Friday, October 23, 2015

Naturopathy's Clinical Experimentation in Connecticut and FDA Regulations Regarding "Clinical Trials and Human Subject Protection"

here, based on what's written in the ND Zampieron co-authored book "Arthritis: The Alternative Medicine Definitive Guide" (2000, 2006), I muse on the topic of possible unauthorized medical experimentation in naturopathy clinics in Connecticut:

001. we're told in the ND Zampieron co-authored book "Arthritis: The Alternative Medicine Definitive Guide" (ISBNs 1887299157, 9781887299152; 1587612585 9781587612589)[my comments are in unquoted bold]:

“first, we [the authors] prescribed the homeopathic remedy Streptococcinum 200C at three sublingual pellets, once a day between meals, for one month. We also prepared an oral auto-sanguis nosode […] in auto-sanguis dilution therapy, small doses of the patient's blood are prepared as a homeopathic remedy and administered to the patient. The effectiveness of this therapy relies on the homeopathic principle that small doses of a substance that in large doses causes disease symptoms can help to reverse the disease […] through the following method: an extraction of a small amount of Yvonne's blood was placed in a centrifuge for 20 minutes; then, one part serum was mixed with nine parts Willard's Water […] the mixture was shaken vigorously 100 times. This process produces a homeopathic nosode at 1X potency. To increase the potency of the nosode, the process was repeated six times, rendering the remedy at a potency of 6X; we added 15% ethyl alcohol to stabilize the solution. We instructed Yvonne to place ten drops of this solution under her tongue three times a day. Upon her second visit, we increased the potency of the original nosode to 12X potency; her third visit to 30X potency; and finally to 60X potency […] we then mixed into the same syringe 1 cc of the homeopathic nosodes Streptococcus viridans-injeel and Streptococcus haemolyticus-injeel, and 1 cc of the homeopathic remedies Traumeel and ZEEL (indicated for inflammation and degenerative processes). The mixture was agitated 20 times rendering a solution at 1X potency and was injected into her buttock. The process was repeated to produce a remedy of 2X potency and injected as well. Yvonne returned for treatment once a week for one month. During this time, injections reached a potency of 4X.”

now, it sounds to me like an invented therapy being experimentally used without authorization by the Federal government.  ND Zampieron's practice is in Connecticut.  When I search the book I've OCR'd, I don't find the terms "ethic", "Federal", or "permission."  "Trial" produces an interesting p. 289 result.  We're told: "clinical trials are under way at the Naturopathic Medical Center of Middlebury, Connecticut." Now, "Naturopathic Medical Center" produces this search result from the book's end notes: "based on clinical observations of Eugene R. Zampieron, ND., A.H.G., Naturopathic Medical Center, Middlebury, CT (1993-1998)."  So, a claimed TRIAL at ND Zampieron's practice is what I glean from this.  So, have ND Zampieron's trials been done the way, legally aka Federally, trials have to be done?

002. the FDA says:

002.a. in "Clinical Trials and Human Subject Protection":

"adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects [...] the Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP.  These FDA regulations and guidance documents are accessible from this site."

sounds reasonable to me.  And it also sounds mandatory.

002.b. in "Step 3: Clinical Research":

"while preclinical research answers basic questions about a drug’s safety, it is not a substitute for studies of ways the drug will interact with the human body. 'Clinical research' refers to studies, or trials, that are done in people. As the developers design the clinical study, they will consider what they want to accomplish for each of the different Clinical Research Phases and begin the Investigational New Drug Process (IND), a process they must go through before clinical research begins.  On this page you will find information on: Designing Clinical Trials, Clinical Research Phase Studies, The Investigational New Drug Process,Asking for FDA Assistance,FDA IND Review Team, approval [...] approval: the FDA review team has 30 days to review the original IND submission. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials [...] FDA can place a clinical hold for specific reasons, including: participants are exposed to unreasonable or significant risk [...or] investigators are not qualified [...or] materials for the volunteer participants are misleading [...] if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study."

so, there be some serious mandatory steps involved with a drug's development and its testing or experimentation on people.

003. ethical implications:

if this happened, I'm truly nauseated.

with homeopathy so implausible and ineffective, there's truly almost ZERO -- because we can't be absolute, scientifically-speaking -- ZERO likelihood that there can ben patient benefit from a homeopathy therapy.  So, the therapy itself is UNREASONABLE.  And here it is injected!  It's not even 'merely oral'.  And there is risk merely with injection of pharmaceutical-grade sterile saline, never mind blended mysterious homeopathic voodoo juices someone cooks up in their ND clinic and decides is worthwhile.

so, I don't think, even if the proper permissions were obtained, that this therapy could have any ethical justification.

now, naturopaths get to invent and employ whatever they so please, without sanction.

so isn't every naturopathic patient contact experimental and a violation of ethical stricture?

the subject, Yvonne, by the way in the book [both editions], is stated as being ONLY 13 years old.
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