Vermont Bill H.524 which proposed giving VT licensed NDs, naturopaths, who had passed a “pharmacology exam” the privilege of administering, using and prescribing the same legend drugs that MDs do passed from the House Government Operations Committee http://rosemary-jacobs.blogspot.com/2012/02/vermont-bill-h524-vt-nds-prescription.html to the Senate Operations Committee which held a public hearing on it on April 10, 2012. I presented written and oral testimony to the committee.
On March 20, 2012 before the hearing took place I sent the State Health Commissioner, Harry Chen, MD, and the Director of the State Office of Professional Regulation, Chris Winters, the following email.
An Open Letter To: Harry Chen, MD, VT Commissioner of Health; and, Chris Winters, Director of the VT Office of Professional Regulation.
If passed as written, Bill H.524 will grant naturopaths, NDs, licensed in VT who pass a pharmacology exam the right to prescribe all the drugs that MDs prescribe.
Representative Mike Marcotte tells me that you are assuring legislators that the exam that NDs will be required to pass will be sufficiently rigorous to demonstrate that they are competent to prescribe drugs.
Can you tell me specifically: what qualifications the person who draws up the test will be required to have; what the test will cover; who will decide what it covers; how it will be administered; will it be an open book test taken anywhere the candidate chooses over a period of days or a supervised exam over a period of hours, etc.?
Can you tell me how you can guarantee that any of the answers you give to the above will in fact be carried out? Even if you were to have the authority, time, knowledge and resources to ensure that specific conditions were met what guarantee would there be that another administration would also meet them when not legally required to do so by law?
Why are you pushing to have a bill passed that will give VT NDs more prescription privileges than they already have knowing that you were unaware that their IV use of silver was dangerous and illegal until I brought it to your attention and since the NDs ignored me when I alerted them to their error? http://rosemaryjacobs.com/naturopaths.html How can you trust their judgment or the state's ability to supervise them?
Why are you pushing to give NDs all the same prescription privileges that primary care physicians have rather than letting them continue to practice under a limited license as they do now? To put it another way, since you were unable to protect the public before, how will you protect it after you give NDs more privileges?
Who drew up the test that the author of the Vermont Medicine Show blog passed? http://vermontmedicineshow.blogspot.com/2012/02/i-have-no-scientific-or-medical.html? What privileges were those who passed that test awarded or going to be awarded?
On March 29, 2012 I forwarded Chen and Winters the same message adding that I expected them to address those issues at the Senate hearing.
I also sent them and the state’s naturopathic advisors, William Warnock & Sam Russo, the two NDs who had testified before the House Government Operations Committee hearing the following email:
When the Senate Government Operations Committee holds its hearing on Bill H.524, I am going to request that you, or if you are not present, Chris Winters, Harry Chen or whoever represents the naturopaths provide me and the committee with the names and contact information of the companies or individuals from whom you purchase the substances that may be administered IV that you have included on p. 5 of your formulary,
I will also request the formulations of any of those substances which are not FDA approved drugs and specifically approved for IV use.
I am especially interested in having this information regarding silver.
I also will request the names and contact information for the companies or individuals who provide you with the "colloidal silver" included on p. 1 of your formulary as well as its formulation. Is it MSP, ionic silver, a silver compound, a silver salt or colloidal silver?
Thank you.
This is the written testimony that I presented to the committee:
Vermont Senate Government Operations Committee Hearing on Bill H.524
April 10, 2012
I oppose the section of Bill H.524 that pertains to naturopaths.
Background:
In the 1950s I was given a drug that contained silver by an MD which discolored my skin. The condition which is well known and well documented is called argyria. My doctor was one of the last MDs to prescribe a silver drug for internal use. If he had read his medical journals in an era when drug companies had as much license as dietary supplement companies have today, he never would have prescribed the drug that disfigured me. He would have seen the articles warning doctors about the drug companies' fraudulent ads and would have learned that ingesting silver offers no benefits and causes argyria.
In 1995 when I learned that silver was being sold as a dietary supplement I asked salesmen for evidence showing that their products were safe and effective for something. They had none. When I predicted new cases of argyria, they laughed. Unfortunately, I was right. There are now many.
When I learned in 2010 that VT NDs have a state sanctioned formulary http://www.vtprofessionals.org/opr1/naturopaths/info/Naturopathic Physician Formulary 20091211.pdf that includes “colloidal silver” for use in the eyes (p.1) and “silver” to be administered IV (p.5), I contacted the OPR and attempted to contact the Health Commissioner.
(Scroll down to see correspondence.)
It was only through the efforts of Rep. Michael Marcotte that I was able to get through to the HC and the Director of OPR.
When NDs learned of my concerns, they ignored them.
Questions Regarding the “pharmacology exam” Bill H.524 proposes
The bill proposes that any licensed ND who wishes to prescribe, administer or use legend drugs pass a “pharmacology exam”.
I would like Dr. Chen and Mr. Winters, the apparent authors of the bill, to explain:
- what qualifications the person who draws up the test will be required to have
- what the test will cover
- who will decide what it covers
- how it will be administered - will it be an open book test taken anywhere the candidate chooses over a period of days or a supervised exam over a period of hours, etc.
- how they can guarantee that any of their answers to the above will in fact be carried out
- even if they were to have the authority, time, knowledge and resources to ensure that specific conditions were met what guarantee would there be that another administration would also meet them when not legally required to do so by law
- why are they pushing to have a bill passed that will give VT NDs more prescription privileges than they already have knowing that they were unaware that their IV use of silver was dangerous and illegal until I brought it to their attention and knowing that the NDs ignored me when I alerted them to their error
- how can they trust NDs’ judgment or the state's ability to supervise them
- why are they pushing to give NDs all the same prescription privileges that MDs have rather than letting them continue to practice under a limited license as they do now
- who drew up the test that the author of the Vermont Medicine Show blog passed http://vermontmedicineshow.blogspot.com/2012/02/i-have-no-scientific-or-medical.html
- what privileges were those who passed that test awarded or going to be awarded
Questions about the sources and formulations of substances that are not approved drugs included in the 2009 Vermont Naturopathic Formulary:
I would like the NDs or their representatives to tell the committee and the public:
- the names and contact information for the companies or individuals from whom VT NDs purchase the substances that may be administered IV that they have included in their formulary
- the formulations of any of those substances which are not FDA approved drugs and specifically approved for IV use, especially silver
- the names and contact information of the companies or individuals who provide VT NDs with the "colloidal silver" included on p. 1 of their formulary as well as its formulation
General Questions:
- under federal law must all drugs be manufactured by a licensed manufacturer or licensed compounding pharmacist
- must all substances intended for IV administration be sterile
- do Vt NDs, the Health Commissioner and the Director of OPR believe that NDs practicing in VT are exempt from federal drug laws
- is the state aware that there is an ND in Quebec charged with manslaughter because her patient died after she illegally injected him with magnesium that was contaminated with bacteria http://montreal.ctv.ca/servlet/an/local/CTVNews/20120201/mtl_naturo_120201/20120201/?hub=MontrealHome
- if an ND injures or kills a person because the State Of Vermont permitted him to violate federal drug laws or gave him privileges based on misinformation he or his colleagues provided about their educations that was accepted but never verified by the state, will the state and all of its citizens be held liable
Conclusion:
Although I believe that the questions I’ve presented are serious issues that the committee must consider, I do not believe that the section of Bill H.524 that pertains to NDs should be passed even if the state bureaucracy satisfactorily responds to them because I think that the manner in which the state and the NDs have dealt with silver shows at best very bad judgment on the part of both parties.
When the state learned in 2010 that the VT ND Formulary illegally included silver, dangerous snake oil, they blithely responded over a year later, “It has to be removed but the way the rules are written we can’t do that. We have to change the law to do it.” To me that makes no sense. Isn’t including an illegal, dangerous substance in the formulary much worse than breaking a law or a rule to remove it?
At the very least the state and the NDs should have jointly issued an official notice and consumer alert to all the NDs licensed in VT and to the media informing NDs and the public that “colloidal silver” and “silver” had mistakenly been included in the formulary, that using them as indicated was illegal, that there was no evidence showing that they offered benefits and a lot of evidence demonstrating that they could cause harm by seriously discoloring people’s skin and eyes.
The way the state and the NDs have dealt with silver along with the way the state has and is still passing laws behind closed doors giving NDs the same privileges that MDs have without their ever having to demonstrate that they deserve them all smells to me of cover-up, back room deals, favors to special interest groups, all things that the majority of Vermonters vehemently oppose, all things that harm the public and betray the trust it has in government.
That is the end of my written comment.
Neither Warnock, Russo nor Chen appeared at the hearing when I was there. Gabriel Archdeacon, ND who said he was covering for Sam Russo, who had been scheduled to attend but was unable to do so, read a written statement.
Mr. Winters said that the test that Ben from the Vermont Medicine Show blog had taken and passed was meant to assess an ND's knowledge of the state formulary. Ms. Mongan a lawyer representing the Vermont Medical Society disagreed. She said that the intention had been to draw up an exam that would test, “an applicant’s knowledge of the pharmacology, clinical use, side effects, and drug interactions of agents in the naturopathic formulary”, adding that what had happened instead was that an exam had been drawn up by the 2 state naturopathic advisors, the same ones who still served in that capacity, and that both of them had also taken the test themselves. Do you think they passed?
I’m sorry. I couldn’t keep from asking that. It is so typical of NDs and so totally different than any other profession I’ve ever dealt with. They start their own schools. Use their own teachers. Name their own courses and then shout from the rooftops that what they learn in those classes is what scientists and MDs learn in classes with the same names. In other words, We study pharmacology. They study pharmacology. We learn pharmacology. They learn pharmacology. We know as much as they do, so there!
While it is possible that all or some of what they learn is the same, I am totally astounded that legislators across N. America take their word for it without ever even trying to independently verify their claims. Is it any wonder people hold our government and politicians in such low esteem? Not only is no one watching the store, they are giving the merchandise away for free! They are giving NDs the same privileges MDs have without making sure that they have earned them.
I wonder what would happen if a group got together and set up an alternative flying school. If they insisted that they had the same education and skills as regular pilots and that they had passed tests that they had drawn up themselves which they insisted were as rigorous as those that real pilots took would governments take their word and license them to fly over my house?
Aside from Mr. Winters’s comment about the purpose of the exam that Ben passed, neither Gabriel nor he addressed any of my other questions although Archdeacon did state that NDs do not use silver intravenously. Addressing the senators, he glanced my way and said, “You have heard complaints about the item silver on our formulary. While it is listed within the minerals section, some of which are used intravenously (IV), to my knowledge no ND has used silver in this way. Furthermore, it is my understanding that there have been attempts by our organization to eliminate this item from our formulary. Unfortunately, the process of updating our formulary is so dysfunctional that this has not happened.”
Unfortunately, Mr. Archdeacon didn’t mention how silver had gotten into the formulary in the first place or how it had been included in the category of minerals that “may be administered” intravenously. Neither did he say how colloidal silver had gotten into the formulary or whether or not he knew of NDs who used CS topically or put it in patients’ eyes nor did he say whether or not he knew any NDs who administered silver orally or sold, promoted or recommended silver supplements to the patients they saw. Of course, even if he didn’t know of any who did any of that, it wouldn’t mean that there weren’t any.
(Ben, owner of the Vermont Medicine Show blog, video taped the hearing. He also gave testimony which I taped. When he posts the video I will link to it.)
I told the committee that the state bureaucrats were asking us to trust the state and the NDs and that I most certainly did not trust them. Based on my experience with both groups I thought that they had demonstrated that they didn’t deserve anyone’s trust and that Bill H.524 needed to include guarantees that the pharmacology test the state intended to give to NDs adequately showed that those who passed had the knowledge and competency required to safely and effectively use prescription drugs.
I added that I believe that adults should be able to choose the health care practitioners, drugs and therapies that they want and that included taking silver internally if they so desired. However, I also believe that once something like a formulary is sanctioned by the state or a practitioner is licensed by it that the standards change. They have to be much higher if for no other reason than that the public assumes that when the state gives such endorsements that it has done their homework for them, that it has investigated and determined that the goods and services being sold are safe and beneficial and that it therefore is unnecessary for the customer or patient to determine that for himself.
I further explained that people who had gotten argyria from silver “dietary supplements” had been having dermatologists treat them with laser therapy. The cost of a whole face was about $7,000. and no one was satisfied with just a face. The cost of a whole body was estimated to be $100,000. The treatment had to be repeated and no one knew if there would be side effects later on.
Most of those who have had laser therapy done to treat argyria have had insurance companies pay for the procedure. I don’t believe that it is fair to use remedies or therapies that have never been tested or that are known to be dangerous or to use the services of practitioners who use such things and then expect others to help pay their bill if they are injured by them, and I don’t think it is fair to ask others to reimburse them for the costs of dangerous or untested drugs and therapies or practitioners who habitually use them.
I also pointed out a memo from Donald R. Swartz, MD, to Sharon Moffatt, Acting Health Commissioner dated December 11, 2007 about the Naturopath Formulary that Madeleine Mongan from the Vermont Medical Society had presented to the commission in which it stated that Dr. McCormack, the pharmacologist who had been consulted about the naturopathic formulary, had been concerned about “the administration of agents intravenously. This concern was a strong element in the recommendations of the advisory group. As a result, in general the formulary prohibits IV use even when that route is allowed by the label. The exceptions to the rule are identified by specifically so noting in the formulary. These exceptions generally fall into one of two conditions. The first is the use of standard IV solutions such as saline, used to treat dehydration. The second is the use of IV preparations of vitamins, minerals, or other ‘natural’ substances which are allowed by the current formulary and which represent well established and standard practice of naturopathy. It is my view that reservations about the safety of the preparations or their use are offset by the long history of use and that the use is so integrally part of naturopathic practice that it falls within the intent of the legislature regarding the scope of practice of the ND. The proposed formulary authorizes IV administration of ‘Childbirth preparations.’ This does not conform to either of these exceptions, and therefore I agree that IV administration of these agents should be disapproved.”
I noted that Dr. Swartz had apparently taken the NDs word for their long history of IV use of the substances in the formulary, but I didn’t think that they could have been using them for a long time, at least not legally, since it is only within the last thirty or so years that NDs have been given the right to use substances intravenously and even today they can only do that in a few states. Also, long history of use does not demonstrate safety.
Vermont naturopaths, naturopaths prescribing drugs, Gabriel Archdeacon, Sam Russo, Bill Warnock, Chris Winters, Harry Chen, Vermont primary care physicians, health care costs
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