HEALTH

Study: SAMe may benefit patients taking antidepressants

BY Michael Johnsen

BOSTON A new study conducted by investigators at Harvard Medical School and Massachusetts General Hospital suggested that the dietary supplement S-adenosylmethionine (SAMe) can be an effective, relatively well-tolerated, adjunctive treatment for adults with major depressive disorders who do not respond to their treatment with antidepressant medication, Pharmavite announced Tuesday.

BOSTON A new study conducted by investigators at Harvard Medical School and Massachusetts General Hospital suggested that the dietary supplement S-adenosylmethionine (SAMe) can be an effective, relatively well-tolerated, adjunctive treatment for adults with major depressive disorders who do not respond to their treatment with antidepressant medication, Pharmavite announced Tuesday.

“With each study, we continue to gain a better understanding of SAMe’s role in treating depression,” stated George Papakostas, associate professor of psychiatry at Harvard Medical School and lead author of the study. “This new finding, albeit preliminary and in urgent need of replication, suggests significant, clinically meaningful differences in outcome among patients who had SAMe added to their antidepressant medication treatment compared to those taking a placebo with their medication,” he said. “Continued research, however, is urgently needed to more definitively further our understanding of the role of SAMe in the treatment of adults diagnosed with depression. Adjunctive SAMe therapy is promising, but cannot yet be recommended for widespread clinical use.”

The first-of-its-kind study was published in the August 2010 American Journal of Psychiatry. According to the National Institute of Mental Health, there are approximately 14.8 million people with major depressive disorders in the United States.

 

The National Institute of Mental Health funded the study.

 

 

Pharmavite, manufacturer of Nature Made SAM-e Complete, provided the SAMe supplements and placebo pills used in the study.

 

 

The study, "S-adenosylmethionine (SAMe) Augmentation of Serotonin Reuptake Inhibitors for Antidepressant Nonresponders With Major Depressive Disorder: A Double-Blind, Randomized Clinical Trial," is the first randomized, placebo-controlled clinical trial conducted on SAMe in a population of patients with major depressive disorders. A total of 73 adults were enrolled in this six -week study and randomly assigned to the placebo control group or the SAMe treatment group. SAMe, in combination with standard depression treatment, was more effective than antidepressant treatment alone in improving measures of depression and remission rates of patients with significant clinical depression. SAMe-treated subjects had a greater response and remission rate to treatment than the placebo-treated group. SAMe was well-tolerated with no reported adverse reactions.

 

 

To date, at least 40 clinical trials have been conducted on SAMe directly and in combination with traditional antidepressant medications. Studies have evaluated SAMe’s use in naturally restoring a healthy mood to the most recent research for treating major depressive disorders. This current study follows a pilot study published in 2004 in the Journal of Clinical Psychopharmacology, which concluded that antidepressants used in combination with SAMe were significantly more effective in relieving depression than medication alone.

 

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KidZerts launches foot insoles for children

BY Michael Johnsen

SAN DIEGO KidZerts on Sunday announced the introduction of its wear-moldable arch support insoles for children.

Features include a moldable sub-layer that slowly will mold to the child’s foot while he or she wears it, an antimicrobial top cover that kills odor-causing bacteria and wicks moisture, a heel cup for stability and alignment, a broad heel seat for additional foot comfort, a beveled forefoot for a smooth transition and a moderate arch for support and alignment.

KidZerts insoles were designed by a team that includes a podiatrist, a pedorthist and specialists in the manufacturing of insoles, the company stated.

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Industry voices opinion on Ninth Circuit decision of Matrixx Initiatives suit

BY Michael Johnsen

WASHINGTON Industry lobbyists last week weighed in on a Ninth Circuit ruling that allowed for a class action lawsuit to proceed against Matrixx Initiatives because that company failed to disclose adverse event reports to its shareholders.

Both the Consumer Healthcare Products Association and the Council for Responsible Nutrition — and separately, the Natural Products Association — filed supporting briefs to the U.S. Supreme Court arguing that the mere nondisclosure of adverse event reports should not give rise to liability under federal securities laws without applying a statistical significance standard. The Supreme Court had agreed to place the case on its docket in June.

The statements were in regard to Matrixx Initiatives vs. James Siracusano and NECA-IBEW Pension Fund.

“The statistical significance standard recognized by most courts of appeals appropriately recognizes that adverse event reports, standing alone, are not ‘material’ for purposes of federal securities laws,” CHPA/CRN wrote in its amicus curiae. “The statistical significance standard addresses the quality of the evidence of a relationship between an adverse event and a product, and therefore it is not the kind of ‘bright-line’ rule that [the Supreme] Court rejected in Basic Inc. vs. Levinson, 485 U.S. 224 (1988).”

“The practical consequence of the Ninth Circuit’s decision, if it is not reversed, is that manufacturers … very likely will be forced to disclose all AERs, however insignificant, in order to avoid meritless — but expensive — strike suits against the supplement industry,” said Jonathan Cohn, who authored NPA’s separate amicus curiae.

CHPA/CRN also argued that the indiscriminate disclosure by public companies of all adverse event reports potentially associated with their products before being actually scientifically vetted may negatively impact consumer selection in one of two ways: Either a consumer will buy wholeheartedly into the alleged link between the use of a particular product and potential harm, and choose not to medicate or supplement with a product that could improve his or her health, or, conversely, a consumer may become so inundated with reports of AERs that he or she becomes numb to the announcements.

“The Food and Drug Administration has recognized that ‘overwarning’ has the effect of not warning at all, because the reader stops paying attention to excess warnings,” CHPA/CRN wrote in their brief.

“The [Ninth Circuit] decision is wrong because evaluation of safety signals is a scientific judgment ultimately made by the FDA,” stated John Gay, executive director and CEO of the NPA in a press release issued Friday. “Companies cannot possibly guess in advance what will be deemed adequate disclosure years later in collateral litigation,” added Scott Bass, a partner at Sidley Austin, which is counsel for NPA. “The [Dietary Supplement and Nonprescription Drug Consumer Protection Act] explicitly states that AERs are not proof of causation.”

Gay added, “The Ninth Circuit’s action is not good for manufacturers, not good for consumers and just is not good law. We hope the Supreme Court will agree.”

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