Are Medical Ethics an Oxymoron?
Hippocrates (460-370 B.C .E.)
The other day, while standing in a supermarket checkout line, a fellow standing behind me heard the cashier greet me by saying “How ya doin Doc?” The fellow asked me “Are you a doctor? You look like one.” (I was clad in a blue pinstripe suit, maroon tie and matching show hankie, topped off with a Panama hat.) “Sort of,” I said to the man, who was wearing a tank-top sporting colorful tats from shoulder-to-wrist.
“What’s that mean. . . sort of? he asked. “I work in the field of medical ethics,” I replied, waiting for what, after nearly 30 years, is a pretty common response. “Isn’t that kinda contradictory?” he asked, a toxic grin on his face. “You mean like oxymoronic?” I asked. His face turned blank, as if he were wondering whether or not I had just called him a moron.
“So tell me,” he said as I started to insert my debit card into the reader, “what do you think of this Dr. Fauci?”
“I think he’s one of the greatest, most brilliant and humble people on the planet,” I said, giving him a broad grin. “And what do you think about him?” I asked.
“I think he’s killed more people than just about anybody in history,” he said . . . just challenging me to get into an argument.
“And how is that?” I asked. “I have always considered him to be a most honorable fellow.”
“Don’t you know? He’s the guy who created COVID-19 in some Chinese laboratory just so he could make billions from selling a phony cure.”
That’s where the conversation ended. Fortunately, the cashier had completed his task, loaded up my recyclable bags, and said “see you next time, Doc.” He imperceptibly jerked his head in the direction of the fellow behind me as if to say “jeez . . . what a moron!” At least it didn’t come from me.
I learned a long time ago never to get into an argument with an idiot . . . or a conspiracy buff . . . especially when it comes to an area where I know a thing or two. I have neither the time to bang my head against a brick wall, nor any particular love of concussions.
Hippocrates, widely considered one of the most outstanding figures in the history of medicine, laid down the first principle of medical ethics: primum non nocere (hoc est, “First, do no harm”). Over many centuries and innumerable plagues and pandemics, an inviolate code of ethics has attached itself to the healing arts. The modern field of medical ethics owes a great deal to the Third Reich, whose doctors, it was discovered during the post-war “Doctors Trial” (officially called United States of America v. Karl Brandt et al), held in Nuremberg at war’s end, of the grossly inhumane “medical procedures” that were carried out on human beings without their knowledge or consent. So breathtakingly shocking were the results of these 12 trials, that a new field - medical ethics - was born.
The 4 most overarching principles of this field of medicine are:
Autonomy (Respect a person’s right to chose what’s right for them);
Non-maleficence (Do no harm);
Beneficence (All choices for a patient are made with the intent to do good). and
Justice (Treat and provide care fairly to all patients).
For close to 30 years, I have served as a member of an “Institutional Review Board” (IRB), a group made up of physicians, scientists, pharmacologists and multidisciplinary academics, who are charged with safeguarding both the rights and the safety of those who participate in clinical trials (medical research). Personally, I attend a minimum of 2 teleconferences each week, during which we review anywhere between 3 and 15 new medical trials, research modifications, and what are called “continuing reviews.” it represents a tremendous amount of research and work, but ultimately is as rewarding (and demanding) as anything we have ever done.
At any given teleconference, we might be dealing with studies involving multiple myeloma (a dangerous form of cancer), amyotrophic lateral sclerosis (ALS - “Lou Gehrig’s Disease”), Crohn’s Disease (“Terminal Ileitis”), Osteogenesis Imperfecta (“Brittle Bone Disease”) or Acromegaly (a rare disease resulting from excessive production of growth hormone) or hundreds of others. Before we begin our meetings, we must swear that we have no financial conflicts of interest with the clinics, corporations or universities engaged in research . . . just to make sure that everything is on the up-and-up.
Make no mistake about it: creating new drugs and medical devices, or seeking to determine if an FDA (Food and Drug Administration) drug can effectively be used for a non-approved purpose, is a lengthy and extremely expensive proposition. For every Viagra (Erectile Dysfunction), Remicade (Crohn’s Disease), Celebrex (Osteoarthritis) or Synthroid (hypothyroidism) which rake in billions upon billions of dollars, there are literally thousands which will never earn a penny . . . let alone receive FDA approval. Sometimes, the research money is provided by ”big pharma”; sometimes, it comes from the Federal government.
When done properly, clinical trials can take years, and be painfully slow. And like it or not, this is just the way things should and must go. Short-cuts can lead to medical catastrophes. Who remembers the “Thalidomide babies” tragedy of the 1950s? Research on Thalidomide had begun to show the drug’s effectiveness in alleviating nausea in pregnant women, and many physicians started prescribing the drug off-label as a treatment for morning sickness. Not long after Thalidomide started being used for this purpose, physicians and scientists began observing birth defects in children born to mothers who had taken Thalidomide during their pregnancy; studies showed that exposure was particularly dangerous for infants born to mothers who had used the drug approximately 20—34 days post-fertilization. Common birth defects seen in these children included deletion of the ears, deafness, severe underdevelopment or absence of the arms, defects in the femur and tibia (bones of the legs), and many more. (Today, Thalidomide is still being prescribed . . . but for the treatment or prevention of certain skin conditions related to Hansen's disease (once known as leprosy) and to treat a certain type of cancer called multiple myeloma (cancer of mature plasma cells in the bone marrow). But back in the day however, Thalidomide had not gone through nearly as extensive research and rigorous oversight as it has in the couple of generations.
But frequently, when a disease hits close to home - one which profoundly changes one’s way of life, such as with paralysis, memory loss, or one which could lead to early death - such as COVID19 - people demand that the medical ethics community throw oversight rules out the window and provide assistance . . . even if the drug or device is not approved . . . or worse, breaks the first principle of medical ethics, by “doing harm.”
The best - and most recent - example of this came not from the CDC, FDA or any researcher of note, but rather from the FPOTUS, who flatly announced to the world that he recommended taking the anti-malarial drug Hydroxychloroquine as a cure for COVID-19. And despite a rapid and all-but unanimous thumbs-down from the medical and scientific community, Trump’s friends in the alt-press community actually touted “research” which “proved” that the medicine could increase survival rates by 200%. (This was actually posited in an edition of the USA Sun which, by the way, is a Rupert Murdoch-owned tabloid. Surprise surprise!)
As a result of increasing pressure from patients (and families) of those suffering from serious, debilitating and/or lethal diseases, the FDA has begun approving the use of medical treatments with drugs which, even though likely to be safe, have not yet proven to be efficacious. Two examples:
The agency recently approved a treatment for A.L.S., (“Lou Gehrig’s Disease”), a fatal neurological disorder, despite questions about whether the drug, called Relyvrio, will extend patients’ lives or slow the progression of their disease. Because the drug appears safe, the agency reasoned that “given the serious and life-threatening nature of A.L.S. and the substantial unmet need, this level of uncertainty is acceptable in this instance.” The F.D.A. could withdraw the drug’s approval at a later date if ongoing confirmatory trials showed poor results.
In 2021, the F.D.A. issued a controversial approval of the Alzheimer’s drug Aduhelm, through one of its programs to speed access to new treatments, called “accelerated approval.” An advisory committee for the agency determined that there wasn’t strong evidence that the drug worked, but the F.D.A. gave the green light anyway, to the delight of some patients and advocacy groups.
There is also an approval rating that the FDA can grant a drug or device, which can make it approvable for “Humanitarian Use Only.” We see these from time to time; they are generally reviewed on a case-by-case basis, and are closely scrutinized before being granted. This does not mean that the Hippocratic Oath has been cast onto the trash heap; rather it points to medicine’s ability to balance science with compassion. This gives me no pause.
What does concern, however, me is that increasingly, pressure from pharmaceutical companies, families and even regulators (such as the FDA) is becoming the bedrock of a new trend: prioritizing access to unproven medical products over gathering evidence that they safely work. As the noted bioethicist Dr. Allison Bateman House, Assistant Professor, Division of Medical Ethics, NYU Grossman School of Medicine, notes recently in a New York Times op-ed piece, If this trend continues, it could result in people increasingly using and paying for ineffective and possibly unsafe medical products. In the worst case, it could mark a return to an era when drug-related harms occurred under insufficient regulation.
In a time when increasingly, the findings and lessons of specialists and experts in many fields - and not just medicine - are being cast aside in favor of the fact-free supporters of hidden agendas, there is reason for concern.
Medical ethics are not an oxymoron; they are the wall which separates fact from fiction, and Hippocrates from Dr. Mengele . . .
Copyright©2022 Kurt F. Stone