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U.S. Government Report Making News: Just Released Report on Dietary Supplement Says ``SAMe'' Effective as Prescription Drugs for Depression, Osteoarthritis.


Business Editors, Health/Medical Writers

NORTHRIDGE, Calif.--(BUSINESS WIRE)--Dec. 23, 2002

Pharmavite LLC (Logical Link Control) See "LANs" under data link protocol.

LLC - Logical Link Control
:
-- Expert SAMe Researchers and Patients Available for Comment

-- Report on Supplement Captures Headlines in Both USA Today and Newsweek

-- Report Estimates Annual Cost for Treatment and Lost Wages for Depression $43.7 to $52.9 Billion, $95 Billion for Osteoarthritis


The little known yet widely studied over-the-counter dietary supplement, SAMe ("SAMMY SAMMY Scholar Athlete Milk Mustache of the Year "), shows promise as an equivalent treatment to prescription antidepressants Antidepressants
Medications prescribed to relieve major depression. Classes of antidepressants include selective serotonin reuptake inhibitors (fluoxetine/Prozac, sertraline/Zoloft), tricyclics (amitriptyline/ Elavil), MAOIs (phenelzine/Nardil), and heterocyclics
 for depression, prescription and over-the-counter drugs for osteoarthritis osteoarthritis
 or osteoarthrosis or degenerative joint disease

Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first.
. This information comes from a just-released report on the supplement commissioned by the U.S. Department of Health and Human Services' (HHS HHS Department of Health and Human Services. ) Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality,
n.pr formerly known as the Agency for Health Care Policy and Research, this agency researches the quality of medical care and health services.
 (AHRQ AHRQ,
n.pr See Agency for Healthcare Research and Quality.
). The news of this much-anticipated report has garnered coverage in both Newsweek (Dec. 2, 2002) and USA Today (Nov. 6, 2002).

"There's a lot of information on this compound. I don't think it can be ignored any longer," said Baylor University Researcher, Dr. Teodoro Bottiglieri. Dr. Bottiglieri has studied SAMe for more than 20 years, and was a reviewer of the HHS report.

"It's very important that (the report) has been commissioned by the Health Department. It shows it is a totally unbiased report. It's not a report that has been produced by an individual company, or a pharmaceutical interest."

The report on SAMe was prepared for the HHS by Rand Corporation, a Southern Calif.-based think tank. A 16-person team of medical professionals worked for more than three years to conduct a literature review and synthesis of evidence on 102 of the 1,500 published clinical studies on SAMe to determine its efficacy for treatment of depression, osteoarthritis and cholestasis Cholestasis Definition

Cholestasis is a condition caused by rapidly developing (acute) or long-term (chronic) interruption in the excretion of bile (a digestive fluid that helps the body process fat).
 of pregnancy and intrahepatic cholestasis associated with liver disease Liver Disease Definition

Liver disease is a general term for any damage that reduces the functioning of the liver.
Description

The liver is a large, solid organ located in the upper right-hand side of the abdomen.
.

According to the report, the team's key findings include evidence that SAMe:

-- Is as effective as prescription antidepressants in treating

depression (47 studies reviewed)

-- Fights osteoarthritis pain as well as prescription and

over-the-counter joint pain relievers called non-steroidal

anti-inflammatory drugs Anti-inflammatory drugs
A class of drugs that lower inflammation and that includes NSAIDs and corticosteroids.

Mentioned in: Antirheumatic Drugs
 (NSAIDS) (14 studies reviewed)

-- May help some liver conditions (more than 40 studies reviewed)

Also according to the report's summary, the objective of the report "was to conduct a search of the published literature on the use of S-adenosyl-L-methionine (SAMe) for the treatment of osteoarthritis, depression and liver disease." The report also refers to the high annual costs -- $43.7 to $52.9 billion -- associated with treatment and lost wages for depression. It also states that an estimated 15 percent of Americans suffer from arthritis and the annual cost to society is estimated at $95 billion. Osteoarthritis is the most common form of arthritis.

Pharmavite LLC, the makers of Nature Made(R) dietary supplements, is pleased with the release of the report, as they are the largest supplier of SAMe in the United States with Nature Made MoodPlus(TM) SAM-e and Nature Made JointAction(TM) (SAM-e + Glucosamine glucosamine /glu·co·sa·mine/ (gloo-ko´sah-men) an amino derivative of glucose, occurring in glycosaminoglycans and a variety of complex polysaccharides such as blood group substances. ). Both Nature Made SAM-e products contain the original, most widely used and extensively studied form of SAMe -- naturally derived tosylate tosylate /to·sy·late/ (to´si-lat) USAN contraction for p- toluenesulfonate.

tosylate

USAN contraction for p-toluenesulfonate.
 disulfate -- the type of SAMe used in the vast majority of the 102 studies reviewed in the HHS report.

"We are thrilled that the Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979
Health and Human Services, HHS
 (HHS) Agency for Healthcare Research and Quality (AHRQ) commissioned the time and resources toward reviewing the extensive body of literature on SAMe supporting its efficacy in the area of mood, joint pain and liver health," said Nature Made SAM-e Product Manager, Charles Conroy.

"We hope it is one of many reports of this nature by the HHS. We now plan to share the report's findings with consumers and the medical community to continue educate them about SAMe's benefits and uses."

Consumers and the medical community may obtain a free copy of this report by calling the U.S. Department of Health and Human Services' Agency for Healthcare Research Quality Clearinghouse toll free at 1-800-358-9295. Callers should ask for Report #64: Evidence Report on S-Adenosyl-L-Methionine for treatment in Depression, Osteoarthritis, and Liver Disease.

About SAMe

SAMe is an acronym for S-adenosyl-L-methionine, a natural compound found in every human cell and involved in over 35 biochemical processes in the body. Low levels of SAMe in the body have been correlated with depression. Clinical research findings also support SAMe's ability to relieve joint pain, and promote liver health. There have been more than 1,500 clinical studies on SAMe. It was officially introduced into the U.S. as a dietary supplement in 1998.

SAMe has been touted for its fast acting benefits and lack of side effects Side effects

Effects of a proposed project on other parts of the firm.
 such as weight gain and sexual problems commonly found in prescription antidepressants, and gastric problems associated with NSAIDS for joint pain. Nature Made MoodPlus SAM-e is sold nationally at food, drug and mass retail locations.

About Pharmavite LLC

Founded in 1971, Northridge, California-based Pharmavite LLC manufactures Nature Made(R) vitamins and minerals, SAM-e, Nature's Resource(R) herbal products, Optimize(TM) fiber/calcium beverages, and other supplements designed to promote health. Pharmavite adheres to a strong code of ethics Code of Ethics can refer to:
  • Ethical code, a code of professional responsibility, noting what behaviors are "ethical".
  • Code of Ethics (band), a 90's Christian New Wave/Pop band
, ensures that all supplements comply with recommended dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices. All Nature Made and Nature's Resource products meet or exceed U.S. Food and Drug Administration requirements. Pharmavite's facilities have been inspected and found to be in compliance with United States Pharmacopoeia's GMPs, the industry's most stringent standards.

The company (Pharmavite) is the first participant in the United States Pharmacopeia's (USP USP - unique sales point ) Dietary Supplement Verification Program. DSVP DSVP Dietary Supplement Verification Program  is designed to build consumer confidence in dietary supplements and helps assure a product's quality, purity and composition through a rigorous inspection process. Rockville, Md.-based USP has set standards for prescription drugs, dietary supplements and other health care products for more than 180 years.

Nature Made is America's number one, broadline brand of vitamins and minerals in the food, drug and mass channels. Several of its products carry the medical seal of acceptance from the American Medical Women's Association, the largest medical organization of female physicians. Nature Made's newly launched Wellness Advisor (NatureMade.com), an online educational initiative, utilizes sophisticated analytical tools to provide consumers with personalized health tips and wellness solutions. Nature's Resource (NaturesResource.com) offers one of the nation's strongest herbal supplement education programs for consumers and medical professionals.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Dec 23, 2002
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