.com" target="_blank">Wall Street Journal</a> read, &#8220;New Study Gives B Vitamin a Boost&#8221; and the first sentence in the <a href="http://online.wsj.com/article/SB10001424052748704538404574540004150300352.html" target="_blank">article</a> was, &#8220;Bring out the niacin.&#8221; It turned out that a vitamin &#8212; even only a prescription formula &#8212; produced better results than <a href="http://www.merck.com" target="_blank">Merck</a>&#8216;s new cholesterol-lowering medicine, <a href="http://www.zetia.com/ezetimibe/zetia/consumer/index.jsp" target="_blank">Zetia</a>.</p>
<p>That was according to a 208-patient trial whose results were announced this month at the annual scientific meeting of the <a href="http://www.americanheart.org" target="_blank">American Heart Association</a>. Score one for the people who have say that vitamins support good health. The smart folks will not claim that niacin lowers cholesterol, but they can leave a copy of the article laying about.</p>
<p>Wait, there is something better. What product and in what dosage? Has it been patented? Uh, no. It&#8217;s called a placebo and its effect is often greater than any drug or nutritional supplement, <a href="http://hosted.ap.org/dynamic/stories/M/MED_UNPROVEN_REMEDIES_PLACEBO?SITE=CAVEN&amp;SECTION=HOME&amp;TEMPLATE=DEFAULT" target="_blank">scientists tell</a> the Associated Press. Example: In tests of a new drug to relieve lupus symptoms, about a third of patients felt better when they got dummy pills instead of the drug. What&#8217;s more, Michael Perlis, a psychologist and neuroscientist at the University of Pennsylvania, says that he does not know of any herbal remedies for insomnia.</p>
<p>Darn. And it gets worse. A study published in the Nov. 18 issue of the <a href="http://jama.ama-assn.org/content/vol302/issue19/index.dtl" target="_blank">Journal of the American Medical Association</a> raised concerns that high does of folic acid could increase the risk of developing cancer. That could impact the more than $1 billion that is spent annually on B vitamins. Maybe consumers will think they are as better off popping Pez than a prescription pill or Internet-catalog vitamin. All a person has to do is believe that the little candy will make him or her better, and it will.</p>
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		<title>Placebos cloud results of clinical trials, medical practice</title>
		<link>http://nutrisuplaw.com/placebos-cloud-results-clinical-trials-medical-practice/</link>
		<comments>http://nutrisuplaw.com/placebos-cloud-results-clinical-trials-medical-practice/#comments</comments>
		<pubDate>Wed, 19 Aug 2009 15:37:20 +0000</pubDate>
		<dc:creator>Hugo Ottolenghi</dc:creator>
				<category><![CDATA[intellectual property]]></category>
		<category><![CDATA[research]]></category>
		<category><![CDATA[sports supplements]]></category>
		<category><![CDATA[trade practices]]></category>
		<category><![CDATA[clinical trial]]></category>
		<category><![CDATA[placebo]]></category>
		<category><![CDATA[study]]></category>
		<category><![CDATA[supplements]]></category>

		<guid isPermaLink="false">http://nutrisuplaw.com/?p=1101</guid>
		<description><![CDATA[Placebos seem to make a difference in research and clinical practice. For that reason, testimonials and open-label trial results should never be provided as sole evidence of efficacy when a product marketing campaign is challenged by a regulatory authority.]]></description>
			<content:encoded><![CDATA[<p><!--[endif]--><strong>GUEST POST by David A. Mark</strong></p>
<div class="wp-caption alignleft" style="width: 111px"><img src="http://blogs.openaccesscentral.com/blogs/jmcrblog/resource/placebo3.jpg" alt="placebo3 Placebos cloud results of clinical trials, medical practice" width="101" height="101" title="Placebos cloud results of clinical trials, medical practice" /><p class="wp-caption-text"> </p></div>
<p>Placebos don’t work when you are asleep. Or if you have Alzheimer’s disease. But they do seem to make a difference in research and clinical practice, as I found when preparing a <a href="http://www.nutraceuticalsworld.com/articles/2009/07/the-placebo-effect-quantified" target="_blank">recent article</a> for <a href="http://www.nutraceuticalsworld.com/articles/2009/07/" target="_blank"><em>Nutraceuticals World</em></a>.</p>
<p>In clinical trials for subjectively reported symptoms such as pain or mental state, the placebo effect is roughly 30%. But the average varies from condition to condition. For chronic fatigue syndrome or Crohn’s disease. the average reported improvement across multiple clinical trials was 20%; for osteoarthritis it was 40%.</p>
<p>And for any of the nearly dozen conditions tabulated for the article, the range from trial to trial was large. In 20 studies of bipolar mania, the average was a 31% improvement in the placebo groups, but the range was from 9% to 59%.</p>
<p>The placebo effect is impacted by variables in the design and conduct of clinical trials. For example, a larger placebo effect was reported when subjects had higher expectations of being successfully treated, or if the trial itself was larger, longer, or had more visits per trial. Use of the opiate antagonist naloxone reverses placebo-induced pain relief, suggesting production of endogenous opioids as a mechanism</p>
<p>At the medical practice level, the worst-case scenario is a charismatic doctor who invents or champions a novel treatment (or surgical procedure) – and then writes a book. The certainty of the healer-researcher raises expectations in the patients, leading to positive results. Sports performance products are also subject to a strong placebo effect.</p>
<p>The lesson? Testimonials and open-label trial results should never be provided as sole evidence of efficacy when a product marketing campaign is challenged by a regulatory authority.</p>
<div class="wp-caption alignleft" style="width: 90px"><img src="http://www.dmarknutrition.com/images/DavidMark.jpg" alt="DavidMark Placebos cloud results of clinical trials, medical practice" width="80" height="102" title="Placebos cloud results of clinical trials, medical practice" /><p class="wp-caption-text">Mark</p></div>
<p><em>David A. Mark, Ph.D., is president of <a href="http://www.dmarknutrition.com/" target="_blank">dmark consulting LLC</a>, a science consulting company serving the dietary supplement and functional food industry. Contact him at <a href="mailto:david@dmarknutrition.com">david@dmarknutrition.com</a> or 978-897-0890.</em></p>
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		<title>Going positive on diets high in nutrients</title>
		<link>http://nutrisuplaw.com/going-positive-on-diets-high-in-nutrients/</link>
		<comments>http://nutrisuplaw.com/going-positive-on-diets-high-in-nutrients/#comments</comments>
		<pubDate>Wed, 19 Aug 2009 03:15:32 +0000</pubDate>
		<dc:creator>Hugo Ottolenghi</dc:creator>
				<category><![CDATA[USDA]]></category>
		<category><![CDATA[food]]></category>
		<category><![CDATA[nutrient]]></category>
		<category><![CDATA[research]]></category>

		<guid isPermaLink="false">http://nutrisuplaw.com/?p=1115</guid>
		<description><![CDATA[In the August edition of the Journal of Nutrition, scientists ranked foods based on how good they are for you to create a Nutrient-Rich Foods Index. To give the index scientific weight, the researchers created a formula for combinations of nutrients and calories that produced the highest correlation to the index. The healthiest -- though maybe not the best-tasting foods -- rise to the top using their math.]]></description>
			<content:encoded><![CDATA[<div class="wp-caption alignleft" style="width: 151px"><img src="http://www.marcresearch.com/blogs/merrill/wp-content/uploads/2007/05/baseball_food_pyramid_1.jpg" alt="baseball food pyramid 1 Going positive on diets high in nutrients" width="141" height="120" title="Going positive on diets high in nutrients" /><p class="wp-caption-text"> </p></div>
<p>We know what to avoid in our diets: fun foods like ice cream sundaes, chocolate pies and most anything sold at a <a href="http://www.destination360.com/north-america/us/illinois/images/s/illinois-chicago-wrigley-field.jpg" target="_blank">baseball park</a>. Researchers are now trying a different approach, emphasizing what we should eat. Reporting in the <a href="http://jn.nutrition.org/content/vol139/issue8/" target="_blank">August edition</a> of the Journal of Nutrition, scientists ranked foods based on how good they are for you to create a Nutrient-Rich Foods Index.</p>
<p>The concept is not new; in 1995, the USDA published the first <a href="http://www.cnpp.usda.gov/healthyeatingindex.htm" target="_blank">Healthy Eating Index</a>. It has been updated several times.</p>
<p>To give the index scientific weight, the researchers created a formula that combines values for nutrients and calories to produce the highest correlation to the index. The healthiest &#8212; though maybe not the best-tasting foods &#8212; rise to the top using their math.</p>
<p>“These results confirmed that better diets do not necessarily come from just restricting certain nutrients; the addition of beneficial nutrients is critical for a higher diet quality,” <a href="http://www.nutraingredients-usa.com/content/view/print/256855" target="_blank">Nutrient Ingredients-USA</a> quotes the scientists as writing in the article, which is restricted to subscribers.</p>
<p>Developing the ranking is just the beginning, say researchers Victor L. Fulgoni III of Nutrition Impact LLC,  Debra R. Keast of  Nutrition Database Research Inc., and  Adam Drewnowski of the Center for Public Health Nutrition at the University of Washington.</p>
<div class="wp-caption alignleft" style="width: 84px"><a href=" "><img src="http://tbn3.google.com/images?q=tbn:zunzXGDmI5F_wM:http://www.wackypackages.org/realproductsscans/crackerjack.jpg" alt="crackerjack Going positive on diets high in nutrients" width="74" height="134" title="Going positive on diets high in nutrients" /></a><p class="wp-caption-text"> </p></div>
<p>“Considerable research is still necessary to determine how to best present nutrient profiling to consumers in a way that will actually lead to selection of foods that improve the overall diet,” they are quoted as writing. In other words, persuading Americans to give up their peanuts and Cracker Jack will take some work.</p>
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		<title>Doctors, nurses practice what they preach on vitamins</title>
		<link>http://nutrisuplaw.com/doctors-nurses-vitamins-patients/</link>
		<comments>http://nutrisuplaw.com/doctors-nurses-vitamins-patients/#comments</comments>
		<pubDate>Fri, 24 Jul 2009 13:53:02 +0000</pubDate>
		<dc:creator>Hugo Ottolenghi</dc:creator>
				<category><![CDATA[supplement business]]></category>
		<category><![CDATA[supplements]]></category>
		<category><![CDATA[Add new tag]]></category>
		<category><![CDATA[ingredients]]></category>
		<category><![CDATA[labeling]]></category>
		<category><![CDATA[research]]></category>
		<category><![CDATA[vitamin]]></category>
		<category><![CDATA[vitamins]]></category>

		<guid isPermaLink="false">http://nutrisuplaw.com/?p=914</guid>
		<description><![CDATA[Nurses and doctors regularly use vitamin supplements, but no more than the general population, a survey finds. And the medical professionals recommend supplements to their patients.]]></description>
			<content:encoded><![CDATA[<div class="wp-caption alignleft" style="width: 191px"><img src="http://l.yimg.com/a/i/us/shine/health/vitamin.jpg" alt="vitamin Doctors, nurses practice what they preach on vitamins" width="181" height="272" title="Doctors, nurses practice what they preach on vitamins" /><p class="wp-caption-text"> </p></div>
<p>What is good for the patient is good for the nurse and doctor, too. The <a href="http://www.crnusa.org/" target="_blank">Council for Responsible Nutrition</a> hired <a href="http://www.ipsos-pa.com/" target="_blank">Ipsos Public Affairs</a> to ask doctors and nurses how often they took vitamins and why. <a href="http://www.nutritionj.com/content/8/1/29" target="_blank">The results</a> offer insights into groups that are rarely asked how they maintain personal health. The survey found that 72% of physicians and 89% of nurses had used dietary supplements. The figures for regular use dropped to about half of doctors and 59% of nurses. Why? That is probably a good topic for another survey.</p>
<p>While the leading reason for taking vitamins was good health, the predominantly female nurses&#8217; group also cited bone health and joint health. Doctors, most of whom were men, cited heart health. And &#8212; FDA alert! &#8212; both groups cited flu or colds as reasons for taking the supplements.</p>
<p>The most common supplement for both doctors and nurses was multivitamins. Of those surveyed, 79% of physicians and 82% of nurses recommended to their patients that they take supplements, too.</p>
<p>A note of caution: Study participants volunteered to be surveyed. That skews the results, as anyone who has researched a supplement ingredient knows. The doctors and nurses were more likely to be interested in supplements, even though as a whole they did not use them on a regular basis more often than the general population, the study found.</p>
<p>Findings often lead to more questions, and here are some we would like answered:</p>
<ul>
<li>To what extent does labeling influence the choice of supplement?</li>
<li>What are the three biggest influences (brand name, referrals, price, etc.) on choice of supplement?</li>
<li>What is the best measure (more energy, feeling better, etc.) in deciding whether a supplement is effective?</li>
</ul>
<p>We look forward to those survey results.</p>
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		<title>Final version of stimulus bill will boost science research</title>
		<link>http://nutrisuplaw.com/final-version-stimulus-bill-boost-science-research/</link>
		<comments>http://nutrisuplaw.com/final-version-stimulus-bill-boost-science-research/#comments</comments>
		<pubDate>Fri, 13 Feb 2009 15:43:45 +0000</pubDate>
		<dc:creator>Hugo Ottolenghi</dc:creator>
				<category><![CDATA[intellectual property]]></category>
		<category><![CDATA[legislation]]></category>
		<category><![CDATA[NIH]]></category>
		<category><![CDATA[research]]></category>
		<category><![CDATA[congress]]></category>
		<category><![CDATA[stimulus]]></category>

		<guid isPermaLink="false">http://nutrisuplaw.com/?p=554</guid>
		<description><![CDATA[Companies keen on product development will likely get a boost from the compromise version of the stimulus bill that the House was set to vote on Friday. There are billions of dollars for government research grants and millions for construction of research buildings. The final legislation did pull back in areas such as agriculture. Here [...]]]></description>
			<content:encoded><![CDATA[<div class="wp-caption alignleft" style="width: 116px"><img title="  " src="http://media.npr.org/programs/atc/features/2009/feb/pipette_200.jpg" alt="pipette 200 Final version of stimulus bill will boost science research" width="106" height="79" /><p class="wp-caption-text">  </p></div>
<p>Companies keen on product development will likely get a boost from the compromise version of the stimulus bill that the House was set to vote on Friday. There are billions of dollars for government research grants and millions for construction of research buildings. The final legislation did pull back in areas such as agriculture. Here are the highlights, according to <a href="http://www.insidehighered.com/news/2009/02/13/stimulus" target="_blank">Inside Higher Ed</a>:</p>
<ul>
<li>National Science Foundation: $3 billion, including $2.5 billion for research, $400 million for infrastructure and $100 million for education.</li>
<li>National Institutes of Health: $10 billion, including $8.5 billion for research and $1.5 billion for university research facilities.</li>
<li>National Institute of Standards and Technology: $180 million for competitive grants for research building construction.</li>
<li>Energy Department: $2 billion for research, including $1.6 billion for Office of Science, $400 million for Advanced Research Project Agency-Energy; no money for infrastructure.</li>
</ul>
<p>For a perspective on what the funds could mean for research, <a href="http://www.npr.org/templates/story/story.php?storyId=100558205" target="_blank">read</a><a href="http://www.npr.org/templates/story/story.php?storyId=100558205" target="_blank"> or listen</a> to this NPR report. Another view comes from a blog at The Scientist under the headline, &#8220;<a href="http://www.the-scientist.com/blog/display/55418" target="_blank">NIH wins stimulus jackpot</a>.&#8221; Because there are so many versions of the bill, read it <a href="http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&amp;docid=f:h1pp.txt.pdf" target="_blank">here</a> in PDF format.</p>
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