Monday, August 2, 2010

Naturopaths & Silver

A student of mine who taught English in Japan liked to tell the story of how when he first arrived there and applied for jobs teaching English, he met several people who had studied English for years and spoke it with each other, only he, an American, had no idea what they were talking about. Seems their “English” had been passed down by teachers who weren’t native speakers and who had had little or no contact with native speakers.


Naturopaths (NDs) think of themselves as physicians and doctors as do several US states as well as a few governments in other countries. According to the website http://www.naturopathic.org/content.asp?contentid=57 of the American Association of Naturopathic Physicians, “Currently, 15 states, the District of Columbia, and the United States territories of Puerto Rico and the United States Virgin Islands have licensing laws for naturopathic doctors.” My state, Vermont, is one of them. In licensing NDs as physicians it grants them the legal right to call themselves doctors, practice “medicine”, treat patients and sometimes get reimbursed by insurance.


According to the website posted by a San Francisco naturopathic clinic, http://www.somaacupuncture.com/license-ND.html,: NDs are educated as general practitioners who specialize in natural medicine and focus on prevention and treatment of disease, and use a variety of treatment modalities such as nutrition, herbal medicine, homeopathy, and lifestyle counseling to restore and maintain good health. NDs can perform complete physical examinations including women's health exams and can order laboratory tests and diagnostic imaging.


Many NDs also try to make the point visually that they are doctors or practitioners of scientific or evidence-based medicine by decking themselves out in white coats, scrubs and stethoscopes, the traditional symbols of MDs, which they are not, even though visually the letters ND look very similar to MD. At least one Vermont ND prominently displays a caduceus, in her ads, http://www.drkowalsky.com/oncology/index.html, you know, “…two serpents criss-crossed around a staff topped by a round knob and flanked by wings” which “has been the symbol of the American medical profession for nearly a hundred years…” http://www.endicott-studio.com/rdrm/forcaduc.html


Many NDs also think of themselves as scientists and advertise themselves as such claiming that they use “science-based natural treatments”.


But like my student who didn’t recognize the English spoken by the Japanese, the vast majority of scientists and doctors who have spent many years studying scientific or evidence-based medicine don’t recognize ND’s treatments as being the least bit scientific or evidence-based and they don't recognize naturopaths as colleagues who practice scientific or evidence-based medicine. In their opinions and mine, NDs practice an antiquated, pre-scientific, belief-based type of medicine built on the philosophy that “Natural is good” and that “natural” things naturally benefit us. That philosophy is the only rational explanation I can think of for why silver, a naturally occurring element, is included in the 2009 Vermont Naturopathic Formulary, the list of substances NDs can use as drugs: http://www.vtprofessionals.org/opr1/naturopaths/info/Naturopathic Physician Formulary 20091211.pdf


On page 1 it reads: Antibacterial Agents: Topical And Ophthalmic Antibacteials: Silver Sulfadiazine Cream, Mupirocin, Neomycin, Chlorhexidine, Clioquinol, Colloidal Silver Preparations


On page 5: Minerals, their derivatives and compounds (May be administered IV): Manganese, Molybdenum, Nickel, Potassium, Selenium, Silicon, Silver, Tin, Fanadium, Trace Mineral compounds, Zinc.


If NDs knew anything about pharmacology or toxicology, neither colloidal silver nor silver ever would have made their list. If they knew how to review the medical literature and had done so, like I, who am neither a physician nor a scientist have done, they would know that colloidal silver is snake oil and that ingesting it is all risk and no benefit. They would know that: silver was used before the advent of antibiotics; it didn’t work; it discolored many people. The well known, well documented skin condition is called argyria. I have had argyria for over fifty years and have had a webpage warning of the danger and uselessness of ingesting silver for more than ten. http://rosemaryjacobs.com


If NDs had searched the medical literature as I have done, and as my FAQ tells others how to do, http://rosemaryjacobs.com/rose6.html#2, they would have found the warnings in the medical journals going back to at least 1919 alerting doctors and pharmacists to the fraudulent ads published by companies selling silver drugs in an era when the pharmaceutical industry was not regulated.


If they had used Google to search the Internet, NDs would have seen the warnings about the danger and uselessness of ingesting silver issued by the FDA, the National Center for Complementary and Alternative Medicine (NCCAM), many doctors, scientists and concerned human beings. Here are just a few:

http://nccam.nih.gov/health/silver/

http://www.fda.gov/OHRMS/DOCKETS/98fr/081799a.pdf

http://www.mayoclinic.com/health/colloidal-silver/an01682

http://www.drweil.com/drw/u/id/QAA363388 http://www.goldenberglaw.com/CM/PracticeAreaDescriptions/Colloidal_Silver-Argyria.asp


If NDs had read those warnings, they would have learned that silver has no known function in the human body, there is absolutely no reason to ingest it and it can permanently turn your skin gray, blue or even a metallic black.


If NDs had glanced at the news once in awhile, they would have caught at least one of the numerous media reports on The Blue Man, Paul Karason, who was even on Oprah or Stan Jones, the wacky Montana Libertarian, who is always running for office and always losing. Likewise they would have found both Paul, Stan and maybe me if they had googled “colloidal silver”. They certainly would have found all of us if they had googled “argyria”, but if they hadn’t reviewed the med. lit. they never would have learned the term “argyria” to google in the first place since it doesn't seem to have come up in any of the classes they took at naturopathic school.


Either NDs: don’t believe in scientific medicine; don’t believe in reviewing the medical literature, something all MDs and scientists are taught to do in their schools in order to learn what is known, unknown and suspected about the drugs they use or want to use; or else NDs simply have never learned how to review the med. lit. the way that real doctors and scientists have.


But what is their excuse for not seeing the NCCAM alerts? Since they call themselves “alternative medical doctors”, wouldn’t you think that they would have someone following and passing on all the information put out by NCCAM, the government agency setup specifically to study “alternative” and “complementary” medicine?


THEIR DEGREE OF IGNORANCE IS TRULY TERRIFYING. At least to me, a woman who was facially disfigured by an ignorant MD over 50 years ago, one who like the NDs of today, never read medical journals or verified the claims in the ads he read.


But it gets worse. At least I think it does. I’m not a lawyer. I could be wrong. However, looking at the rules governing the VT ND formulary http://healthvermont.gov/regs/naturopath_rules.pdf, my guess is that the naturopaths are violating them since section 3.2 states that their formulary may not include substances “prohibited by other Vermont or federal law.” If my interpretation is correct, they are either ignoring or ignorant of the rule the FDA posted in the FR (Federal Register) stating that: “…all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.” [Federal Register/Vol. 64, No. 158/Tuesday, Aug. 17, 1999/Rules & Regulations, p. 44653-44658] http://www.fda.gov/OHRMS/DOCKETS/98fr/081799a.pdf


What other explanation is there besides ignorance of the FDA rule that would explain the listing of “colloidal silver preparations” and “silver” in the formulary and in section 15 c of this same rules document which states that NDs can use “Topical antibiotics - Silver sulfadiazine cream, colloidal silver preparations”? Silver sulfadiazine is an FDA approved topical drug. So there is no problem with violating the rule there, but there are no FDA approved “colloidal silver preparations” and there is a specific rule stating that colloidal silver preparations are “misbranded” which is FDA-speak for saying that drug claims cannot legally be made for them.


When I learned that the NDs in my state included silver in their formulary, I contacted their licensing board at the Secretary of State’s office about my concerns. They forwarded them to the naturopathic advisor who, in my opinion, simply brushed them off completely failing to understand how disturbed I am and how frightened I am about the danger he and his colleagues are subjecting their patients to. THE THING THAT FRIGHTENS ME FAR MORE THAN THE INCLUSION OF SILVER IN THE ND FORMULARY IS THE ASTOUNDING DEGREE OF IGNORANCE AND LACK OF CONCERN ON THE PART OF PEOPLE LICENSED TO TREAT PATIENTS AND PERMITTED TO CALL THEMSELVES DOCTORS WHICH THEY HAVE DEMONSTRATED BY THEIR INCLUSION OF SILVER IN THEIR FORMULARY. I also worry about the other substances listed in the formulary which sound bizarre to me, but which I presently lack the expertise to evaluate.


The correspondence in question follows. Judge for yourself whether or not my views are correct and my fears well founded.


From: Rosemary Jacobs

Subject: VT Naturopathic Formulary

Date: May 24, 2010 2:21:17 PM EDT

To: Terry Gray


Dear Mr. Gray, I have questions about the Vermont Naturopathic formulary: http://www.vtprofessionals.org/opr1/naturopaths/info/Naturopathic Physician Formulary 20091211.pdf

My questions specifically relate to the following excerpts:

QUOTE:

“Use of medications included in the following formulary is limited to FDA approved indications, routes and dose regimens. However, ‘off-label’ indications, routes and dose regimens may be prescribed for patients and conditions the naturopathic physician is competent to treat based on that physician’s training and experience. ‘Off-label- shall conform to the generally acceptable standards of practice, including safety and efficacy, for both allopathic and naturopathic practitioners. See, generally, Food and Drug Admin., Guidance for Institutional Review Boards and Clinical Investigators 1988 Update: ‘Off-Label” and Investigational Use of Marketed Drugs, Biologics and Medical Devices, http://www.fda.gov/oc/ohrt/irbs/offlabel.html.

snip

p. 1

Antibacterial Agents: Topical And Ophthalmic Antibacteials: Silver Sulfadiazine Cream, Mupirocin, Neomycin, Chlorhexidine, Clioquinol, Colloidal Silver Preparations

snip

p. 5

Minerals, their derivatives and compounds (May be administered IV): Manganese, Molybdenum, Nickel, Potassium, Selenium, Silicon, Silver, Tin, Fanadium, Trace Mineral compounds, Zinc.

END QUOTE.


Questions: How can NDs use “colloidal silver preparations” as topical or ophthalmic antibacterials and how can they administer silver IV when:

· The FDA issued a rule in the Federal Register stating, “…that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.” [Federal Register/Vol. 64, No. 158/Tuesday, Aug. 17, 1999/Rules & Regulations, p. 44653-44658] http://www.fda.gov/OHRMS/DOCKETS/98fr/081799a.pdf

· The FDA’s Pharmacy Compounding Advisory Committee (5/7/99) advised against including Mild Silver Protein (MSP), a type of colloidal silver, on the list of bulk substances that pharmacists are permitted to manufacture. Compounding pharmacists had wanted to be able to compound MSP specifically for ophthalmic use. http://www.fda.gov/ohrms/dockets/ac/99/minutes/3513m1.pdf

· The NCCAM (National Center for Complementary and Alternative Medicine) has warned consumers about silver supplements. http://nccam.nih.gov/health/silver/

· Many others including doctors and scientists have issued similar warnings. Here are 3. http://www.mayoclinic.com/health/colloidal-silver/an01682; http://www.drweil.com/drw/u/id/QAA363388; http://www.goldenberglaw.com/CM/PracticeAreaDescriptions/Colloidal_Silver-Argyria.asp


A review of the links I am providing shows that silver is dangerous. It can discolor a person’s skin (argyria) and eyes (argyrosis). It is also useless when taken internally. Argyria is well known and well documented in the scientific medical literature. There was even a book written about it in 1939 called Argyria. I have had argyria for over fifty years. When I first learned that silver, often called “colloidal silver” or “CS”, was being sold as a dietary supplement, I predicted that new cases would soon appear. Salesmen said I didn’t know what I was talking about. Unfortunately, they were wrong. There are now many cases of argyria caused by silver supplements of which Paul Karason’s case is the best known. http://abclocal.go.com/kfsn/story?section=news/local&id=5843725. You will find other cases if you search PubMed, http://www.ncbi.nlm.nih.gov/PubMed using the term “argyria” or “colloidal silver”. I have had a webpage posted for about 10 years warning the public about the danger and uselessness of ingesting silver. http://rosemary@rosemaryjacobs.com I presented oral and written testimony to the FDA advisory committee cited above. http://rosemaryjacobs.com/msp.html http://rosemaryjacobs.com/PharmacyCompounding.html


In light of this how can any health care provider use silver on patients? How can anyone administer silver IV? How can it be included in a legally recognized formulary? I do not have the expertise to evaluate the other items in the Vermont ND formulary but suggest that you ask a medical scientist like a pharmacologist or toxicologist to do so because I find the idea of naturopath's using silver, especially IV, terrifying. It shows a complete and utter lack of knowledge of the basics of the pharmacology and toxicology of silver as well as of the FDA’s rulings about it, things which I think anyone using a substance to treat patients with should know backwards and forwards before even considering its use and because the idea of deliberately putting things like tin into the human body sounds to me as if it could be as bad or worse than doing that with silver. Thank you.

[address & phone #]


Rosemary

http://rosemaryjacobs.com

http://www.webanstrich.de/rosemary/


From: Terry Gray

Subject: FW: VT Naturopathic Formulary

Date: May 27, 2010 7:27:27 AM EDT

To: Rosemary Jacobs


Rosemary: I have forwarded your email to our Naturopathic Advisor for their input. Below is their response. I will keep your information for review of the Advisors. Thank you. Terry


Sent: Wednesday, May 26, 2010 5:10 PM

To: Terry Gray

Subject: Re: VT Naturopathic Formulary


Terry, This is interesting. Antibiotics are not allowed to be administered IV which includes colloidal silver. In the minerals section it says "may be administered IV". The list of minerals is an example of minerals that are prescribed, some but may used IV. Silver is not intended to be administered IV. Other minerals are meant to be administered IV. There are no NDs in the state that I know of administering silver IV. Silver is generally used in medicine as a topical antimicrobial in other forms than the colloidal form and we will consider updating the language of the formulary to reflect this. None the less, you should probably respond thanking her for her comments which we will take into consideration as we annually update the formulary which is done with the opportunity for review of professionals from other professions.

Sam


From: Rosemary Jacobs

Subject: Re: VT Naturopathic Formulary

Date: May 27, 2010 9:50:26 AM EDT

To: Terry Gray


On May 27, 2010, at 7:27 AM, Terry Gray wrote:

I have forwarded your email to our Naturopathic Advisor for their input. Below is their response. I will keep your information for review of the Advisors. Thank you.


Terry, thank you for getting back to me. If I understand correctly, the VT Health Commissioner who is an MD has oversight of the ND formulary. Please forward my emails and the advisor's responses to her. There is a very serious problem here that she may not be aware of.


Sent: Wednesday, May 26, 2010 5:10 PM

To: Terry Gray Subject:

Re: VT Naturopathic Formulary


This is interesting.


It may be interesting to Sam. To me it is terrifying - terrifying that NDs have included silver in their formulary and terrifying that the information I sent appears to have been previously unknown to them.


Antibiotics are not allowed to be administered IV which includes colloidal silver.


Sam seems to have misunderstood me. "Minerals" are permitted to be administered IV (p.5 of the formulary) and I assume that they can be given orally too and, the formulary specifically lists "silver" as one of the minerals that can be given this way. This in spite of the fact that silver has no known function in the body, offers no benefits when taken internally and is dangerous when taken internally. http://www.fda.gov/OHRMS/DOCKETS/98fr/081799a.pdf http://nccam.nih.gov/health/silver/


The formulary, p. 1, also permits the topical and ophthalmic use of "colloidal silver preparations" even though the FDA forbids both uses and that putting any form of silver in the eye can permanently discolor it. http://www.fda.gov/ohrms/dockets/ac/99/minutes/3513m1.pdf http://www.fda.gov/OHRMS/DOCKETS/98fr/081799a.pdf


In the minerals section it says "may be administered IV".


"May be administered IV" means that it is legally permissible for NDs to administer it IV. Why would it be legally permissible, especially for people seeing patients, to put a substance into a human being when that substance is known to be dangerous and has no known physical function? Why would NDs want that legal right to do that? This is what truly terrifies me.


The list of minerals is an example of minerals that are prescribed, some but may used IV.


Does that mean that NDs can prescribe other minerals not specifically named in the formulary?


Silver is not intended to be administered IV.


Then why on earth does the formulary permit it to be used that way? Why would NDs even consider including it in their formulary when it is dangerous and useless? I suspect it is because they didn't know any of that until they got my email. Once more. That is what is terrifying. What else are they using that is useless and dangerous? And do they administer silver orally or tell patients to take it orally? I assume that including it by name in the mineral section of the formulary (p.5) that they do, but if not, they have obtained the legal right to do so by listing it in their formulary. Do they sell silver supplements to the patients they see? Do any of them manufacture silver supplements?


Other minerals are meant to be administered IV. There are no NDs in the state that I know of administering silver IV.


Thank God he doesn't know of any, but that doesn't mean that there aren't any. Furthermore, right now any of them who wanted to could. And again are there NDs selling, giving or advising people to take silver internally such as by mouth?


I don't think Sam realizes the degree of my concern. Unless the NDs can present solid scientific evidence demonstrating that the FDA and scientific community are wrong about the danger and uselessness of taking silver internally and putting it in the eye, it should be removed immediately from the formulary. Including it there puts people at risk and exhibits an utter lack of knowledge that NDs have about the safety and efficacy of the substances they use to treat patients with.


Again, please ask a medical scientist to review the formulary to see if there are other dangerous products on it besides silver and please forward this correspondence to the Health Commissioner who may have overlooked silver and other dangerous or useless products.


Terry, I am not a crank. I am a woman who has been facially disfigured for over fifty years ago by snake oil that NDs in my state are legally allowed to use on human beings in spite of the overwhelming scientific evidence demonstrating that ingesting silver is at best useless and at worst harmful! I can't put into words how much this terrifies me. I am also very concerned about the other products NDs in their ignorance my be using on people and intend to do all that I can to alert the public to the problem. I will also gladly meet with and discuss this issue with anyone who is interested.


I was a trustee, water and sewer commissioner for the little village of Derby Center for 7 years serving 3 terms and refusing to run for a fourth. (Agreeing to run when everyone else was smart enough to refuse is one of the dumbest things I've ever done, but if you check with the village, I am sure they will tell you that I am not a crank and that my concerns about silver are very real and both rational and reasonable.)

Thank you so much for your help to date. I really appreciate it.


Rosemary

http://rosemaryjacobs.com

http://www.webanstrich.de/rosemary/

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