IHR Journal 2018 Edition
Rima E. Laibow, MD
Abstract: Rima E. Laibow, MD addresses, from her nearly half century of clinical experience as a psychologist and physician, the profound disorder of autism. This paper expresses Dr. Rima’s view of the autism tragedy and the autism spectrum. She reviews the toxic environment that leads to the disorder and she establishes the necessary conditions for the development of therapies to address autism and its cure. She concludes: “Even if every external cause of autism, including vaccination and toxic chemicals, were to vanish from our world tomorrow, the autistic casualties of their use would not similarly vanish. We have among us millions and millions of chemically and vaccine damaged individuals, often then further damaged by drugs and more chemicals. And yet, do they not deserve our compassionate care?”
Comments to FDA at Regulations.gov on Homeopathy Guidance
Rima E. Laibow, MD and Ralph Fucetola JD
In re: Drug Products Labeled as Homeopathic } COMMENTS REGARDING
Draft Guidance for Food and Drug } FDA GUIDANCE
Administration Staff and Industry } FDA Docket FDA-2017-D-6580
Abstract: Rima E. Laibow, MD and Ralph Fuctola JD comment on the proposed FDA Guidance.
- The Food and Drug Administration (FDA)’s attempt to restrict the development of homeopathy by applying pharmaceutical drug “risk/benefit” analysis was never authorized by Congress.
- FDA is required to conduct evaluations using appropriate methodological methods and tools. “Risk/Benefit” Analysis is a methodologically inappropriate tool when any potential benefit has been assumed, a priori, to be zero, as in the FDA’s use of “risk/benefit”.
- Biological individuality precludes the application of standard pharmaceutical “risk/benefit” analysis. One of the central premises upon which classical homeopathy is based is that biological individuality must be accounted for in order to apply a remedy for a clinical benefit. the proposed “risk/benefit” evaluation of this medical art which precludes consideration and evaluation of biological individuality is impossible, rendering “risk/benefit” analysis invalid in this application.
- “Risk/benefit” analysis is valid only when all variables are controlled for but this is impossible both in Holistic Health and in homeopathic interventions since the personalization of the requirements of each individual’s needs are so particularistic to preclude valid comparison or control subjects using the diagnostic schema of the systems themselves. Application of other diagnostic schemata for evaluation of “risk/benefit” values is a logical absurdity and renders any “risk/benefit” analysis meaningless, even if the presumption of zero benefit is nullified.
- Holistic health care, such as homeopathy, is not a proper subject for standard pharmaceutical “risk/benefit” analysis because it is not unitary and is highly personalized.
- Pharmaceutical care similarly becomes an improper subject for “risk/benefit” analysis once a single drug is no longer the subject of the evaluation and the subject has entered the realm of polypharmacy.
- The Homeopathic Pharmacopeia of the United States (HPUS) remains the appropriate non-governmental source of substantiated Homeopathic Provings.
- Homeopathic remedies are specifically protected by law (Citation) from being evaluated or regulated as if they were pharmaceuticals. The attempt by the FDA to do so is outside the regulatory and legal authority of that agency.
- FDA lacks the legal authority to curtail access to, sale or use of Homeopathic remedies since they are part of the English Common Law Tradition as a protected under the Herbalists Charter.
- The Case Law of the several States is clear: Americans have the right to seek to achieve and maintain a healthy status using means that are not part of standard, licensed medicine approved by Federal Agencies.