Pharmacotherapy without Philosophy is Dangerous - Ep 90

Welcome to the JACCP podcast. My name is Jerry Bauman, and I'm the editor of the Journal of the American College of Clinical Pharmacy. Today, we're talking with Dr. Charles, or Doug, as he goes by, Hepler. Dr. Hepler is Distinguished Professor Emeritus in the Department of Pharmaceutical Outcomes and Policy at the University of Florida College of Pharmacy. Dr. Hepler published a thought-provoking paper entitled Pharmacotherapy and Philosophy in the November issue of JCCP.

I'm certain most of the listeners will know of his seminal work on pharmaceutical care, and we're quite fortunate to be able to speak to him today. Dr. Hapler, welcome to the podcast. Thank you very much, Jerry. I think many, including me, have traditionally thought of the term philosophy as one's personal credo or perhaps in the context of

the great historic philosophers in College Philosophy 101. But you see it in a different, and as I found out, a more accurate way, specifically for pharmacotherapy and drug therapy. Could you explain the use of this term for the listeners and why you decided to write about this topic? Yeah, I'd be delighted to. Thank you for that introduction. And that's a great opening question, Jerry.

Your understanding of philosophy as a personal credo is a great place to start for most of us, most people who are not familiar with philosophy the way I see it anyway.

a personal credo influences how you live your life i'm proposing a professional credo a set of values beliefs and ways of thinking that influence how we practice our profession regarding the ancient philosophers that we studied in school science has greatly influenced modern philosophy it has replaced much of the metaphysical speculation that we might have studied, shall I say, sat through in school with a much more realistic starting place.

But what remains in philosophy is a disciplined way of thinking that has developed over millennia and is still valid today. I wrote...

this editorial to remind us in a manner of speaking that rational therapeutics is not drug of choice therapeutics we know that we need a clear therapeutic objective for each patient We know that we then need a therapeutic plan that takes into account a patient's psychological, social and economic circumstances. But how do we think about that?

We need to use ways of thinking that are more familiar in philosophy than they are in science. They may be common sense to some, but not to others. Furthermore, We should consider these issues systematically. That's why I chose to use the framework of philosophy. I wanted to suggest that we need to consider the circumstances of therapy in a systematic and disciplined way. If I could offer a simple example, we're careful to avoid drug-drug interactions. Every pharmacist knows that.

But what about drug lifestyle interactions? For example, can the patient afford the regimen? Can he or a caregiver understand how to administer it correctly? and what signs and symptoms to look for of treatment success or failure. Once a clinician adopts that attitude, they may need to decide on the minimum information they need.

to treat a patient, and then how and when they're going to acquire that information. Science does not tell us everything we may need to know in order to make the best decision for the patient. Relying only on science may produce distorted views of reality and lead to suboptimal decisions. So I would say you need both science. but also wisdom and judgment, defined as philosophy. Yes.

Wisdom and judgment have fascinated me for years because they're difficult to define and recognize. One of the sad things about getting older is we adopt wisdom that young people don't appreciate. What I'm really saying is philosophy is a way of formalizing this idea of wisdom and judgment. So you also make the clear point that science and technology of drug therapy has preceded.

at a very rapid rate. But the philosophy of pharmacotherapy has not kept pace. Could you explain this point and why you think this is so? Sure. First of all, science is dominant everywhere. not just in health professions and that's because it has achieved so much that is beneficial but its value to society can be greatly increased

if we can apply scientific achievements with the intelligence that philosophy can provide. And if you don't care for the word intelligence, perspective will do us very well there, I think. Clinical pharmacology makes observations on groups of people. In contrast, clinicians treat individuals one at a time who may not eat like the subjects in those clinical studies at all.

A clinician's job is to apply scientific knowledge to the specific needs of the individual. Wabsipoli once said that drugs do not have doses, people have doses. That's an elegant way to remind us of this way of thinking. The problem comes when we ignore individual differences, not just in physiology, but in socioeconomic. This is always very tempting because we were trained in science and because scientific knowledge is so much more reliable than anecdotal information about a person.

It is easy to become biased in favor of the science and to ignore the messy details of individual circumstances. Philosophy has different standards of evidence than science.

Maybe we are not comfortable with the reports and anecdotes about a person's circumstances. But if we truly want to achieve the therapeutic objective, the messy details... may be more important than drug of choice if we truly want to achieve the therapeutic objective and the treatment fails it does not help to say the patient failed therapy because of non-adherence or whatever. The truth is that therapy failed the patient. It may often not be possible for a clinician to obtain Alzheimer's.

information about a patient? The consequence of that should never be to ignore the importance of the missing information. Rather, the monitoring plan should include, for example, asking the patient to explain how he takes the medicine. Perhaps he is not taking it because he does not understand how to take it or cannot afford it and so forth. In your commentary,

There are three major fallacies that you point out. I think you call them causal, ecological, and reductionism. And these could be pitfalls for all clinical pharmacists. Could you review a couple of these and perhaps provide some examples? Yeah, I'd be very pleased to do that. This idea of fallacy, we use the word fallacy all the time to mean falsehood.

But the way that philosophers use fallacy is a way of thinking that isn't logical. And I'll be glad to give some examples. Some of these examples, I think, are very poignant and show us. I think the importance of thinking about it this way. For example, the assumption that drug choice can be made by a pharmacy benefit management company instead of by a health professional.

is what philosophers would call the ecological fallacy. The ecological fallacy is one size fits all. The assumption that all members of a group are the same. It's the basis of a lot of isms.

that we would rather avoid sexism racism and so forth is basically at the root this idea that one member is the same as any other this ignores the whole reason that professions exist professionals adapt scientific knowledge to the needs of an individual patient to assume that one drug can be chosen among alternatives to represent a therapeutic class is a good example of the

ecological fallacy as i've said earlier a patient may be physiologically unlike the subjects in a clinical study and his social and economic circumstances surely vary greatly from those of the trial They also vary greatly among individual patients. The clinical pharmacist's great value is in finding a drug and a therapeutic regimen that fits the individual patient.

Turning to the reductive fallacy you mentioned, the reductive fallacy is when we treat one or a few elements of a complicated system as if they represent the entire system. A favorite example of mine is when pharmacists tend to think of prescribing and dispensing as if they were the end of drug therapy. They are not the end of drug therapy. They are the beginning.

The patient outcome is the end of drug therapy, and it depends on multitudes of factors that very often require therapy to be adjusted or otherwise managed towards the objective.

This does not routinely occur for many drugs and many patients. To continue on that line of thinking, you also use the interesting example of the approval of OxyContin. to demonstrate the incongruence between evaluating the science of opiate pharmacology and evaluating its impact on society. For the listeners, could you review how this could have been avoided?

Great question. The adoption of OxyContin is, of course, wrapped up in population therapeutics and politics and so forth. And so it's a somewhat of a departure from the example so far of individual clinical practice but it's such a great example and it's of course on everybody's mind now that i really wanted to to get into that So, the problem with OxyContin is not with the science of pharmacology. As far as I know, OxyContin is a safe and effective opioid analgesic when used properly.

but it continues to have significant negative effects on American society. The Food and Drug Administration, in effect, considered only OxyContin's pharmacology before approving it for Wanketing. Now that was all the law allowed the FDA to do, so the fallacy is in the law rather than the agency. This decision was another example of the reductive fallacy.

The socioeconomic significance of OxyContin went way beyond its safety and efficacy as an analgesic. Furthermore, this disaster was, to a large extent, predictable. Like other opioids, OxyContin has psychological effects, which turned out to be much more important to society than its analgesic effects. We have been down this road before with a wonder drug.

called morphine and again with another wonder drug called heroin the makers of oxycontin claimed that it was less addictive than other opioids and safe for use in chronic pain Any pharmacologist would be very skeptical about that, based on theory and past experience with morphine and heroin. But the sponsors shifted the burden of proof to the Food and Drug Administration.

By the way, shifting the burden of proof is another ancient fallacy. Even though we should have seen that OxyContin would be addictive when used for chronic pain, the sponsor put the burden of proof on the skeptics.

the term for how people gain knowledge is epistemology the rules for scientific epistemology are much more strict than those in philosophy of course scientific observations are more valid than informal knowledge such as experience with morphine and heroin so the epistemology of science won out over the epistemology of philosophy in this case

they won out over obvious common sense. In effect, what I'm saying is that we as a society carried out a study to prove that OxyContin is addicting and detrimental to society as a whole.

to our great regret we should have known how that study would come out in fact we did know how it would come out and I'm arguing that philosophical thinking could have prevented this from happening and finally before i leave the subject of oxycontin the ethical issues another form of philosophy another branch of philosophy

of the ethical issues of releasing OxyContin without real safeguards against malprescribing seem to have been given short shrift. Couldn't we have predicted that the manufacturer and some distributors prescribers and pharmacies would exploit addiction for money? At least appropriate safeguards were not put in place. Those are great points. Do you imagine that

when a new drug is being proposed to the FDA, that there should be an assessment of its societal impact or its philosophy and its basic and clinical pharmacology. Yes, I do. It depends on the drug. I think there are some drugs that, for example, drugs that have similar drugs already on the market, and we can pretty much tell one proton pump inhibitor is going to.

have the same effect as others but yes i think that innovative drugs do need a formal review with the perspective that i've been arguing for here i think this is going to be a dramatic change i know there are editors who actually ask authors to remove commentaries about such subjects because they say they're not quote scientific

And what I'm really arguing is that professional journals should probably solicit commentaries about drugs that they suspect may have a profound social impact. So the short answer to your question is yes. So going forward, do you have any other recommendations specifically for clinical pharmacists? Well, I have two main points that I would want to leave the listener with. First, I think, as I've just been saying,

Some professional and scientific journals really need to include philosophical reflections on therapy instead of avoiding them. I think that they should be welcoming to such things. again maybe the the scientific author of a scientific paper is not the person to write the commentary on its social impact but i think those commentaries should become a routine or familiar

part of professional literature. And I think that would require editors to actually go out and solicit those kinds of commentaries. And you can find that in... the the professional journals of other disciplines but my second main point is that scientific thinking as valuable as it is provides only a part of what we need to have to make valid clinical decisions

It is essential, but it is nonetheless incomplete. We need to see the big picture. This may sound to some people like common sense. I'm sure... a lot of clinicians already do this on an informal basis but i chose to frame this argument in terms of philosophy instead of common sense because common sense is not necessarily all that common

and because it is informal and unstructured. I wanted to remind us that there is a formal disciplined way of thinking that can be a very useful complement to scientific thinking. again not a substitute but a supplement recognizing fallacies is an example of a structure that can broaden our understanding of our role in society

and how we can best fulfill that role. Well, thank you again, Dr. Hepler. I think this is really must reading, not only for clinical pharmacists, but other healthcare providers, educators, and regulators. So thank you again.