The following post is lengthier than my typical posts, because it was originally an essay I submitted as a school assignment. Now that the assignment has been completed and graded, I wanted to share it with you, as well — with the caveat that it’s a bit longer and more formal than most of what you read around here. 🙂  (Links, of course, were added later.)

Informed Consent

In the wake of the “Disneyland measles outbreak,” there has been a lot of talk about mandating vaccines. Twenty-three states are entertaining legislation this year to remove or restrict vaccine exemptions of various kinds, and/or to expand mandatory vaccination laws (NVIC, 2015). All the resultant discussion has me thinking about informed consent, because mandating vaccinations removes an essential element from that equation. Legitimate informed consent requires that the patient (or patient’s parent, in the case of a minor) be thoroughly informed of the positives and negatives regarding the drug or procedure in question, that he be reasonably informed regarding alternatives, and that he have the right to refuse. Remove any one of these elements and it is either no longer informed or it is no longer consent.

In order to be properly informed regarding the proposed medication or procedure, there are a number of things the patient needs to know. What is the process or method of administration? What is the expected outcome? What is the success rate in similar cases? What are the potential side effects or negative reactions? What are the contraindications? If there is a substance involved, what are the ingredients? An information gap in any of these areas may alter a patient’s understanding of the proposed treatment, resulting in a different decision than he would otherwise make.

At first blush, some of these details might appear unimportant but, depending on the treatment at hand, a seemingly small detail can make a big difference. Consider something as basic as magnesium supplementation. The method of administration and the exact form of magnesium chosen have a significant impact on the absorption rate and the severity of side effects. Oral magnesium, intravenous magnesium, and transdermal magnesium, for instance, have radically different absorption rates. Transdermal magnesium does not produce the gastrointestinal side effects of oral magnesium, nor does it have the “flushing” effect often seen with intravenous magnesium. Even among oral magnesium supplements, the mineral form chosen makes a difference, as does whether or not the magnesium is chelated. I trust it is clear that telling a patient you want to supplement magnesium is not sufficient information.

The expected outcome of a procedure can potentially also have a notable impact. In some cases it might directly affect the patient’s health. Other times it might only make a difference in how he plans. When my husband was scheduled for a tilt table test, he would have appreciated knowing in advance that the goal was to make him pass out! He still would have gone in for the test, but he probably would not have scheduled a lengthy drive immediately afterward.

Side effects may seem to be a minor concern, easily brushed aside, but they are no small matter! A 2001 study found that drug-related problems – which include side effects, as well as issues such as improperly-prescribed drugs – result in estimated costs of over $117 billion a year (Ernst & Grizzle, 2001). The large financial cost points to this being a sizable problem; however, I am sure most people would agree that the non-monetary costs of such reactions are even more significant. It is likely many of these undesirable effects could be avoided if patients were more effectively engaged in the treatment process.

Not only does an informed patient require a complete knowledge of the proposed procedure or medication, he also needs to have a reasonable knowledge of the alternatives. One treatment option may sound very good when examined on its own, but fall short of another, alternative option. It is not fair or ethical to withhold information regarding the better alternative in an attempt to make the inferior option sound appealing. Each patient is an individual; a patient may simply assign different weights to various factors than does his doctor, shifting the balance in favor of a different treatment. Finally, the patient is probably aware of his full medical history and current environment and may recognize the relevance of a contraindication his doctor has missed. This will not be possible if the doctor withholds information about the contraindications for a given treatment option.

One alternative often overlooked is the option to do nothing. In most cases, doing nothing is not going to be a good option. However, the patient is unable to properly weigh the treatment options available without this necessary baseline knowledge. A procedure with a survival/recovery rate of 75% measures up very differently against a situation where doing nothing has a survival/recovery rate of 5% than it does against a situation where doing nothing has a survival/recovery rate of 70%.

In addition to education about the proposed treatment and its alternatives, in order to be fully provided with the right to informed consent, it is requisite that the patient be given the opportunity and right to refuse the proposed treatment altogether, or to choose whatever option he believes best balances the risk-to-benefit ratio. If the treatment is mandated, the patient (or his representative) is no longer giving his consent; rather, it is being forced upon him.

[Tweet “”If a treatment is MANDATED, there is not informed CONSENT.””]

The problem of inadequate information is frequently present within the medical community as a whole; however, the concern regarding the right to refuse particularly stands out in situations where patients prefer less mainstream options. Take, for instance, the case of “Cassandra C.,” a 17-year-old Connecticut teen who was taken into custody so the Department of Children and Families (DCF) could force her to receive chemotherapy against her wishes (Fox News, 2015). (Cassandra had her mother’s support for her refusal.) Sarah Hershberger was similarly court-ordered to submit to chemotherapy in late 2013 (Perez, 2013). I, myself, have been refused an ultrasound – indicated by my medical history to be potentially life-saving – based on my unwillingness to commit to (and pay for) a specific later action the doctor’s office preferred.

Sometimes an entire community of people is influenced to accept a given option through partial information or misinformation. For example, consider water fluoridation. Most of the municipal water in this country is fluoridated. This is not for functional reasons. That is, fluoride is not an integral part of the water purification process. Fluoride is merely added – or so we are told – for its supposed health benefits. As the public is not informed of its makeup, potential side effects, alternatives, etc., and we really do not have the individual opportunity to “opt out,” this constitutes mass medication without informed consent.

Of course this recent movement to mandate vaccines and do away with exemptions is itself an example of the degradation of informed consent. As the vaccine debate heats up, we are seeing an increased push for the dissolution of informed consent – by taking away the right to refuse. This is, in large part, a result of many years of uninformed consent, as parents have been told of many alleged benefits of vaccines, but not of their actual success rates, their potential side effects, their ingredients, or their alternatives.

Medical ethics and the American ideal of personal liberty dictate the importance of informed consent, but our medical establishment has failed us in this area. I urge health practitioners to take this responsibility seriously and help restore truly informed consent: that which provides full and accurate information about the proposed treatment, offers a survey of the alternatives unbiased by majority opinion or financial interests, and leaves the ultimate decision in the hands of the only one with the authority to make it – the patient himself or, in the case of a minor, his parent.

References:

• Ernst, F., & Grizzle, A. (2001). Drug-related morbidity and mortality: Updating the cost-of-illness model. Journal of the American Pharmaceutical Association, 41(2), 192-9.
• Fox News (2015, January 5). Connecticut teen with cancer forced by state to undergo chemo treatments. Retrieved April 10, 2015, from http://www.foxnews.com/health/2015/01/05/connecticut-teen-with-cancer-forced-by- state-to-undergo-chemo-treatments/
• National Vaccine Information Center. (2015, January 1). Welcome to the NVIC Advocacy Portal(NVICAP). Retrieved April 16, 2015, from https://nvicadvocacy.org/members/Home.aspx
• Perez, A. (2013, October 9). Ohio Hospital Can Force Chemo on Amish Girl, Court Says.Retrieved April 10, 2015, from http://abcnews.go.com/Health/ohio-hospital-force-chemo-amish-girl-court/story?id=20513841

This post is being shared at Wellness Wednesday.

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