Messaging by the pharmaceutical industry deserves scrutiny. We tend to take everything they claim for granted. Yet they fuse empirical facts with hypotheses, and we assume it is all good science. It is not. The medicines we take may work, but maybe not for the reasons they postulate. The biological action of those medicines may be tangential to the biology of the disorder treated. It varies by medication.
It is well-known that researchers no longer think about cancer as being a single disease. They have been pursuing the biology of many cancers and in the process developing targeted solutions. The success of precision medicine is growing. We know that scattershot treatments like radiation and chemotherapy kill good and bad cells. A more precise treatment only impacts the biological origin of the disorder.
We hear similar statements from researchers in the behavioral healthcare field. For example, experts note that we may refer to depression, but there are many different depressions rather than a singular one. There is a practical side to this. Some work focuses on matching specific interventions with specific symptoms. Yet there is also an assumption that, like cancer, many biologically based types exist.
Will research into the biological origins of depression find many sources, just like cancer? This is possible, but it should be noted that research has already identified the biological origins of several cancers. None have been identified for any mental illness. This may change, and with it we may have vastly improved biological treatments. Yet this is merely hypothetical for now.
Biological assumptions are pervasive in psychopharmacology. Note this learning objective from a CME seminar currently being offered on “next-generation neurosteroids.” The course intends to:
Discuss the diverse pathophysiologic mechanisms that may contribute to MDD and PPD and resultant implications for therapeutic targeting
The goal of the seminar is to share promising early results for synthetic neurosteroid agents in the treatment of some types of depression. The treatment is theoretically connected with a biological hypothesis about depression. This course discusses biological mechanisms “that may contribute” to depression. This sort of speculation has been common since the advent of antidepressants in the 1950s.
The historical marketing of antidepressants addressed a “chemical imbalance” that was never validated as hoped. We now have new products in the pipeline that may be helpful based on new pathways. Of course, the biological mechanism for these unproven drugs is still hypothetical. Research may validate some new medications, but in the process, we may learn nothing more about what causes depression.
We accept bold pronouncements about how unproven products may work. The model for how it may work is promoted on an equal footing with the new product itself. Two things are then possible. The value of a new drug may be due to the identified mechanism of action, or its effects might be unrelated. What should we do with an irrelevant mechanism of action once a drug has been found to work?
The chemical imbalance hypothesis persisted within marketing campaigns long after its irrelevance was known. It might be time for demanding a lower profile for untested hypotheses. Manufacturers should promote what the FDA specifically approves, safety and efficacy, and leave other theories in the background until proven or found to be relevant. We can then let the irrelevant ones disappear.
Creating an educated public
What does the public understand? Many people mistakenly think biological models of causation are advanced when drugs are found to be helpful. Antipsychotic medications are useful in treating psychotic patients, but they provide no such understanding of psychosis. So too for depression. Biological causes remain unknown, and yet people are made to feel at ease with hypothetical models.
These comments are not directed at the medical researcher intent on finding the biological causes for depression and other mental illnesses. They rightly base their work on a successful medical model, and they must be patient. My concern is that they have most of us accepting their hypotheses as facts. Biological causation is presumptive, and people should clearly understand that.
Why? There is great value in having a population that is highly literate in science. The current COVID-19 pandemic is an example of this. We value independence more than conformity in our culture, and this is fine if it is combined with knowledge. We need scientific literacy in a pandemic so that people decide what to do based on their needs and a solid grasp of existing facts.
Consumers should understand that the FDA ensures new medications are safe and effective. It does not validate theories about how pharmaceuticals deliver clinical value. The FDA is surely approving a biological process of some sort since the pills they approve are not inactive. People naturally want to know how treatments work, but they should be educated about what is known and what is speculation.
Public education beyond medication
Consumers have no well-funded source of information about the psychosocial model that has produced remarkably effective treatments. This reality was brought home to me in a new way recently in my work with primary care physicians. In my collaboration on a project to redesign the primary care setting with active participation from psychotherapists, it became clear that therapy is still highly stigmatized.
There are many sources for this, but one of them is that people do not understand psychotherapy. It not only seems very private and potentially painful, but it is foreign and somewhat mysterious. Let me close with a simple point. During the time that psychoactive drugs have been on the market, psychotherapy has been validated in countless clinical trials.
Leaders in behavioral healthcare should own those results. The conclusion here is not to overly focus on the routine fusing of evidence with hypothesis in pharmaceutical advertising. Let us instead actively promote psychosocial evidence. We should reduce stigma and educate the public about this other body of evidence. Let us promote all our impressive data and set aside the conjecture.
The candor promised earlier must guide us to a conclusion. The biological basis of mental illness is still hypothetical, and yet it is commonly accepted as factual. Evidence about the value of psychotherapy is overwhelming, and yet many still regard therapy as unscientific and stigmatizing. Leaders in our field should routinely encourage the public to let the evidence shape attitudes, not the other way around.
Ed Jones, PhD, is senior vice president for the Institute for Health and Productivity Management.