A Skeptical Look at Dr. Nelson Kraucak
and Sequenced Amino Acid Modulation Therapy

Stephen Barrett, M.D.

Sequenced Amino Acid Modulation—abbreviated SAM or SAAM—is an obscure treatment in which amino acid derivatives are injected or placed under the tongue to treat a wide variety of diseases and conditions. Despite considerable searching, I was unable to find a proponent Web site that fully described the products, supportive studies, or who is distrbuting them. The best source of information I have acquired is a 12-page brochure downloaded from a link that was e-mailed to a parent who telephoned a clinic mentioned in a chat group. The brochure, titled "Amino Acids," is not mentioned on the clinic Web site.

The clinic—Healthcare Partners—is located in The Villages, Florida and headed by Nelson Kraucak, M.D. Its Web site states:

Amino Acid Injection is a NON-DRUG treatment with NO Side Effects for the following Autoimmune Disorders: autism; support for cancer treatment; cardiovascular conditions; Crohn's disease; chronic hepatitis; drug related auto-immune disorder; geriatric disorder; glomerulonephritis; infertility; myasthenia gravis; multiple sclerosis; osteoarthritis; pernicious anemia; ligand-receptor errors or CNS cells; pulmonary fibrosis; psoriasis; rheumatoid arthritis; sarcoidosis; silicon reaction; systemic lupus; antibodies against thyroid gland; termination of long term corticosteroid; ulcerative colitis; onset of allergies after viral infection; and Epstein Barr virus or infectious mono [1].

In 2010, in an article about him in a Philippine newspaper, Kraucak said he had been administering amino acid treatment in his Florida practice for six years. He also described the treatment as "the product of a 35-year medical research project completed at Oxford University in England." [2] In 2015, another media outlet announced that Kraucak "would share the secrets of fixing your immune system" in a bi-monthly conference call and that "his studies at Oxford have allowed him to bring cutting edge healing to his practice." [3] During the program, Kraucak claimed that toxins cause immune system dysfunction that causes a wide range of diseases but can be corrected by giving specific peptides [4]. (Peptides are chains of amino acids.)

Claims in the SAM Brochure

The SAM brochure [5], pictured to the right, identifies five products called "Solutions of Peptides" that are supposed to be injected into a patient's muscle at monthly intervals.

  • Solution of Peptides RA® is intended for rheumatoid arthritis and other autoimmune joint diseases.
  • 'Solution of Peptides SL® is intended for systemic lupus.
  • Solution of Peptides AL® is intended for allergies and allergic conditions such as bronchial asthma.
  • Solution of Peptides GD® is for geriatric disorders.
  • Solution of Peptides HS®, described as a "broad spectrum immunomodulator," is intended for 22 conditions that include most of those listed on the Web site.
 

Describing SAM as "a medical breakthrough in Oxford," the brochure states:

Naturally, this very group of devastating diseases had been the main focus of attention of the Oxford medical researchers. Solutions of Peptides had finally been developed for several serious diseases which could not be effectively treated until now.

Subsequent clinical trials, where more than 15,000 patients had been treated, established the fact that this form of therapy is completely safe (there had been no fatalities associated with the treatment - and not even one single adverse reaction was recorded which would necessitate a discontinuation of the treatment, throughout the entire five years of clinical trials.)

The clinical trials also demonstrated the astonishing efficacy of this new therapeutic regimen; 96 per cent of patients responded to the therapy, most within days of being commenced on the treatment.

The Solutions of Peptides are administered by intra muscular injections. In almost all cases, the effect takes place within one or two days following the first treatment.

Several pages of the SAM brochure appear to be a reproduction of "Circular Dispatch No. 2" issued by the Oxford Center of Molecular Immunology" and intended "Only to physicians practicing in the USA." This section states:

Our firm and unequivocal assertion is that the majority of serious disorders have their roots in clinical or sub-clinical allergies of a long duration. We have have demonstrated the accuracy and consistency of this premise beyond a shadow of doubt.

You might think that with all of this supposed "breakthrough" research, there would be some news reports, but I have found none. Google searches for the five "Solutions of Peptides" products found only the download link for the brochure. My PubMed search did not locate a single article authored by anyone named Kraucak. The "Oxford Centre of Molecular Immunology" does not appear to have a Web site, but I found a registry which stated that a company with that name was incorporated in 2003 and dissolved in 2006. When I looked up the street address given for the company, I found that it was a building that offered "high-quality fully furnished offices for one to six persons." [6] I have been unable to identify the manufacturer or distributor of the peptide products.

Other Providers

Robert M. Battle, M.D., who operates the Comprehensive Health Center in Houston, Texas, has been offering treatment with "Solutions of Peptides" since at least 2013. His Web site calls the products "neural peptides" and says "Medical researchers in the ancient university city of Oxford, England, in association with a group of their Swiss colleagues, completed a medical research venture, which had lasted for over twenty-five years." [7]

Jack T. Hinkle, D.O., a family practitioner who practices in St. George, Utah, states on a Web page that he is a member of the Oxford Institute of Immunology and "one of 28 American physicians trained in the use of sequenced amino acids to modulate the body's immune response to a variety of (auto)immune and allergic disorders."

The Advanced Rejuvenation Institute in Atlanta, Georgia, mentions SAAM on its Web site but provides no details. It is operated by R. Douglas Wichman M.D., who is described as a board certified radiologist who practices anti-aging medicine.

Relevant Laws and Regulations

Products marketed in interstate commerce for the prevention or treatment of disease are subject to federal regulation. Marketing a drug product without FDA approval is illegal. Section 321(g)(1) of the Federal Food, Drug, and Cosmetic Act defines "drug" as any article (except devices) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or function of the body." Regulation 201.5 require labeling to contain adequate directions for all intended uses. Labeling includes any written, printed or graphic material that accompanies a product. Intended use is determined by the facts at hand. Drugs not generally recognized as safe and effective by experts are "new" drugs. Marketing an unapproved (by FDA) new drug in interstate commerce is a federal crime. Marketing a drug without adequate directions for use is a federal crime (misbranding). It is also illegal to import drug products that lack FDA approval. I can find no record that the FDA has approved "Solutions of Peptides" as drugs. For this reason I believe it is illegal to market them in interstate commerce or import them into the United States for use as drugs.

Extracts used for the management of allergic conditions may be subject to different regulations. These extracts are sterile liquids manufactured from natural substances known to elicit allergic reactions in susceptible individuals. The products are currently manufactured in two forms: standardized and non-standardized. For the standardized allergen extracts, manufacturers compare the allergen extract to a U.S. reference standard for potency. There are currently 19 standardized allergenic extracts. Extracts for which there are no U.S. reference standards are called non-standardized extracts. Only six companies are licensed to manufacture them.

Generally speaking, allergenic extracts are biological products that must be licensed by by FDA for diagnosis, immunotherapy, or both. They are licensed only for use by injection (not for oral use). Licensure requires submission of an investigational new drug and/or biologics license application [8]. I can find no record that any such submission has been made or approved for the "Solutions of Peptides" products. Thus I believe it would be illegal to market any of them in interstate commerce or import them into the United States for use as as allergen extracts (food extracts).

The administration of allergen extracts to patients is subject to regulation by state licensing boards, which can determine whether their use is medically appropriate (meets the standard of care). In 2012, the Missouri State Board of Registration for the Healing Arts reprimanded James W. Willoughby II, D.O., for administering SAM treatment to three patients, one of whom was autistic. The consent order noted that Willoughby did not know where or how the product he used was manufactured, what was in the product, whether it was safe, and whether it was legally marketed [9].

I know of another case in which a physician injected "Solution of Peptides AL" into a child who had been improperly diagnosed with food allergies. The prevailing medical opinion is that allergy shots are never appropriate for treating food allergies [10,11].

Government Actions against Drs. Kraucak and Battle

In 2002, Kraucak pleaded guilty to filing a false income tax return and was fined $5,000 and ordered to pay $9,607 for restitution. The case involved under-reporting of his 1996 income. After he was sentenced, the Florida Department of Health (DOH) charged that his conduct had reflected "lack of honesty, integrity and judgment and an unwillingness to abide by law" that "directly relates to the practice or the ability to practice medicine." In 2002 he signed a consent agreement under which the Florida Board of Medicine reprimanded him, fined him $3,000 plus administrative costs, and ordered him to take ten hours of continuing medical education courses in ethics [12].

The Texas Medical Board disciplined Battle in 1990, 2006, and 2009. In the 1990 case, he was charged with treating patients with an unapproved "auto immune vaccine." In the 2009 case, he was accused of relying on "junk science" to support his diagnosis and treatment [13].

Request for Help

I am aware of no published evidence that SAM is safe and effective for the treatment of any health problem. Nor have I been able to determine who makes or distributes the SAM peptide products or teaches how to use them. If you encounter this information or anything else that you think would be relevant to this topic, please e-mail me.

References

  1. Services. Healthcare Partners Web site, accessed April 18, 2016.
  2. The latest breakthrough treatment for autoimmune disorders. Manila Bulletin, Nov 24, 2010.
  3. Bi-monthly conference call—Dr. Nelson Kraucak. World Wellness Education Web site, accessed April 19, 2016.
  4. Kraucak N. Interview. World Wellness Education Web site,
  5. Amino acids. Healthcare Partners, The Villages. Florida, revised April 21, 2015.
  6. Clarendon House. Novalog Web site, accessed April 17, 2016.
  7. Allergy therapy. Neural peptides: "tomorrow's medicine today" new therapy for the treatment of allergic diseases. Comprehensive Health Center Web site, archived Jan 3, 2013.
  8. Richards P. E-mail from FDA Center for Biologics Evaluation and Research to Dr. Stephen Barrett, April 15, 2016.
  9. Settlement agreement between the Missouri State Board of Registration for the Healing Arts and James Willoughby, II, D.O., effective May 22, 2012.
  10. Allergy relief for your child. FDA Consumer Health Information, Sept 2011.
  11. Allergy shots (immunotherapy). American Academy of Allergy Asthma & Immunology Web site, accessed April 18, 2016.
  12. Final order. Department of Health vs. Nelson Kraucak, M.D. Case No ME 2002-13239, Feb 25, 2003.
  13. Barrett S. Disciplinary actions against Robert M. Battle, M.D. Casewatch Web site, Nov 16, 2009

This article was revised on April 23, 2016.

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