Media Warns of L-Arginine Dangers

On January 4, 2006 the Wall Street Journal reported “Heart Patients Urged to Avoid L-Arginine.” The article stated that the dietary supplement L-arginine “May harm heart patients” and that “Heart attack patients should avoid the dietary supplement L-arginine, based on a study that was scuttled after six volunteers taking the over-the-counter supplement died.”

The Wall Street Journal announcement was triggered by the clinical study reported in the January 2006 issue of the Journal of the American Medical Association (JAMA) entitled L-Arginine Therapy in Acute Myocardial Infarction (1).

The L-arginine double-blind, placebo-controlled clinical trial was headed by Dr. Steven Schulman, M.D. of Johns Hopkins Medical Institutions, and involved administering various doses of the amino acid L-arginine orally to subjects who had experienced cardiac events (myocardial infarction).

The clinical trial was abruptly stopped when death occurred (within six months) in 6 patients (8.6%) in the L-arginine group and none (-0-) in the placebo group (P = .01). After six months of a planned two-year study, the researchers became alarmed at the mortality rate in the group taking L-arginine, as compared to those taking a placebo. None of the subjects in the placebo (non-arginine) group died.

Researchers conducting the clinical trial stated that instead of the expected benefits from L-arginine, increased risk of death was seen, leading to early termination of the study. As reported in JAMA, “Because of the safety concerns, the data and safety monitoring committee closed enrollment.”

NEWS MEDIA SEEKS DR. ANN de WEES ALLEN’S OPINION

On December 30, 2005, Bloomberg News called Dr. Ann de Wees Allen’s office and requested an immediate live interview. Bloomberg is the leading global provider of data, news and analytics.
The Bloomberg Terminal and Bloomberg's Media Services provide real-time and archived financial and market data, pricing, trading, news and communications tools in a single, integrated package to corporations, news organizations, financial and legal professionals and individuals around the world.

As the leading worldwide L-arginine researcher and expert (2), Dr. Allen was asked to provide Bloomberg Media Services (BMS) with an expert opinion on the JAMA L-arginine study and subsequent deaths.

Dr. Allen had spoken at length with Dr. Steven Schulman regarding the JAMA publication, and has publicly defended Dr. Schulman, Lead Researcher of the clinical trial, stating that:

“Dr. Steven Schulman is a well-respected doctor and researcher, who focused on the best interests of his patients and the subjects in the study” and that “Dr. Schulman is a kind and caring man, who would never risk human lives in any format. Further, Dr. Schulman conducted a responsible and humane clinical study, with no knowledge of the unfortunate outcome.”

MORTALITY RELATED TO INGESTION OF L-ARGININE

Learned scientists can speculate on the cause of the high mortality rate in the L-arginine JAMA/Johns Hopkins clinical trial, but to do so one must possess intricate knowledge of L-arginine biochemistry as well as cardiovascular medicine, and clinical trial variables.

There are thousands of published clinical trials utilizing L-arginine that have not resulted in mortalities. In terms of future L-arginine clinical trials, it is recommended that the form of L-arginine be bound to a Blind Amino Acid Rider, and formulated by an L-arginine expert with a background in safe arginine Isoform pathways.

TWO DECADES OF L-ARGININE RESEARCH

Dr. Ann de Wees Allen has been researching L-arginine since 1983, longer than any other arginine researcher, and has tracked oral ingestion of specific L-arginine compounds in over 250,000 human subjects over a 23-year period. Due to Dr. Allen’s discovery that L-arginine has the capacity to access different Isoform pathways, L-arginine was named a “Blind Amino Acid.”

Dr. Allen has spent the past two decades researching efficacious L-arginine protocols in humans, and designing glycoside Riders for the safe transport of oral L-arginine in humans (3). Her research and resulting Patents (4) have been named "Breakthrough Product of the Year" by Success magazine and have been featured on the front page of the Wall Street Journal.

Dr. Allen’s long-standing reputation as the leading expert in the field of L-arginine, as well as the Glycemic Index, is evidenced by 23 years of accolades and accomplishments:

• Who's Who of American Inventors

• Association of Clinical Research Professionals

• American Diabetes Association Council on Nutritional Science & Metabolism

• Who’s Who in Diabetes Education and Research, American Diabetes    Association

• Received first Glycemic Patent ever awarded worldwide

• Filed the first Patent on Safe L-arginine Biochemical Pathways (full Patent     awarded)

• Discovered the first Isoform Pathway for L-arginine that Circumvents Disregulated    Arginine Metabolism

GENERATING SAFE FORMS OF L-ARGININE

The scientific community only accepts proven and quantified Protocols for the safe and efficacious administration of L-arginine in humans.

L-arginine M² is the result of the entire body of work conducted by Dr. Ann de Wees Allen, with a documented 23-year proven history of safe L-arginine in humans.

L-arginine M² represents the First Generation of safe and effective L-arginine, as the first L-arginine product proven to be safe in humans long-term. L-arginine M² is also the only L-arginine product to be used safely in humans over a 23-year period.

EXAMINING THE SAFETY OF L-ARGININE

Prior to using any L-arginine product, one must examine the history of its availability on the market. The length of its use in humans must be ascertained in order to determine long-term safety in humans.

Consumers must also be allowed to examine the Patents on any L-arginine product, and the name of the scientist (s) who formulated the product. If the formulator is not named, or is not a proven L-arginine specialist, caution is dictated. Once the formulator’s name is provided, do a “Google” search on their name to make sure this person is recognized as an L-arginine expert. Professional corporations will openly display the name of the formulator. If the formulator is not named, or is not a proven L-arginine specialist, and Patent-holder, caution is dictated.

Many L-arginine products claim to have Patents, when they do not, despite the fact that it is a Federal offense to say “Patent or Patent-Pending” on a label if there is no Patent filed with the United States Federal government (www.USPTO.gov).

The most important aspect in selecting a safe L-arginine product is the addition of a “Blind Amino Acid” Rider. Without this essential facet, L-arginine cannot take a safe Isoform pathway.

Since the JAMA article was published, consumers have become extremely cautious about using L-arginine. It is unwise to use any L-arginine product without first ascertaining its history, use in humans, formulator, Patent-status, and Isoform pathway.

DOSAGES

Subjects in the study started taking L-arginine HCL, 1 g three times daily for 1 week, increasing to 2 g three times daily in week 2, followed by 3 g three times daily in week 3. Patients were maintained at this dose for 6 months. Dosages of L-arginine are clearly not the culprit in the high mortality rate evidenced during the JAMA Johns Hopkins study, as the subjects in the upper-limit doses only consumed 9 grams of L-arginine per day.

Safe doses of L-arginine taken with a Blind Amino Acid Rider range up to 50 grams of elemental L-arginine taken daily in humans for over a 20-year period. Since dosages were not responsible for the deaths in the JAMA study, that aspect can be disregarded.

EDUCATION

The layperson cannot be expected to possess scientific knowledge of the intricacies of L-arginine and its many forms and functions. To this end, www.ArginineAnswers.com has been designed to educate the public on safety issues, Protocols, contraindications, and other issues related to ingestion of L-arginine. The new website will also offer live, online real-time discussion forums with leading L-arginine researchers.

Long-Term Safety of L-Arginine In Humans Partial Listing of References

(1) JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (JAMA)
     Vol. 295 No 1, January 4, 2006
     L-Arginine Therapy in Acute Myocardial Infarction
     The Vascular Interaction With Age in Myocardial Infarction (VINTAGE MI)      Randomized Clinical Trial
     Steven P. Schulman, MD et al
     Johns Hopkins Hospital

(2) CV of Dr. Ann de Wees Allen
     Chief L-Arginine Researcher
     Medical Advisory Board
     www.GeneFoundation.com

     Chief of Biomedical Research
     Human In Vivo Clinical Testing
     www.GlycemicIndexTesting.com

(3) www.ArginineResearch.com Arginine Research
     75 L-arginine Research Topics Conducted by Dr. Ann de Wees Allen

(4) List of Patents held by Dr. Ann de Wees Allen
     www.ArginineResearch.com

Circulation. 2000;101:2126. American Heart Association; What We Know and Don’t Know About L-Arginine and NO

The American Society for Nutritional Sciences. J. Nutr. 134:2820S-2825S, October 2004. Arginine Metabolic Enzymes, Nitric Oxide and Infection

2001. Regulatory role of arginase I and II in nitric oxide, polyamine, and praline syntheses in endothelial cells. Am. J. Physiol. 280:E75-E82.

Wiesinger H. Arginine metabolism and the synthesis of nitric oxide in the nervous system. Prog Neurobiol 2001;64:365-91.

Thomas G, Ramwell PW. Nitric oxide, donors and inhibitors. In: Bertram G Katzung, editor. Basic and Clinical Pharmacology. United States: McGraw Hill; 2004.p.313-8.

Prog Neurobiol. 2001 Jul;64(4):365-91. Arginine metabolism and the synthesis of nitric oxide in the nervous system.