Barbara Brewitt Ordered to
Curb Homeopathic Marketing
Stephen Barrett, M.D.
The Washington Department of Health has ordered Barbara Brewitt and her company Biomed Comm, Inc. to stop manufacturing drug products without a license. The Temporary Order to Cease and Desist, shown below, also directs her to stop representing herself as a medical doctor. Documents in the case state that
- Biomed manufactures and markets homeopathic products for conditions including Alzheimer’s disease, autism, cancer, menopausal symptoms, attention deficit hyperactivity disorder (ADHD), and HIV/AIDS;
- Brewitt represented herself as a medical doctor more than 20 times to a Seattle-based pharmacy in order to obtain Norditropin, a growth hormone drug used in Biomed Comm's manufacturing process; and
- Brewitt holds a Ph.D. in biological structure but possesses no medical degree.
- Inspections of her manufacturing facility revealed multiple law violations. On one occasion, Brewitt hid materials in her car that she did not want the inspector to see.
The health department plans to notify firms that bought products for retail sale that the products are unapproved.
Biomed Comm's is described on its Web site as "a small Seattle biotechnology company that sells small proteins that tell an aging body to begin making and repairing cells, a process that sparks internal rejuvenation." Its products include “Cell Signal Enhancer – Human Growth Hormone;” “Athletic Edge;” and “Naturally hGH." According to the site:
Sold in pill form and requiring no prescription, . . . cell signalers are sparking a new classification of medicine. In clinical studies, patients have reported increased memory, focus and energy, stronger heart and immune systems, relief from stress and headaches, weight loss, increased muscle mass and improved sleep, among other factors. Biomed’s cell signalers are being taken by autism and HIV (AIDS virus) patients as well as baby boomers who want to stave off aging.
Some of Biomed's claims violate the FDA Compliance Policy Guideline that restricts the labeling of nonprescription homeopathic drugs to self-limiting conditions readily diagnosable by consumers. The Department of Health's investigation was triggered by a complaint from a former employee who stated that many of the products were mixed by Brewitt herself in her own kitchen as she chanted over a crystal bowl.
STATE OF WASHINGTON
DEPARTMENT OF HEALTH
SECRETARY OF HEALTH
UNLICENSED PRACTICE PROGRAM
In the Matter of the Unlicensed Practice
BARBARA BREWITT, individually and
TEMPORARY ORDER TO
This matter came before Health Law Judge John F. Kuntz, Presiding Officer on February 3, 2006 on the Ex Parte Motion for Temporary Cease and Desist Order by the Unlicensed Practice Program Manager (the Program), Designee of the Secretary of the Department of Health (Secretary), represented by and through Dorothy H. Jaffe, Assistant Attorney General. The Presiding Officer, having reviewed the motion and the documents submitted in support of the motion, hereby enters the following:
Section 1: FINDINGS OF FACT REGARDING UNLICENSED PRACTICE ALLEGATIONS
The Program has issued herein a Notice of Intent to Issue a Cease and Desist Order based upon the investigative report of the Board of Pharmacy Investigator Stan Jeppesen, whose declaration tiled therewith provides evidence to support the following findings:
1.1 Barbara Brewitt (the Respondent) has never been licensed to practice medicine in Washington State, and has held no other health care credential in Washington State during the relevant time period discussed herein.
1.2 The Respondent is the founder, Chief Executive Officer, and Chief Scientific Officer of Biomed Comm, Inc., a business currently operating in the state of Washington.
1.3 The Respondent possesses no medical degree or designation but does hold a Ph.D. in the field of Biological Structure.
1.4 On or about August 29,2005, the Respondent applied to the Board of Pharmacy for a license to manufacture drugs in the state of Washington. That license has not been granted.
1.5 Since approximately 1996, the Respondent (dba Biomed Comm, Inc.) has manufactured (in part or total) drug products in the state of Washington. The finished products have been sold in the state of Washington, throughout the United States and internationally. The drugs are marketed as treatment for numerous conditions including, but not limited to, Alzheimer's, autism, cancer, menopausal symptoms, ADHD and HIV/AIDS.
1.6 Between at least August 2002 and October 2005, the Respondent fraudulently presented herself as a medical doctor to Ballard Plaza Pharmacy located in Seattle, Washington, in order to obtain Norditropin, a legend drug used in the manufacturing process.
Section 2: FINDINGS OF FACT REGARDING RISK OF IRREPARABLE HARM
The Program has filed a Motion for the Issuance of a Temporary Cease and Desist Order based upon the investigative report and declaration of the Board of Pharmacy investigator Stan Jeppesen, whose declaration filed herewith, provides evidence to support the following findings:
2.1 Current Circumstances: At the current time, the evidence establishes:
2.1.1 The Respondent is manufacturing drug products in the state of Washington. The products contain, inter alia, diluted forms of the legend drug Norditropin, human growth hormones and/or other active ingredients intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or function of the human body.
2.1.2 The Respondent's marketing materials claim that her products treat a variety of serious medical conditions and disorders including but not limited to autism, cancer, ADHD, and HIV/AIDS.
2.1.3 The Respondent is marketing and selling the drug products in the state of Washington and elsewhere utilizing three strategies--direct personal sales, distribution through retail outlets such as Costco, and internet sales.
2.1.4 The Respondent is aware that a license to manufacture drugs is required by the Board of Pharmacy acting on behalf of the Department of Health.
2.1.5 The Respondent has fraudulently presented herself as a medical doctor in order to obtain Norditropin, a legend drug used in the manufacture of the Respondent's products.
2.2 Risk of Harm:
2.2.1 The state's regulatory statutes and rules generally guarantee the quality of drug products manufactured within its jurisdiction. Those rules address the minimum standards for manufacturing, such as: facilities, equipment, production, control procedures, packaging, labeling, stability, expiration dating, and distribution records. The Respondent's products are manufactured, marketed, and distributed to patients without any safeguards, guarantees, or adherence to the Board of Pharmacy requirements. This presents a substantial risk of harm to the health and well-being of the public.
2.2.2 The claims made by the Respondent regarding the usefulness and efficacy of her products, which have never been approved by the Food and Drug Administration, the Homeopathic Pharmacopeia of the United States, or other regulatory body, are designed to encourage the patient's reliance for treatment. Although the Respondent's products are not known to inflict actual harm to patients, a real risk exists that patients will forego effective treatment in favor of untested and questionably manufactured drugs.
2.2.3 The Respondent's intentional misrepresentation of herself as a medical doctor is indicative of her general disregard for the rules and laws of this state which are designed to protect the health, safety, and well-being of the public.
2.4 Conclusion: The Respondent's actions are a hazard to the public and immediate issuance of a temporary cease and desist order is necessary to avoid irreparable harm. The public cannot be adequately assured that the Respondent will not continue to endanger her clients and disregard the professional health care laws and regulations of the state of Washington without the force of a temporary cease and desist order.
Section 3: CONCLUSIONS OF LAW
3.1 The Secretary has jurisdiction over the Respondent's unlicensed practice of medicine and drug manufacturing in the state of Washington.
3.2 The Secretary is authorized under RCW 18.130.190(4) of the Uniform Disciplinary Act to issue a Temporary Cease and Desist Order.
3.3 The Findings of Fact in Section 1 were established on an ex parte basis by clear and convincing evidence for the issuance of an order to cease and desist the unlicensed practice of medicine and drug manufacturing against the Respondent.
3.4 The above Findings of Fact in Section 2 were established on an ex parte basis by clear and convincing evidence that the public interest will be irreparably harmed by delay in issuing a cease and desist order against the Respondent.
Section 4: ORDER
Based on the above Findings of Fact and Conclusions of Law, the Secretary enters the following Order:
4.1 IT IS HEREBY ORDERED that Respondent Barbara Brewitt, individually and dba Biomed Comm, Inc., immediately CEASE AND DESIST from the practice of medicine and drug manufacturing without a license. This temporary cease and desist order shall remain in effect until further order of the Secretary.
4.2 The Respondent shall be provided an opportunity for a prompt hearing or to request a regularly scheduled hearing.
4.3 If the Respondent fails to timely request a prompt or regularly scheduled hearing, then the Respondent will be in default and the Secretary may enter a permanent
Dated this 3rd day of February, 2006.
JOHN F. KUNTZ, Health Law Judge
This page was posted on April 9, 2006.