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The Fallacies of Statutory Informed Consent (pertaining to amalgam installation)

By G. Scott Crowther
June 2001

Dental amalgam restorations consist of 50% mercury, 35% silver, 13% tin, 2% copper, and a trace amount of zinc. After an amalgam is installed in a tooth it slowly releases mercury and the other metals into the body. Every amalgam daily releases on the order of 10 micrograms of mercury into the body. There is a growing body of scientific documentation that indicates mercury released from the amalgam does great harm to the body. The amalgam has been used to restore patients teeth for more than 160 years. It has both widespread and systematic use by dentistry.

With a state statutes, which requires some form of informed consent before an amalgam is installed, it becomes appropriate for a dentist to install it if the patient concurs with information presented. I believe that a state statute requiring informed consent be obtained before amalgam installation is inappropriate in the anti-amalgam movement because of the following fallacies:

1) It is contrary to tradition “I will give no deadly medicine to anyone if asked, nor support any such counsel. While I continue to keep this Oath unviolated, may it be granted to me to enjoy life and the practice of the art, respected by all men, in all times! But should I trespass and violate this Oath, may the reverse be my lot!” Oath of Hypocrites, 500 BC

Informed consent for the installation of any harmful product, such as the amalgam, does not adhere to the timeless principles of the Hippocratic Oath, taken by Western physicians for nearly 2,500 years. Dentists take the Hippocratic Oath upon graduating. Because of the 2500 year tradition of the Oath our society assumes that dentists will abide by it. So it is my belief that statutory informed consent, which permits the installation of a harmful product such as the amalgam, does  not adhere to Western tradition, and our societies assumption.

Requiring Informed consent pertaining to the placement of a harmful product, which is a standard of industry, into a healthy person by a health care professional is contrary to Western tradition.

2) It originally was meant for experimental purposes “The voluntary consent of the human subject [for an experiment] is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.” The Nuremberg Code, 1947

Informed consent, which became formalized per the Nuremberg Code, was meant for voluntary, experimental purposes. It was not meant as an approach to health care for procedures and products that have widespread and systematic use. The amalgam is a standard product that has widespread and systematic use by the dental profession. It is placed in the teeth of many patients on a routine and not an experimental bases.

Two purposes of informed consent, per the Nuremberg Code, are to: 1) provide the patient with complete information on which to make a decision prior to an experiment, and 2) protect the physician from liability (provided that the procedure is properly executed according to the prevailing standard of care and without negligence). In general the experiment should: 1) yield fruitful results for the good of society, unprocurable by other methods, and 2) not be conducted where there is a reason to believe that death or disabling injury will occur.

3) It usurps government responsibility The patient, who probably is a voter and taxpayer, has participated in  developing a government system that today has legal authority and responsibility to police the products and material used in medicine and dentistry. Most patients trust this system to watch out and protect them from harmful products and material. In the USA the Food and Drug Administration (FDA) has this responsibility.

The FDA has not approved the combined constituents of the amalgam for use as dental restorative material. The amalgam is truly a rogue product. Informed consent gives personal approval for amalgam installation and usurps government responsibility. When it comes time to push the FDA to review amalgam safety, they may be more reluctant to do so if state informed consent statutes exist that justify amalgam installation. That is state informed consent statutes indicate that dentist can use the amalgam is a patient concurs.

4) It ruins professionalism “The difference between a professional person and a technician is that a technician knows everything about his job except its ultimate purpose and his place in the scheme of things.” Richard W. Livingston

“The patient may doubt his relatives, his sons and even his parents, but he has full faith in his physician. He gives himself up in the doctor's hands and has no misgivings about him. Therefore, it is the physician's duty to look after him as his own.” Charaka, circa 78

A dentist completes a graduate school curriculum that educates him in the science pertinent to his profession. He then becomes licensed to perform a service as a professional. With true professionalism the fundamental decisions of a practice, such as proper material to use, are made by the dentist. The fees a patient pays for this service is reimbursement for these professional decisions.

If a dentist is required to inform a patient of the products and material used and does so, the first responsibility for their choice is then on the innocent and trusting patient. The amalgam then becomes a consumer product instead of a professional product. Thus professionalism is ruined by statutory informed consent.

5) It provides statutory permission for a dentists to use the amalgam “A prince never lacks legitimate reasons to break his promise.” Machiavelli

The amalgam is a rogue product that does not have institutional approval to be placed as restorative material in patients teeth. If the dentist did not inform a patient that the amalgam contains mercury, then he is responsible for placing the amalgam into a patients tooth. Statutory informed consent requires that a dentist inform a patient about amalgam contents (depending on how the statute is written). A dentist is then given statutory permission to install an amalgam if consent is given by the patient.

6) If done it will be biased information “Bias and impartiality is in the eye of the beholder.” Lord Barnett

There is a tremendous amount of information pertaining to the amalgam. The amalgam is a standard product and the complete amount of information pertaining to it will never be presented to the uninformed patient during the short time of a dental visit. If the dentist follows through with informed consent, before installing an amalgam, there is going to be a bias with the limited amount of information that can be presented. This bias will be favorable to amalgam installation.

7) It will be rarely if ever done “The more I study the world, the more I am convinced of the inability of brute force to create anything durable.” Napoleon Bonaparte

Dictation of a certain bias won’t be performed through a person who does not have it.

A dentist, who knowingly performs a harmful act by installing an amalgam is rarely if ever going to adhere to informed consent with the patients being effected just because a statute exists. The greatest fear of amalgam installing dentists is disclosure; they will not disclose themselves. Denial of sin is simple human nature.

8) It may make amalgam removal unethical Most patients may agree to amalgam installation because they don’t understand science and trust the government and their dentist to watch out for them based on the age old traditions. Also the immediate cost of an amalgam is much less than a composite restoration.

The decision of the majority of patients will set the morality. If a
majority of patients agreed to amalgam installation based on information provided during informed consent then amalgam removal may be become an unethical act. Thus patients may become locked into a harmful situation based on informed consent.

9) Changing the health care system approach will cause confusion for generations “Scientists had another idea which was totally at odds with the benefits to be derived from the standardization of weights and measures. They adopted to them the decimal system on the basis of the meter as a unit; they suppressed all complicated numbers. Nothing is more contrary to the organization of the mind, of the memory, and of the imagination. The new system of weights and measures will be a stumbling block and a source of difficulties for several generations. It's just tormenting the people with trivia.” Napoleon Bonaparte

Changing from a parochial to a rationally based measurement system has been a source of difficulties for more than 200 years. Changing from a professionally based to a consumer based health care system will also cause difficulties and confusion for several generations.

So why do anti-amalgam people ask for a system of informed consent pertaining to installation of a harmful product like the amalgam?

A Solution: Allow Neo-Orthodox Dentistry to Exist

I believe that human outreach, which is in accordance with Western tradition, is appropriate in the anti-amalgam movement. That can be obtained by allowing the proper removal of all amalgams for scientific reasons.

“It is better to light a candle than to curse the darkness.” Chinese Proverb

"You must be the change you wish to see in the world." Mahatma Gandhi

"Unless we put medical freedom into the constitution, the time will come when medicine will organize itself into an undercover dictatorship. To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are un-American and despotic." Benjamin Rush, Revolutionary war hero, physician, and signer of the Declaration of Independence

"The transfer of concepts as models from one field to another requires intimacy, informality, and friendliness because the transfer usually is not a conscious process." Edwin Land

A people which is able to say everything becomes able to do everything. Napoleon Bonaparte

“In the course of treatment, the physician is obligated to the patient and to no one else. He is not the agent of society, nor of the interests of medical science, the patient's family, the patient's co-sufferers, or future sufferers from the same disease. The patient alone counts when he is under the physician's care.” H. Jonas, 1969

Proposed State Statute: "A patient in a clinical setting may be informed of contents and scientific documentation pertaining to dental restorative material. A patient may have dental restorative material removed in accordance with professionally recognized protection techniques.”

The purpose of this proposed statute is to move the dental amalgam issue from the social arena to the professional arena. The American Dental Associations code of ethics forces the amalgam issue into the social arena. ("...the removal of amalgam restorations from the non-allergic patient for the alleged purpose of removing toxic substances from the body when such treatment is performed solely at the recommendation of the dentist is improper and unethical...." ADA Resolution 42H-1986. Transaction 1986:536) A dentist has to agree to the resolution when applying for and renewing a license. On the basis of this resolution, state dental boards are taking disciplinary action against dentists who inform their patients that they are receiving a toxic insult from the amalgam. The proposed statute will pre-empt the ADA's resolution and allow a dentist to inform a patient that they are receiving a toxic insult from the amalgam. A dentist will then be able to remove the amalgam in accordance with professionally recognized protection techniques if the patient concurs.