With the help of Michael Marcotte, a local state representative, who put me in contact by email with the Vermont State Health Commissioner, Harry Chen, MD I met with Chris Winters, a lawyer who is the Director of the state Professional Licensing Board, on July 13, 2011. This is a summary of our communications, mostly the relevant emails which I’ve edited for clarity by deleting repetitious material such as links contained in my email signature and private email addresses. Where an explanation was needed, I inserted it in parenthesis.
At our meeting in his Montpelier office, Chris was charming and professional. Since he had sent me an email saying that the naturopaths, NDs, were going to remove "colloidal silver" products, p. 3, from their formulary,
I specifically wanted to ask if they were going to remove "silver", p. 5, also. He said he didn't think so and asked me to explain the difference.
I told him that colloidal silver, CS, is the name usually used for silver dietary supplements. Supplements were put in a special legal category in 1994 with the passage of the Dietary Supplement Health and Education Act, DSHEA - pronounced duh shay. They are considered food under the law and for all practical purposes neither the FDA nor any other government agency has much jurisdiction over them. Unlike drugs, manufacturers do not have to present evidence of safety and efficacy before they sell them. Anyone can make a supplement although they are supposed to follow good manufacturing practices if they sell them to others. Under DSHEA, supplements are taken by mouth and it is illegal to make drug claims for them although "structure and function" claims can be made. I provided him with a copy of this article which gives a good summary of the subject.
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/05/10/FDCQ1788VE.DTL
I told Chris that I thought that including colloidal silver in the formulary was illegal because by including a supplement in a drug formulary a drug claim was being made for it. And since it appears that they were not administering it by mouth but rather topically and in the eye, they were illegally using a supplement as a drug. While anyone can make a supplement, I believe that only licensed pharmacists and licensed drug manufacturers can legally make drugs. I asked Chris if NDs are licensed as pharmacists in Vt and he said that they are not.
When pharmacists make drugs, they call it compounding. They are only permitted to compound drugs using substances on what the FDA calls the bulk drug list. I am pretty certain that silver isn't there, and I know there are no FDA approved drugs that contain silver which are used internally. There is an approved topical silver drug called silver sulphadiazine (SSD) which is also in the ND formulary. I said that I saw no problem with its inclusion since SSD is an approved drug with little potential for abuse.
I explained to Chris that the FDA has a rule in the Federal Register (FR) saying that silver cannot be used as a drug and gave him a copy of the relevant material regarding silver in "the Bible of Pharmacology", Goodman & Gilman, 5th edition, 1975 which I believe is the last or next to the last edition that includes silver as well as an article from Clinical Toxicology, 34(1), 119-126 (1996), Review Silver Products for Medical Indications: Risk-Benefit Assessment by Fung and Bowen, two FDA doctors. All these references explain that the active ingredient in CS is silver, that there is no reason to ingest silver and that doing so can result in discolored skin, argyria.
Since the introduction to the ND VT Formulary states that naturopaths will comply with federal law, I said I didn’t know how they could include silver in the formulary and I didn’t know where they could legally obtain it. I simply couldn’t understand how they could find a legal manufacturer of an illegal drug and I was especially concerned about the silver and other substances that they used intravenously since I believe that the laws for manufacturing IV drugs are very stringent due to the need that they be sterile.
I asked Chris if the NDs had given him the information I had requested about the formulation and manufacturers of the “minerals” which include silver that their formulary permits them to use intravenously. He said they had told him that they couldn't give him that info and that they got the substances from places they had always gotten them from.
I found that most disturbing for two reasons. First, how on earth can anyone be sure that they are safe without knowing the sources? Do NDs really expect the public to simply trust them on the matter? And second because of the double standard. MDs and most professionals are over regulated to the point where it sometimes becomes ridiculous, but NDs who have been granted the privileges to practice medicine like MDs, even though they lack their training, are a law unto themselves and not required to answer to anyone. What would happen if you asked an MD for the formulation, brand name and manufacturer of the drug he wanted to put in your vein and he said, "None of your business, Charlie"?
Regarding the other substances listed in the formulary under the category of minerals that may be used intravenously, I explained that NDs administering such things have to have evidence showing that they are needed, the amount or the normal range generally found in humans and the amount that is toxic. They also have to have reliable tests to quantify the amount in a person’s body as well as a source of the product from a legal manufacturer to administer in case of a deficiency. Regarding silver which is not an essential mineral, I knew quite well that they lacked this.
Chris wondered why no one had ever brought these concerns up before. I suspect it is because so very few people know that NDs are licensed as "primary care physicians" and granted the privilege of using prescription drugs, ordering diagnostic tests, doing physical exams and even injecting people with substances they believe are safe and beneficial without any evidence to support their beliefs. I for one would love to know how they ever got the privilege to act as "primary care physicians" with prescription privileges without my knowing it. I think it is another example of special interest groups having laws passed behind closed doors.
Correspondence
1.
From: Rosemary Jacobs
Sent: Monday, June 06, 2011
To: Chen, Harry
CC: George Till (I have never had contact with Dr. Till. I CCed him because I had read that he is a state rep and an MD.)
Subject: VT Naturopaths
Hi, Doctor Chen. I hope you see this since I doubt that the previous Health Commissioner saw the message I sent her. I got your email address from Rep. Mike Marcotte and am CCing this email to Dr. Till as well since I think the matter may also interest him.
Have you seen the still current 2009 VT Naturopathic Formulary which I believe your predecessor was supposed to have reviewed before it was approved?
I was horrified when I saw it. Although I am not an MD or a scientist, I suspect that some of the substances it contains are very dangerous and that many are useless. I can't imagine why anyone would use things like nickel, molybdenum or tin intravenously (p.5). I also wonder what formulations they are used in and who manufacturers them. While I don't know, I seriously doubt that they are on the list of bulk substances pharmacists are allowed to use for compounding.
Silver for IV use and colloidal silver for use in the eye are also included in the formulary (p. 5 & p.1). Silver is a topic I do know a lot about since I have had generalized argyria (skin turned gray or blue by silver) for over 50 years, a condition I got from silver containing nose drops prescribed by a caring but very naive MD. If my doctor had read his medical journals instead of fraudulent ads from silver drug manufacturers in an era when they were not strictly regulated, he never would have prescribed the drug that disfigured me. I have those articles and the fraudulent ads and many of them are older than I am.
When I learned in 1995 that silver, often called "colloidal silver" or "CS", was being sold as a "dietary supplement", I was horrified and predicted new cases of argyria. The salesmen laughed and said I didn't know what I was talking about. Unfortunately they were wrong. There are now many cases caused by silver supplements some of which you will find on PubMed.
Dermatologists are now experimenting with laser therapy as a treatment for argyria. Those that I have spoken with and their patients are very pleased with the results. One well known clinic charges $7,000 to treat an entire face and no one is satisfied with just a face. The cost of treating a whole body has been estimated at 100K. To my horror, insurance has been picking up the tab! This in a nation that can't provide affordable basic health care to all its citizens. Furthermore, the treatment isn't permanent. It has to be repeated and no one knows if their will be side effects later on.
I have had a webpage for about 15 years trying to alert the public to the dangers and uselessness of ingesting silver. My website has been cited in several medical journal articles. My story has gotten extensive international, national and local media coverage. Because of that and the fact that the FDA, NCCAM and many others have issued warnings about the danger and uselessness ingesting silver, I was horrified to learn that naturopaths licensed in my own state had included it in their state formulary. Worse yet, my efforts to alert them to the problem were completely ignored. For details and citations please look here: http://rosemaryjacobs.com/naturopaths.html and also at my blog.
Over the years many people have told me that silver had been recommended to them by an ND, but I always assumed it was the mail order kind. I couldn't imagine that those graduating from their 4 year (naturopathic) colleges would do that. In fact in light of the FDA rule in the Federal Register, I think that their use of it as a drug is illegal.
http://www.fda.gov/OHRMS/DOCKETS/98fr/081799a.pdf
I would be happy to meet with either or both of you to discuss this further and to show you any references you may want to see.
Rosemary
http://www.webanstrich.de/rosemary/
http://rosemary-jacobs.blogspot.com
2.
From: Harry Chen
Subject: RE: VT Naturopaths
Date: June 14, 2011
To: Rosemary Jacobs
CC: Rep. George Till, Michael Marcotte
Rosemary,
Thanks for your email. Naturopaths are licensed and regulated by the Office of Professional Regulation not the Department of Health. The Department of Health does consult on the formulary but the ultimate decision rests with OPR. I appreciate your concerns and will examine them in more detail but suggest you contact Chris Winters at the Secretary of State's office with your concerns as they are the official regulators of Naturopaths.
Harry
Harry Chen, MD
Commissioner
Vermont Department of Health
802.863.7280
3.
From: Rosemary Jacobs
Subject: VT Naturopathic Formulary
Date: June 14, 2011
To: Chris Winters
CC: Michael Marcotte
Dr. Chen suggested that I speak with you about my concerns about the VT Naturopathic Formulary. May I have an appointment to speak with you in person?
I have already corresponded with and spoken to Terry Gray in person. You will find our correspondence here;
http://rosemary-jacobs.blogspot.com/2010/08/naturopaths-silver_6314.html and a summary of the problem here: http://rosemaryjacobs.com/naturopaths.html
I spoke with Terry shortly before the last election. She told me that I should speak with the legislature, something I had planned on doing, but I wanted to wait till after the new government was in place. It is now and I expect that elected officials are as comfortable in their jobs as they will ever be, but since Dr. Chen suggested speaking to you, I thought I'd try doing that before approaching the legislature.
Rosemary Jacobs
(address deleted)
(phone # deleted)
Rosemary
4.
From: Chris Winters
Subject: RE: VT Naturopathic Formulary
Date: June 15, 2011
To: Rosemary Jacobs
CC: Terry Gray
Dear Ms. Jacobs,
Thank you for your email and for the wealth of information on your websites regarding the dangers of silver. The advisors to the profession have agreed that colloidal silver should be removed form the naturopathic physician formulary and I will be working to make that happen as soon as possible. We do have a process for updating the formulary that includes seeking input from the Commissioner of Health, Naturopathic Physicians, MDs, and a Pharmacologist, so it may take some time to accomplish this.
If you would still like to meet in person, I would be happy to schedule an appointment.
Sincerely,
Chris
Christopher D. Winters, Director
Vermont Secretary of State's Office
Office of Professional Regulation
802.828.2458 (phone)
802.828.2368 (fax)
(Our meeting was scheduled for July 11, but Chris had to cancel it at the last minute. We rescheduled for July 13th.)
5.
From: Rosemary Jacobs
Subject: Drug Sources
Date: July 11, 2011
To: Chris Winters
Chris, one of the things I had planned on asking you to get for me at our meeting today was the formulation and brand name, if it is a commercially manufactured product, of the silver the NDs list on p. 5 of their formulary in the IV Minerals category. I'd also like to know if the NDs make it themselves and, if not, the name and address of the compounding pharmacist or manufacturer. Actually, it would be very interesting to have this information for several other substances in this category like tin, vanadium, nickel, molybdenum, copper....
I believe that since these substances are included in a state approved or sanctioned drug formulary that the information must be made available to anyone in the public who requests it and that since the NDs have included it in their formulary that they must have all that information at their fingertips.
I'd really appreciate it if you you get it to me at or before our meeting.
Thanks.
Rosemary
(At our meeting on July 13th, I gave Chris copies of Goodman & Gilman and Fung and Bowen. Although I had already sent the URL to the Final Rule in the Federal Register to Terry Grey who works in Chris’s office and included it in my blog, I was not sure that he had seen it. Therefore, on July 14th I sent him he following email.)
6.
From: Rosemary Jacobs
Subject: Silver
Date: July 14, 2011
To: Chris Winters
Chris, if you go here, http://www.fda.gov/OHRMS/DOCKETS/98fr/081799a.pdf, it will bring you to the Federal Register/Vol. 64, No. 158/Tuesday, August 17, 1999 Rules and Regulations (p. 44653) where it states:
QUOTE:
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 310 [Docket No. 96N–0144]
Over-the-Counter Drug Products Containing Colloidal Silver Ingredients or Silver Salts
AGENCY: Food and Drug Administration, HHS. ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule establishing 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. FDA is issuing this final rule because many OTC drug products containing colloidal silver ingredients or silver salts are being marketed for numerous serious disease conditions and FDA is not aware of any substantial scientific evidence that supports the use of OTC colloidal silver ingredients or silver salts for these disease conditions. DATES: This regulation is effective September 16, 1999.
FOR FURTHER INFORMATION CONTACT:
Bradford W. Williams, Center for Drug Evaluation and Research (HFD–310), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 301– 594–0063.
END QUOTE
(You might want to contact the FDA at that # and ask them about using silver intravenously and about federal laws regarding the manufacture of drugs, especially for IV use.)
Under the heading “Background”, the rule states, “Colloidal silver is a suspension of silver particles in a colloidal base.” That means that silver is an ingredient in colloidal silver and covered by this FR rule. But if that isn’t clear enough, on page 44658 in the middle column right at the very top it sates:
QUOTE:
Further, there is a lack of adequate data to establish general recognition of the safety and effectiveness of colloidal silver ingredients or silver salts for OTC use in the treatment or prevention of any disease. These ingredients and salts include, but are not limited to, silver proteins, mild silver protein, strong silver protein, silver, silver ion, silver chloride, silver cyanide, silver iodide, silver oxide, and silver phosphate.
END QUOTE
It specifically lists silver, and all the relevant medical literature indicates that ingesting silver in any form or amount offers no known benefits and can cause argyria.
I am not a lawyer, but from my understanding of the FR rule I believe that the NDs are violating it. (I actually think they are violating many federal drug laws.) The introduction to their VT formulary specifically says that, “Use of medication included in the following formulary is limited to FDA approved indications, routes and dose regimens.” It goes on to speak of off-label uses, but as far as I know, off-label refers to using approved drugs for indications that they have not specifically been approved for. This is something done a lot in veterinary medicine where a drug approved for use in dogs is used “off-label” in cats. (It also occurs if a drug approved to treat one kind of cancer like ovarian is used to treat another like breast.)
I seriously doubt that the VT legislature ever intended to permit NDs to violate federal drug laws, especially not when by doing so they would be endangering people. I suspect the NDs believe that they know far more about medicine and law than they do and that they convinced the legislators of that. All their lobbying efforts repeat the mantra that they use science-based treatments and that they study the same subjects in their colleges (sometimes called "medical schools") as MDs do in their schools. All of which is baloney and shows how truly ignorant they are.
Rosemary
(Since Chris had asked about recent cases of argyria, I sent him the following.)
7.
From: Rosemary Jacobs
Subject: Recent Argyria Cases
Date: July 14, 2011
To: Chris Winters
Chris, it was a pleasure speaking with you today. I will get you the names and contact numbers of a few doctors who know about silver. Although I'm sure there are many in VT, especially dermatologists, toxicologists and opthamologists, aside from my own doctor who is seriously ill now, those I know are out-of-state.
You asked about recent cases of argyria. Tragically, there are many. You will find a few on PubMed if you use the search term “argyria”.
http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed
You will find Paul Karason if you search on Google either using "argyria" or his name as the search term. I have been in contact with several others personally (who won’t speak publicly).
If you go here http://rosemaryjacobs.com/naturopaths.html you will find more links and also see a photo of my friend Arline who got argyria about 10 years ago from a silver supplement. I think I was as dark as she is before I was dermabraded. She is pictured with my friend Andy. Colin (a lawyer Chris and I know) and Andy are good friends. Tell Colin to ask Andy what Arline looks like. Andy forgets names so he may have forgotten hers, but he has not forgotten her face.
Rosemary
8.
From: Rosemary Jacobs
Subject: Correction
Date: July 14, 2011
To: Chris Winters
Chris, I was incorrect when I told you that "colloidal silver products" are dietary supplements. I should have explained that colloidal silver and CS are the names that most silver salespeople and users use for silver supplements. The more accurate term would be silver supplements because, as you can see in the FR, there are no silver drugs approved for internal use. All silver products that are sold to be taken internally are legally "dietary supplements", foods, and drug claims cannot legally be made for them.
When I first heard about silver supplements in 1995 almost all the promoters claimed that the stuff consisted of very tiny particles of "pure" silver suspended in "pure" water. In addition to selling ready-made CS, they also sold, and still do, gadgets to make your own silver supplement electrically. These came with recipes. Chemists who reviewed the promotional material laughed. They said that the silver promoters knew zilch about chemistry and what they were making was not what they thought it was. Depending on the recipes, they made solutions that contained a mix of silver compounds, colloidal silver, ionic silver and sometimes silver salts. Eventually a few engineers got into the silver business and explained this to the others. After that a few started using other names for their supplements like ionic silver. Many said that their product was good and the other guy's was bad. Some said it didn't matter. All were good. Scientists disagree. They say ingesting silver in any amount or form is all risk and no benefit.
Rosemary
9.
From: Rosemary Jacobs
Subject: Fwd: Drug Sources
Date: July 18, 2011
To: Chris Winters
Cc: Michael Marcotte
Chis, please tell the naturopathic advisors that I want this information in an email from them. I don't care if they send it to you and you forward it to me or if they send it directly to me and CC it to you. As i said, I believe that this information must be given to anyone requesting it since the substances I'm asking about are included in the ND's VT sanctioned formulary.
Begin forwarded message:
From: Rosemary Jacobs <rosemary@rosemaryjacobs.com>
Date: July 11, 2011
To: Chris Winters <cwinters@sec.state.vt.us>
Subject: Drug Sources
Chris, one of the things I had planned on asking you to get for me at our meeting today was the formulation and brand name, if it is a commercially manufactured product, of the silver the NDs list on p. 5 of their formulary in the IV Minerals category. I'd also like to know if the NDs make it themselves and, if not, the name and address of the compounding pharmacist or manufacturer. Actually, it would be very interesting to have this information for several other substances in this category like tin, vanadium, nickel, molybdenum, copper....
I believe that since these substances are included in a state approved or sanctioned drug formulary that the information must be made available to anyone in the public who requests it and that since the NDs have included it in their formulary that they must have all that information at their fingertips.
I'd really appreciate it if you you get it to me at or before our meeting.
Thanks.
Rosemary
10.
From: Chris Winters
Subject: RE: Drug Sources
Date: July 18, 2011
To: Rosemary Jacobs
Hello Rosemary,
It is my understanding that there is no single manufacturer or compounder of any of these minerals. It is also my understanding that drugs, nutritional medicines, and botanical medicines are regulated by the FDA and these regulations include manufacturing guidelines. As such, I don't have a list for you and don't think it was intended under the formulary to have the state provide a list. Sorry if that is not a very helpful answer.
As I said before, the advisors believe silver should come off the formulary and we will remove it as soon as we do the next formulary update.
Chris
11.
From: Rosemary Jacobs
Subject: Re: Drug Sources
Date: July 18, 2011
To: Chris Winters
On Jul 18, 2011, at 4:17 PM, Chris Winters wrote:
It is my understanding that there is no single manufacturer or compounder of any of these minerals.
Chris, unless I hear otherwise, I have to assume that the naturopaths are refusing to provide me with the names of those who manufacture the products they use intravenously, even the name of their source of silver, which to the best of my knowledge there is no legal source for.
It is also my understanding that drugs, nutritional medicines, and botanical medicines are regulated by the FDA and these regulations include manufacturing guidelines.
I am aware of that. What I want to see is evidence that VT naturopaths are in compliance with those drug regulations.
As such, I don't have a list for you and don't think it was intended under the formulary to have the state provide a list.
If the state did not intend that the formulations of drugs on an state sanctioned formulary and the names of the manufacturers be given to anyone who requested it (sic), I seriously doubt that it represents the views of the citizens of the state. I also suspect that if the sources were legal that the NDs would not hesitate to provide them.
As I said before, the advisors believe silver should come off the formulary and we will remove it as soon as we do the next formulary update.
You said that the advisors where going to remove "colloidal silver products" from the formulary but probably not silver. Have they changed their minds about that? Are they now removing silver also? (As I told you, silver sulfadiazine is not a problem. It is an FDA approved topical drug with little potential for abuse.)
Rosemary
12.
From: Mary Skovira
Subject: On behalf of Harry Chen: VT Naturopaths
Date: July 25, 2011
To: Rosemary Jacobs
Cc: Rep.George Till
Ms Jacobs:
Attached is Commissioner's Chen response to your e-mail.
(The letter included in the email was in PDF format. Since I do not know how to copy or paste it here, I retyped it. If anyone would like me to forward them the original email in which it is contained, please let me know.)
Dear Ms. Jacobs,
Thank you for your email regarding the 2009 Vermont Naturopathic Formulary. I have met with the Director of the Office of Professional Regulation and understand that they are considering revising the formulary in the near future. In the course of that revision, I will formally review the proposed formulary.
I do want to respond to your specific concerns about the metals in the current Naturopathic Formulary. As noted below, there are some appropriate uses for these metals in medical treatment, although, as with all medications, there may be contraindications and other precautions that must be taken into account prior to prescribing treatment.
Molybdenum is an essential trace element and some people may be deficient in it and require supplements to be administered intravenously. Intravenous administration of minerals lessens the quantity necessary to address the deficiency and also avoids the formation of metal salts during digestion.
Tin is sometimes administered by naturopaths who believe tin can be used to treat baldness based on a few studies involving mice. The efficacy of this treatment has not been demonstrated in the medical literature. Tin is not an essential nutrient.
Nickel is a toxic metal and use or handling of objects made of nickel may cause asthma, urticaria, erythema multiform, contact dermatitis, and hand eczema. Nickel carbonyl is a possible human carcinogen. Also, it is a nutritionally essential element, although a specific deficiency state has not yet been defined in humans.
Silver salts and colloidal silver, as you note in your email, have been determined by the Federal Drug Administration not to be safe or effective for use in over the counter products. Nevertheless, when properly prescribed, silver may be appropriate for use topically in bandages and dressings used to treat burns, skin wounds or skin infections and in medicines used to prevent the eye condition conjunctivitis in newborn infants.
As I consult with the Director of the Office of Professional Regulation in regard to the proposed new formulary, I will consider whether to make any specific recommendations concerning these metals.
Thank you for your interest in the Naturopathic Formulary and for contacting me with your concerns.
Sincerely,
Harry L. Chen, MD.
13.
From: Rosemary Jacobs
Subject: Re: On behalf of Harry Chen: VT Naturopaths
Date: July 25, 2011
To: Mary Skovira
Cc: Rep.George Till
Dr. Chen, I have no idea if you and the office of the Secretary of State share information or if you have reviewed my webpage and blog.
You state in your email, "Silver salts and colloidal silver, as you note in your email, have been determined by the FDA not to be safe or effective for use in o/c products. Nevertheless, when properly prescribed, silver may be appropriate for use topically in bandages and dressings used to treat burns, skin wounds or skin infections and in medicines used to prevent the eye condition conjunctivitis in newborn infants."
As I explained to Mr. Winters, there is no problem with including silver sulfadiazine in the formulary. It is an FDA approved topical drug that cannot easily be abused. I gave him copies of the relevant material in Goodman & Gilman, 5th edition, 1975 which I believe is the last or next to the last edition that included silver as well as Clin Tox, 34(1), 119-126 (1996), Review Silver Products for Medical Indications: Risk-Benefit Assessment by Fung and Bowen, two FDA doctors. The later lists prescriptions drugs that contain silver. All are topical except Argyrol, the most famous brand of Mild Silver Protein, MSP, a type of colloidal silver. Argyrol was for ophthalmic use. However, since the article was written, Argyrol has been removed from the list and silver impregnated bandages have been added.
I am well aware of the use and effectiveness of silver nitrate in neonates eyes. However, MSP was also used and didn't work. When compounding pharmacists wanted to add it to the list of bulk drugs they are permitted to use to compound, the FDA advisory committee unanimously voted against including it. I know that because I was there. I presented written and oral testimony.
http://rosemaryjacobs.com/msp.html
http://rosemaryjacobs.com/PharmacyCompounding.html
Now would you please be so kind as to ask the ND advisors to email you (to forward to me) or to email me directly the formulation of the "colloidal silver preparations" on p. 3 of their formulary and the formulation of the "silver" they list under "minerals" for IV use along with the names and addresses of the manufacturers. I would also like this information for the other substances listed under "minerals" for IV use. I am not bothering to ask the NDs myself because of the way they have ignored me when I attempted to explain my concerns with silver.
Please understand.I have no problem at all with people using belief-based systems of medicine. What I have a problem with is their not fully disclosing that. I believe that anyone who sells or administers silver and other substances not backed by strong evidence of safety and efficacy as well as substances known to be harmful should be required to tell that to customers and patients. In other words taking silver as an example, if NDs want to believe that silver offers benefits that outweigh the risks, I think that they should have to tell people that the FDA, NCCAM, and numerous scientists disagree with them claiming that there is no evidence that ingesting silver in any form or amount offers any benefits whatsoever, and there is a lot of evidence indicating that it causes argyria, discolored skin which in severe cases is disfiguring.
I also believe that government should be transparent and that the public should be informed of the differences between NDs and the system of medicine they practice and that of MDs who practice EBM.
If tin safely and effectively treats baldness, that should be very easy to demonstrate for all the world to see. Maybe Andrew Weil would volunteer to be the first test subject. I find it very difficult to believe that the VT legislators would knowingly agree to let NDs inject people with tin when it is not an essential element and there is no evidence showing that it works. I also would love to know the formulation and source of the tin.
Rosemary
14.
From: Rosemary Jacobs
Subject: Re: On behalf of Harry Chen: VT Naturopaths
Date: July 26, 2011 10:56:34 AM EDT
To: Mary Skovira
Cc: Rep.George Till, MD, Rep. Michael Marcotte, Chris Winters
Ms. Skovira, please tell Dr. Chen that I went to the FDA homepage
http://www.accessdata.fda.gov/scripts/cder/ob/docs/queryai.cfm
the “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations” page and searched using the "Minerals" that may be used intravenously which are included in the ND formulary.
There are no approved FDA Rx or OTC drugs for about half of them. Silver sulphadiazine cream is listed as being approved for topical use, but there are no other approved Rx or OTC drugs listed that use silver as the active ingredient. (I've already stated that SSD is not a problem in the formulary because it is approved and has little potential for abuse.) This brings us back again to: what formulation of silver do the VT NDs use intravenously; what formulations are they using of the other substances for which there are no approved drugs; and, who manufactures them.
I will be 69 in a month. I am not aging well and don't have lots of energy to waste. I'm also sure that all of you are very busy and don't have time to waste. I think the simplest way to get to the bottom of this is for a VT state official acting in that capacity to contact the FDA directly and ask them if the NDs are complying with or violating federal drug laws by including unapproved drugs in their drug formulary and for making drug claims for "colloidal silver products", since CS can only legally be sold as a dietary supplement not a drug and it is illegal to make drug claims for supplements.
If the NDs are violating federal drug laws, the state either has to admit it and tell them to stop or admit that it doesn't care and let them continue, but either way it has to be honest and opened about it. Being honest, opened and transparent is all the more essential since the state has licensed NDs as primary care physicians and given them the privilege of using legend (prescription) drugs even intravenously.
The only thing I find more appalling than having silver listed in a state sanctioned formulary is the reaction of the NDs when the professional board initially forwarded them my concerns. Instead of speaking with me and reviewing the documentation I presented, they brushed me off. That is totally incredible and a big contrast to the reactions I've gotten over the years from those who practice scientific evidence (sic, should read “scientific or evidence-based medicine) many of whom are embarrassed and apologize to me because of what someone in their profession did to me. They wish my parents had sued the responsible MD. When I said he was naive and made a mistake, they told me no he was incompetent and negligent and never should have used a silver drug in the 1950s. One actually tried to find a lawyer to sue of my behalf but the statute of limitations had long since expired.
If the NDs had listened to me and taken my concerns seriously when they first heard them, this probably would have stopped there, but they didn't and it gets worse. They ignore me every step of the way. My friend Arline who got argyria from a supplement even attended a conference full of NDs with me. She is in her 70s, has very little money and is not in the best of health. She is far more severely discolored than I am although I believe that I was as bad before I was dermabraded. http://rosemaryjacobs.com/naturopaths.html http://rosemaryjacobs.com/argyria_photos_intro.html
When I spoke out at a workshop at the conference, the woman next to me patted my hand. Afterwards several of the people there came up to thank us for attending and me for speaking out. The ND manning their information booth was very nice, but not one of them said, My God, look what silver does to people! How could we be so ignorant? How could we include it in our formulary? Thank goodness you have alerted us!
Over the years I have consulted some of the leading dermatologists in the world and been seen at 3 US medical schools. Dozens of doctors come to look at me and listen to me tell them what I know about silver and argyria, and they don't charge because they say that they learn from me even though the older ones have seen and investigated other argyric people besides myself.
Arline flew here all the way from her home in Las Vegas. She lives from hand-to-mouth. Since she worked for the airlines she can fly standby for very little money, but to make sure that she got here in time for the conference the NDs would be at, she paid for her flight here. I wanted to contribute but she wouldn't hear of it. Perhaps that gives you an idea of how important it is to us to inform the public about the dangers of silver and other substances which either are known to be dangerous or have never been adequately studied and how frustrating it is to be brushed off by people, NDs, who have gotten the state to license them as physicians.
People cannot make informed choices without accurate information and without complete disclosure. NDs licensed by the state as physicians have to be held (to) the the same standards of transparency as those who practice evidence-based medicine. Greater privileges bring greater responsibilities. NDs can't have their cake and eat it too. Scientists regularly publish the errors and abuses that they discover in scientific medicine. If alts. want to be licensed to practice medicine, they should have to do the same.
Rosemary
thanks for the good work on this. can you send me Chen's real e-mail?
ReplyDeletevermontmedicineshow@yahoo.com
I filed a complaint awhile back with Chris and the OPR about Naturopaths using supplements as drugs. His claim that he didn't know about this is a little specious. I'm not sure anybody there really understands the formulary.