Physician’s Six S’s For How to Evaluate Treatment
Author: Craig DeLisi, MD, Family Care Center Mt. Pleasant
Last month marked the beginning of my third decade as a practicing physician. In the previous five months, I have been asked my opinion regarding medications or therapies (to treat COVID) more times than I’ve ever been asked in my career, maybe combined. Friends, family, and patients – everybody is hearing about “new” options stirring hope we can find a “magic bullet” to kill this bug and return life and society back to normal.
These daily inquiries usually want an answer to a simple questions – “Do you think (insert medicine) is a good treatment/prevention option for COVID, and would/do you use it?” I’ve heard this exact question for azithromycin, remdesivir, ribivarin, vitamin D, melatonin, albuterol, budesonide, zinc, hydroxychloroquine…to name a few.
Responding to these questions so often has made me consider the way I (and physicians in general) make decisions regarding new treatments. Whether information from an article, a pharmaceutical rep, or on social media, how do we process new ideas in a way that informs what we believe and therefore changes our practice? As I made a mental list, I came up with six things that I think we doctors consider, either consciously or subconsciously, each time we are confronted with potential new therapies. To keep it simple, I used alliteration. I call it the “Physician’s Six S’s of How to Evaluate Treatment”.
- What is the SOURCE of information?
It is important to know who is making a claim. Is it a consensus statement from a respected medical organization or academy? That carries much more weight than an individual physician or scientist. If it is published information, is it in a well-respected, peer reviewed medical journal such as JAMA, New England Journal of Medicine, or the Lancet? If it comes from a news source, a major news network would carry more weight than an internet news source. It is also important to consider whether or not the source of information has a strong potential bias. This is seen most often when an individual or company is promoting effectiveness of a product they also sell.
- Does it make Scientific Sense?
When it comes to effective therapies in medicine, biologic science matters. Just because something works in a test tube does not guarantee it will work in a human. In fact, it often does not. On the other hand, if something is scientifically irrational, it almost always assures that it will not be valid.
- Is it Safe? How are the Side effects?
Some treatment options are more benign that others. The fewer risks and side effects of a medication, generally the lower the threshold is for using it. That’s not to say we don’t ever use potentially harmful medications when there are no other options. Many chemotherapy drugs, for example, are quite toxic. But their risk is offset by the potential lifesaving benefit to the cancer patient. For many of the possible COVID treatments, all though the potential benefit is unknown, the risk is very low. Often, that is a reasonable gamble to take.
- Is the claim Substantiated? Does it stand up to Scrutiny?
This is probably the most important question a doctor ponders when considering a new therapy to treat any medical condition. The “gold standard” for proof is a randomized (patients are randomly assigned to a treatment group vs placebo group), double blinded (neither the patient nor the doctor know who is receiving placebo vs medication), placebo controlled trial. These types of trials usually take months and require collaboration between physicians in different medical centers in order to assure enough patients are enrolled. During this pandemic, there have been some of these types of trials, but not many. For the most part, we have not been afforded the option to wait 6 months or more to analyze data to see conclusions. In addition to experimental studies, there are observational studies that carry varying amounts of weight. Some of them analyze patients in the past (cross sectional, case-control) and some follow patients in the future (cohort). Typically, the LEAST helpful type of information is given by a case report (single patient) or case series (group of patients). These are anecdotal reports of treatment (“I tried this medication in (1 patient, 10 patients), and it worked!”). Unfortunately, with respect to COVID, we have a LOT of anecdotal case studies. Remember, this doesn’t mean it isn’t true. It just means it isn’t reliable or substantive.
- How is the Supply?
By “supply”, I mean cost and availability of the medication. A given treatment might be wonderful – effective, risk-free, thoroughly evaluated. But if we cannot get it to the patient who needs it, it does not matter. The medication that thus far has shown the most promising results is remdesivir – an intravenous medication for hospitalized patients that is very expensive and in short supply. Ideally, we prefer medications that are inexpensive and widely available. That is the reason there is appeal in considering some of the above treatment options – melatonin, hydroxychloroquine, azithromycin.
- Does it Satisfy ethical concerns?
The practice of medicine is a moral one. We deal with issues of life and death and are sometimes presented with ethical dilemmas. Even though it is rare, occasionally there are “moral absolutes” for a given physician that are violated by a specific therapy. As a Christian, there are treatments and procedures in which I will not participate. For example, it is important to me to guard the dignity of all human life including the elderly, preborn, and disabled. If a treatment is derived from embryonic (preborn child) stem cells, I could not in good conscience use or endorse it. I realize not everybody shares my personal convictions, but nearly everyone evaluates the propriety of treatment through the lens of some sort of moral code.
As a physician, it has been daunting over the last several months to try to process/evaluate information regarding the details of the SARS-CoV-2 virus and its treatment. The deluge of information has been complicated by a politicization and polarization of that which should not be. I can only imagine that for my friends, family, and patients, figuring out what is real and who or what to believe can be even more overwhelming. It is my opinion that it is the responsibility of your physician or health care provider to do the heavy lifting in this arena. I, personally, do not feel burdened by my patients or family or friends asking my opinion. In fact, I consider it a privilege to help, and I am SO THANKFUL they have humility to seek my opinion rather than be firmly entrenched in a belief that may not be true.
Hopefully, this gives you some insight into how physicians process new information regarding COVID treatment and any other medical problem. Whether one is a medical professional or not, there is a degree to which everyone considers “The Six S’s”.