by Craig Klugman, Ph.D.
Jump to The Resident (Season 2: Episode 7): Phase 1 testing; Bad devices; Jump to The Good Doctor (Season 2; Episode 6): Patient stories vs. scans; emotional vs. technical perspectives; Jump to Chicago Med (Season 4; Episode 7): Crisis Ethics: Who gets the dose?

The Resident (Season 2: Episode 7): Phase 1 testing; Bad devices

This episode dealt with two large ethical issues—phase 1 testing of new drugs and the lack of FDA oversight of medical devices. When a patient comes in with multiple organ failure, blindness, and hearing loss, Hawkins suspects poisoning. The culprit turns out to be a flawed hip replacement (metal on metal) that sheds cobalt and steel into his body. This leads to a conversation about how such a device could have been approved. Hawkins explains that the 510(k)processallows a company to “fast track a device if the device is similar to something on the market.” The device rep says that this process brings “life saving devices” to market faster. She believes that there must be oversight but Hawkins explains that many of the people serving on the FDA review committees have company ties. Voss says that the cost of the lawsuit is mere pennies compared to the potential profits (i.e. they put bad products on the market because the potential for riches is higher than the costs of injuring people). The surgery to replace the hip could fix many of his problems, but it’s risky since his heart is damaged. Without surgery, he will deteriorate and die within a year. His wife does not know what to do. She finally agrees to surgery which is difficult since the faulty hip caused more severe damage than tests indicated. In the end, they are successful, but do bring up the issue of the 510(k) process and lack of oversight and testing.

The second storyline concerns a phase I cancer drug trial taking place in the hospital, coordinated by a private company. Trial subjects start getting severely sick when Hawkins shuts it down (a powerful resident) and moves the subjects into the ICU. Hawkins believes the drug caused a cytokine spiral and subjects need high dose of steroids to stop it. The drug company states the problem is sepsis caused by unclean conditions in the hospital. Hawkins turns out to be right, but not before one subject dies. Bell explains that every drug and every device was at one time tested as a phase 1 experiment on humans. Hawkins points out that the problem is that the people who volunteer are desperate and do it for the money, not to further science. They may sign the form, but their financial and social situation do not really allow for them to say no. In reality, there is an ethical concern that phase 1 trialsmay prey on the socioeconomically disadvantaged. Given the lack of potential benefits to the healthy subjects, money may be their driving force in participating. However, the opposite situation exists for clinical cancer trialswhere access is related to higher SES, possible because there tends to not be compensation for participating in these Phase 2 and 3 trials, which can be harder to get into for this disease.

The Good Doctor (Season 2; Episode 6): Patient stories vs. scans; emotional vs. technical perspectives

A 13-year-old girl is brought to the ED with a severe nosebleed. Parke cauterizes the blood vessel and as her divorced parents are about to take her home, the patient starts coughing and spits up blood. Her parents said she has had a lot of symptoms and no doctor found anything; a psychologist believes it is stress from the divorce and a call for attention. After being released, her father brings her back in with what appears to be pneumonia, Browne suspects an underlying, undiagnosed disease. A shadow on her scans suggests, to Browne, a possible tumor. She recommends a surgery to go poking around and see what it is. Parke thinks it is too risky. After presenting the options to the parents, they go ahead with the surgery. Complications require moving from laparoscopic to open procedure but they do find a Lego, that had been there for years, became encapsulated and led to an immune response. Browne said that she relies on her emotional intelligence rather than tests that repeatedly show nothing. However, as we have seen, Browne continuously demonstrates poor judgement. Is this a statement from the show that an emotional approach (also seen in the second storyline and usually exemplified by the female characters) is problematic and a more technical (usually exemplified by the male characters) is better? Or is the practice of medicine more complicated?

In a second storyline, a violinist comes into the ED after getting a bad manicure that has led to an infected finger. Shaun says it could be necrotizing fasciitis and wants to test for that, a procedure that requires cutting into the finger and getting a tissue sample. However, that procedure could cut small nerves that might affect the patient’s ability to play the violin. Reznick tries to reason with him explaining that the chances of her having that infection are small, but if they test, the chances of affecting her skill are high. When the patient does not respond, Reznick moves on to treated MRSA, but her temperature continues to rise. Shaun and Reznick decide that they have to biopsy her finger. Shaun believes that Renick’s desire to maintain the integrity of the patient’s finger is clouding her medical gaze. The test shows that Shaun is right and she will need to lose the finger, perhaps more. They perform a conservative surgery, trying maintain as much of the finger function as possible, but she has to be watched carefully overnight. An alarm wakes everyone in the patient’s room and they see that she is septic, the infection having spread to an extent that she will need to have the arm amputated. When the patient awakens, she blames Reznick for the loss of her arm, saying they should have listened to Shaun. However, I suggest that Reznick was the better doctor here because she was considering the patient’s life and profession and worked for a procedure that preserve those as much as possible whereas Shaun was taking an emotionless, purely technical perspective that ignored the effect that his actions would have on the patient. There are times where one or the other approach can lead to the right outcome (and of course, all of these medical shows are focused on the consequences), but in this case the intent of providing the best option for a particular patient is the better route.

<h2><strong><a name=”Chicago Med (Season 4; Episode 7): Crisis Ethics: Who gets the dose? “></a>Chicago Med (Season 4; Episode 7): Crisis Ethics: Who gets the dose?</strong></h2>

After a decreased patient’ husband (Mr. Patrick) releases a toxic substance in the ED (later found to be cyanide), the unit is evacuated. Choi was near the attacker, so he and the perpetrator were directly exposed. Both are in bronchospasm and in need of epi but there is only one dose left (hopefully more will be coming, but turns out not to be). Sexton (who until recently was dating Choi) says that the dose should go to Choi. Goodwin asks who is doing worse and the answer is Mr. Patrick. Goodwin says the protocol is that the patient with the greatest medical need gets treated first: Mr. Patrick gets the epi. When Choi weakens, Halstead suggests another drug which is not great, but it’s something. Sexton holds her breath and runs into the ED to get the alternative drug; she does so and then has to be decontaminated. Mr. Patrick dies. After identifying the substance, the ED is cleaned and Choi is put onto a vent, treated and recovers.

Making decisions about how to distribute scarce resources is a difficult choice, which is why many institutions and towns/states have spent years developing protocols that are carefully crafted and vetted. Although Sexton wants to make the emotional choice, Goodwin stuck to the protocol, which is the right thing to do. If circumstances, information, or resources change, then deviating from the protocol would be justified. However, given the chaos of a crisis situation, following a protocol can make good sense and help in making decisions. There are many ways to distribute a scarce resource: need being one of them. However, when crafting our crisis standards of care plan in Illinois, one of the questions we dealt with was “do we owe a reciprocal obligation to the first responder?” Our answer was “yes” as long as the treatment would get the responder back up on their feet and able to help. Choi was not only directly exposed to the cyanide, but he was also working to help evacuate, evaluate and treat patients. When he became sicker, there was nothing that was going to let him get immediately back in the game so he would not have any special consideration. The correct decision was made under this fictional hospital’s plan and the real state of Illinois plan.