Health and Medical News and Resources

General interest items edited by Janice Flahiff

A Scientist Debunks The ‘Magic’ Of Vitamins And Supplements : Shots – Health News : NPR

 

Screen Shot 2013-10-26 at 8.14.15 AMA Scientist Debunks The ‘Magic’ Of Vitamins And Supplements : Shots – Health News : NPR.

From the 23 July 2013 NPR item

A pediatrician who spent years defending childhood vaccines against the likes of actress/activist Jenny McCarthy has launched an assault on megavitamins and dietary supplements.

“If you take large quantities of vitamin A, vtamin E, beta carotene [or] selenium you increase your risk of cancer, risk of heart disease, and you could shorten your life,” says Dr. Paul Offit, a researcher at The Children’s Hospital of Philadelphia.

Many large studies in recent years have shown that vitamins and dietary supplements rarely help and often hurt, Offit says. Yet a huge number of people still believe that these products will improve their health. So, Offit says, he decided to challenge the false beliefs of “the church of vitamins and supplements.”

Offit made the remarks during an appearance in Washington, D.C., Monday to promote his latest bookDo You Believe in Magic? The Sense and Nonsense of Alternative Medicine.

Offit, an infectious disease specialist and the co-inventor of a rotavirus vaccine, is best known for publicly challenging groups that claim there is a link between childhood vaccines and autism. That effort often pitted him against actress Jenny McCarthy, who became a spokeswoman for anti-vaccine groups.

One big problem with dietary supplements is a 1994 law that exempts them from the tighter scrutiny the FDA applies to its regulation of medicines, Offit says. So the makers of a garlic supplement can say that it “supports cardiovascular health” even though a government study found that garlic supplements didn’t lower cholesterol. Meanwhile, Offit says, patients clearly benefit from a range of FDA-approved statin drugs that actually do what garlic supplements claim to do.

Dietary supplements are often advertised as “natural,” Offit says, even though that term can be misleading. For example, almonds are a natural source of vitamin E. But you would have to eat 17 pounds of almonds to get the amount of vitamin E in a single capsule sold by one supplement maker, Offit says. “So how is this a natural thing to do?”

Offit says doctors are partly to blame for the growing popularity of high-dose vitamins and other dietary supplements. Rather than pushing back against patients who want to take them, he says, doctors have acted like waiters at a restaurant, simply asking, “What would you like?”

Many hospitals also include unproved dietary supplements in their list of medicines available to patients, Offit says. But he says his own institution, The Children’s Hospital of Philadelphia, plans to remove nearly all supplements from its list later this month.

Offit says his attack on dietary supplements has generated a steady stream of hate mail. But he says it’s not as harsh as the hate mail he used to get from people who believe vaccines cause autism. “This is more, I’m ‘a liar and a shill for the pharmaceutical industry,’ ” he says, “not, ‘You’re going to hell.’ “

Offit has some strong defenders, though, including former President Jimmy Carter and Carter’s wife, Rosalynn. They sat in the front row at Offit’s appearance in D.C. And during a question and answer session, the former president rose to tell Offit: “You’ve been a hero around our house for a long time.”

 

October 26, 2013 Posted by | Consumer Health, Nutrition | , , | Leave a comment

Dietary Supplement Quality – Resources

Dietary supplements, such as the vitamin B sup...

Dietary supplements, such as the vitamin B supplement show above, are typically sold in pill form. (Photo credit: Wikipedia)

This morning I read a post about the health benefits of green tea.  It included a resource new to me – ConsumerLab.com. Their stated mission is to “identify the best quality health and nutritional products through independent testing”. To be honest, I was a bit wary. Testimonials always raise a red flag with me, I am not sure who the folks are and who initiated the testimonial. The section “Where to buy products” also concerned me, I was wondering if this was paid advertising…not that this alone would discredit the company. (Click here for tips on how to evaluate a Web site).

The Alliance for Natural Health has a decent review on Consumer Lab, outlining how Consumer Lab conducts business.
Consumer Lab  asks companies to pay for the tests. If the company does not wish to pay, Consumer Lab often conducts the test (through outsourcing to unidentified companies)  anyway without billing the company. And then publishes the results. Interesting… The

Dr. Sanford Levy, board certified in Integrative Holistic Medicine, has written a short informative article on the quality of Dietary Supplements. 

His professional judgements include the following

  • FDA (Food and Drug Adminstration) – Their final rules on dietary supplements tend to be reactive rather than proactive.
  • Consumerlab- He is rather neutral on how they operate, as opposed to The Alliance (above). He does note there is a $33 subscription fee to access the information at the site
  • Companies which certify manufacturers of supplements.
    (Beware though that even if a company is certified …this information is not necessarily included on the product label.)

    • uspcertificed.com -addresses bioavailability as well as chemical composition
    • Natural Products Association – addresses only chemical composition, not bioavailability
    • Emerson Ecologics- serves health care professionals as a distributor for multiple manufacturers. Emerson initiated a quality program in 2010, ranking manufacturers based on a number of criteria. Manufacturers who choose not to distribute through Emerson Ecologics will not be listed in any of the categories.

More detailed information on supplements by him at http://www.acsu.buffalo.edu/~shlevy/dietsuppqualitysafetyefficacy.htm
   His outline on supplement regulation is at
http://www.acsu.buffalo.edu/~shlevy/Regulation%20of%20Dietary%20Supplements.htm

He covers other topics at http://www.acsu.buffalo.edu/~shlevy/

August 26, 2013 Posted by | Health Education (General Public), Nutrition, Tutorials/Finding aids | , , , , | Leave a comment

Vitamin D Fraud: Lack of Truth in Labeling

Vitamin Packaging

Vitamin Packaging (Photo credit: colindunn)

 

From the 14 March post at Mind the Science Gap

 

….All told, the vitamin D content of “off-the-shelf” and compounded vitamins was highly variable

 

                            “ . . . potency ranged from 9% to 146%.”…

 

…. Why aren’t dietary supplements regulated like drugs or food additives?

 

….

 

 

 

 

 

 

March 22, 2013 Posted by | Nutrition | , , | Leave a comment

Look up medications more quickly and easily on Google

From the Google Announcement

11/30/12 | 9:00:00 AM

Labels: 

We get a lot of queries for medicine on Google. So to make it quick and easy for you to learn about medications, we’ll start showing key facts — side effects, related medications, links to in-depth resources, and more — right on the search results page.


This data comes from the U.S. FDA, the National Library of Medicine, and the Department of Veterans Affairs, among others. It’s part of the Knowledge Graph — our project to map out billions of real-world things, from famous artists to roller coasters to planets (and now medications). We hope you find this useful, but remember that these results do not act as medical advice.

Posted by Aaron Brown, Senior Product Manager, Search

 

Related Resources (because there are other reputable resources besides the one’s Google mines! with additional drug info)

MedlinePlus Trusted Health Information for You

 
 
 
Learn about your prescription drugs and over-the-counter medicines. Includes side effects, dosage, special precautions, and more.
Browse dietary supplements and herbal remedies to learn about their effectiveness, usual dosage, and drug interactions.
 
Information about label ingredients in more than 6,000 selected brands of dietary supplements. It enables users to compare label ingredients in different brands. Information is also provided on the “structure/function” claims made by manufacturers.
These claims by manufacturers have not been evaluated by the Food and Drug Administration. Companies may not market as dietary supplements any products that are intended to diagnose, treat, cure or prevent any disease.
 
 
Drug Information Portal
A gateway to selected drug information from the US government.  It links you to information on over 12,000 drugs from trusted consumer drug information sources (as MedlinePlus Drug Information), the US Food and Drug Information (as Drugs @FDA)LactMed(summary of effects on breastfeeding), and more.
 


 
Pillbox enables rapid identification of unknown solid-dosage medications (tablets/capsules) based on physical characteristics and high-resolution images.
Once a medication is identified, Pillbox provides links to drug information and drug labels.
 
 
MedWatch logo
Clinically important safety information and reporting serious problems with human medical products.
Safety information includes drug information, recalls & alerts, drug shortage information, and medication guides.
 

Together we

Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products, recalls, advisories, and warnings from the Canadian government
 
 
More Drug Resources at Drug Information Resources 
      (by the Consumer and Patient Health Information Section of the Medical Library Association)
 
Including…..
  • CenterWatch/Clinical Trials Listing Service
    This useful resource lists newly approved drugs, drugs in current clinical research, weekly trial results, as well as a link to the PDR Family Medical Guide for Prescription Drugs.
  • Longwood Herbal Task Force
    This site has in-depth monographs about herbal products and supplements written by health professionals and students. It provides clinical information summaries, patient fact sheets, and information about toxicity and interactions as well as relevant links. The task force is a cooperative effort of the staff and students from Children’s Hospital, the Massachusetts College of Pharmacy and Health Sciences, and the Dana Farber Cancer Institute.
  • FDA Recalls  provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products
  • Epocrates

 

 

December 12, 2012 Posted by | Consumer Health, Educational Resources (High School/Early College(, Finding Aids/Directories, Health Education (General Public) | , , , | Leave a comment

Herbal and Dietary Supplements Can Adversely Affect Prescribed Drugs, Says Extensive Review

Dietary supplements, such as the vitamin B sup...

Dietary supplements, such as the vitamin B supplement show above, are typically sold in pill form. (Photo credit: Wikipedia)

Those of you who follow this blog know I continually harp on the necessity of sharing your use of complementary/alternative therapies as well as supplements with your health care providers.

From the 24 October 2012 article at ScienceDaily

A number of herbs and dietary supplements (HDS) can cause potentially harmful drug interactions, particularly among people receiving medication for problems with their central nervous or cardiovascular systems.

Those are the key findings of an extensive research review published in the November issue of IJCP, theInternational Journal of Clinical Practice.***

Researchers examined 54 review articles and 31 original studies. They found that the greatest problems were caused by interactions between prescribed drugs and HDS that included ingredients such as St John’s Wort, magnesium, calcium, iron or ginkgo.

“Consumer use of HDS has risen dramatically over the past two decades” says co-author Dr Hsiang-Wen Lin from the College of Pharmacy, China Medical School, Taiwan.

“In the USA, for example, it is estimated that more than 50 per cent of patients with chronic diseases or cancer use them and that many patients take them at the same time as prescribed medication.

“Despite their widespread use, the potential risks associated with combining HDS with other medications, which include mild-to-severe heart problems, chest pain, abdominal pain and headache, are poorly understood.”

Key findings of the review included:

  • The literature covered 213 HDS entities and 509 prescribed medications, with 882 HDS-drug interactions described in terms of their mechanisms and severity.
  • Warfarin, insulin, aspirin digoxin and ticlopidine had the greatest number of reported interactions with HDS.
  • More than 42 per cent of the drug interactions were caused by the HDS altering the pharmacokinetics of the prescribed drugs — the process by which a drug is absorbed, distributed, metabolised and eliminated by the body.
  • Just over 26 per cent of the total were described as major interactions.
  • Among the 152 identified contraindications, the most frequent involved the gastrointestinal system (16.4%), neurological system (14.5%) and andrenal ⁄ genitourinary diseases (12.5%).
  • Flaxseed, echinacea and yohimbe had the largest number of documented contraindications.

Related Resources

  • Evaluating Health Information (links at Health/Medical News and Resources by yours truly) 
  • Drugs, Supplements, and Herbal Information (MedlinePlus)Learn about your prescription drugs and over-the-counter medicines. Includes side effects, dosage, special precautions, and more.Browse dietary supplements and herbal remedies to learn about their effectiveness, usual dosage, and drug interactions.
  • Dietary Supplements Label Database (US National Library of Medicine) offers information about label ingredients in more than 6,000 selected brands of dietary supplements. It enables users to compare label ingredients in different brands. Information is also provided on the “structure/function” claims made by manufacturers. These claims by manufacturers have not been evaluated by the Food and Drug Administration. Companies may not market as dietary supplements any products that are intended to diagnose, treat, cure or prevent …
  • Drugs and Supplements (sponsored by the Mayo Clinic)  Somewhat lengthy drug and over-the-counter medicationinformation with these sections: description, before using, proper use, precautions and side effects. From Micromedex, a trusted source of healthcare information for health professionals. Herb and supplement information includes information on uses based on scientific evidence as well as safety and potential interactions with drugs, herbs, and supplements. From Natural Standard, an independent group of researchers and clinicians.

**Unfortunately this article is only available through paid subscription.
Ask for an available copy at your local public, academic, or medical library. (Many academic and medical libraries will help anyone who walks in, call ahead and ask for a reference librarian)

If your library does not have it, ask about Interlibrary loan. You may be able to get a copy from another library at little or no cost.

October 26, 2012 Posted by | Consumer Health, health care | , , , , | Leave a comment

Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements

 

Dietary supplements

Dietary supplements (Photo credit: Andrei Z)

 

From the 2 October 2012 report by the Office of the Inspector General, US Department of Health and Human Services

 

Summary

WHY WE DID THIS STUDY

The Government Accountability Office and public interest groups have raised concerns about a specific type of claim-called a structure/function claim-that manufacturers may use on dietary supplement labels. Manufacturers have used these claims to promote health benefits of their products. Stakeholders have urged FDA to strengthen oversight of these claims because they are potentially misleading and may lack scientific support. FDA lacks authority to review or approve these claims before products enter the market. Manufacturers must have competent and reliable scientific evidence to show that claims are truthful and not misleading, but they do not have to submit the substantiation to FDA, and FDA has only voluntary standards for it. A manufacturer must notify FDA when it uses structure/function claims, and a product label must include a disclaimer stating that FDA has not reviewed the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease.

HOW WE DID THIS STUDY

We analyzed structure/function claims for a purposive sample of 127 dietary supplements marketed for weight loss or immune system support. We reviewed the claims to determine the extent to which they complied with FDA regulations. We reviewed substantiation provided by manufacturers to describe the quantity and nature of the evidence. We also assessed the accuracy and completeness of notification letters that manufacturers must submit to FDA for their structure/function claims.

WHAT WE FOUND

Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence. FDA could not readily determine whether manufacturers had submitted the required notification for their claims. Seven percent of the supplements lacked the required disclaimer, and 20 percent included prohibited disease claims on their labels. These results raise questions about the extent to which structure/function claims are truthful and not misleading.

WHAT WE RECOMMEND

We recommend that FDA seek explicit statutory authority to review substantiation for structure/function claims to determine whether they are truthful and not misleading. We recommend that FDA improve the notification system for these claims to make it more organized, complete, and accurate. We also recommend that FDA expand market surveillance to enforce the use of disclaimers for structure/function claims and to detect disease claims. In its comments on the draft report, FDA did not explicitly concur with our first recommendation, but said it would consider it. FDA concurred with our second and third recommendations.

 

 

October 4, 2012 Posted by | Nutrition | , , , , | 2 Comments

Red Yeast Rice: An Introduction (A Fact Sheet from NCCAM)

English: red rice3 wine before filtering 2 -mo...

Excerpts from Red Yeast Rice backgrounder Web page (US National Center for Center for Complementary and Alternative Medicine)

Red yeast rice is a traditional Chinese culinary and medicinal product. In the United States, dietary supplements containing red yeast rice have been marketed to help lower blood levels of cholesterol and related lipids. Red yeast rice products may not be safe; some may have the same side effects as certain cholesterol-lowering drugs, and some may contain a potentially harmful contaminant. This fact sheet provides basic information about red yeast rice, summarizes scientific research on effectiveness and safety, discusses the legal status of red yeast rice, and suggests sources for additional information.

Key Points

  • Some red yeast rice products contain substantial amounts of monacolin K, which is chemically identical to the active ingredient in the cholesterol-lowering drug lovastatin. These products may lower blood cholesterol levels and can cause the same types of side effects and drug interactions as lovastatin.
  • Other red yeast rice products contain little or no monacolin K. It is not known whether these products have any effect on blood cholesterol levels.
  • Consumers have no way of knowing how much monacolin K is present in most red yeast rice products. The labels on these products usually state only the amount of red yeast rice that they contain, not the amount of monacolin K.
….

Safety

  • The same types of side effects that can occur in patients taking lovastatin as a drug can also occur in patients who take red yeast rice products that contain monacolin K. Potential side effects include myopathy (muscle symptoms such as pain and weakness), rhabdomyolysis (a condition in which muscle fibers break down, releasing substances into the bloodstream that can harm the kidneys), and liver toxicity. Each of these three side effects has been reported in people who were taking red yeast rice.
  • Red yeast rice supplements should not be used while pregnant or breastfeeding.
  • Lovastatin can interact with a variety of drugs to increase the risk of rhabdomyolysis; these drugs include other cholesterol-lowering agents, certain antibiotics, the antidepressant nefazodone, drugs used to treat fungal infections, and drugs used to treat HIV infection. Red yeast rice containing monacolin K could interact with drugs in the same way.
  • If the process of culturing red yeast rice is not carefully controlled, a substance called citrinin can form. Citrinin has been shown to cause kidney failure in experimental animals and genetic damage in human cells. In a 2011 analysis of red yeast rice products sold as dietary supplements, 4 of 11 products were found to contain this contaminant.
….

Legal Status of Red Yeast Rice

In 1998, the FDA determined that a red yeast rice product that contained a substantial amount of monacolin K was an unapproved new drug, not a dietary supplement. On several occasions since then, the FDA has taken action against companies selling red yeast rice products that contain more than trace amounts of monacolin K, warning them that it is against the law to market these products as dietary supplements.

The US National Center for Complementary and Alternative Medicine (NCCAM) includes the section Herbs at a Glance.

This  series of fact sheets that provides basic information about specific herbs or botanicals—common names, uses, potential side effects, and resources for more information.

MedlinePlus Trusted Health Information for You

Drugs, Supplements, and Herbal Information 
Learn about your prescription drugs and over-the-counter medicines. Includes side effects, dosage, special precautions, and more.
Browse dietary supplements and herbal remedies to learn about their effectiveness, usual dosage, and drug interactions.


Dietary Supplements Labels Database 

Information about label ingredients in more than 6,000 selected brands of dietary supplements. It enables users to compare label ingredients in different brands. Information is also provided on the “structure/function” claims made by manufacturers.
These claims by manufacturers have not been evaluated by the Food and Drug Administration. Companies may not market as dietary supplements any products that are intended to diagnose, treat, cure or prevent any disease.
Longwood Herbal Task Force
This site has in-depth monographs about herbal products and supplements written by health professionals and students. It provides clinical information summaries, patient fact sheets, and information about toxicity and interactions as well as relevant links. The task force is a cooperative effort of the staff and students from Children’s Hospital, the Massachusetts College of Pharmacy and Health Sciences, and the Dana Farber Cancer Institute.

July 16, 2012 Posted by | Finding Aids/Directories, Health Education (General Public), Nutrition | , , | Leave a comment

Dietary Supplement Advisory Items: Cancer Prevention & Food Supplements

As many of you readers know, I continually advise to learn the facts before using dietary supplements.
They are not regulated by the FDA for efficacy(preventing or curing conditiions], just for safety.

Two recent items…

The “Crazy” World of Diet Supplements | FOOD, FACTS and FADS

Excerpt from the blog..

A popular herbal supplement, Aristolochia, commonly sold as birthwort has recently been linked to kidney failure and kidney and bladder cancer.  This herb is commonly prescribed in Taiwan as part of traditional medicine and it was recently observed that nearly 12% of that country’s population suffers from chronic kidney disease.  Now the herb has been conclusively associated with these diseases through gene analysis.

This herb is not marketed in the U.S. since 1994 following FDA warnings. Since cancer may take years to develop, it still may be a causative substance even since it’s ban. In the case of supplements, manufacturers must ensure safety, efficacy, and proper labeling but this regulation does not appear to be enforced. Due to the passage of a supplement…

Beware Of Dietary Supplements For Cancer Prevention

Excerpt from the 26 April Medical News Today article

Government regulators and the scientific community should work to ensure that they give clear guidance to the public about dietary supplements and cancer risk, according to a commentary published in the Journal of the National Cancer Institute.

Evidence from animal, in vitro and observational studies has suggested that taking dietary supplements may lower cancer risk. However, the small number of randomized controlled studies, the gold standard in evidence-based medicine, has not confirmed this – and some studies have actually shown that supplements may increase cancer risk. Still, the supplement industry is booming, with estimated annual sales at $30 billion in the U.S. …

Related Resources

 offers information about label ingredients in more than 6,000 selected brands of dietary supplements. It enables users to compare label ingredients in different brands. Information is also provided on the “structure/function” claims made by manufacturers. These claims by manufacturers have not been evaluated by the Food and Drug Administration. Companies may not market as dietary supplements any products that are intended to diagnose, treat, cure or prevent …
 

April 27, 2012 Posted by | Consumer Health, Nutrition | , , , | Leave a comment

Unregulated supplements are a tragedy

Calcium dietary supplement tablets.

Calcium dietary supplement tablets. (Photo credit: Wikipedia)

Who knows how many other unexplained deaths and near-deaths can be attributed to the vast experiment foisted upon an unwary American populace by such drugs — I mean, “supplements”?

Thanks to 1994′s Hatch Act, the Dietary Supplement Health and Education Act (DSHEA), pushed through Congress and released upon a then-unprotesting public by Utah’s Sen. Orrin Hatch (R-UT), substances which may be benign, toxic, and everything in between, as long as they are sold as “dietary nutritional supplements,” get a virtual free pass…

A “Perspective” article in a recent New England Journal of Medicine by Dr. Pieter Cohen called for a tightening — no, not even that, merely actually enforcing the law as written — by having the FDA demand that, instead of pleading with, the supplement manufacturers supply the agency with at least the legal minimum of data on their products’ safety.

Some have responded with protests over “Big Government” intervention.

One of these days some supplement, contaminated or virginal, will kill a bunch of naive customers, and cries will ring out over their lax regulation.

Responsible public health authorities should effect long overdue legal and regulatory control over this millions-strong, uncontrolled experiment before such a tragedy forces their hands.

  • Drugs, Supplements, and Herbal Information (MedlinePlus)

    Learn about your prescription drugs and over-the-counter medicines. Includes side effects, dosage, special precautions, and more.Browse dietary supplements and herbal remedies to learn about their effectiveness, usual dosage, and drug interactions.

  • Dietary Supplements Labels Database 

    Information about label ingredients in more than 6,000 selected brands of dietary supplements. It enables users to compare label ingredients in different brands. Information is also provided on the “structure/function” claims made by manufacturers.

    These claims by manufacturers have not been evaluated by the Food and Drug Administration. Companies may not market as dietary supplements any products that are intended to diagnose, treat, cure or prevent any disease.

March 21, 2012 Posted by | Consumer Health | , | Leave a comment

Medication Safety Booklet in Spanish and English | Health Information Literacy – for health and well being

Medication Safety Booklet in Spanish and English | Health Information Literacy – for health and well being.

 

The following was posted on the BHIC Blog; August 30, 2011.

by Siobhan Champ-Blackwell

Spanish http://1.usa.gov/niu45x
English http://1.usa.gov/jClN3h
AHRQ has released a revised Spanish-language medication safety booklet, “Su medicamento: Infórmese. Evite riesgos” (“Your Medicine: Be Smart. Be Safe.”) to help Spanish-speaking patients learn more about how to take medicines safely. The booklet includes a detachable, wallet-size card that can help patients keep track of medicines they are taking, including vitamins and herbal and other dietary supplements. Print copies are available by sending an e-mail to AHRQPubs@ahrq.hhs.gov.

November 22, 2011 Posted by | Consumer Health, Consumer Safety, Health Education (General Public) | , , , | Leave a comment

In the News: Dietary Supplements Research [NCCAM News and Events]

A woman's hands on a pill bottle, angled to imply the label is being read.

In the News: Dietary Supplements Research (from the US National Center for Complementary and Alternative Medicine)

via In the News: Dietary Supplements Research [NCCAM News and Events].

 

Three recently published studies have highlighted the use and research surrounding natural products.

  • Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT) in the Journal of the American Medical Association.
  • Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial in the Journal of the American Medical Association.
  • Monounsaturated, trans, and saturated fatty acids and cognitive decline in women in the Journal of the American Geriatrics Society.

Many people take natural products in an effort to be well and stay healthy. In fact, according to the 2007 NHIS survey, 17.7 percent of American adults had used “natural products” (i.e., dietary supplements other than vitamins and minerals) in the past 12 months. It is important to study the safety and efficacy of widely used natural products that hold promise for treating or preventing disease or symptom management so that consumers, health care providers, and policy makers can make informed health care decisions.

NCCAM Research Spotlights

Other Resources

November 20, 2011 Posted by | Consumer Health, Nutrition | , , , | Leave a comment

Dietary Supplement Reform (Comments from the Director of NLM)

NLM Director’s Comments Transcript
Dietary Supplements Reform: 08/15/2011

 

Picture of Dr. Lindberg Greetings from the National Library of Medicine and MedlinePlus.gov

Regards to all our listeners!

I’m Rob Logan, Ph.D. senior staff National Library of Medicine for Donald Lindberg, M.D, the Director of the U.S. National Library of Medicine.

Here is what’s new this week in MedlinePlus.listen

Dietary supplement reform should focus on reducing product contaminants, removing false marketing claims, as well as providing more evidence about the clinical efficacy of the vitamins, minerals and herbs intended to enhance one’s diet, suggests an editorial recently published in the Journal of the American Medical Association.

The editorial notes a 2010 U.S. Government Accountability Office (GAO) report found trace amounts of at least one contaminant, such as lead, arsenic, mercury, and assorted pesticides, in 37 of the 40 dietary supplement products the GAO tested.

The editorial adds there can be legally defensible differences between the technical description of a diet supplement’s clinical efficacy and its marketing language.

The editorial’s author, Bryan Denham Ph.D., a social scientist at Clemson University, writes (and we quote): ‘as long as (diet supplement) products do not claim to treat, prevent, or cure specific diseases, they can enter and remain in the marketplace’ (end of quote).

Moreover, Denham notes the marketing latitude that is currently provided to manufacturers can be used to advance the impression that a dietary supplement is more effective than medicines that have been tested in rigorous clinical trials to treat a disease or condition.

Denham writes and we quote: ‘among the most egregious marketing efforts were claims that garlic could be taken in place of high blood pressure medication and that Ginkgo biloba could be used to treat Alzheimer disease, depression, and impotence’ (end of quote).

Denham emphasizes the burden of proof and evidentiary standards of clinical efficacy and safety required of dietary supplement manufacturers are sometimes the reverse of drug and medical product firms. While drug and medical product firms must demonstrate a product’s safety and clinical efficacy to the U.S. Food and Drug Administration (FDA), Denham explains the FDA or the U.S. Drug Enforcement Agency must demonstrate a dietary supplement is unsafe, includes a controlled substance, or does not contain ingredients listed on the product’s label to take it off the market.

Denham finds these relaxed standards can foster an inconsistent use of clinical evidence by food supplement manufacturers.

For example, Denham writes (and we quote): ‘it is safe to assume that supplement manufacturers will not make an announcement each time a study finds no relationship between a dietary supplement and a health condition’ (end of quote). Yet, when a null hypothesis is rejected (or clinical efficacy is statistically significant), he notes the existing law permits manufacturers to promote these findings, which he writes (and we quote): ‘is a practice with which they appear comfortable’ (end of quote)…..

Read the entire article

August 19, 2011 Posted by | Consumer Health, Consumer Safety | | Leave a comment

   

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