Be Wary of Russell Roby, M.D. and the Roby Institute


Stephen Barrett, M.D.
January 18, 2017

Russell R. Roby, M.D., J.D., who operates the Roby Institute in Austin, Texas, would like you to believe that he is “a pioneer in the fields of hormone allergy and hormone therapy treatment.” According to the institute’s Web site:

Through years of trials, tests, research and results, Dr. Roby has found that the human body may in fact develop an actual allergy to its own hormones. These allergies often result in hormone imbalance, weight gain, fatigue, pain (fibromyalgia, arthritis, interstitial cystitis), asthma, and other symptoms that greatly diminish an individual’s quality of life. Dr. Roby’s use of sublingual dilutions of hormone solutions to neutralize and treat these symptoms has resulted in countless individuals living pain-free for the first time in years. Relief occurs within seconds of the administration of the proper dilution using Dr. Roby’s methods. The sublingual dilutions may be self-administered at home, reducing the need for visits to the doctor’s office. The dilutions are tailored to the patient’s individual needs and monitored regularly to help the patient achieve optimal health [1].

In 2007, the site also stated:

One of the treatments involves the use of homeopathic dilutions of substances patients are reacting to in an allergic fashion. For the last one hundred years physicians have used very weak solutions of the very substances they suspected of causing the reaction, to stop the reaction they are suspected of causing. Conventional allergists use dilutions of up to 1:1,000,000 parts, as do Pan American Allergy Society physicians. I have found far weaker dilutions to be amazingly effective not only in diagnosing a wide variety of symptoms, but also in quickly reversing these symptoms [2].

Roby has received a patent for “methods and composition for the treatment of pain and other hormone-allergy-related symptoms using dilute hormone solutions.” [3] In 2008, his Web site stated that he had about ten more patents pending or “under study and review” for treating multiple sclerosis, autoimmune diseases, obesity and several other conditions [4]. However, patents can be granted for inventions and procedures that differ from previous patents. However, evidence of effectiveness is not required, so the granting of a patent do not mean that a procedure works.

Despite his “years of trials, tests, and research,” Roby has had only four reports in scientific journals during the past 35 years. One report, published in 2006, concluded that antibodies exist to estrogen and progesterone and that “this leads to the possibility of treating a wide variety of disorders by determining hormone allergy and initiating desensitization.” [5] The study involved blood tests performed by a laboratory that does nonstandard testing and was cited by state authorities for inadequate quality control. (The lab’s director was a co-author of the article.) Even if such allergies exist, there’s no logical reason to believe that Roby’s “hormone neutralization therapy” could cure them. The other three reports, published in 1979, concerned a 12-month investigation of the incidence of fungal spores in the homes of allergic patients in an agricultural community.

Government Actions

Roby has an extensive history of adverse government actions.

  • Roby’s California medical license was revoked because of drug and alcohol abuse.
  • In 1983, the Texas Medical Board revoked and cancelled his medical license for the same reason.
  • In 1984, his license was reinstated and he was placed on probation that required him to participate in an Alcoholics Anonymous program and continue psychiatric care.
  • In 1989, he was charged with failure to maintain adequate records, reporting inconclusive allergy tests as positive, and billing insurance companies for allergy treatments he had not performed. After upholding these charges, the Texas board added probationary terms forbidding him from continuing to do these things [6].
  • In 1990, the board apparently concluded that Roby’s performance had improved and ended his probation.
  • In 2004, Roby consented to an agreed order under which he was reprimanded for failing to obtain informed consent from a patient to whom he administered “dilute tetanus toxoid” injections to treat a bacterial infection. The order called for his practice to be monitored for a 12-month period [7].

In 2006, the Texas Medical Board filed a complaint which stated:

  • Roby’s “hormone neutralization” therapy involves a process in which oral syringes are used to place a liquid solution containing a dilution of hormones under patients’ tongues.
  • Roby states that “neutralization” of progesterone with homeopathic concentrations leads to relief of pain, fatigue, viral colds, Temporo-Mandibular Joint Dysfunction (TMJ), depression, migraine, asthma, loss of sex drive, and many other disorders.
  • Roby claims that pain relief from his sublingual drops occurs faster than the circulation time required for the solution he uses to get to the brain or body part. He fails to explain or substantiate how pain relief from the hormone neutralization occurs faster than the circulation required to get to the brain or body part.
  • Roby does not perform controlled skin or patch tests to demonstrate functional sensitivity reactions. . . .
  • One type of dilution he uses in the “hormone neutralization therapy” is a dilution of progesterone, which he states is a 10 to the 30th dilution. [Solutions of this type are so dilute that they are unlikely to contain a single molecule of the original substance.]
  • Roby had no evidence that there are any other medical practitioners in Texas or in the United States who utilize or espouse the effectiveness of the progesterone neutralization therapy he uses.
  • There is no scientific evidence that “hormone neutralization therapy” has any medical validity. He has not demonstrated that it works or has any science-based rationale.
  • Roby’s advertising about the effectiveness of his treatment is misleading.
  • Roby is not board certified in allergy and immunology. A resumé states that he has had some training in these subjects, but it does not provide sufficient detail to enable people to check or make an informed decision [8].

In 2007, the board fined Roby $15,000 and placed him on four years’ probation with advertising and practice restrictions. The provisions include:

  • His practice must be monitored by another physician designated by the board.
  • He shall not treat any patient with thyroid therapy.
  • He must provide copies of all proposed or on-going research to the board.
  • Any advertisement or infomercial must plainly disclose that his methods are not FDA-approved and have not been verified by any type of objective testing [9].

In 2011 the board determined that Roby had entered into a sexual relationship with a patient, violated a 2007 agreed order by not disclosing all the ingredients in a non-FDA-approved formulation (sublingual allergy drops) he had used, failed to use diligence in his practice, and did not maintain adequate medical records. Roby and the board then entered into an agreed order under which he was publicly reprimanded, ordered to pay a $3,000 administrative penalty, and required to (a) complete the medical record-keeping and professional boundaries course offered by the University of California San Diego Physician Assessment and Clinical Education (PACE) Program, (b) complete eight hours of continuing medical education courses in ethics, (c) continue getting treated for bipolar disorder, (d) and demonstrate to the board that his written media, commercials, advertisements and other materials are in strict compliance with the disclosure requirement of his 2007 agreed order [10].

In 2012, the board charged that Roby had still not complied with the 2007 order by (a) failing to include the required disclaimer in his product promotions and (2) failing to implement record-keeping recommendations made by his monitoring physician [11]. In 2015, the board ordered him to:

  • Continue on probation for at least one year.
  • Increase the use and prominence disclaimers in his marketing and patient care.
  • Stop treating thyroid disorders.
  • Take 12 hours of approved continuing medical education courses in endocrinology.
  • Continue psychiatric treatment for his bipolar disorder.
  • Be closely monitored.
  • Demonstrate basic medical competence by passing the Federation of State Medical Board’s Special Purpose Examination [13].

In 2013, Roby was charged with billing Medicare and TRICARE for unapproved hormone therapy treatments, medically unnecessary services, services not rendered, and overutilization of procedures [13]. The case was settled with an agreement under which he was ordered to pay $1,318,392 and excluded from participating in federal healthcare programs for 20 years [14].

The Texas Medical Board Web site states that Roby’s medical license was “cancelled by request” in 2016 and is no longere active.

References
  1. Dr. Russell R. Roby granted patent for the treatment of hormone allergy. Roby Institute Web press release, March 25, 2007. Accessed online, Jan 18, 2017.
  2. Roby Institute Web site, accessed Oct 22, 2007.
  3. Roby R. Methods and composition for the treatment of pain and other hormone-allergy-related symptoms using dilute hormone solutions. Patent No. 7,179,798, Feb 20, 2007.
  4. Our patents. Roby Institute Web site accessed Oct 22, 2007.
  5. Roby RR, Richardson RH, Vojdani A. Hormone allergy. American Journal of Reproductive Immunology 55:307-313, 2006.
  6. Board order. In the matter of Russell R. Roby, M.D. before the Texas State Board of Medical Examiners. July 28, 1989.
  7. Agreed order. SOAH DOCKET NO. 503-12-8054.MD Entered Dec 10, 2004.
  8. Complaint. In the matter of the complaint against Russell R. Roby, M.D. before the Texas Medical Board. Filed April 26, 2006.
  9. Mediated agreed order. In the matter of the complaint against Russell R. Roby, M.D. before the Texas Medical Board. Entered Aug 27, 2007.
  10. Agreed order. In the matter of the complaint against Russell R. Roby, M.D. before the Texas Medical Board. Entered June 3, 2011.
  11. Complaint. In the matter of the complaint against Russell R. Roby, M.D. before the Texas Medical Board, August 23, 2015.
  12. Final order. In the matter of the complaint against Russell R. Roby, M.D. before the Texas Medical Board. Filed April 10, 2015.
  13. Complaint. USA v. the Roby Institute, Texan Allergy Clinic, and Russell Roby, M.D. U.S. District Court for themmWestern District of Texas, Austin Division. Filed June 28, 2013.
  14. Consent judgment. USA v. the Roby Institute, Texan Allergy Clinic, and Russell Roby, M.D. U.S. District Court for themmWestern District of Texas, Austin Division. Filed July 1, 2013.

This article was revised on January 18, 2017.