Erosion of Informed Consent in Medicine: What Is Real And Fake In Today’s Medical Field
Informed Consent refers to the practice whereby a patient is informed of all of the risks and potential rewards of a given treatment, whether the treatment be oral prescription medication, pharmaceutical injections, tests, or surgeries. According to law and long-standing medical practices based on ethical guidelines, patients are always supposed to be completely informed, so that they can make an informed decision that is best for them. This article will delve into several treatments and tests, including amniocentesis, labor and delivery practices including epidural and pitocin, and gender dysphoria treatments including hormone therapy and surgeries.
The idea behind informed consent is that the best patient is a well-informed patient. Such a person has carefully considered the pros and cons of a given treatment, weighing the risks and rewards and making the best possible decision. Part of the requirements of informed consent are the right to refuse treatment, and the right to be informed of alternative therapies or treatment approaches. There is in New York state a law covering informed consent with regard to the right of the patient to initiate a malpractice lawsuit, and where that is not permissible by law (such as in an emergency situation). If it can be determined that a reasonable person would not have made the same choice had they been exposed to all of the available information about a given treatment, then the requirement has been violated.
This is worse than buyers remorse, however, as there can be real consequences to the failure to provide informed consent. Such consequences can include disability of the patient, both long term and short term, loss of the patient or a fetus, if the treatment involves pregnancy, and also long-term health effects, such as those being discovered with hormone therapies.
Amniocentesis: A totally unworthwhile test that can often lead to miscarriage
The amniocentesis, also sometimes known in colloquial medical language as amnio, is a test to determine if a developing fetus has a certain abnormality that would result in a child having Down’s Syndrome or a few other genetic anomalies. While many people who are getting this test, particularly people in Australia, would want to have an abortion if the test were to result in a positive result, there are many who would not want to terminate the pregnancy. When a child is born with Down syndrome, it does often mean that the raising of that child would have a higher cost. Often, such children require specialized education which not every state provides. However, this also minimizes the contributions of such people to our society.
There are quite a few examples in the modern day of people with Down’s Syndrome breaking down barriers and helping others in all types of situations. People with this condition have shown that they can be capable, productive members of society. Advocacy groups such as the National Down Syndrome Society fight for equal rights for people with this genetic anomaly. In some cases and in many states, it is legal to pay people with disabilities less than the federal or state level minimum wage. While New Jersey has passed legislation to stop this at the state level, New York is not on the list of states that have enacted such legislation. Particularly with Down Syndrome, where the variation in ability is so great, but also with all persons who are disabled, the ability to make a liveable wage is critical. Being forced into a separate workforce, with different rules and wage requirements based on archaic standards from decades and centuries past, makes it nearly impossible for an individual who is disabled to become self-sufficient.
Amniocentesis is a test that can determine the presence of certain genetic anomalies, of which Down Syndrome is one. In some countries, particularly Australia (according to the Australian Broadcasting Corporation), 90% of pregnancies are terminated after a positive diagnosis of Down Syndrome from an amniocentesis. In the United States, a study done to estimate the termination rate of fetuses diagnosed with Down Syndrome was estimated at 50% for anomaly-based studies, 85% among nine hospital based studies, and 67% among seven population based studies. The rates of termination have gone down in recent years.
However, the most concerning aspect of the amniocentesis is that it has a 1 in 100 rate of the test causing a miscarriage. This estimate is from England, which tends to keep better numbers with regard to maternal care (for example, they annually publish a giant volume, called “Why Mothers Die” to concatenate every cause of death among mothers who have died within two weeks of delivering a baby. In the US, this is not done due to the pressure of physician liability in these deaths, so they are not reported). In the US, according to the March of Dimes, that rate is 1 in 200, and other US sources place the risk at 1 in 900. Even this variation can be confusing, and many women are not given this disclosure of increased risk. They are told that the amniocentesis is almost 100% accurate in predicting the genetic anomaly. Mothers who are older than the age of 35 are routinely offered this test.
However, as disclosed above, more women are opting to keep the baby even with a positive result. Since the test itself can cause a miscarriage, women are not informed of this. As this test is described, it is inherently risky, and it makes sense that it carries such a miscarriage risk. A long thin needle is inserted into the amniotic sac around the growing fetus. Then a bit of the fluid is extracted and tested. The needle can easily accidentally puncture the sac, causing leakage. Expecting women are not normally told about this risk, and as you can see from the wide variation in the reported risk from US sources, it is often downplayed as a minor risk. However, as prenatal tests go, it is among the only tests that is implicated in causing miscarriage.
Informing Of The Risks Of Epidural, Especially Regarding What Epidural Is And Its Possible Adverse Reactions
I was shocked to recently learn what an epidural actually is. It is not just a pain killer. It is in fact a mixture of fentanyl and something similar to novocaine. That same fentanyl that is flooding the country causing overdose deaths to skyrocket? Yes, that fentanyl. Injected directly into the spinal fluid space during labor in the hospital. However, it is said that the fentanyl stays in the spinal fluid and does not cause the regular side effects usually associated with fentanyl, such as drowsiness.
Where does this come in with regard to informed consent? It is very unlikely that a person can become addicted to opioids just by having an epidural. Unless the doctor is unskilled and the medication does not go into or stay in the spinal space, generally this is not an issue. But if every woman knew that this is what an epidural is, would they still go for it in such high numbers? Instead, everyone knows the name of it as epidural, rather than opioid concoction for pain relief during labor.
There are some problems, though, with this medication nevertheless. And this is where the informed consent issue comes to light. There is a condition called Epidural-Related Maternal Fever. As the name states, it is a fever that occurs after the administration of an epidural. According to a mini review study on this issue, it turns out that about 20% of maternal patients receiving an epidural develop this type of maternal fever. That’s one-fifth of all women who get this pain-killer. Now, why is this important?
It is super critical to understand that during labor and delivery, a maternal fever is a big deal. It can sometimes mean that she has developed an infectious and deadly condition called chorioamnionitis. This is an intrauterine infection that must be treated, usually with intravenous antibiotics during labor. This condition is most common in the period just before birth, and can occur from more than the necessary amount of vaginal exams. If she has developed this infection, treatment must start right away. However, it is very difficult during labor and delivery for a doctor to determine if the cause of maternal fever is this infection or if it is just ERMF (Epidural-Related Maternal Fever), described above, which happens to one in every five women.
When this fever is present, according to the review study mentioned previously, the rate of cesarean is greatly increased. it does not state what the rate of C-sections in this instance are, but it is higher than in those who did not have a maternal fever.
Now, the question you should be asking yourself, if you are a mom and delivered in a hospital with an epidural, is why was I not told about this. If women were aware that there is a 20% risk of maternal fever caused solely by the epidural treatment, and that such fever can lead to increased incidence of C-section, would it be as popular? Most women do not want a C-section. As a consequence, they would want to know if a given intervention is likely to cause this unwanted surgery.
In most instances, though, informed consent is not provided to laboring women. In the intensity of the pain, doctors often ask if they want an epidural like they ask if they want Tylenol. They usually fail to disclose the risks and potential outcomes of having an epidural, thus having the twofold effect of increasing the epidural uptake rate (epidurals are quite expensive in themselves) along with raising the rate of C-sections. The cost for an epidural by itself is between $1,300 and $1,500 in NYC and NJ, respectively.
Most people don’t know that this treatment will increase their risk of a C-section. Not only that, but having a C-section significantly increases their cost of having a baby. Where a regular hospital birth featuring a vaginal delivery costs about $10,000 in our area, of which insurance companies almost never cover the full amount, a C-section has a price tag closer to $50,000. New Jersey has the highest cost for c-section in the US, at $51,000, whereas New York follows closely behind at $45,000.
As far as uncomplicated vaginal deliveries, New York’s average cost is $15,000, and New Jersey has the highest national cost at about $29,000
However, at least in this area, there are ways that an expectant mother can overcome these issues. Hiring a doula to accompany her to the hospital and to provide real-time, in-the-moment informed consent is probably the easiest and least expensive way. Having a midwife-led birth is another, since midwives cannot administer an epidural, and they have other ways of assisting a woman with bearing the pain. Birth education classes are also very valuable in teaching a pregnant person non-medication based ways to deal with the pain.
Gender-Affirming Care Possible Adverse Risks Not Understood Or Recorded
At this time, limited data is available on the adverse effects related to gender-affirming care and treatment with hormone therapy for transgender people. However, there are issues that may be concerning related to these drugs.
For instance, in France there is a database where adverse events for medications and treatments are reported called the French pharmacovigilance database
According to the little data available, regarding treatments for transgender women and transgender men, both of these groups reported more cardiovascular events, including venous thromboembolism, ischemic stroke, and myocardial infarction. The incidence of these effects is greater than it is in similar populations of cisgender women.
However, a significant limitation of this and other studies in the area is the lack of clinical evidence. Since these medications have not been employed for that long in the populations currently receiving them, there is very little long-term data on the side-effects related to their use. It is concerning, though, that the incidence of heart-related adverse health events is higher in these populations. In the interest of informed consent, additional research studies should be undertaken to determine if these cardiovascular events are caused by the treatment or if they are merely coincidental and are only negligibly higher than in normal populations.
It has also been shown recently that transgender women (who are biologically male) undergoing hormone therapy have a slightly higher incidence of breast cancer than do cisgender men (who are also biologically male). However, they have a lower incidence than cisgender women (who are biologically female). This particular risk is not well-studied or well known, and no conclusions can really be drawn about it. But it is likely that more research will come out as more transgender individuals are given this type of therapy.
The issues mentioned herein were sufficient to convince at least one public transgender personality to stop taking the hormone treatments some time ago after many years due to the increased cancer risk described above. While they still appear female due to intense cosmetic surgery and long-term hormone use, they are no longer experiencing the acute effects of the hormone therapy (such as softened skin, less deep voice, and other secondary characteristic changes).
Trans Surgeries Do Not Lack Informed Consent When Physicians Follow Governing Body’s Guidance
In the instance of gender-affirming surgeries performed on transgender individuals, the risks of the surgery are many and varied. On the American Society of Plastic Surgeon’s website, they list the following as some of the possible complications of the transfeminine bottom surgery: “bleeding, infection, poor healing of incisions, hematoma, nerve injury, stenosis of the vagina, inadequate depth of the vagina, abnormal connections between the urethra and the skin, painful intercourse, and anesthesia risks.”
According to personal stories of transgender individuals who have undergone these surgeries, they have stated that these risks were not explained to them. According to the above site, which is a type of governing body for plastic surgeons, they are supposed to fully disclose all of these risks, and they are to provide consent forms underlining the risks so that patients understand and are fully informed.
Most of the patients who have been interviewed were informed of the risks and knew what to expect. Those that did not may not have carefully read the consent forms and other information provided to them. If such information wasn’t provided, they can possibly make a complaint against their surgeon, but most patients have signed informed consent forms. Patients who have read the forms usually knew about the risks, but chose to undergo the surgery anyway. As with any surgery or medication, side effects and negative consequences are often disclosed, but people believe that their surgery or medication use will go well.
In addition to those risks, there have been complications related to actual use of the reconstructed sexual organs. In some cases, this has led to hemorrhage and other life-threatening issues. Plastic surgery, particularly elective, non-medically necessary cosmetic surgery, does not carry the same liability to the surgeon as other types of medically necessary surgeries. So if something goes wrong, there is a lot less liability on the part of the physician, particularly if they were vigilant in sharing these risks with their patients. While there have been some patients of these types of reconstructive surgery that have come forward and shared their regrets, the majority of people who undergo these surgeries are satisfied with their outcomes.
Most medical associations have maintained that transgender affirming care is the best route for people with the medically diagnosed condition of gender dysphoria. Whether or not a person gets such care, they are now protected from discrimination in employment and housing on the basis of their gender identity. Gender affirming care is a relatively new field, which is why there are so few long term studies
Informed Consent Can become A Reality With Patient Advocacy And Assertiveness
Patients can advocate for their own informed consent. At this point, we all have the medical cornucopia of scientific research literally at our fingertips. If you find studies that cause you to question the applicability of a particular medical treatment, do not be afraid to speak up.
Share the research with your doctor, and require that they help you to navigate the information that is available. If your present doctor will not afford you that respect, you can always find a new doctor. In some cases, there are physicians who cannot stand patients that question them. These are not the doctors to keep.
Doctors that don’t respect their patient’s intelligence are, quite literally, a dime a dozen. You could spend some time looking at doctor ratings on sites like healthgrades, and you will see a vast difference between physicians, including with regard to their bedside manner, which just means how they act toward you when you come to see them. Are they friendly and supportive? Combative and easily angered?
It is always super critical to remember that you are the only person you can trust to be in charge of your medical care. You are the one that has to live with the decisions you make based on your doctor’s suggestions or your own research. Only you can decide, because you live in your body. Providing your body with the best care is a good way to stay healthy and live a richer, healthier life. Making sure you get all the nutrients your body needs, including protein, vegetables, vitamins, and minerals is a great way to start living your best life. You are your own best caretaker, so take good care of yourself. When considering any medical intervention or treatment, be an informed patient. It will almost always improve your outcomes.
Banner Image: Medical worker. Image Credit – Ani Kolleshi
