Meaningless formalities of informed consent caused by knowledge gaps

translated by Yuji Ikeda

Today, the amount of new medical knowledge is increasing rapidly. “Accelerating” is not even adequate to describe the advancing pace of knowledge generation. Under the current circumstances, it is almost impossible even for medical professionals to keep up to date by themselves.


For example, about fifty years ago, cancer was classified by organ, such as gastric, colon, and lung cancers. Then, microscopic diagnosis was introduced to classify them into pathological subtypes such as small cell and non-small cell lung cancer (including adenocarcinoma, squamous cell carcinoma and large cell carcinoma). Accordingly, these pathological subtypes changed therapeutic strategies as well.


Now we are in the21st century, and genetic alterations have become a focus of cancer classification. Of course, these genetic classifications involve a wide range of information. For example, breast cancer treatment is determined based on specific properties of the estrogen receptor (ER), progesterone receptor (PgR) and human epidermal growth factor receptor 2 (HER2). The various genetic mutations in lung cancer are listed as KRAS, EGFR, FGFR, FGFR1, PTEN, ALK, MET, DDR2, BRAF, PIC3CA, ROS and so on.  Depending on whether a patient has an EGFR mutation or an ALK mutation, a precision medicine approach would dictate different therapeutic interventions. Today, genetic information is an important factor for drug choice.


 I am often informally consulted by cancer patients or their families. Once, I was talking with a patient and her family members about lung cancer, as I was told she had lung cancer.  However, our discussion was not on the same wavelength.  For example, I looked at the medical records, and found that the patient had colon cancer with lung metastasis!  The primary cancer location is critically important, however, even such basic knowledge seems to be absent from the curriculum of the current educational system.


 What is taught in middle and high schools is absolutely inadequate to keep pace with the rapid progress of science, which produces knowledge gaps between persons who explain and those who receive explanations.  For many people, genetics terms like KRAS and EGFR might sound like words from another dimension, which would leave them with a lot of “??” in their minds.  Even during the time when I was a medical student (this was maybe too long ago!), genetic mutations had not yet been identified.


In addition, too much detailed information about side effects might make patients even more confused.  It is often difficult for healthcare providers to determine the optimal level of explanation for patients, which only adds to everyone’s mental and physical burdens.  It would be a lot easier to explain things according to a standard manual and imagine that one’s obligations have been fulfilled.  However, I don’t think that is very kind or fair to patients.


 In cases of medical malpractice, mass media and so-called watchdogs and moralists sometimes irresponsibly accuse medical staff of wrongdoing and lack of accountability.  However, without comprehensive societal efforts to narrow the knowledge gap between the public and health care providers, the burdens on medical staff to provide information that is understood by patients will certainly rise to uncomfortably high levels. Or the current status of insufficient understanding will certainly become worse.


I don’t understand why pharmacists need to record drug histories every time.


Recently, I read an article about a pharmacist who dispensed prescribed drugs to patients without recording drug histories.  In the article, unlawful billing to the medical insurance system was the focus.  While disorganized management of drug history information is a serious problem in medical systems, this article wrongfully diminishes the point.


Basically, I think repeating the patient’s drug history every time to the pharmacist is obsolete.  I take multiple drugs myself, but it would take a long time to write them all down if I was asked to do so.  I don’t understand why they keep sticking with those out of date customs?  I believe all we need to do is just enter this information once into a smart card or smart phones.


With smart card or smart phone systems, computers could alert pharmacists of any potential problems such as inappropriate drug combinations, and then they could contact patients and their physicians or clinics with information about other options.  We cannot expect pharmacists to remember every piece of information about every drug combination; this is a job for computers.  Also, many patients would not want to listen to long-winded explanations about possible side effects as they are all printed out already.  These disorganized information systems may prevent us from accessing critically important information.


For example, tamoxifen (a breast cancer drug) should not be combined with a tricyclic antidepressant.  Tamoxifen is metabolized in the liver by CYP2DP into endoxifen, which is the active form required in breast cancer treatment.  However, CYP2D6 is also required to metabolize medicines such as tricyclic antidepressants; therefore taking these two drugs at the same time makes them compete with each other, which results in inadequate amount of endoxifen being produced.  Naturally, with reduced drug efficacy the risk of recurrence will increase.


Even among breast cancer specialists it is not so unusual to find persons who do not know about the contraindication of taking tamoxifen and a tricyclic antidepressant simultaneously.  It is almost irrational to expect that individuals can stay up to date on information about the practically infinite number of drug combinations.  Therefore, we urgently need to develop medical databases that continuously collect and compile information about medications, and to foster IT industries that enable us to use the databases effectively and efficiently.  If we are to take seriously the desire for fully informed discussion and decision making between medical professionals and our patients, these issues need to be taken up at the national level.