by Paul Connett
The Need for Informed Consent
Every doctor knows, or should know, that he or she cannot force an individual to take medicine without that patient’s informed consent. Doctors must tell their patients the benefits of any medicine prescribed and warn of any possible side effects. After they have done this, it is the patient—and only the patient— who should make the final decision as to whether to take the medicine.
This is what the American Medical Association (AMA) has to say about informed consent:
Informed consent is more than simply getting a patient to sign a written consent form. It is a process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention.
In the communications process, you, as the physician providing or performing the treatment and/or procedure (not a delegated representative), should disclose and discuss with your patient:
• the patient’s diagnosis, if known;
• the nature and purpose of a proposed treatment or procedure;
• the risks and benefits of a proposed treatment or procedure;
• alternatives (regardless of their cost or the extent to which the treatment options are covered by health insurance);
• the risks and benefits of the alternative treatment or procedure; and
• the risks and benefits of not receiving or undergoing a treatment or procedure.
In turn, your patient should have an opportunity to ask questions to elicit a better understanding of the treatment or procedure, so that he or she can make an informed decision to proceed or to refuse a particular course of medical intervention.
This communications process, or a variation thereof, is both an ethical obligation and a legal requirement spelled out in statutes and case law in all fifty states of the United States. 1
By violating the individual patient’s right to informed consent, fluoridation allows decision makers, without medical qualifications, to do to the whole community what an individual doctor is not allowed to do to his or her individual patients.
Counterargument 1: It Is Unethical Not to Fluoridate
Proponents respond to this ethical argument by turning it upside down. They argue that it is unethical to deprive children of a benefit that might reduce pain and help them lead healthier lives, especially children from low-income families.
However, by not putting fluoride in the water, you are not depriving anyone of access to fluoride: It is available in tablet form and in fluoridated toothpaste. (For a discussion about topical versus systemic benefits, see chapters 2 and 6. )
From an economic perspective, avoiding fluoride in water is an expensive business, whether it involves purchasing bottled water for cooking and drinking or the use of distillation equipment or reverse osmosis systems. Thus, low-income families are disproportionately burdened by fluoridation since by and large they cannot afford avoidance measures.
In the United States, dental decay is concentrated in poor and minority families. Fifty-five years after fluoridation began, the U. S. surgeon general stated in his 2000 report, Oral Health in America: “There are profound and consequential disparities in the oral health of our citizens. Indeed, what amounts to a ‘silent epidemic’ of dental and oral diseases is affecting some population groups. Those who suffer the worst oral health are found among the poor of all ages, with poor children and poor older Americans particularly vulnerable. Members of racial and ethnic minority groups also experience a disproportionate level of oral health problems. ”2
The motivation for targeting poor children for extra help is highly laudable, but adding fluoride to the drinking water to do so is misguided. In fact, it makes an inequitable situation even worse. This is because in Western countries the children most likely to suffer from poor nutrition come from low-income families, and we will see in chapter 13 that people with inadequate diets are those most vulnerable to fluoride’s toxic effects. In our view, children from low-income families are the very last children who should be exposed to ingested fluoride.
Counterargument 2: No One Is “Forced” to Drink the Water
Proponents of fluoridation further counter the notion that fluoridation in the public water system violates the individual’s right to informed consent to medication by arguing that fluoridated water is only delivered to the tap and no one is actually forced to drink it.
This argument certainly does not apply to low-income families. Their economic circumstances do force them to drink the water coming out of the tap. Thus, a program that is billed as equitable is actually inequitable, since families of low income are trapped by a practice that may cause them harm (see chapters 11, 13–19).
Moreover, even for families with the means to buy bottled water for drinking and cooking, or equipment to remove the fluoride at the tap, it is very difficult to avoid fluoride once it has been put in the community’s water supply. It will be in every glass of water and cup of coffee or tea consumed in town—at work and in friends’ homes. It will also be in the water that is used to water the garden and in the shower and bath water.
Counterargument 3: Fluoride Is a Nutrient, Not a Drug
Proponents have tried to muddy the waters in the argument of violation of informed consent and unacceptability of “mass medication” by insisting that fluoride is not a medicine or drug, but a nutrient. We examine the evidence for their claims.
Is Fluoride an Essential Nutrient?
There is little or no evidence that fluoride is an essential nutrient. To demonstrate that a substance is an essential nutrient one has to demonstrate that some disease results from depriving an animal or a human of this substance. This has never been done for fluoride (see chapter 12).
In a 1998 letter by Bruce Alberts, president of the National Academy of Sciences, and Kenneth Shine, president of the Institute of Medicine, to Professor Albert Burgstahler, editor of the journal Fluoride and several other scientists, in response to their complaint to the National Academy about the Institute of Medicine’s inclusion of fluoride in the list of nutrients in its report Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride, 3 the following quote appeared:
First, let us reassure you with regard to one concern. Nowhere in the report is it stated that fluoride is an essential nutrient. If any speaker or panel member at the September 23rd workshop referred to fluoride as such, they misspoke. As was stated in Recommended Dietary Allowances 10th Edition, which we published in 1989: “These contradictory results do not justify a classification of fluoride as an essential element, according to accepted standards. Nonetheless, because of its valuable effects on dental health, fluoride is a beneficial element for humans. ”4
What Alberts and Shine do not discuss here is whether the supposed benefits of this “beneficial element” are obtained from some internal biological process or via some nonbiological interaction of the fluoride with the surface of the tooth enamel. This is a crucial difference when considering water fluoridation, since the former would necessitate swallowing fluoride and the latter would not (see chapter 2).
While there is no solid scientific evidence supporting the notion that fluoride is a nutrient, strenuous attempts have been made by a number of proponents throughout the history of fluoridation to try to establish this notion in the public mind. In chapter 26 we examine these efforts, in particular the effort by Harvard researcher Dr. Frederick Stare and the aid given to him by the sugar and food lobbies.
Is Fluoride a Drug?
In a letter sent in December 2000 to Congressman Kenneth Calvert, chairman of the Subcommittee on Energy and the Environment, of the Committee on Science, the U. S. Food and Drug Administration (FDA) stated, “Fluoride, when used in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal, is a drug that is subject to Food and Drug Administration regulation. ”5 The National Association of Pharmacy Regulatory Authorities in Canada lists “sodium fluoride” and “fluori
de and its salts” as drugs. 6
According to Cheng et al. in an article appearing in the British Medical Journal, “The legal definition of a medicinal product in the European Union (Codified Pharmaceutical Directive 2004/27/EC, Article 1. 2) is any substance or combination of substances ‘presented as having properties for treating or preventing disease in human beings. ’”7
Both the Centers for Disease Control and Prevention (CDC)8 and the American Dental Association (ADA), 9 the main proponents of fluoridation in the United States, describe dental caries (tooth decay) as a “chronic infectious disease” and recommend fluoride to prevent the disease.
If fluoride is a drug or medicinal product, fluoridation is medication delivered on a massive scale.
An Unapproved Drug
In a June 3, 1993, letter to FDA commissioner Dr. David Kessler, former New Jersey assemblyman John V. Kelly wrote, “The Food and Drug Administration Office of Prescription Drug Compliance has confirmed, to my surprise, that there are no studies to demonstrate either the safety or effectiveness of these drugs [fluorides], which FDA classified as unapproved new drugs. ”10
It goes without saying that it would be highly questionable to deliver any drug via the public water system—let alone fluoride, which the FDA calls an unapproved drug. The designation “unapproved drug” means that it has not gone through rigorous trials to establish either its effectiveness or its safety. This designation also puts into question the ethics and legality of school nurses and teachers administering fluoride pills and/or rinses to students in U. S. schools located in non-fluoridated areas.
Other Arguments
Violating the modern medical ethic of informed consent is not the only feature of fluoridation that makes it a poor medical practice. In a recent videotaped interview, Earl Baldwin, a member of the British House of Lords and one of the advisory board members for the York Review, the UK-sponsored review of fluoridation, 11 explained why he thought fluoridation was a bad idea: “What physician do you know, who in his or her right mind, would treat someone he does not know and has never met, with a substance that’s meant to do change in their bodies, with the advice: ‘Take as much, or as little, as you like, but take it for a lifetime because it may help someone’s teeth’?”12
Independent observers have been saying similar things since the inception of fluoridation, but these arguments have fallen largely on deaf ears. This is not because the reasoning lacks merit, but because those who promote fluoridation have the power to ignore both common sense and scientific argument. We examine the strategies and tactics used in the promotion of fluoridation in chapter 23. In the following sections we examine some of the commonsense arguments of opponents such as Earl Baldwin in more detail.
No Control over Who Gets the Medicine
For those who promote fluoridation, one of its attractions is that it delivers fluoride to everyone indiscriminately. But for opponents this is one of its greatest weaknesses. When fluoride is added to the water supply, it goes to everyone, including those most vulnerable to fluoride’s known toxic effects. These include above-average water consumers; the very young; the very old; those with diabetes; those with low thyroid function or kidney disorder; and those with an inadequate diet, including those suffering from outright or borderline iodine deficiency (see chapter 16). Also, as we indicated above, it goes to families of low income who cannot afford avoidance measures.
No Control of Dose
A critical problem with delivering a medicine via the water supply is that there is no control over the dose. Dr. Arvid Carlsson discussed this issue in a letter he wrote in February 2009:
Fluoridation is an obsolete practice. It goes against all principles of modern pharmacology. The use of the public drinking water supply to administer the same dose of fluoride to everyone, from the infant to those who consume copious amounts of water (such as diabetics), goes against all principles of science because individuals respond very differently to one and the same dose and there are huge variations in the consumption of this drug. 13
Concentration versus Dose (from water and other sources)
Proponents of fluoridation stress how well engineers can control and monitor the concentration of the fluoridating agent added to the water supply. However, controlling concentration, measured in the case of fluoride in milliCAF grams per liter (mg/liter), is not the same as controlling dose, which is measured in milligrams consumed per day (mg/day).
If someone drinks 1 liter of water containing fluoride at 1 mg/liter (i. e. , 1 ppm, which is the concentration at which it is administered), they will ingest 1 mg of fluoride. If they drink 2 liters, they will receive 2 mg of fluoride, and so on. The dose gets larger the more water is drunk; and the larger the dose, the more likely it will cause harm. This is particularly serious for a substance like fluoride, which is known to be highly toxic at moderate to high doses, which accumulates in the bone, and for which there is little, if any, margin of safety to protect the most vulnerable against known health risks (see chapter 20).
We also receive fluoride from sources other than the water supply, and this amount varies from individual to individual. Thus, it is the total dose from all sources we should be concerned about.
To determine potential harm, we also have to take into account the body weight of the consumer. We discuss the difference between dose and dosage below.
Dose versus Dosage
The dose of aspirin or any other drug considered safe for a grown-up is not a safe dose for a baby. Similarly, a safe dose of fluoride for an adult cannot be considered safe for a baby. Thus it is alarming when one discovers that, over the course of the day, bottle-fed babies can receive nearly as much fluoride as an adult who drinks 1 liter of fluoridated water. According to the U. S. Environmental Protection Agency in a 2008 article on why children may be especially sensitive to pesticides, “In relation to their body weight, infants and children eat and drink more than adults. ”14 The way toxicologists determine the safe dose for different ages is to adjust for the average body weight of the age range in question.
According to the EPA’s 1986 calculation of a safe drinking water standard, a safe daily dose of fluoride for a 70-kg (154-lb) adult is supposed to be 8 mg per day. 15 In chapter 20, we challenge the faulty reasoning that led to this high figure. But in the meantime, if we adjust this figure of 8 mg per day for body weight, that would mean that only 0. 8 mg per day would be safe for a 7-kg (15-lb) infant (i. e. , a ten times lower dose because the baby’s body weight is ten times lower). Even that dose may be too high for a baby, however, because a baby’s developing tissues, particularly the brain, are much more vulnerable to toxic agents than an adult’s. An infant is not simply a miniature adult.
Dose divided by a person’s body weight is called dosage and is measured in milligrams per kilogram of body weight per day (mg/kg/day). The safe dose for an adult divided by an adult’s body weight (assumed to be 70 kg) is called the reference dose, or RfD. Strictly speaking, we should call this a reference dosage, but people seldom do. Note the different units here. If we are talking about dose, we are speaking about mg/day, but if we are talking about a reference dose, or dosage, we are speaking about mg/kg/day. This is a big difference.
Now let’s look at a real-life example of using a reference dose. The EPA lists IRIS reference doses for a number of toxic substances. IRIS stands for Integrated Risk Information System; it is used for health-risk assessments. The EPA’s RfD for fluoride listed in IRIS is 0. 06 mg/kg/day. 16
It is worrying to see that this IRIS RfD is easily exceeded by a baby consuming formula made with fluoridated water. For example, a 10-kg infant drinking each day 1 liter of water containing fluoride at 1 ppm will get a dosage of 0. 10 mg/kg/day (1 mg/day divided by 10 kg). That is almost twice the IRIS RfD.
It was after the 2006 U. S. National Research Council report17 made it clear that bottle-fed babies were exceeding the IRIS RfD that the ADA finally recommended to its membership, in November 2006, that they advise
their patients not to use fluoridated water to make baby formula. 18 The CDC followed suit, 19 but neither has made much of an effort to get this information to parents.
Different Responses to Same Dose
It is well known that there is a very wide range of sensitivity across the human population to any drug or toxic substance. Some people will be very resistant, while others will be very vulnerable or sensitive to the same substance. Most of us will have an average tolerance; however, we can anticipate that the most sensitive will be at least ten times more vulnerable than the average responder. Those who promote fluoridation gloss over the insufficient margin of safety to protect all citizens, especially the most sensitive, from the known adverse health effects of fluoride (see chapters 13 and 20).
Warnings, Help, and Compensation
One thing that is generally accepted about water fluoridation is that where it is implemented, the rates of dental fluorosis (mottling and discoloration of the enamel; see chapter 11) in children will rise. Very little warning is being given about this, especially to low-income families who bottle-feed their babies with formula made with fluoridated tap water. Nor is any financial help being provided to those families whose children are so affected. It can cost up to $1, 000 to treat a fluorosed tooth with veneers—more when the veneers have to be replaced in subsequent years.
According to the CDC, 32 percent of American children are affected by dental fluorosis. 20 While most of those children have the very mild condition, those with the mild, moderate, or severe condition make up about 10 percent of the total, and many of those may need treatment (see chapter 11). Ten percent being affected would mean some 32, 000 children in a city of one million needing cosmetic treatment that few families can afford. Public and media concern is growing on this issue; for example, see the transcript of a TV news clip from CBS in Atlanta, Georgia, broadcast in March 2010, at http://www.cbsatlanta.com/health/22776266/detail.html. 21